Category Archives: Vol 10 | Issue 1 | January-June 2024

An Innovative Scoring System Combining Clinical and Radiological Factors for Determining Spinal Fusion Necessity in Degenerative Spondylolisthesis is Valid: A Hypothesis


Vol 10 | Issue 1 | January-June 2024 | page: 03-06 | Shashank O. Jajoo, Ashok Kumar Shyam Murari, Siddharth Aiyer, Pramod Bhilare, Shailesh Hadgaonkar, Ajay Kothari, Parag Sancheti

https://doi.org/10.13107/jmt.2024.v10.i01.212


Author: Shashank O. Jajoo [1], Ashok Kumar Shyam Murari [1], Siddharth Aiyer [1], Pramod Bhilare [1], Shailesh Hadgaonkar [1], Ajay Kothari [1], Parag Sancheti [1]

[1] Department of Orthopaedics, Sancheti Institute for Orthopaedics and Rehabilitation, Pune, Maharashtra, India.

Address of Correspondence
Dr. Shashank O. Jajoo,
Department of Orthopaedics, Sancheti Institute for Orthopaedics and Rehabilitation, Pune, Maharashtra, India.
E-mail: shankrocks139.sj@gmail.com


Abstract

Background: As the global population ages and lifestyles become more sedentary, Degenerative spondylolisthesis has emerged as a major cause of lower back pain and disability. It poses significant challenges for both patients and healthcare professionals. One of the most critical decisions in the treatment is whether to pursue non-operative options like physiotherapy, medication, or lifestyle modifications, or to explore surgical intervention. This decision is often made based on careful evaluation of various clinical, radiological, and patient-specific factors, but a standardized and universally accepted comprehensive scoring system for evaluating these factors is widely absent in current clinical practice. Moreover, there’s an ongoing debate over the appropriate surgical management, with one group supporting stand-alone decompression, whereas other group supporting decompression along with fusion. A new scoring system can provide standardized criteria for surgical management of Degenerative spondylolisthesis. This thesis aims to validate a new scoring system that addresses the limitations of existing tools and embraces a more holistic and patient-specific approach, that can guide healthcare providers and patients in deciding optimal surgical management in cases of Lumbar Degenerative Spondylolisthesis.
Hypothesis: An innovative scoring system combining clinical and radiological factors for determining spinal fusion necessity in degenerative spondylolisthesis is valid.
Clinical Importance: A subgroup of patients with Degenerative Spondylolisthesis can get away with just stand-alone decompression, without the need of fusion which is more morbid surgical intervention. This have benefits of reduced surgical risk, reduced surgical time, shorter recovery time, preservation of motion, lower cost of surgery, etc. This scoring system can help to identify that subgroup of patients.
Future Research: We will also keep a close follow up with patient and check whether they get benefitted by undergoing surgery based on the proposed new scoring system. Future research should focus on validating the system across diverse patient populations and clinical settings through multi-center trails.
Keywords: Degenerative spondylolisthesis, stand-alone decompression, Fusion, scoring system


Background
As the global population ages and lifestyles become more sedentary, Degenerative spondylolisthesis has emerged as a major cause of lower back pain and disability. It poses significant challenges for both patients and healthcare professionals. One of the most critical decisions in the treatment is whether to pursue non-operative options like physiotherapy, medication, or lifestyle modifications, or to explore surgical intervention. This decision is often made based on careful evaluation of various clinical, radiological, and patient-specific factors, but a standardized and comprehensive scoring system for evaluating these factors is widely absent in current clinical practice. Moreover, there’s an ongoing debate over the appropriate surgical management, with one group supporting stand-alone decompression, whereas other group supporting decompression along with fusion.
Over the years, numerous classification systems and guidelines have been developed to assist healthcare professionals in making informed decisions regarding fusion surgery for degenerative lumbar spondylolisthesis. Meyerding classification [1] , Wiltse classification [2], and the Clinical And Radiographic Degenerative Spondylolisthesis Classification (CARDS) [3], have offered valuable insights into the assessment of spinal instability and spondylolisthesis severity. However, despite their utility, these systems often lack the comprehensiveness and precision required to accommodate the evolving understanding of this condition and the nuances of individual patient cases. The main reason behind this debate is that Lumbar Degenerative Spondylolisthesis is assumed to be a homogenous entity and such oversimplification of the disease can lead to undertreatment or overtreatment. The relevance of the popularly followed Meyerding classification is limited because slips associated with Degenerative Spondylolistheisis rarely progress beyond grade I [1] or 30 percent unless there has been surgical interference [2]. Moreover, patients with high grade listhesis might not have much clinical complaints [2]. SPORT (Spine Patient Outcome Research Trial) in 2007 was a multi-centre trial which concluded that patients with degenerative spondylolisthesis treated surgically showed substantially greater improvement in pain than patients treated non-surgically [3, 4]. But there’s no mention about which type surgical management is better. Many other studies have been done in past to compare stand-alone decompression and fusion for Degenerative Spondylolisthesis, but none of them considered any scoring system to make the decision to manage patients [5–8]. A new scoring system can provide standardized criteria for surgical management of Degenerative spondylolisthesis [9]. This thesis aims to validate a new scoring system that addresses the limitations of existing tools and embraces a more holistic and patient-specific approach, that can guide healthcare providers and patients in deciding optimal surgical management in cases of Lumbar Degenerative Spondylolisthesis.

Hypothesis
This newly developed clinic-radiological scoring system will provide a reliable, evidence based method to decide whether fusion is necessary in cases of degenerative spondylolisthesis, leading to improved patient outcome and consistent surgical decision making. It integrates clinical symptoms, physical examination findings and radiological parameters to generate a holistic score.
Components of Scoring System (Total 11 points) are as follows : 1) Mechanical back pain, 2) Age < 70 years, 3) High-demand activity, 4) Segmental kyphosis, 5) Segmental dynamic spondylolisthesis, 6) Disk height, 7) Bilateral facet effusion, 8) Sagittal facets, 9) Technical factor [9].
The idea is to study reliability of the variables used in the new clinic-radiological scoring system, and to compare the inter-observer and intra-observer reliability of the new clinic-radiological scoring system [10].

Positive Evidence
1. Objective Decision-Making: - A scoring system provides the standardized objective parameters, reducing the variability in surgical decision-making among different surgeons.
2. Tailored Treatment: - Patients receive treatment based on a comprehensive individual assessment, potentially leading to better clinical outcomes and patient satisfaction.
3. Preliminary Data:- Preliminary studies and pilot cases have shown that patients selected for standalone decompression based on lower scores had good outcomes (only 7.6 percent patients undergoing standalone decompression underwent a secondary fusion surgery) [9].

Negative Evidence
1. Complexity:- The scoring system may be perceived as complex and time-consuming, potentially leading to resistance in adoption.
2. Subjectivity in Scoring:- Some elements of the score, such as the assessment of high demand activity and technical factor, may still be subjective despite the scoring guidelines.
3. Need for Validation:- The system requires extensive validation through large-scale, multicenter studies to confirm its reliability and effectiveness.

Index Example case
A 75-year-old female presents with chronic low back pain and intermittent radicular symptoms in the right leg. Patient had moderate demand activity. Radiological evaluation shows a Grade I spondylolisthesis at L4-L5, but no dynamic translation or segmental kyphosis on dynamic lateral imaging with significant disc height reduction. MRI showed bilateral facet effusion, but no sagittal orientation of facets. Total score came out to be 3, and based on the scoring system, the patient underwent standalone decompression without fusion. Now the patient is doing well at one year follow up.

Discussion
The creation of a new clinico-radiological scoring system represents a significant step forward in the management of Degenerative Spondylolisthesis. This discussion will explore the potential impacts, benefits, and obstacles associated with this system, based on the hypothesis that it can effectively guide the decision to favor standalone decompression when suitable.
Current literature highlights the variability in surgical decision-making for Degenerative Spondylolisthesis, often based on subjective assessments and surgeon experience [6]. The proposed scoring system introduces a standardized method, reducing this variability. By integrating clinical symptoms, physical examination findings, and radiological parameters into a composite score, it ensures a thorough and consistent evaluation of each patient’s condition.
Literature suggests that standalone decompression can be highly effective for selected patients, offering benefits such as lower surgical risks, faster recovery, and preservation of spinal motion [5]. However, the criteria for selecting these patients are not well-defined. The scoring system could fill this gap, providing clear guidelines to identify candidates for standalone decompression, thus promoting its use when appropriate. By providing an evidence-based method for decision-making, the scoring system may enhance patient outcomes, resulting in better pain relief, functional recovery, and overall satisfaction.
Despite its potential benefits, the complexity of the scoring system may pose a barrier to its adoption. Surgeons need adequate training to use the system effectively, and the additional time required for scoring could be seen as burdensome, particularly in high-volume clinical settings. Streamlining the scoring process and integrating it into routine practice will be crucial for its success. The proposed system requires extensive validation through large-scale, multicenter studies to confirm its reliability and effectiveness. Although preliminary data and pilot cases are promising (only 7.6 percent patients undergoing standalone decompression underwent a secondary fusion surgery), robust evidence is necessary to gain widespread acceptance in the orthopedic community [9]. This will involve rigorous testing across diverse patient populations and clinical settings.

Clinical Importance
The validation of a new clinico-radiological scoring system to determine the need for fusion holds significant clinical importance and have potential of transforming the management of degenerative spondylolisthesis. The scoring system standardizes the decision-making process, reducing the variability that currently exists among surgeons. This standardization ensures that patients receive consistent and appropriate care, regardless of the treating surgeon.
A subgroup of patients with Degenerative Spondylolisthesis can get away with just stand-alone decompression, without the need of fusion which is more morbid surgical intervention. This have benefits of reduced surgical risk, reduced surgical time, shorter recovery time, preservation of motion, lower cost of surgery, etc. By accurately identifying patients who can benefit from decompression alone, the system helps avoid unnecessary fusion surgeries, thereby minimizing the associated morbidity and healthcare expenses.

Future Direction
In this thesis, patients will be given scoring by 2 spine consultants, 4 spine fellows and 2 residents in the department of Orthopaedics. The inter-observer and intra-observer reliability of the proposed scoring system will be done. We will also keep a close follow up with patient and check whether they get benefitted by undergoing surgery based on the proposed new scoring system.
Future research should focus on validating the system across diverse patient populations and clinical settings. Additionally, integration with digital health technologies, such as electronic health records (EHRs) and artificial intelligence (AI), could streamline the scoring process and enhance its accuracy [11]. AI algorithms could assist in analyzing radiological parameters, providing a more objective assessment and reducing the potential for human error.


References

1. Martin FH, Foundation FHMM, Surgeons AC of. Surgery, Gynecology & Obstetrics [Internet]. Franklin H. Martin Memorial Foundation; 1932. 371–377 p. Available from: https://books.google.co.in/books?id=oRInMK5Hq0QC
2. Wiltse LL, Newman PH, Macnab I. Classification of spondylolisis and spondylolisthesis. Clin Orthop. 1976 Jun;(117):23–9.
3. Kepler CK, Hilibrand AS, Sayadipour A, Koerner JD, Rihn JA, Radcliff KE, et al. Clinical and radiographic degenerative spondylolisthesis (CARDS) classification. Spine J. 2015 Aug;15(8):1804–11.
4. Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson ANA, Blood EA, et al. Surgical versus Nonsurgical Treatment for Lumbar Degenerative Spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257–70.
5. Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, et al. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Apr 14;374(15):1424–34.
6. Försth P, Ólafsson G, Carlsson T, Frost A, Borgström F, Fritzell P, et al. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413–23.
7. Austevoll IM, Hermansen E, Fagerland MW, Storheim K, Brox JI, Solberg T, et al. Decompression with or without Fusion in Degenerative Lumbar Spondylolisthesis. N Engl J Med. 2021 Aug 5;385(6):526–38.
8. Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802–8.
9. Kulkarni AG, Kunder TS, Dutta S. Degenerative Spondylolisthesis: When to Fuse and When Not to? A New Scoring System. Clin Spine Surg Spine Publ. 2020 Oct;33(8):E391–400.
10. McHugh ML. Interrater reliability: the kappa statistic. Biochem Medica. 2012;22(3):276–82.
11. Li Z. Digital Orthopedics: The Future Developments of Orthopedic Surgery. J Pers Med. 2023 Feb 6;13(2):292.


How to Cite this Article: Jajoo SO, Murari AS, Aiyer S, Bhilare P, Hadgaonkar S, Kothari A, Sancheti P. An Innovative Scoring System Combining Clinical and Radiological Factors for Determining Spinal Fusion Necessity in Degenerative Spondylolisthesis is Valid: A Hypothesis. Journal Medical Thesis 2024 January-June ; 10(1):03-06.

 

 


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Enhancing the Visibility and Impact of Medical Research Through the Journal of Medical Thesis


Vol 10 | Issue 1 | January-June 2024 | page: 01-02 | Sachin Kale, Ashok Shyam

https://doi.org/10.13107/jmt.2024.v10.i01.210


Author: Sachin Kale [1], Ashok Shyam [2]

[1] Department of Orthopaedics, D Y Patil Hospital, Navi Mumbai, Maharashtra, India.
[2] Department of Orthopaedics, Sancheti Institute for Orthopaedics and Rehabilitation, Pune, Maharashtra, India.

Address of Correspondence
Dr. Sachin Kale,
Department of Orthopaedics, D Y Patil Hospital, Navi Mumbai, Maharashtra, India.
E-mail: sachinkale@gmail.com


Editorial

As the Editors of the Journal of Medical Thesis we are privileged to present this edition, which not only highlights ground-breaking research but also addresses a critical gap in the academic landscape. Each year, more than six to seven thousand medical theses are produced, yet less than 10% of these valuable works find their way to publication. The Journal of Medical Thesis was created to bridge this gap, offering a platform for these theses to reach a wider audience and ensuring that the efforts of students and their mentors are recognized and rewarded.

The journal’s mission is to prevent the important research undertaken by medical students from languishing in obscurity. Instead of gathering dust in library archives, these theses can now contribute to the collective knowledge of the medical community. By publishing with us, authors ensure that their work is accessible, citable, and impactful, providing numerous advantages to both students and teachers alike.

Advantages of Publishing in the Journal of Medical Thesis:

▪️ Preservation of Work: Your thesis will not be forgotten in a library box but will instead be immortalized through publication, ensuring its availability to a global audience.

▪️Citations and Recognition: Publishing your thesis in our journal enables you to receive academic citations, thereby contributing to your academic reputation. Both the student and the mentor will gain recognition for their collaborative efforts.

▪️Wider Dissemination: The journal ensures that your research is widely dispersed, allowing your findings to reach a broader audience, thereby extending the impact of your work.

▪️ Ethical Justification: Sharing your research through publication also honour’s the cooperation of your patients, fulfilling an important ethical contract by ensuring that the knowledge gained is used for the greater good.

▪️Reduction of Plagiarism: With your thesis published online, the risk of plagiarism is significantly reduced. This transparency fosters the generation of higher-quality research in the future.

▪️Enhanced Validity: The peer review process at our journal further strengthens the validity and credibility of your thesis, adding value to your research.

▪️ Immortalizing First Research Efforts: The publication of theses allows for the immortalization of the first research endeavours of medical students and their faculty across the globe, serving as a lasting testament to their hard work and dedication.

The Journal of Medical Thesis is more than just a repository of academic work; it is a beacon that shines a light on the important research conducted by medical students. By providing a platform for these theses to be published, we are ensuring that the time, effort, and intellectual investment of both students and teachers do not go unrecognized. This journal also serves as a catalyst for the advancement of medical science, promoting the dissemination of knowledge and fostering a culture of academic integrity.

In closing, I encourage all students and their mentors to consider the value of publishing their theses. By doing so, you not only enhance your own academic credentials but also contribute to the global medical community. Together, we can ensure that no valuable research is lost and that the knowledge gained is shared for the betterment of all.

Sincerely,

Dr Sachin Kale Dr Ashok Shyam

Editor, Journal of Medical Thesis (JMT)


How to Cite this Article: Kale S, Shyam A. Enhancing the Visibility and Impact of Medical Research Through the Journal of Medical Thesis. Journal Medical Thesis 2024 January-June ; 10(1):01-02.


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Total Knee Arthroplasty with Constrained Implants in Patients with Neuropathic Arthropathy of the Knee Provides Good Functional Outcomes, and is Not Associated with a High Rate of Complications


Vol 10 | Issue 1 | January-June 2024 | page: 46-49 | Arpit Mutha, Parag Sancheti, Sunny Gugale, Kailash Patil, Darshan Sonawane, Ashok Shyam

https://doi.org/10.13107/jmt.2024.v10.i01.220


Author: Arpit Mutha [1], Parag Sancheti [1], Sunny Gugale [1], Kailash Patil [1], Darshan Sonawane [1], Ashok Shyam [1]

 

[1] Department of Orthopaedics, Sancheti Hospital, Shivajinagar, Pune, Maharashtra, India.

Address of Correspondence
Dr. Arpit Mutha,
Department of Orthopaedics, Sancheti Hospital, Shivajinagar, Pune, Maharashtra, India.
E-mail: arpitmutha97@gmail.com


Abstract

Neuropathic (Charcot) arthropathy is a progressive degenerative condition that leads to the destruction and collapse of weight bearing joints, often accompanied by large effusions that compromise supporting soft tissue structures. Historically, neurosyphilis was the primary cause, but today, poorly controlled diabetes mellitus is the most common underlying factor. Total Knee Arthroplasty (TKA) was considered a contraindication in neuropathic arthropathy due to the risk of complications such as periprosthetic joint infection, tibiofemoral dislocation, and periprosthetic fracture. However, recent studies suggest that using constrained implants, along with advanced surgical techniques, provide improved functional outcomes in this challenging patient population.
This study aims to evaluate the functional outcomes and complication rates of TKA with constrained prostheses in patients with neuropathic arthropathy, addressing the gap in existing literature that is primarily based on older techniques, small sample sizes and a short follow up period. Data of 25 patients from 2018-2023 who have undergone TKA with constrained implants and with inclusion and exclusion criteria will be collected. Primary outcomes, i.e., range of motion (ROM) and pain scores, will be assessed using paired t-tests, while the Kaplan-Meier method will estimate implant survival. Secondary outcomes, i.e., functional scores and complication rates, will be analyzed with descriptive and inferential statistics.
Results of existing studies indicate that while constrained prostheses offer good functional outcomes, they are associated with a high rate of complications. These results highlight the need for careful patient selection and personalized treatment strategies. Future research should focus on larger sample sizes and long-term follow-up studies to refine patient selection criteria, improve surgical planning, and explore innovative implant designs to minimize complications. This study could contribute to the advancement of clinical knowledge and may influence treatment guidelines for managing neuropathic arthropathy, potentially improving patient outcomes and surgical decision-making.
Keywords: Neuropathic arthropathy, Charcot joint, total knee arthroplasty, constrained implants, functional outcomes, complication rates.


Background and Rationale
Neuropathic (Charcot) arthropathy is a progressive degenerative process leading to the destruction and collapse of the weight-bearing surface of joints, as well as the formation of large effusions that stretch supporting soft-tissue structures [1]. Historically, the primary underlying reason for loss of nociception was neurosyphilis. Today the most common cause of Neuropathy is long-standing and poorly controlled Diabetes Mellitus (DM) [2].
The diagnosis was previously considered an absolute contraindication to Total Knee Arthroplasty. Arthrodesis was used for neuropathic arthropathy with severe deformity and instability, showing good clinical outcomes [3]. However, a few cases reported complications like fractures and infections. Fused knees were also susceptible to trauma [3].
The outcome of total knee arthroplasty (TKA) in the Charcot joint is likely to be less favourable because of the unstable neurologic status; development of ataxia; and severe joint destruction, bone defects, and deformity[4] .
Total Knee Arthroplasty in patients with Neuropathic Arthropathy has shown a high rate of complications like periprosthetic joint infection (PJI), tibiofemoral dislocation, and periprosthetic fracture [2, 5, 6] with one study showing 47% complication rates, majority of them being aseptic loosening and poor functional outcomes [5].
However, more recent reports have described satisfactory outcomes with the use of increased constraint, stems, augments, and revision-type TKA components [2, 5, 6, 7].
There is limited literature that describes the long-term functional outcomes of patients with Neuropathy treated with constrained prosthesis. They are based on older surgical techniques and implant designs. Very few of the existing studies have a large sample size. Our study will assess the functional outcomes of doing TKA with constrained prosthesis in patients with Neuropathic Arthropathy and whether these results have changed as compared to older literature.
Our study aims to address the gap that exists in determining whether TKA with constrained prosthesis has good functional outcomes in patients with Neuropathy.

Literature review
Three studies [2, 5, 6] on Total Knee Arthroplasty (TKA) in patients with neuropathic arthropathy were reviewed. Across these studies, a total of 67 TKAs were performed in 46 patients, with follow-up periods ranging from 5 to 22 years. The number of knees treated varied from 11 to 37. All the studies reported fair to good functional outcomes. The mean range of motion (ROM) improvements differed significantly, from a decrease of 4° [6] to an increase of 19° [2], with an overall average improvement of 8.5°. Functional outcomes, measured by various scoring systems, showed an average increase of 42.5 points, ranging from a low of 37 to 82 points [2] to a high of 44.9 to 95.0 points [5].
The studies reported high complication rates, varying from 27% [2] to 47% [5] with an average complication rate of approximately 30.7%. Major complications included aseptic loosening, dislocations, infections, and fractures, often necessitating additional surgeries such as revisions, arthrodesis, or amputations. The strength of these studies lies in their focus on a challenging patient population with advanced joint pathology and their use of diverse follow-up periods to assess outcomes. Moreover, they have incorporated advanced surgical techniques and modern implants, providing insights into the potential of TKA for neuropathic arthropathy.
The limitations of these studies are small sample sizes, retrospective designs, and the absence of control groups, which limit the generalizability and robustness of their findings. Additionally, the variability in surgical approaches and the use of different prostheses add complexity to interpreting the overall effectiveness of TKA in this patient population.
Building on the findings of these studies, our hypothesis aims to address the gaps in current knowledge by evaluating the functional outcomes of TKA with constrained prostheses in a contemporary setting using more standardized surgical techniques and implant designs. Unlike previous studies, which often relied on older methods or lacked sufficient sample sizes, our study seeks to provide a more comprehensive analysis of the efficacy and safety of constrained prostheses in treating neuropathic arthropathy, thus contributing to the development of evidence-based clinical guidelines.

Hypothesis Statement
In our study, we hypothesize that TKA with constrained prosthesis in Neuropathic Arthropathy of the Knee gives good functional outcomes and is not associated with a high number of complications.

Objectives
To evaluate the functional outcomes, complication rates, and clinical outcomes of total knee arthroplasty with constrained implants in patients with neuropathic arthropathy of the knee joint. Secondary objectives include evaluating the safety of TKA with constrained implants in patients with Neuropathic Arthropathy.

Type of Study: Descriptive
Population: All patients undergoing Total Knee Replacement with constrained prosthesis
Sample size: 25
Intervention: TKA with constrained prosthesis

Outcome measures
1) Knee Society Score (KSS): The scores will be measured at multiple follow-up intervals: Immediate Post operative, 1 month, 3 months, 6 months, and 12 months postoperatively
2) Western Ontario and McMaster University Osteoarthritis Index (WOMAC): The WOMAC scores will be measured at multiple follow-up intervals: Immediate Post operative, 1 month, 3 months, 6 months, and 12 months postoperatively.
3) Visual Analog Scale (VAS): Will be used to assess pain intensity, with measurements taken preoperatively and at various intervals postoperatively: Immediate Post operative ,1 month, 3 months, 6 months, and 12 months.
4) Hospital for Special Surgery (HSS) Knee Score: The scores will be measured at multiple follow-up intervals: Immediate Post operative, 1 month, 3 months, 6 months, and 12 months postoperatively
5) Range of Motion (ROM): Will be Measured in degrees preoperatively and at Immediate Post operative, 1 month, 3 months, 6 months, and 12 months
6) Joint Stability: Evaluates the stability of the knee joint before and after surgery. This will be assessed Immediate Post operative,1 month, 3 months, 6 months, and 12 months postoperatively
7) Joint Effusion, Swelling, and Tenderness: will be evaluated at Immediate Post operative,1 month, 3 months, 6 months, and 12 months postoperatively.

Timeline
2018-2023

Statistical analysis
Both descriptive and inferential statistics will used to evaluate the outcomes of Total Knee Arthroplasty (TKA) in patients with neuropathic arthropathy. The sample size of 25 patients is determined based on the inclusion criteria for cases from 2018 to 2023, including both retrospective and prospective data.
Primary outcomes, such as changes in range of motion (ROM) and pain scores (Visual Analog Scale, VAS), will be analyzed using paired t-tests to compare preoperative and postoperative values, with a p-value of <0.05 indicating statistical significance. The Kaplan-Meier method will be used to estimate implant survival free from aseptic and any revision at 5 and 10 years.
Secondary outcomes, including functional scores (Knee Society Score, Hospital for Special Surgery scores) and complication rates, will also be analyzed using paired t-tests, while chi-square tests will be employed for categorical data like complications. Descriptive statistics (mean, median, standard deviation) will summarise patient demographics and clinical outcomes and provide a comprehensive assessment of the efficacy and safety of TKA with constrained prosthesis in this patient population.

Discussion
Total Knee Arthroplasty (TKA) with constrained prostheses offers good functional outcomes but is associated with a higher complication rate in patients with neuropathic arthropathy. It is well-supported by scientific evidence and clinical observations. Patients with neuropathic arthropathy have severe joint destruction, instability, and deformity due to underlying neuropathy. Joint reconstruction in these patients is a significant challenge. Constrained prostheses address these issues by providing increased stability when the surrounding soft tissues are compromised. However, the altered biomechanics, poor bone quality, and reduced proprioception in these patients increase the risk of complications such as aseptic loosening, dislocations, and infections. Previous studies have reported both improved function with constrained prostheses but a higher rate of complications. Our hypothesis proposes the idea that these implants can offer significant benefits in terms of pain relief and function and are not associated with a high rate of complications.
The study might face several challenges and limitations, including a small sample size, lack of a long-term follow-up, and potential biases inherent in the retrospective study component. The small sample size limits the generalizability of the findings, and the variability in patient characteristics, such as differing degrees of joint deformity and underlying neuropathic conditions, could introduce variability in outcomes. To mitigate these limitations, strict inclusion criteria will be used to create a more homogeneous sample representative of the broader patient population. Additionally, statistical adjustments, such as stratification based on severity and underlying conditions, will be applied to reduce the impact of confounding variables. The use of standardized outcome measures and consistent follow-up protocols will further ensure reliable and comparable data.
The study's findings hold important clinical relevance, particularly for managing patients with neuropathic arthropathy undergoing TKA. The observed benefits of constrained prostheses in improving knee function and reducing pain support their use in cases where traditional implants may fail due to joint instability and severe deformity. However, the high complication rate, as seen in other studies [2, 5, 6] suggests that clinicians must carefully balance these benefits against the risks, emphasizing the importance of thorough preoperative assessment and patient selection. The results advocate for a personalized approach to care, where the decision to use constrained prostheses is based on individual risk profiles, comorbidities, and functional needs. Additionally, the findings would provide a basis for refining postoperative management strategies, including enhanced monitoring for early complications and structured rehabilitation protocols. Overall, this study could contribute valuable insights that could improve surgical decision-making, enhance patient counselling, and potentially formulate standardized treatment guidelines for patient population.
Future research should focus on having a larger sample size to improve the generalizability of the findings. Long-term follow-up studies are also needed to understand the durability of constrained prostheses and the long-term impact on patients’ quality of life. Randomized controlled trials should be conducted to compare constrained prostheses with alternative implants or conservative management strategies. Investigating patient-specific factors that predict better outcomes and identifying risk factors associated with complications could help refine patient selection criteria and surgical planning. Additionally, exploring new implant designs, surgical techniques, or adjunctive therapies that could minimize complications while maintaining functional benefits would add value to the treatment protocols. This could further enhance the understanding and management of neuropathic arthropathy, ultimately leading to improved patient outcomes.

Conclusion
The hypothesis that Total Knee Arthroplasty (TKA) with constrained prostheses provides good functional outcomes but is not associated with a high complication rate in patients with neuropathic arthropathy is a crucial area of exploration that addresses a significant gap in medical knowledge and clinical practice. This study will contribute to understanding how constrained prostheses can be effectively used in cases where joint instability and severe deformity exist. These cohort of patients usually pose challenges to the usage of traditional implants. Through this study we could evaluate the risks involved, including complication rates, which are critical for guiding clinical decision-making.
By advancing knowledge of the benefits and limitations of using constrained prostheses in this unique patient population, the study supports a more nuanced, personalized approach to TKA, emphasizing careful patient selection and tailored surgical planning. The results of this study could lay the groundwork for future research, optimize postoperative management strategies, and potentially lead to the development of standardized treatment guidelines. Ultimately, this hypothesis and its exploration could play an essential role in advancing both the science and practice of treating neuropathic arthropathy, promoting better patient outcomes and contributing to the overall improvement of orthopedic care.


References

1. Charcot JM: Sur quelques arthropathies qui paraissent dépendre d’une lésion du cerveau ou de la moelle épinière. Arch Physiol Norm Pathol 1:161–178, 1868.
2. Tibbo ME, Chalmers BP, Berry DJ, Pagnano MW, Lewallen DG, Abdel MP: Primary total knee arthroplasty in patients with neuropathic (Charcot) arthropathy: contemporary results. J Arthroplasty 33(9):2815–2820, 2018.
3. Drennan DB, Fahey JJ, Maylahn DJ: Important factors in achieving arthrodesis of the Charcot knee. J Bone Joint Surg Am. 1971 Sep;53(6):1180-93.
4. Illgner U, van Netten J, Droste C, Postema K, Meiners T, Wetz HH: Diabetic Charcot neuroarthropathy of the knee: conservative treatment options as alternatives to surgery: case reports of three patients. Diabetes Care 37(6):e129–e130, 2014.
5. Kim YH, Kim JS, Oh SW: Total knee arthroplasty in neuropathic arthropathy. J Bone Joint Surg Br 84(2):329–336, 2002.
6. Bae DK, Song SJ, Yoon KH, Noh JH: Long-term outcome of total knee arthroplasty in Charcot joint: a 10- to 22-year follow-up. J Arthroplasty 24(8):1152, 2009.
7. Yoshino S, Fujimori J, Kajino A, Kiowa M, Uchida S: Total knee arthroplasty in Charcot's joint. J Arthroplasty 8(3):335, 1993.
8. Parvizi J, Marrs J, Morrey BF: Total knee arthroplasty for neuropathic (Charcot) joints. Clin Orthop Relat Res (416):145, 2003.
9. Zeng M, Xie J, Hu Y: Total knee arthroplasty in patients with Charcot joints. Knee Surg Sports Traumatol Arthrosc 24(8):2672, 2016.
10. Yang JH, Yoon JR, Oh CH, Kim TS: Primary total knee arthroplasty using rotating-hinge prosthesis in severely affected knees. Knee Surg Sports Traumatol Arthrosc 20(3):517, 2012.
11. Soudry M, Binazzi R, Johanson NA, Bullough PG, Insall JN: Total knee arthroplasty in Charcot and Charcot-like joints. Clin Orthop Relat Res 208:199–204, 1986.
13. Fullerton BD, Browngoehl LA: Total knee arthroplasty in a patient with bilateral Charcot knees. Arch Phys Med Rehabil 78(7):780–782, 1997.
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How to Cite this Article: Mutha A, Sancheti P, Gugale S, Patil K, Sonawane D, Shyam A. Total Knee Arthroplasty with Constrained Implants in Patients with Neuropathic Arthropathy of the Knee Provides Good Functional Outcomes, and is Not Associated with a High Rate of Complications. Journal Medical Thesis 2024 January-June ; 10(1):46-49.

 


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Evaluation of Safety and Efficacy of Distal Nail Implant for Correction of Coronal Plane Deformity: A Prospective Observational Study


Vol 10 | Issue 1 | January-June 2024 | page: 30-45 | Ayush Saheta, Sachin Kale, Ajit Chalak

https://doi.org/10.13107/jmt.2024.v10.i01.218


Author: Ayush Saheta [1], Sachin Kale [1], Ajit Chalak [2]

[1] Department of Orthopaedics, D Y Patil Hospital, Navi Mumbai, Maharashtra, India.
[2] Department of Orthopaedics, MGM Belapur, Navi Mumbai, Maharashtra, India.

Address of Correspondence
Dr. Ayush Saheta,
Resident, Department of Orthopaedics, D Y Patil Hospital, Navi Mumbai, Maharashtra, India.
E-mail: ayushsaheta@rediff.com


Abstract

Introduction: Coronal plane deformities of the distal femur can significantly impact knee biomechanics and patient quality of life. While various surgical techniques exist for correction, the use of distal femoral nails presents a potentially advantageous approach. This study aims to evaluate the efficacy and safety of distal femoral nails in correcting coronal plane deformities of the distal femur.
Methods: A prospective study was conducted on 30 patients with distal femoral coronal plane deformities. Patients underwent correction using distal femoral nails. Pre- and post-operative assessments included radiographic measurements, functional scores (Lysholm), and complication rates.
Results: The majority of patients (63.3%) were aged 20-40 years. Significant improvements were observed in radiographic parameters, with medial joint space width increasing from 2.9±1.5 mm to 27.1±6.7 mm post-operatively. The mean time for union was 11.4±3.4 weeks. Lysholm scores improved substantially, with 86.7% of patients achieving fair to excellent scores post-operatively compared to 100% poor scores pre-operatively. Complication rates were low, with no cases of non-union reported.
Conclusion: The use of distal femoral nails for correcting coronal plane deformities of the distal femur demonstrates promising results, with significant improvements in both radiographic and functional outcomes. The technique appears to be safe and effective, offering good stability and allowing for early rehabilitation.
Keywords: Distal femur, Coronal plane deformity, Distal femoral nail, Osteotomy, Knee alignment, Functional outcome, Lysholm score


Introduction
Coronal plane deformities of the distal femur, including valgus and varus malalignments, can lead to abnormal loading of the knee joint. This is associated with accelerated cartilage wear, early osteoarthritis, and knee pain [1].
The coronal plane deformities affecting the long bones of the lower extremities of the distal femur may emerge verities of reasons including trauma sequel, metabolic disorders, skeletal dysplasia, infection and congenital limb deficiencies. The coronal deformities may predispose to pain and instability, ligament injury and cartilage degeneration. In addition, those deformities around the knee may deteriorate ambulatory capacity of individual patient [2-4].
Genu Valgum deformity of distal femur may cause knock knees and deteriorate feet position during the stance phase. The patellofemoral joint subluxates laterally as the q ankle increases which inturn may cause patellofemoral joint instability. In long term mechanical loading on the lateral compartment of the knee potentially may cause chondral degeneration eventually leading to osteoarthritis. Correction of Genu Valgum deformity can balance the load distribution in the knee and prevent long term effect of malalignment.
For severe deformities, realignment osteotomies are often required to unload the affected compartment and correct malalignment [5]. Traditionally, these osteotomies have been done open with plate fixation [6]. However, they carry substantial risks such as infection, stiffness, and wound complications [7]. Several treatment options for coronal plane deformity of distal femur including growth guided surgery, osteotomy and distal femoral nailing is the treatment of choice in patient who has multiplanner deformities along with limb, length inequality [8].
More recently, there has been interest in using intramedullary implants to achieve distal femoral osteotomy fixation while minimizing surgical dissection [9]. Specifically, distal femoral nail implants have been developed for this application. They can be inserted through a small incision and provide stable internal fixation, potentially enabling early mobilization and accelerated recovery [10].
This prospective study was conducted to analyse management of coronal plane deformity of distal femur using distal femoral nail.

Aim & Objectives
AIM: To analyse the correction of coronal plane deformity of distal femur using distal femoral nail

Objectives: To compare the functional outcome among coronal plane deformity of distal femur treated with distal femoral nail in terms of the following
• Intra operative time
• Blood loss
• Time for union
• Knee range of movements
• Deformity correction
• Knee society score

Review of literature
Anatomy of femur

Introduction
The femur is the longest, heaviest, and strongest human bone. At the proximal end, the pyramid-shaped neck attaches the spherical head at the apex and the cylindrical shaft at the base. There are also two prominent bony protrusions, the greater and lesser trochanter, that attach to muscles that move the hip and knee. The angle between the neck and shaft, also known as the inclination angle, is about 128 degrees in the average adult. However, the inclination angle decreases with age [11, 12]. The adductor tubercle for the attachment of the posterior half of the adductor magnus and the linea aspera are other important features.
The hip is a ball-in-socket joint composed of the acetabulum of the pelvis encompassing the femoral head. The head is pointed in a medial, superior, and slightly anterior direction. The ligamentum teres femoris connects the acetabulum to the fovea capitis femoris, which is a pit on the head.
The shaft has a mild anterior arch. At the distal femur, the shaft flares out in a cone shape onto a cuboidal base of the medial and lateral condyle. The medial and lateral condyles join the femur to the tibia, forming the knee joint.
Both the hip and the knee joints are synovial joints covered by cartilage to reduce friction and optimize the range of motion. The bony features serve as landmarks for measuring the axis along the femur [13, 14].

Distal femur
The distal femur forms the upper part of the knee joint and plays a crucial role in lower limb biomechanics. Its complex anatomy can be divided into several key structures:
Condyles: The distal femur features two large, rounded prominences called condyles. The medial condyle is slightly larger and more prominent than the lateral condyle. These condyles articulate with the tibial plateau to form the tibiofemoral joint, the primary weight-bearing component of the knee.
Intercondylar notch: Between the condyles lies the intercondylar notch, a deep groove that houses the anterior and posterior cruciate ligaments. These ligaments are vital for knee stability and proper joint function.
Articular surfaces: The condyles are covered with smooth hyaline cartilage, allowing for low-friction movement within the joint. The patellar surface, located anteriorly between the condyles, articulates with the patella to form the patellofemoral joint.
Epicondyles: Located on the non-articular sides of the condyles, the epicondyles serve as attachment points for various ligaments and tendons. The medial epicondyle provides attachment for the medial collateral ligament, while the lateral epicondyle anchors the lateral collateral ligament.
Adductor tubercle: This small bony prominence on the superior aspect of the medial epicondyle serves as the attachment site for the adductor magnus tendon.
Supracondylar lines: These ridges extend proximally from the condyles, with the medial supracondylar line being more prominent. They provide attachment points for the intermuscular septa and various muscles.
Popliteal surface: Located posteriorly between the condyles, this area forms part of the floor of the popliteal fossa, a diamond-shaped space behind the knee.
Metaphysis: The region just above the condyles, characterized by its wider cross-section and trabecular bone structure, plays a crucial role in load distribution and is a common site for fractures in older adults.
Blood supply: The distal femur receives its blood supply primarily from the superior and inferior genicular arteries, branches of the popliteal artery. This rich vascular network is essential for bone health and healing.

Structure and function
The main functions of the femur are weight bearing and gait stability. The weight of the upper body rests on the two femoral heads. The capsular ligament is a strong thick sheath that wraps around the acetabulum periosteum and proximal femur [15]. This ligament holds the femoral head within the acetabulum of the pelvis. The capsular ligament limits internal rotation but allows for external rotation [16, 17].
The knee is a hinge joint between the distal femur and proximal tibia. The medial and lateral meniscus stabilize and cushion the tibiofemoral articulation. The medial and lateral ligaments prevent valgus or varus deformity. Within the knee joint, the anterior and posterior cruciate ligaments allow for some rotational movement of the knee while preventing anterior or posterior displacement of the tibia. The patellofemoral joint is used in knee extension [18, 15].

Embryology
The limb bud development of the femur and lower limb begins with the cells of the lateral plate mesoderm. These cells become activated in week four and form the limb bud. The lower limb forms soon after the upper limb bud [19].
The apical ectodermal ridge of the limb bud induces limb growth and development. The lateral plate somatic mesoderm of the lower limb bud gives rise to the femur, which develops from endochondral ossification, in which bone replaces hyaline cartilage models. Articular cartilages and epiphyseal plates develop by intramembranous ossification, a process in which there is no cartilage model.
The lateral plate somatic mesoderm also gives rise to tendons, the perimysium, and the epimysium. The myotomic component of the somites generates the muscles of the femur. The periosteum surrounds the femur and serves a nutrient function through the adjacent blood supply. The compact bone of the femur provides strength; it is greatest in the middle third of the femur, where the stresses are highest.

Blood Supply and Lymphatics
The femoral artery is the main blood supply to the lower extremity. This artery is the major branch of the external iliac artery after crossing the ilioinguinal ligament. The medial and lateral circumflex arteries are branches of the femoral artery. Along with the obturator artery, a branch of the internal iliac artery, these vessels supply the femoral head via significant anastomotic connections [20]. The foveal artery, a branch of the obturator artery that runs through the ligamentum teres femoris, acts as a supportive blood supply to the femoral head, albeit not the primary source.
At the level of the lesser trochanter, the femoral artery bifurcates into the deep and superficial femoral artery. The perforating branches of the deep femoral artery supply the shaft and the distal portion of the femur [21, 22].

Muscles
The thigh muscles are divided into the anterior, medial, posterior, and gluteal compartments. The femur is located within the anterior compartment.

Anterior Compartment Muscles
The anterior compartment is composed of muscles that are mainly used for hip flexion and knee extension. The hip flexors include the pectineus, iliopsoas, and the sartorius muscle. The femoral nerve innervates all the hip flexors other than the iliopsoas. The iliopsoas muscle is the most powerful hip flexor, and it is composed of the psoas major and iliacus [23].
The iliacus arises from the iliac fossa, iliac crest, and ala of the sacrum and inserts on the lesser trochanter. The iliacus is innervated by the femoral nerve (L2-L3). The psoas muscle arises from the lateral aspect of the T12-L5 vertebrae and inserts with the iliacus on the lesser trochanter of the femur. The iliacus is innervated by the ventral rami of L1-L3. Taken together, the iliopsoas is the most powerful flexor of the thigh at the hip.
The pectineus arises from the superior pubic ramus and inserts on the pectineal line of the femur. The pectineus is innervated by the femoral nerve and serves as a flexor of the thigh at the hip, as well as assisting in the medial rotation of the thigh.
The sartorius arises from the anterior superior spine of the iliac bone and inserts on the medial surface of the tibia as part of the pes anserinus (goose's foot) tendon (composed of the tendons of the sartorius, gracilis, and semitendinosus). The sartorius is innervated by the femoral nerve (L2-L3) and flexes, abducts, and externally rotates the thigh and flexes the leg at the knee. The name sartor is Latin for tailor and is appropriate because tailors often sit on the floor cross-legged to hem a skirt or cuff a pair of pants.
A mnemonic for the sartorius is the FABER muscle. This stands for Flexion, Abduction, and External Rotation. Note that the sartorius is effective as a flexor of the thigh only when the leg is extended at the knee. If not, the muscle serves to flex the leg at the knee.
The quadriceps femoris muscle consists of the rectus femoris, vastus medialis, vastus intermedius, and vastus lateralis. All four muscles insert onto the patella, which is then connected with the tibial tuberosity via the patellar tendon. All are innervated by the femoral nerve (L2, L3, L4). (Note that the more proximal muscles of this compartment are innervated by the femoral nerve (L2, L3), whereas the quadriceps femoris is innervated by the femoral nerve (L2, L3, L4). The rectus femoris arises from the anterior inferior iliac spine. The vastus medialis muscle arises from the medial lip of the linea aspera. The vastus lateralis arises from the greater trochanter and lateral lip of the linea aspera. The vastus intermedius arises from the anterolateral femur.
The further down the limb, the higher value of the ventral rami. This is termed the proximal-distal myotome principle.

Posterior Compartment Muscles
Posterior compartment muscles are mainly hip extensors and knee flexors. They include the biceps femoris, semitendinosus, and semimembranosus muscles. The tibial division of the sciatic nerve (L5, S1, S2) innervates most of the posterior thigh muscles except for the biceps femoris. The biceps femoris has two heads, the long and short head. The long head is innervated by the tibial branch of the sciatic nerve (L5, S1, S2). The short head is innervated by the common peroneal (fibular) division of the sciatic nerve (L5, S1, S2) [23].
The superficial and deep layers of muscles organize the gluteal region. The superficial layer is composed of the gluteus maximus, medius, and minimus.
The gluteus maximus arises from the posterior aspect of the ilium, sacrum, coccyx, and sacrotuberous ligament and inserts on the gluteal tuberosity and iliotibial tract. The gluteus maximus is a powerful thigh extensor that is especially useful when arising from a chair or climbing a flight of stairs. The iliopsoas flexes the thigh at the hip to reach the next stair, but the gluteus maximus raises the body to the next level through its action in power extension.
The gluteus medius arises from the posterior aspect of the ilium between the anterior and posterior gluteal lines and inserts on the lateral aspect of the greater trochanter. The gluteus medius is innervated by the superior gluteal nerve (L5, S1). The gluteus minimus has a similar origin on the posterior aspect of the ilium. The muscle inserts on the lateral aspect of the femur and is innervated by the superior gluteal nerve (L5, S1).
Both muscles abduct and laterally rotate the thigh at the hip. They also prevent the pelvis from dropping when the contralateral leg is raised from the ground. These actions are also assisted by the tensor fasciae latae (TFL), which arises from the anterior superior iliac spine and inserts on the Gerdy tubercle on the tibia. The TFL is also innervated by the superior gluteal nerve (L5, S1).
The deep layer is composed of the piriformis, obturator internus, quadratus femoris and the superior and inferior gemellus muscles, and the obturator internus.
The piriformis muscle arises from the anterior sacrum and sacrotuberous ligament and inserts on the superior border of the greater trochanter of the femur. The piriformis is innervated by ventral rami of S1, S2.
The obturator internus arises from the bones surrounding the obturator foramen. The obturator internus is innervated by the nerve to the obturator internus (L5, S1). The obturator internus inserts on the medial surface of the greater trochanter. The deep muscles all laterally rotate the thigh when it is extended. They all abduct the flexed thigh at the hip and steady the head of the femur in the acetabulum. The superior gemellus is innervated by the nerve to the obturator internus (L5, S1). The inferior gemellus arises from the ischial tuberosity and inserts on the greater trochanter of the femur. The inferior gemellus is innervated by the nerve to the quadratus femoris (L5, S1). The quadratus femoris arises from the ischial tuberosity and inserts on the quadrate tubercle. The quadratus femoris is innervated by the nerve to the quadratus femoris (L5, S1). Quadratus femoris laterally rotates the thigh at the hip and steadies the head of the femur in the acetabulum. These shorter and deeper gluteal muscles assist in the external rotation of the hip [23].

Medial Compartment Muscles
Adduction of the thigh at the hip is the primary function of the muscles of the medial compartment of the thigh. The muscles of this compartment include the adductor longus, adductor brevis, adductor magnus, gracilis, and obturator externus muscles. The obturator nerve is the principal nerve innervation of the medial compartment [24].
The adductor longus arises from the pubis and inserts on the middle third of the linea aspera. The adductor longus is innervated by the obturator nerve (L2, L3, L4) and serves to adduct the thigh.
The adductor brevis arises from the pubis and inserts on the pectineal line and linea aspera. The adductor brevis is innervated by the obturator nerve (L2, L3, L4) [24].
The adductor magnus is a complex muscle with a dual innervation. The anterior half arises from the ischiopubic ramus and inserts onto the linea aspera. This muscle is an adductor of the thigh at the hip, and it is innervated by the obturator nerve. The posterior part arises from the ischial tuberosity and inserts onto the adductor tubercle of the femur and receives innervation from the tibial aspect of the sciatic nerve (L4), and functions as a hamstring.
The gracilis arises from the body and inferior ramus of the pubis and inserts on the medial surface of the tibia as part of the pes anserinus (goose's foot) tendon. The gracilis is innervated by the obturator nerve (L2, L3); it laterally rotates the thigh and steadies the head of the femur in the acetabulum.
The obturator externus arises from the obturator foramen and inserts on the trochanteric fossa of the femur. The obturator externus is innervated by the obturator nerve (L3, L4) and laterally rotates the thigh and steadies the head of the femur in the acetabulum.

Alignment of lower limb
The alignment of the lower limb can be evaluated with standard radiographic techniques. However, the mechanical and anatomic axes of the lower limb are only precisely assessed if the ankle and hip positions are known. Standing views allow the assessment of the tibiofemoral knee compartments states, including the joint space. For evaluation of the patellofemoral joint, skyline or Merchant views are used. However, computerized tomography (CT) and magnetic resonance imaging (MRI) can give more subtle information. Definition of human normal limb alignment and malalignment are formulated from statistics. Thereby, the deformities of the lower limb are defined as a deviation of the physiological axes. Limb alignment deformities may have a congenital or constitutional aetiology. During childhood they may be due to growth disorder with the premature closure of the epiphyseal plate. They are also associated with trauma, metabolic disorders such as rickets, or osteopathies such as renal osteopathy. Systemic myopathies or neurologic pathologies may also be related.
Posttraumatic deformities may occur after florid fracture healing. Other causes may be related to osteonecrosis of the knee, tumours, rheumatoid arthritis, and secondary to cartilage damage that follows major meniscal resections. The ultimate result is the secondary deviation of the mechanical axis of the lower limb [25].

Defining and measuring limb alignment
The anteroposterior (AP) projection full-length standing radiograph is the primary tool for evaluating the lower limb alignment. Lower limb alignment is best assessed by radiography in AP projection with a horizontally focused X-ray beam of the hip, knee, and ankle with the subject standing upright to support body weight. Patient positioning must be standardized to have reproducible results, especially leg rotation to get a flexion/extension plane aligned in the anterior-posterior direction.
The patella must be aligned in the anteroposterior projection with the centre of the femoral condyles. To achieve this position, 8–10° lateral rotation of the feet is classically needed. However, some situations, as seen in torsional deformities, cause medialization or lateralization of the patella. In these cases, the correct position is attained through the internal or external rotation of the lower leg until the patella is centred amongst the femoral condyles [26].
The weight-bearing X-ray of the entire lower limb is mandatory to evaluate the axis. The mechanical axis defined by the hip–knee–ankle line is measured on a full-length standing radiograph in the anteroposterior projection. It is considered a gold standard since it allows for consistent and precise measurement of mechanical tibiofemoral angle and assessment of limb deformities. However, in general practice, alignment is often inaccurately estimated using the anatomic tibiofemoral angle on standard anteroposterior weight-bearing X-rays, eventually causing imprecision in operative planning [26, 27].
When standard weight-bearing X-rays are used to calculate alignment, the estimated angle on the X-ray is called the anatomic tibiofemoral angle or femoral-shaft–tibial-shaft angle (FS–TS) (Fig. 3). This angle is defined by a line drawn from the centre of the proximal femoral shaft towards the knee and a line from the centre of the tibial shaft distal to the knee. To calculate the femoral and tibial shaft points, it usually is measured 10 cm from the knee joint to adjust the portion of the long-bone shafts commonly seen on a knee X-ray. In the tibia, both the anatomic and mechanical axes are similar.
It is possible that the anatomic tibiofemoral angle does not reproduce a correct estimation of the mechanical tibiofemoral angle. The anatomic tibiofemoral angle is valgus with an offset of 4–6° for healthy individuals. In patients with knee osteoarthritis, the anatomic mechanical femoral angle ranges from 1.5° to 7°, with a low to a high correlation between the two measurements. Consequently, the variation of offset between the two angles is significantly greater in individuals with knee OA [26].
The femoral diaphysis silhouette affects the correlation between the mechanical and anatomic tibiofemoral angles. This correlation is affected by the lateral femoral bowing, the tibial bowing, and the proximal tibial angle by the rank of significance. The anatomic tibiofemoral angle estimation also shows more inaccuracy than the mechanical tibiofemoral angle determination. The inconsistency is amplified when the femur and the tibial anatomic axes are calculated using a smaller distance or lower length on their diaphysis. Consequently, it is highly recommended that the anatomic tibiofemoral angle should be obtained from a full-length weight-bearing radiograph to guarantee a correct determination of lower limb alignment [28]. This fact is even more critical for the preoperative planning of osteotomies around the knee and TKA.

Physiological axes and angles of the lower limb
The axes of the lower limb must be differentiated between anatomic and mechanical.

Anatomic axes of the femur and tibia
The anatomic axes of the femur and tibia are obtained from a line centred in the diaphysis of each bone. To determine the anatomic femoral axis, a line is drawn bisecting the femoral diaphysis into two parts. This line can be retrieved by joining two points in the middle of the medullar canal, one 10 cm above the knee joint and the other in the middle of the shaft, resulting in the distal anatomic femoral axis [29, 30]. The anatomic tibial axis bisects the tibial shaft, uniting two points, one proximally and other distally centred in the medullary canal. The anatomic femoral axis is not perpendicular to the axis of the tibia because of the deviation from the midline created by the femoral neck. Therefore, they form a physiological slight valgus angle.

Anatomic tibiofemoral angle
The anatomic tibiofemoral angle is measured between the anatomic axes of the femur and the tibia. This angle may be compared to the physiological value revealing the amount of deformity [31, 32]. The anatomical axes of the femoral and tibial diaphysis form a lateral angle of 173–175° (anatomic tibiofemoral angle/aTFA).

Mechanical axes of the femur and tibia
The femur and tibia mechanical axes are defined by the centre points of the hip, knee, and ankle joints. The femur mechanical axis is defined by a line from a point in the centre of the femoral head to a point in the centre of the knee. The femoral head centre is easily found by drawing several bisecting lines corresponding to the head circumference diameter. To find the centre of the knee, several points may be used. A commonly used point is the centre of the tibial spines. Alternatively, Moreland et al [29] described a unique point on the knee that resulted from several measurements of different knee landmarks. Other authors define two different points for the centre of the knee. When drawing the mechanical axis of the femur, the distal point in the knee is marked in the centre of the femoral intercondylar notch. The centre of the tibial interspinous groove is then used as the starting point for the mechanical axis of the tibia. Using two different points at the knee brings some advantages: the identification of the tibial and femoral contributions to the deformity and the extent of the knee subluxation [26].
The mechanical axis of the femur forms a physiological angle of 6° ± 1° with the anatomical femoral axis and is named the anatomical mechanical femoral angle (aMFA) [33]. The mechanical axis of the tibia is marked from the centre of the knee, previously assessed, and the centre of the talus or tibial plafond, defined using a ruler placed on the X-ray [26, 31, 32]. The tibial mechanical and the anatomic axes are almost indistinguishable. Consequently, it is assumed that both lines run physiologically parallel to each other.

Mechanical axis of the lower limb
The mechanical axis of the lower limb, also called the Mikulicz line, is drawn by connecting a point in the centre of the femoral head to a point in the centre of the ankle. This line’s physiological position runs, on average, 4 ± 2 mm medial to the centre of the knee. Any deviation from this physiological range indicates either a valgus, if the line runs lateral, or a varus if it runs medially. The value of the deviation is measured in millimetres and is named mechanical axis deviation (MAD). The mechanical axis of the lower limb creates an approximate angle of 3° to the perpendicular axis of the body (Fig. 5) [34].

Deformities of lower limb
Deformities of the lower limb are defined as a deviation of the physiological axes in the frontal, sagittal or transverse planes and ultimately result in malalignment of the lower limb. Variations of the physiological longitudinal torque of the femoral and tibial diaphysis result in torsional deformities of the lower limb [25].

Frontal or coronal plane deformities
Most of the lower limb deformities occur in the frontal plane and are known as varus and valgus deviations. One frequent cause of secondary varus and valgus malalignment is the cartilaginous damage that results from a meniscectomy [38].
In the presence of a frontal plane deformity, a non-physiological load distribution occurs in the knee’s medial or lateral compartment. The resulting mechanical overload originates progressive cartilage wearing and progressive degenerative disease.

Genu valgum or Knock knees
Genu valgum or "knocked knees" are part of the coronal plane deformities of the lower extremity. The majority of patients are asymptomatic and have no functional limitations. This condition can be preceded by flat feet and occasional medial foot and knee pain. Children start developing physiologic genu valgum starting by age 2, and it becomes most prominent between ages 3 to 4. After that, it typically decreases to a stable, slightly valgus position by age 7 years. In the adolescent age group, minimal, if any, change in this alignment is expected. Intermalleolar distance has been used to assess the degree of genu valgum. It is the distance between the medial malleoli in a standing patient with touching medial femoral condyles. Intermalleolar distances greater than 8 cm is considered pathologic [35]. Rarely, in cases where valgus alignment continues to increase, it can be associated with an out-toed gait, lateral subluxation of the patella, and rubbing of the knees together as the child ambulates [36, 37].

Etiology [38]
Bilateral Genu Valgum
• Physiologic genu valgum
• Skeletal dysplasias
• Metabolic bone diseases
• Lysosomal storage diseases
• Overweight and obesity

Unilateral Genu Valgum
• Post-traumatic
• Tumors
• Infection

Epidemiology
Most patients present to the clinic between ages 3 to 5 years for the evaluation of genu valgum. The most common site of pathologic deformity is the distal femur, however, it can arise from the tibia as well [38].

History and physical examination
Most patients present to the clinic between ages 3 to 5 when parents generally become concerned about knocked kneed appearance. Bilateral genu valgum in this age group is typically physiologic but can also be secondary to skeletal dysplasia such as spondyloepiphyseal dysplasia and chondroectodermal dysplasia (Ellis van Creveld syndrome), metabolic bone diseases such as rickets (renal osteodystrophy and hypophosphatemic rickets), and lysosomal storage disease such as Morquio syndrome. Unilateral genu valgum is most often secondary to physeal or metaphyseal trauma. Radiographs should be assessed for physeal narrowing, premature closing, and the presence of growth recovery lines (Park-Harris lines), giving attention to their morphology.
Cozen phenomenon is a post-traumatic valgus deformity seen after proximal tibial fractures [39]. Of note, this can be seen even in the presence of non-displaced fractures [40 The most accepted theory of this phenomenon is the increased vascularity that occurs during fracture healing resulting in medial metaphyseal overgrowth. Other causes of genu valgum include radiation, infection, and tumors (osteochondromas, multiple hereditary exostoses, fibrous dysplasia).

Evaluation
Gait and rotational profile analysis are important aspects in the workup of angular deformities and help providers to identify the etiology of angular deformities, especially in the pediatric population. Primary or true valgus deviations about the knee can present as a stance-phase valgus thrust as seen in metabolic bone disease like renal osteodystrophy and longitudinal deficiency of the fibula that is associated with lateral femoral condyle hypoplasia. Secondary or apparent valgus gait deviations are associated with both axial and sagittal plane deviations. For example, increased femoral anteversion has an apparent valgus angulation attributed to internal rotation of the distal femur.
Radiographs are not indicated in children in the physiologic valgus phase. However, they are indicated in the setting of asymmetrical findings, excessive genu valgum clinically, age group beyond which is expected of physiologic changes, patients whose height falls below the tenth percentile for their age, and a history of trauma or infection. Radiographic assessment begins with obtaining weight-bearing long leg alignment images in which both patellae are facing forward. Coronal plane angulation of the lower extremities can be analyzed based on the deviation of the center of the knee from the mechanical axis and the tibiofemoral angle. The mechanical axis is a line connecting the center of the femoral head to the center of the ankle. In normal coronal alignment, the mechanical axis passes through the center of the knee. There is lateral and medial deviation of the center of the knee with respect to the mechanical axis of the lower extremity in genu varus (bowed legs) and genu valgum (knocked knee), respectively.
The tibiofemoral angle is the acute angle formed between the longitudinal axes of the tibial and femoral shafts. At birth, there is between 15 to 20 degrees of varus tibiofemoral angulation. As the child grows, this corrects to neutral by about age 2 and between 10 to 15 degrees of valgus tibiofemoral angulation between ages 3 and 4. At this point, the limb’s valgus angulation then starts to gradually decrease to approximately 3-5 degrees of valgus by age 7. This is the residual normal coronal plane angulation of the lower extremity that will be carried to adulthood and should not increase [41].
It is important to determine whether the deformity is primarily originating from the femur or tibia. This is done by measuring the mechanical lateral distal femoral angle (angle between the femoral shaft and the mechanical axis of the femur) and medial proximal tibial angle (angle between the tibial plateau and mechanical axis of the tibia). The normal range of these angles is between 85 and 90 degrees [42].

Measurement of valgus deformity
To assess the degree of a deformity, the mechanical tibiofemoral angle should be measured. A straight line is drawn from the centre of the femoral head to the centre of the knee (mechanical axis of the femur) and projected downward beyond the knee. The mechanical tibial axis, running parallel to the shaft of the tibia, is also drawn. The angle formed by the portion of the line projected beyond the knee and the tibial shaft axis is then evaluated. A measurement of about 0°/180° implies an average axis of the limb. Otherwise, the resulting tibiofemoral angle corresponds to the degree of the deformity [31, 32].
To characterize the deformity (answering the ‘how’ question), either the position of the foot or the mechanical axis of the limb (Mikulicz line) may be used. According to the position of the foot, a valgus is determined if the foot is lateral to the femoral axis and a varus if the foot is medial. When assessing the mechanical axis of the limb, a deviation from this physiological range designates either a valgus, if the line runs lateral, or a varus if the line runs medial.
In certain situations, including height, obesity, and radiograph quality, the visibility of the femoral head may be impaired. In these cases, the tibiofemoral angle may be assessed by calculating the anatomic femoral axis and assuming the anatomical mechanical femoral angle as 6°, so the difference is taken as the amount of deformity. In this case, the anatomic tibiofemoral angle is used instead of the mechanical angle and compared with the assumed standard value of 6° of valgus [33].
In the case of an indistinct ankle joint, the tibial axis line should be drawn from the centre of the knee to a midpoint on the visible end of the tibia shaft.

Assessment of the deformity location
Due to the greater distance between the centre of the hip and knee joints than between the knee and ankle, the mechanical tibiofemoral axis runs slightly oblique, from craniolateral to mediocaudal, to the perpendicular axis of the body at an angle of approximately 3° [31, 32].
The tangent to the femoral condyles (knee baseline) and the tangent to the tibial plateaus, under physiological conditions, run almost parallel (joint line convergence angle = JLCA, 0–1 medial convergence).
The physiological femoral joint angle (FJA) is 2–3° valgus to the femoral mechanical axis and 8–9° valgus to the femoral shaft axis [31, 32].
The result of the parallelism between the mechanical and anatomical axes of the tibia is that the anatomical and mechanical medial proximal tibial angle (aMPTA/mMPTA), between the tangent to the tibial plateau and the anatomical and mechanical axes, is 87 ± 3 in both cases. The anatomical and mechanical lateral distal tibial angle at the line of the ankle joint is 89 ± 3 [34, 43].
Regarding the femur, the mechanical lateral distal femoral angle, calculated between the mechanical femoral axis and the baseline of the knee, is 87 ± 3. The knee baseline forms an angle of 81 ± 2 with the anatomical axis of the femur [34, 43].
Malalignment in the frontal plane is analysed using the ‘malalignment test’  and is the result of the deviation of the mechanical axis. A clinically significant deviation in the frontal plane is identified when the mechanical tibiofemoral axis runs more than 10 mm lateral to the centre of the knee joint (valgus deviation) or more than 15 mm medial (varus deviation). The origin of the deformity can be femoral, tibial, or both. Thereby, to evaluate the individual contribution, we must assess the mechanical lateral distal femoral angle (mLDFA, standard value 87 ± 3) and the mechanical medial proximal tibial angle (mMPTA, standard value 87 ± 3). If the mLDFA is lower than the standard value, a femoral valgus deformity is found [34, 43].

Treatment modalities for coronal plane deformities

Observation
Patients with physiological varus or valgus knee (that is, who fall within the two standard deviations from the normal value for their age or within the second zone on the X-ray) require no treatment other than observation. Parents should be reassured that it is not a true deformity or disease, but a variant of normal lower limb alignment, which usually corrects spontaneously. These patients should be clinically evaluated every 3-6 months to monitor the deformity. Radiographic assessment should be repeated if there is suspicion of clinical worsening 44]. Conservative treatment (e.g., shoe wedges or bracing) is not effective, is poorly tolerated, and is unnecessary in cases of physiological deviation [45-47].

Surgical treatment
It is generally accepted that a significant deformity that persists into preadolescence will not correct spontaneously. Physiological alignment of the lower limb is crucial for the symmetrical distribution of weight over the surfaces of the joints, especially the knee. Indeed, severe coronal malalignment has been linked to knee pain, altered gait, and occasionally patellofemoral problems.48 Moreover, it can contribute to the development of osteoarthritis of the knee [49, 50]. Additionally, MA deviation in the lateral or medial compartment can lead to compression in the lateral or medial physis, thereby further delaying growth as a result of the Hueter-Volkmann effect [51].

Preoperative planning
Preoperative planning could involve the malalignment test on a long-standing X-ray, as described by Paley and Tetsworth [42]: (1) Evaluation of MA and MAD. The first step is tracing the MA of the lower limb (e.g., from the center of the femoral head to the center of the ankle). The MA should pass through the center of the knee joint. If the MA axis does not go through the center of the knee joint, there is a MAD. Furthermore, the MA deviation can be classified into three zones as defined by Müller and Müller-Färber [52]. When the MAD exceeds the normal range (e.g., > 8 ± 7 mm medial to the center of the knee joint line)53 or the MA passes to the first zone [51, 52] a pathological malalignment is present and the following steps will determine the origin of the deformity; (2) Measurement of the mechanical lateral distal femur angle (n.v. = 87.5 ± 2.5): The lateral angle between the MAF and the line through the femoral condyles; (3) Measurement of the medial proximal tibial angle (n.v. = 87.5 ± 2.5): The medial angle between the MAT and the line through the tibial plateaus; (4) Measurement of the joint line convergence angle (n.v. = 0-2 degrees medial convergence): The angle between the femoral condyle and the tibial plateau joint line. This helps to evaluate any source from the ligament or capsular laxity or joint cartilage loss; (5) Ruling out a medial or lateral subluxation: The midpoints of the femur and the tibia should be aligned; and (6) Ruling out an intraarticular origin of the malalignment: The femoral condyles and the tibial plateaus should be aligned with respect to each other. A depressed or elevated femoral condyle or tibial plateau may indicate an intraarticular source of malorientation.
The authors stress that these measurements are only reliable if the X-ray projection is anteroposterior with the knee in the frontal plane, which is defined as the position where the patella is centered in the femoral condyles [55, 56]. This means that care must be taken to place the patient in the patella forward position, rather than in the feet forward position, as the latter is affected by tibial torsion and leads to incorrect measurement [55].

General indications
Surgical correction of coronal angular knee deformities is indicated if: (1) The MA falls within zone 2 and the patient is symptomatic; and (2) The MA is beyond zone 2 [51, 52]. If the deformity only involves the distal femur or the proximal tibia, the correction should only take place within the affected bone. If the deformity originates from both the femur and the tibia and is symmetrical, both bones should be treated. If, on the other hand, the deformity is asymmetrical, only the bone whose angle (LTFA and MTFA) deviates more than 5 degrees from the reference values should be treated [46, 57].

How to treat pathological genu varum and genu valgum
In growing children, the treatment strategies for coronal angular deformities around the knee are: (1) Hemiepiphysiodesis; and (2) Osteotomy.

Osteotomy
The use of corrective osteotomy is indicated in patients close to or at skeletal maturity, or in those whose growth cartilages are not functional (e.g., after an infection, or in the presence of a physeal bar). The specifics of realignment osteotomies are beyond the scope of this article and have been reported in articles on this theme and summarized by Paley [53]. However, it is necessary to introduce the fundamental concept of the CORA, which can be summarized as the point of maximum deformity. When a corrective osteotomy is planned, the correction should be established close to the CORA to avoid introducing translation deformity [55]. In varus and valgus deformities of the knee, the CORA is adjacent to the articular surface and the physis. For this reason, osteotomy, whether of the distal femur or the proximal tibia, is generally not feasible in skeletally immature patients. This is to avoid iatrogenic damage to the growth plate. Thus, in order to achieve realignment with corrective osteotomy, preoperative planning should take account of both the original angular deformity and any translation deformity introduced [55].
Correction through osteotomy can be acute, achieved using internal fixation devices (e.g., Kirschner wires, intramedullary nail, plates) or gradual, using an external fixator and distraction osteogenesis [58]. Gradual correction is attractive in cases of multiplanar deformity and modern hexapod systems are particularly useful in these situations [59].
The different types of osteotomy used to correct a deformity acutely are: [60] (1) Opening wedge; (2) Closing wedge; (3) Reverse wedge; and (4) Dome osteotomy. Acute deformity correction predisposes the patient to certain risks that should be taken into consideration during planning. Non-union or delayed union should be considered in opening wedge osteotomies greater than 20 degrees [83].
Neurovascular structures risk being stretched during acute correction. It is reported that the risk of injury to neurovascular structures is related to the magnitude of correction, but the limit is not well defined. Other factors that add to this risk are the site and type of osteotomy and the direction of correction. For example, a correction of a valgus to varus deformity of the knee by osteotomy of the distal femur or proximal tibia puts the common peroneal nerve (CPN) at risk, even if the correction is small (about 5 degrees) [62]. Conversely, a correction of a varus deformity releases the CPN. Further-more, the deep peroneal nerve (DPN), which passes under the intermuscular septum between the lateral and anterior compartment of the leg, is more at risk of injury than the superficial peroneal nerve (SPN) [53]. For the same reason, internal or external rotation osteotomies involving tensioning of the intermuscular septum create more risk for the DPN and less for the SPN. For these reasons, some authors suggest performing prophylactic peroneal nerve decompression before acute correction [62]. Additionally, the motor branch to the extensor hallucis longus is particularly at risk during fibular osteotomy [63].

Idiopathic pathological genu valgum and genu varum
It is generally established that growth plate modulation with staples or TBPs determines less morbidity than osteotomy. However, it is essential to evaluate the timing of epiphysiodesis and to schedule close clinical monitoring to avoid overcorrection.

Post-traumatic
Trauma is one of the most frequent causes of pathological coronal deformity around the knee. The deformity may be a result of inadequate reduction or injury to the growth cartilage with a consequent alteration or arrest in growth (e.g., physeal bar). In the latter case, some authors report a high risk in cases of type 3 Salter-Harris (SH) fracture of the proximal tibia, whereas the type of SH fracture in the distal femur is poorly predictive. In some cases, the physeal injury may be misdiagnosed if concomitant with another fracture of the femur or tibia. Therefore, some authors recommend knee X-rays in all patients with a traumatic lower limb injury [64].
Depending on the age of the patient, the location, the cause and the extent of the deformity, treatment may involve observation, physeal bar resection, epiphysiodesis, chondrodiastasis, or corrective osteotomy. Physeal bar resection consists of removing the bone bridging the metaphysis and the epiphysis and filling the gap with interposition material (e.g., fat, methyl methacrylate or polymeric silicone) to prevent the bony bar from reforming. This is indicated when there are at least 1 or 2 years of remaining growth, and when the bar involves < 50% of the growth plate. If a clinically unacceptable deformity is present at the time of physeal bar resection, an osteotomy or hemiepiphysiodesis is indicated to realign the lower limb. In fact, a successful physeal bar resection alone would not be able to fully correct the deformity [65].
A frequent form of post-traumatic knee valgus is tibia valga following fracture of the proximal metaphysis of the tibia, also known as Cozen’s phenomenon. The exact etiology is still under debate. In these cases, the maximum magnitude of deformity is variable, and is reached approximately 12 month after injury. Parents should be advised of this eventuality and be informed that the deformity tends to resolve spontaneously within 2-4 years and only requires observation. Surgical treatment should be reserved for severe and symptomatic cases or for patients close to skeletal maturity with residual deformity [66]. Some authors report that, to prevent this deformity, the proximal tibial fracture should be treated with a varus-molded long-leg cast, although the efficacy of this procedure has been disputed in the literature [67]. Hemiplateau elevation (HE) is the treatment of choice for growing children with persistent deformity requiring surgery [68]. This must be performed within about three years of the trauma, since deformities tend to migrate distally at the level of the diaphysis during growth. Therefore, delayed HE could lead to a secondary “Z”-shaped deformity of the tibia (varus deformity proximal to the valgus deformity of the diaphysis). Corrective osteotomy should be avoided in growing children, as it can produce effects similar to the traumatic event itself and accentuate valgus deformity. It may be indicated in patients close to skeletal maturity with residual deformity [69].

Material and Methods
o Study design: Prospective Analytical Study
o Study area: Department of Orthopedics D Y Patil University School of Medicine & Hospital, Nerul, Navi Mumbai.
o Study period: Research study was conducted from November 2022 to June 2024. Below is the work plan.
o Sample size: 30 cases

o Inclusion criteria:
• All patients giving consent.
• Patients with distal femur deformity.
• Patient showing Xray changes distal Femur fractures valgus deformity.
• Patients >18 years or

o Exclusion criteria:
• Patient 80 years
• Patient not showing interest for long follow-up
• Patients not willing and not motivated for surgery and lifestyle changes postoperatively.

Method of Data collection:
After taking informed consent, 30 patients were recruited for our study. After informed written consent we analysed all patients with distal femur coronal plane deformity of distal femur in our hospital (all included patients were less than 80 years old). The demographic and radiological data of these patients was collected from the history presented by the patient.
The aim of this study was correction of the coronal plane deformity of the distal femur using distal femoral nail. Deformities of the distal femur may be due to infection, congenital limb deficiencies, metabolic disorders and idiopathic causes. When combined with malalignment of the lower extremity axis, compartmental cartilage damage and knee osteoarthritis may develop. Therefore, realignment osteotomy of the distal femur is an ideal option to preserve the joint deformed into valgus position.
Various osteotomy techniques and fixation methods have been used to correct distal femoral deformities. The closed-wedge technique, with the fixation of an angled blade plate, has been a common procedure in distal femur osteotomy. The technical complexity and wide surgical dissection, however, contribute to high rates of complications, such as non-union, inaccurate correction of the deformity, plate irritation, superficial infection or risk of osteomyelitis loss of correction, as well as revision surgery. Recently, open-wedge osteotomy with an improved plate design has been attempted that makes it is easier to correct the mechanical axis (MA) and adjust the amount of wedge opening Intraoperatively. As healing time of the open wedge is expected to be longer, inferior mechanical stability at the osteotomy site is of great concern with the use of short plate.
For these reasons, we introduced a technique using a long locking distal femoral nail, as performed in acute coronal plane deformity of the distal femur, with the concept of minimally invasive osteosynthesis by intramedullary nail assistance. We hypothesized that the results and complication rate would better than previous techniques of distal femur osteotomy. The purpose of this study was to describe the surgical procedure for correction and to document the outcome after patients underwent the newer technique of distal femoral coronal plane deformity correction with distal femoral nail.

Parameter that were evaluated at discharge and follow-up at 3 months and 6 months:
• Width of medial joint space
• Joint line convergence angle (JLCA)
• Posterior tibial slope (PTS)
• Kellgren-Lawrence (KL) grade
• Medial proximal tibial angle (MPTA)
• Lateral distal femoral angle (LDFA)
• Time for union
• Lysholm Score

Lysholm knee scoring scale

SECTION 1 - LIMP
• I have no limp when I walk. (5)
• I have a slight or periodical limp when I walk. (3)
• I have a severe and constant limp when I walk. (0)

SECTION 2 - Using cane or crutches
• I do not use a cane or crutches. (5)
• I use a cane or crutches with some weight-bearing. (2)
• Putting weight on my hurt leg is impossible. (0)

SECTION 3 - Locking sensation in the knee
• I have no locking and no catching sensation in my knee. (15)
• I have catching sensation but no locking sensation in my knee. (10)
• My knee locks occasionally. (6)
• My knee locks frequently. (2)
• My knee feels locked at this moment. (0)

SECTION 4 - Giving way sensation from the knee
• My knee gives way. (25)
• My knee rarely gives way, only during athletics or vigorous activity. (20)
• My knee frequently gives way during athletics or other vigorous activities. In turn I am unable to participate in these activities. (15)
• My knee frequently gives way during daily activities. (10)
• My knee often gives way during daily activities. (5)
• My knee gives way every step I take. (0)

SECTION 5 – PAIN
• I have no pain in my knee. (25)
• I have intermittent or slight pain in my knee during vigorous activities. (20)
• I have marked pain in my knee during vigorous activities. (15)
• I have marked pain in my knee during or after walking more than 1mile. (10)
• I have marked pain in my knee during or after walking less than 1mile. (5)
• I have constant pain in my knee. (0)

SECTION 6 – SWELLING
• I have swelling in my knee. (10)
• I have swelling in my knee on1y after vigorous activities. (6)
• I have swelling in my knee after ordinary activities. (2)
• I have swelling constantly in my knee. (0)

SECTION 7 – CLIMBING STAIRS
• I have no problems climbing stairs. (l0)
• I have slight problems climbing stairs. (6)
• I can climb stairs only one at a time. (2)
• Climbing stairs is impossible for me. (0)

SECTION 8 – SQUATTING
• I have no problems squatting. (5)
• I have slight problems squatting. (4)
• I cannot squat beyond a 90deg. Bend in my knee. (1)
• Squatting is impossible because of my knee. (0)
Total: __________/100 [3 months]
Total: __________/100 [6 months]

Results
The present prospective analytical study was conducted among 30 patients with distal femur deformity presenting to department of orthopedics in Dr D Y Patil Hospital, Nerul, Navi Mumbai for a period of two years to study the correction of coronal plane deformity of distal femur using distal femoral nail.
Following are the study findings:

Distribution of patients according to age
This shows the age distribution of the 30 patients in the study. The majority of patients (63.3%) were between 20-40 years old, followed by 30% in the 41-60 age group, and only 6.7% in the 18-20 age group. This suggests that distal femur deformities in this study were most common in young to middle-aged adults.

Distribution of patient according to gender
The gender distribution of patients was fairly balanced, with a slight majority of females (53.3%) compared to males (46.7%). This indicates that the condition affects both genders relatively equally in this study population.

Distribution of patient according to Body Mass Index
This categorizes patients based on their Body Mass Index (BMI). The largest group (36.7%) had a normal BMI (18.5-24.9), followed by overweight patients (26.7%), obese patients (23.3%), and underweight patients (13.3%). This distribution suggests that while the condition affects people of all body types, there might be a slight tendency towards higher BMI categories.

Distribution of patient according to malunion/deformity
The most common mode of injury was malunion/deformity (40%), followed by equal proportions of Road Traffic Accidents (RTA) and sports injuries (30% each). This indicates that pre-existing conditions or improper healing of previous injuries may be a significant factor in distal femur deformities.

Distribution of patient according to symptoms
This breaks down various symptoms experienced by patients. In our study 40% reported severe pain, while 20% each reported mild, unbearable, or no pain. Whereas 36.7% had no swelling, 30% had mild swelling, 23.3% moderate, and 10% severe swelling. There were 26.7% of patients who experienced a "give away sensation." Regarding function, 63.3% had no limitation in daily activities, while 36.7% could not perform daily activities. These results suggest a wide range of symptom severity among patients.

Distribution of patient according to imaging findings
This compares pre-operative and post-operative measurements. The width of medial joint space increased from 2.9±1.5 to 27.1±6.7. Joint line convergence angle decreased from 6.5±2.5 to 4.7±2.7. Posterior tibial slope remained relatively stable (10.8±2.9 to 10.8±3). Medial proximal tibial angle and lateral distal femoral angle both increased slightly. These changes indicate successful surgical correction of the deformity.

Distribution of patients according time for union
The average time for union was 11.4±3.4 weeks, with a minimum of 6 weeks and a maximum of 16 weeks. This suggests a relatively quick healing process for most patients.

Distribution of patients according to range of movements
Post-operative knee flexion averaged 109.3±11.8 degrees (range 90-160), while knee extension averaged 0.07±3.4 degrees (range -5 to 5). This indicates good functional outcomes in terms of knee mobility.

Distribution of patients according to functional outcome(lysholm scores)
This shows a significant improvement in functional outcomes. Pre-operatively, all patients (100%) had poor scores. Post-operatively, 56.7% had fair outcomes, 16.7% good, 13.3% excellent, and only 13.3% remained poor. This demonstrates the effectiveness of the surgical intervention in improving patient function.

Distribution of patient according to complications
Complications were relatively low in our study with Knee stiffness in 6.7% cases, Infection in 3.3%, Nail displacement in 3.3%, Mal union in 3.3%. No cases of non-union were reported. This suggests that the procedure is generally safe with a low complication rate.

Association of functional outcome with age
This cross-tabulation shows the relationship between age and functional outcomes. The 20-40 age group had the most diverse outcomes, with representations in all categories. The 18-20 age group had only good and excellent outcomes. The 41-60 age group had only poor and fair outcomes. However, the p-value of 0.133 suggests that this association is not statistically significant.

Association of functional outcome with BMI
This examines the relationship between BMI and functional outcomes. Underweight patients had either fair or excellent outcomes. Normal BMI patients were represented in all outcome categories. Overweight patients had poor to good outcomes, but none in the excellent category. Obese patients had outcomes ranging from poor to good, with the highest proportion in the good category. The p-value of 0.205 indicates that this association is not statistically significant.

Discussion
Distal femoral deformities present a significant challenge in orthopedic surgery, often resulting in pain, functional limitations, and altered biomechanics of the knee joint. The correction of coronal plane deformities in the distal femur is crucial for restoring proper alignment and improving patient outcomes. This study aimed to evaluate the efficacy of using distal femoral nails in correcting such deformities. The following discussion will analyze our findings in the context of existing literature, highlighting the similarities and differences in patient demographics, surgical outcomes, and complications.

Demographics and Patient Characteristics:
Our study included 30 patients with a predominant age group of 20-40 years (63.3%). The gender distribution in our study was relatively balanced, with 16 females and 14 males.
The BMI distribution in our study showed that 36.7% of patients had a normal BMI (18.5-24.9), while 50% were either overweight or obese. This finding is particularly relevant as Ekeland et al. [70] reported that higher BMI is associated with increased risk of complications in distal femoral osteotomies.

Mode of Injury and Symptoms:
In our study, malunion/deformity was the most common mode of injury (40%), followed by road traffic accidents (RTA) and sports injuries (30% each). These findings highlight the diverse etiologies of distal femoral deformities.
Regarding symptoms, 80% of our patients reported pain ranging from mild to unbearable, with 40% experiencing severe pain. This high prevalence of pain aligns with the observations of Wylie et al. [71], who emphasized pain as a primary indication for surgical intervention in distal femoral deformities.

Imaging Findings and Surgical Outcomes:
Our study demonstrated significant improvements in radiographic parameters post-operatively. The mean width of the medial joint space increased from 2.9±1.5 mm to 27.1±6.7 mm, indicating successful correction of the deformity. This substantial improvement is comparable to the findings of Jacobi et al. [72], who reported significant increases in joint space following distal femoral osteotomy.
The mean time for union in our study was 11.4±3.4 weeks, which is slightly shorter than the average of 14 weeks reported by Brinkman et al. [73] in their study of distal femoral osteotomies. This difference might be attributed to the use of intramedullary nailing in our study, which potentially provides better stability and promotes faster healing.

Functional Outcomes:
The Lysholm scores in our study showed remarkable improvement, with 86.7% of patients achieving fair to excellent scores post-operatively, compared to 100% poor scores pre-operatively. This significant functional improvement is consistent with the findings of Saithna et al. [74], who reported substantial increases in Lysholm scores following distal femoral osteotomy.
Our study found no significant association between age and functional outcomes (p>0.05), which contrasts with the findings of Ekeland et al. [70], who reported better outcomes in younger patients. This discrepancy might be due to differences in sample size or the specific surgical technique used.

Complications:
The complication rate in our study was relatively low, with infection, nail displacement, and knee stiffness each occurring in 3.3% of cases, and malunion in 3.3% of cases. Notably, we observed no cases of non-union. These rates are comparable to those reported by Khakharia et al. [74], who found similar complication rates in their series of distal femoral osteotomies.
The absence of non-union in our study is particularly encouraging and may be attributed to the stability provided by the distal femoral nail. This finding supports the observations of Brinkman et al. [73], who emphasized the importance of stable fixation in achieving successful union.
In conclusion, our study demonstrates that the use of distal femoral nails for correcting coronal plane deformities of the distal femur is an effective and safe procedure. The significant improvements in radiographic parameters, functional outcomes, and low complication rates are consistent with existing literature on distal femoral osteotomies. Future studies with larger sample sizes and longer follow-up periods may provide further insights into the long-term outcomes and potential advantages of this technique over other methods of fixation.

Conclusion
This prospective study on the correction of coronal plane deformities of the distal femur using distal femoral nails demonstrates promising results in terms of both radiographic and functional outcomes. The procedure proved effective across various age groups and BMI categories, with significant improvements in joint space width, alignment angles, and patient-reported functional scores.
The use of distal femoral nails resulted in satisfactory union rates, with an average time to union of 11.4 weeks. This relatively quick healing time, combined with the substantial improvements in knee range of motion, suggests that the technique provides adequate stability for early rehabilitation and functional recovery.
The low complication rate observed in this study, particularly the absence of non-union cases, further supports the safety and efficacy of this approach. However, the occurrence of minor complications such as infection, nail displacement, and knee stiffness highlights the need for meticulous surgical technique and appropriate post-operative management.
While the study shows encouraging results, it's important to note that long-term follow-up would be beneficial to assess the durability of the correction and the potential development of late complications. Additionally, future comparative studies with other fixation methods could further elucidate the specific advantages of distal femoral nails in managing these challenging deformities.
In conclusion, the use of distal femoral nails for correcting coronal plane deformities of the distal femur appears to be a viable and effective treatment option, offering good functional outcomes and a low complication rate. This technique may be particularly valuable in cases where stability and early mobilization are crucial for patient recovery.


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How to Cite this Article: Saheta A, Kale S, Chalak A. Evaluation of Safety and Efficacy of Distal Nail Implant for Correction of Coronal Plane Deformity: A Prospective Observational Study. Journal Medical Thesis 2024 January-June; 10(1):30-45.


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Assessing the Risk of Renal Microvascular Involvement in Patients with Type II Diabetes Mellitus


Vol 10 | Issue 1 | January-June 2024 | page: 13-29 | Swati P Panbude, Anita S Chalak, Prasad A Panbude, Rupesh Malla

https://doi.org/10.13107/jmt.2024.v10.i01.216


Author: Swati P Panbude [1], Anita S Chalak [2], Prasad A Panbude [3], Rupesh Malla [1]

[1] Department of Biochemistry, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, Maharashtra, India.
[2] Department of Biochemistry, K.E.M. Hospital, Mumbai, Maharashtra, India.
[3] Department of Anaesthesia, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, Maharashtra, India.

Address of Correspondence
Dr. Swati P Panbude,
Assistant Professor, Department of Biochemistry, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha, Maharashtra, India.
E-mail: drswatibs@gmail.com


Abstract

Aim: To assess the risk of Renal microvascular involvement in patients with Type II Diabetes Mellitus.
Objectives: To study the usefulness of various biochemical parameters as marker of renal microvascular damage, Type II DM patients. To study the relationship of inflammatory marker (hs¬CRP) with renal microvascular damage, in all the three groups.
Material and Methods: In present study, 150 individuals were included & divided into 3 groups, depending on their HbA1C levels: Group I (n=50) – Normal individuals (HbA1C 8%), Parameters were measured by : 1) Plasma glucose – GODPOD method, 2) Glycated hemoglobin – Latex agglutination inhibition assay, 3) Urine Microalbumin – Immunoturbidemetric method, 4) Sr. Urea – Urease-Kinetic method, 5) Sr. Creatinine – Modified Jaffe’s kinetic method, 6) Sr. Uric acid – UricasePAP method, 7) eGFR – Cockcroft Gault equation and 8) hsCRP by Turbidimetric immunoassay.
Results: FPG, PMPG, HbA1C, Microalbumin, Sr. Urea, Sr. Creatinine, Sr. Uric acid & hsCRP in Group III was significantly increased, as compared to Group I and II. eGFR was significantly decreased in group III than Group I & II. There was poor positive correlation of hsCRP with Microalbumin & eGFR in Group II. There was poor negative correlation of hsCRP with Microalbumin & eGFR in Group III.
Conclusion: HbA1c is a good predictor of long term glycemic control of type II DM patients. Also, microalbumin is one of the best parameter to assess renal damage, since it directly predicts the poor glycemic status of type II DM patients. In addition, eGFR level is a sensitive marker to assess renal damage in type II DM, since its level falls markedly with the onset of diabetic nephropathy.
Keywords: Diabetes Mellitus, Microalbumin, Inflammatory marker, Diabetic nephropathy


Introduction
The term Diabetes Mellitus (DM) describes a metabolic disorder of multiple aetiology characterized by chronic hyperglycaemia with disturbances of carbohydrate, fat and protein metabolism, resulting from defects in insulin secretion, insulin action or both. The total number of people with diabetes is projected to rise from 171 million in 2000 to 366 million in 2030 [1].
The two broad categories of DM are designated type I and type II. Type I result due to beta cell destruction, usually leading to absolute insulin deficiency. Type II DM is a heterogeneous group of disorders characterized by variable degrees of insulin resistance, impaired insulin secretion, and increased glucose production. About one third of those affected, will eventually have progressive deterioration of renal function [2].
Diabetes results in both microvascular and macrovascular complications. Among the microvascular complications, diabetic kidney disease is one of the most serious, with significant impact on morbidity, mortality, and quality of life [3]. Diabetic nephropathy occurs in approximately one-third of all people with diabetes and is the leading cause of renal failure in developed and developing countries [4]. Death due to renal disease is 17 times more common in diabetics than in nondiabetics [5].
Diabetic nephropathy affects all the kidney cellular elements, that is, glomerular endothelia, mesangial cells, podocytes, and tubular epithelia [6]. It is characterized by excessive accumulation of extracellular matrix (ECM) with thickening of glomerular and tubular basement membranes and increased amount of mesangial matrix, which ultimately progresses to glomerulosclerosis and tubulointerstitial fibrosis [6-8].
The National Diabetes Data Group and World Health Organization have issued diagnostic criteria for DM based on the following premises:
(1) the spectrum of fasting plasma glucose (FPG) and the response to an oral glucose load varies among normal individuals,
(2) DM is defined as the level of glycemia at which diabete-specific complications occur rather than on deviations from a population-based mean.
Interventions effective in slowing progression from microalbuminuria to overt nephropathy include:
(1) near normalization of glycemia,
(2) strict blood pressure control,
(3) administration of ACE inhibitors or ARBs and
(4) treatment of dyslipidemia.
Improved glycemic control reduces the rate at which microalbuminuria appears and progresses in type I and type II DM. However, once overt nephropathy exists, it is unclear whether improved glycemic control will slow progression of renal disease. During the phase of declining renal function, insulin requirements may fall as the kidney is a site of insulin degradation. Furthermore, glucose-lowering medications (sulfonylureas and metformin) are contraindicated in advanced renal insufficiency. Different studies identified different markers for detection of diabetic nephropathy.
According to Shehnaz A Sheikh et al, screening for microalbuminuria (MAU) and glycosylated hemoglobin (HbA1c) test should be done in both newly and already diagnosed type II diabetic patients as an early marker of renal dysfunction and glycemic control [9].
Mohd. Idrees Khan et al, discovered that the early detection of MAU combined with glycemic control and improved lipid profile are fundamentals in prevention and control of diabetic complications [10]. Microalbuminuria also showed a significant correlation with HbA1c and duration of diabetes, thus serving as an invaluable tool in monitoring of glycemic status and screening for diabetic nephropathy [11].
There is an additive value of micro total protein estimation along with eGFR assessment in diagnosing incipient nephropathy and hence, increasing the chances of detecting renal damage at initial stages in type II diabetes mellitus patients [12]. New formulae for the calculation of eGFR corrected by the glycemic control indices were said to be better than the original eGFR, particularly in diabetic patients [13].
According to a survey done in year 2014, serum hs-CRP levels, independent of possible confounders, were associated with a subsequent risk of developing, not progressing, diabetic nephropathy in type II diabetic patients.14 In fact, serum hs-CRP may be useful for predicting the future risk of developing diabetic nephropathy [14].
In support one of the studies done in 2015, it was concluded that, the increase in serum hs-CRP value in type II diabetic patients increase the risk of diabetic nephropathy and thus increase the value of serum uric acid level [15]. Serum uric acid is also said to be a strong and independent risk factor for diabetes [16]. According to Suryawanshi K.S., et al, serum uric acid and urine microalbumin are not only early diagnostic markers for atherogenic cardiovascular disease and renal disease but also prognostic monitoring of the disease in type II diabetes mellitus patients [17].
Several studies were done in the past on identifying the various factors causing and not preventing, diabetic nephropathy. Subsequent studies showed that, microalbumin and eGFR are the markers of renal microvascular damage in type II diabetes mellitus [18]. These studies encouraged us to design the present study for early identification of at risk diabetic patients for diabetic nephropathy using screening tools like serum and urinary markers, that will help in preventing and/or postponing renal microvascular complications.
We, therefore, studied the usefulness of fasting and postmeal plasma glucose, glycosylated hemoglobin (HbA1c), microalbumin, serum urea, creatinine, uric acid, estimated glomerular filtration rate (eGFR) and highly sensitive C-reactive protein (hs-CRP), as a marker of renal microvascular damage in all the three groups i.e., normal, well & poorly controlled type II diabetes mellitus. We have also studied two important correlations of inflammatory marker with renal microvascular damage marker i.e., hs-CRP with microalbumin and hs-CRP with eGFR.
With this background, we aim to assess the risk of renal microvascular involvement in patients of type II diabetes mellitus.

Review Of Literature
Molnar M et. al. in 2000 [19], studied the prevalence of microalbuminuria (MA) and macroalbuminuria (MAA), their relationship with other diabetic complications and with some known cardiovascular risk factors in 200 in type II diabetic patients (100 females and 100 males). Sixty eight patients (33%) were normalbuminuric (NA), 55 (27.5%) had MA and 77 (38.5%) had MAA. There was no significant difference among these three groups in age, BMI or the time actually elapsed since the diabetes and hypertension were diagnosed. BMI was high in each group (28.8 ± 5.29, 28.0 ± 5.2 and 29.8 ± 4.6 kg/m2 mean ± SD). Sixty five percent of patients with NA, 77% of those with MA and 81% of patients with MAA had hypertension. MAA patients were more frequently smokers and former smokers, than MA and NA patients (56% vs 32% and 22%). Average GFR values (ml/min/1.73 m2) were 71.9 ± 26.8 in NA patients, 82.3 ± 36.8 in MA patients and 56.3 ± 32 in MAA patients. There was no significant correlation between the urinary albumin excretion (UAE) and glycemic control, serum cholesterol and serum HDL cholesterol. At the same time UAE showed a significant positive correlation with serum trigliceride (P < 0.01), serum uric acid (P < 0.01) and serum creatinine (P < 0.01) while a significant negative correlation was found with GFR (P < 0.01). Diabetic non-proliferative retinopathy (RP) was detected even in NA patients (27%) while 51% of MAA patients were without RP. Fifty six percent of NA patients, 57% of MA patients and 93% of MAA patients had macroangiopathy. They finally concluded that:
(1) renal function can be impaired even in type II diabetic pts with NA and MA,
(2) well-known cardiovascular risk factors seem to have a close relation with renal damage in type II diabetes,
(3) renal lesions in type II diabetic pts may be caused by diseases other than diabetes (e.g. arteriosclerosis, hypertension),
(4) unlike in type I diabetes, where the strict glycemic control is the main preventive factor of diabetic nephropathy, in type II diabetes, the control of hypertension, hyperlipidemia, obesity, hyperuricemia may have priority.
Garg, et. al. in 2002 [20], observed that a number of screening criteria, applied either at a single point in time or serially, can be used for the purpose of identifying individuals at risk of end-stage renal disease (ESRD). This study focused on two such criteria measured on a single occasion, proteinuria and renal insufficiency, and examined their prevalence in a sample representative of the adult U.S. non-institutionalized population. Such knowledge guides the utility of population screening to prevent ESRD. The prevalence of albuminuria (microalbuminuria and macroalbuminuria from a random urine albumin-to-creati- nine ratio) and renal insufficiency [GFR estimated from serum creatinine] was determined in different age categories in various adult screening groups in the cross-sectional ‘Third National Health and Nutrition Examination Survey (NHANES III)’. A total of 14,622 adult participants were included in the analysis. In the general population, 8.3% and 1.0% of participants demonstrated microalbuminuria and macroalbuminuria, respectively. To identify one case of albuminuria, one would need to screen three persons with diabetes mellitus, seven non-diabetic hypertensive persons, or six persons over the age of 60. When albuminuria and renal insufficiency were considered together, it was clear that these tests were identifying different segments of the population; 37% of participants with a GFR less than 30 mL/min/1.73m2 demonstrated no albuminuria. Non-albuminuric renal insufficiency was most evident in the ages of 60 to 79; 34% of diabetics and 63% of non-diabetic hypertensives with a GFR less than 30 mL/min/1.73m2 demonstrated no albuminuria. They concluded that, albuminuria is prevalent, and when considered together, screening tests of albuminuria and renal insufficiency measured on a single occasion identify different segments of the population. The prevalence of albuminuria and renal insufficiency in populations of interest should be considered, as this knowledge has implications for the effectiveness of screening.
Banerjee, et. al. in 2005 [21], studied the status of GFR estimation vis-a-vis other noninvasive modes of assessment of renal involvement in type II diabetes mellitus and assessment of the temporal profile of the prevalence of nephropathy with a cross sectional cohort. A total of 100 patients of type II diabetes mellitus were selected after screening and segregated into 3 groups according to duration of type II diabetes mellitus. Duration of <5 years constituted group A and had 31 patients, group B duration was between 5-15 years and had 40 patients, rest belonged to group C with duration >15 years. The parameters studied and compared were:
(1) various grades of albuminuria- normal, micro and macro by 24 hrs urinary albumin excretion rates (UAER-gm/24hr),
(2) sonologically detected renal size(normal, small, large) and morphology (loss or presence of corticomedullary differentiation,
(3) serum creatinine level (</> 1.4 mg/dl) and
(4) different levels (high, normal, low, very low) of GFR (ml/min) by Diethylene Triamine Tetra-acetic acid) DTPA renal scan.
There was high prevalence of nephropathy in all durations. Microalbuminuria had a high prevalence in patients of shorter duration (group A-74.2%). Albuminuria increased with duration but plateued off with longer duration (>15 yrs) (UAER- 0.0842 ± 0.083 vs. 0.906 ± 0.84 vs. 1.346 ± 1.28). Sonographic loss of corticomedullary differentiation and azotemia were late feature only and none had a contracted kidney. Only the parameter of GFR showed a graded and rather linear decrement with duration (132.57 ± 19.3 vs. 76.33 ± 20.8 vs. 40.08 ± 17.1). Hyperfiltration had a high prevalence in patients of early detection (61.3%) and was the earliest change noted before change in any other parameter. GFR shows wide variation in various grades of albuminuria, especially microalbuminuria and azotemia. A value in the normal range was uncommon (8%). They concluded that, GFR estimation is probably the most rational noninvasive mode of assessing the renal status in patients of type II diabetes mellitus, irrespective of the status of the other noninvasive methods as they express significant variation in inception and progression.
Parving, et. al. in 2006 [22], described the characteristics in a referred cohort of type II diabetic patients in the developing education on microalbuminuria for awareness of renal and cardiovascular risk in diabetes study evaluating the global prevalence and determinants of microalbuminuria (MA). A cross-sectional study evaluating 32,208 type II diabetic patients without known albuminuria from 33 countries was performed. Overall, 8057 patients were excluded, either because of prior known proteinuria or non-diabetic nephropathy (3670), or because of invalid urine collections (4387). One single random urinary albumin/creatinine ratio was obtained in 24,151 patients (75%). The overall global prevalence of normo, micro, and macroalbuminuria was 51%, 39% and 10%, respectively. The Asian and Hispanic patients had the highest prevalence of a raised urinary albumin/creatinine ratio (55%) and Caucasians the lowest (40.6), P<0.0001. HbA1c, systolic blood pressure, ethnicity, retinopathy, duration of diabetes, kidney function, body height and smoking were all independent risk factors of MA, P<0.0001. eGFR was below 60 ml/min/1.73m2 in 22% of the 11,573 patients with available data. Systolic BP below 130 mmHg was found in 33 and 43% had an HbA1c below 7%. The frequency of patients receiving aspirin was 32%, statins 29% and BP-lowering therapy 63%. A high prevalence globally of MA and reduced kidney function, both conditions associated with enhanced renal and cardiovascular risk, was detected in type II diabetic patients without prior known nephropathy. Early detection, monitoring of vascular complications and more aggressive multifactorial treatment aiming at renal and vascular protection are urgently needed.
Hanan M. Kamel, et. al. in the year 2008 [23], studied the assessment of the urinary α -1 microglobulin and its relation to microalbminuria as regarding early prediction of diabetic nephropathy and glycaemic control in diabetic patients. The study population included 60 subjects; they were classified into three groups: Group 1: 21 patients with type I diabetes mellitus under insulin therapy and dietary control; Group II: 21 patients with type 2 diabetes mellitus under oral hypoglycaemic therapy; Group III: 18 apparently healthy subjects. All cases and control groups were subjected to the following, complete history taking, complete physical examination, lab investigations included fasting, post prandial blood glucose, Glycated Hb (HbA1c), kidney function tests(blood urea, serum creatinine), lipid profile tests(total cholesterol, serum triglyceride(TG), high density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol, urine tests included creatinine urine, microalbuminuria, urinary α-1 microglobulin. They found that there was statistically significant increase in blood glucose level, serum urea level, TG, HDL-cholesterol in group I when comparing to group III (p-value=0.0001) also there was statistically significant increase in blood glucose level, all serum lipid profile in group II when comparing to group III (p-value=0.0001, but p-value=0.02 for serum total cholesterol, LDL-cholesterol).
Also there was statistically significant decrease in serum urea level (p-value=0.0001) and serum total cholesterol (p-value=0.05) when comparing group I to group II. There was statistically significant increase in microalbumin, α-1 microglobulin, HbA1c, microalbumin/creatinine ratio when comparing group I to group III (P-value= 0.05, 0.006, 0.02, <0.02 respectively). Also there was statistically significant increase in microalbumin, α-1 microglobulin, HbA1c, microalbumin/creatinine ratio and α-1 microglobulin/creatinine ratio, all with (P value = 0.0001) when comparing group II to group III but there was statistically significant decrease in microalbumin with (p value = 0.007), statistically significant increase in α-1 microglobulin (P value =0.01), statistically significant decrease in HbA1c with (p value= 0.009), statistically significant decrease in microalbumin/creatinine ratio with (p value = 0.01) when comparing group I to group II. In addition, in group I there was significant positive correlation between HbA1c and microalbuminuria (r value = 0.7, P =value 0.0001), the same in group II, also in group I there was significant positive correlation between α-1 microglobulin and HbA1c (r value 0.56, P valve 0.009),the same correlation in group II (r value 0.70 with p value 0.001) Also in group I and group II there was positive correlation between microalbumin/creatinine ratio and each of microalbumin, α-1 microglobulin, and HbA1c (r=o.6, p value=0.002), (r=0.66, p value=0.000), (r=0.40, p value=0.06) in group I respectively but in group II (r=0.73, p value=0.0001), (r=0.53, p value=0.01), (r=0.68, p value= 0.001) respectively, also this study showed significant correlation between α-1microglobulin/creatinine ratio and α-1microglobulin in group I only. They concluded that α-1 microglobulin, microalbumin are considered the best predicted markers for early glomerular and proximal tubular dysfunction predicting diabetic nephropathy.
Abbas Dehghan, et. al. in 2008 [24] study, investigated the association between serum uric acid level and risk of type II diabetes. The population for analysis consisted of 4,536 subjects free from diabetes at baseline. During a mean of 10.1 years of follow-up, 462 subjects developed diabetes. They observed that, the age- and sex-adjusted hazard ratios (HRs) (95% CIs) for diabetes were 1.30 (0.96 –1.76) for the second, 1.63 (1.21–2.19) for the third, and 2.83 (2.13–3.76) for the fourth quartile of serum uric acid, in comparison with the first quartile. After adjustment for BMI, waist circumference, systolic and diastolic blood pressure, and HDL cholesterol, the HRs decreased to 1.08 (0.78 –1.49), 1.12 (0.81–1.53), and 1.68 (1.22–2.30), respectively. They concluded that, the results of this population-based study suggest that serum uric acid is a strong and independent risk factor for diabetes.
Mohammad Afkhami-Ardekani, et. al. in 2009 [25], studied that, Type II diabetes is a common disorder recognized as a major health problem in Iran. Diabetes is a major source of morbidity, mortality and economic cost to society. Diabetic patients are at risk of experiencing macrovascular and microvascular complications of diabetes. The aim of this study was to assess the prevalence of type II diabetes complications and their contributing factors. This cross-sectional study was carried out on 1000 the type II diabetic patients referred to Yazd Diabetes Research Center. All diabetic patients underwent the specific tests for retinopathy, nephropathy, neuropathy, peripheral vascular diseases (PVD) and
cardiovascular diseases (CAD). Logistic regression analysis was used to find out strength of association of risk factors with a specific complication. In this study 1000 type II diabetic patients (457 male, 543 female) were studied. Nephropathy was diagnosed in 285 (28.5%), retinopathy in 519 (51.9%), CAD in 251 (25.1%), PVD in 143 (14.3%), CVA in 109 (10.9%) and foot ulcer in 84 patients (8.4%). They finally concluded that the most important contributing factors in diabetic complications were age, duration of diabetes, systolic and diastolic blood pressure, glycated hemoglobin and body mass index (BMI). So glycemic and blood pressure control can prevent diabetic complications or at least delay them.
According to a study by Shehnaz A Sheikh, et. al. in 2009 [10], diabetes is one of the most common endocrine disorders characterized by hyperglycemia. Diabetic nephropathy is a consequence of long standing diabetes. The prevalence of microalbuminuria predicts progression to diabetic nephropathy. The present study was conducted to determine the prevalence of microalbuminuria in relation to duration of diabetes, BMI, serum creatinine and HbA1c in an ethnic group of type II diabetes mellitus residing in Karachi. This cross-sectional descriptive study was carried out in a community diabetic centre, located at Garden East Karachi from july to december 2007. One hundred known type II diabetic patients with age 30–70 years were included in the study. Informed consent and a structured questionnaire of each patient were recorded. Fasting venous blood and morning urine sample was collected for analysis of creatinine, HbA1c and microalbuminuria respectively. Pearson correlation was applied to observe association of microalbuminuria with different parameters. All p-values <0.05 were considered as statistically significant. Microalbuminuria had a highly significant correlation with duration of diabetes, serum creatinine (p<0.001), HbA1c (p<0.05) and BMI (p<0.024). A strong correlation exists between age and serum creatinine (r=0.73). The present study found an early onset of microalbuminuria in the selected community which could be due to poor glycaemic control (high HbA1c >7%) or heredity factors. Screening for microalbuminuria and HbA1c test should be done in both newly and already diagnosed type II diabetic patients as an early marker of renal dysfunction and glycemic control.
Francisco Javier del Canizo Gomez, et. al. in 2011 [26], conducted a prospective study in patients with type II diabetes mellitus with no microvascular complications, analyzing the association between various baseline risk factors and development of microvascular complications at follow-up. A prospective, observational study in 376 patients with type II diabetes mellitus enrolled in 2004. The clinical end-point was urinary albumin excretion (UAE)>30 mg/24h and/or presence of retinopathy at follow-up in 2007. Baseline variables included age, gender, duration of type II diabetes mellitus, fasting plasma glucose, glycated hemoglobin (HbA1c), systolic and diastolic blood pressure, body weight, height, BMI, waist circumference, total cholesterol, TGs, HDL-C, LDL-C, hs-CRP, fibrinogen, UAE, creatinine, smoking status, exercise, alcohol consumption, use of hypoglycemic and lipid-lowering drugs, antihypertensive medications, and other data related to family history of diabetes and risk factors. Ninety-five subjects (25.2%) developed a microvascular complication at the end of the follow-up period. In logistic regression analyses, the main independent risk factors were UAE>12 mg/24h (odds ratio [OR]: 6.12; P = 0.000), hs-CRP> 3 mg/L (OR: 3.00; P = 0.004), and hypertension (OR: 2.43; P = 0.023). They found that, UAE levels higher than 12 mg/24 h, hs-CRP >3 mg/L, and presence of hypertension were all independent risk factors for development of microvascular complications in patients with type II diabetes mellitus studied.
Doyle M. Cummings et. al in another study of 2011 [27], studied that, reducing glycosylated hemoglobin (HbA1c) to near or less than 7% in patients with diabetes is associated with diminished microvascular complications, but this level is not consistently achieved. The purpose of this study was to examine the relationship between fluctuations in HbA1c and changes in eGFR and estimated stage of chronic kidney disease (CKD) in an academic primary care practice. They analyzed data from 791 diabetic primary care patients (25% white; 75% African American) enrolled between 1998 to 2002 and followed through 2008 (mean follow-up, 7.6-1.9 years). They calculated baseline and final follow-up eGFR using the modification of diet in renal disease equation. They examined the relationship between fluctuations in HbA1c and changes in eGFR and stage of CKD using multivariable linear and logistic regression models that controlled for demographic and clinical variables associated with CKD progression. From baseline to follow-up, mean eGFR in african americans declined to a greater extent and more rapidly than in whites. Age, mean systolic blood pressure, initial HbA1c, initial eGFR, and number of HbA1c values (all P <0.01) were significant predictors of change in eGFR. Among HbA1c fluctuation measures, the strongest predictor of change in eGFR was the proportion of HbA1c values >7% (P <0.02); however, this contributed little to explaining model variance. They finally found that traditional demographic and clinical risk factors remain significantly associated with changes in eGFR and that the pattern of variability in HbA1c is only modestly important in contributing to changes in eGFR among African-American and white diabetic patients in primary care.
Deepa.K, et. Al in 2011 [28], stated that, India as a developing country has more prevelance of diabetes and now has more people with type II diabetes (more than 50 million) than any other nation. Diabetes mellitus is a chronic metabolic disorder that can lead to cardiovascular, renal, neurologic and retinal complications. Type II diabetes has quickly become a global health problem due to rapidly increasing population growth, aging, urbanization and increasing prevalence of obesity and physical inactivity. A total of 40 diabetic patients of both sex aged between 35 to 75 years attending medicine OPD were included in the study. After obtaining informed consent from the study group 5 ml of fasting venous blood sample was collected. Plasma glucose was estimated by GOD – POD method. Estimation of plasma creatinine was done by the modified jaffe’s method. Serum urea was estimated by urease-berthelot’s method. There was significant increase in levels of serum urea, creatinine and FPG (p<0.001) in diabetic patients compared to healthy controls. On applying pearson’s correlation serum urea correlated positively with creatinine (p<0.001, r = 0.910) in cases and also in controls (p<0.001, r = 0.868). Blood urea and creatinine is widely accepted to assess the renal functions. Good control of blood glucose level is absolute requirement to prevent progressive renal impairment.
Nirmitha Dev, et al, in the year 2012 [29], discovered that, hs-CRP, a non specific inflammatory marker has been shown to be increased in metabolic syndrome a risk state for the development of cardiovascular disease and type II diabetes mellitus. Obesity is a predisposing condition to metabolic syndrome. Therefore, this study was intended to measure hs-CRP levels in obese females to assess their risk status. 55 healthy adult obese females with BMI >23 kg/m2 were taken as cases and 55 age matched healthy adult non-obese females with BMI <23 kg/m2 were taken as controls. Anthropometric measurements (waist circumference, hip circumference & waist to hip ratio) and biochemical estimations (blood glucose, hs-CRP and lipid profile) were carried out. There was significant increase in waist circumference, fasting blood sugar, total cholesterol, TG, VLDL, LDL levels and hs-CRP levels in obese females as compared to controls. Blood glucose levels & lipid profile were within the reference range in both obese and non obese females. hs-CRP did not show any correlation with blood glucose or lipid profile. hs-CRP behaved as an independent inflammatory marker in obesity. Therefore, hs-CRP might be an early novel marker of inflammation, for identifying the obese females who are at risk for obesity related co-morbidities.
Mohd. Idrees Khan, et al in 2012 [11], found that an Inflammatory marker hs-CRP may play role as predictor of inflammation in patients with type II diabetes. The aim of this study was to estimate hs-CRP levels and glycemic control status and to determine association with microalbuminuria. The relationship between inflammation and microalbuminuria complications in type II diabetes mellitus which has not yet been reported in North Indians. Forty two patients with microalbuminuria and twenty type II diabetes without microalbuminuria were enrolled. We analyzed serum concentrations of hs-CRP, serum lipid profile, HbA1c and urine microalbumin levels. HbA1C and hs-CRP were significantly higher in patients with microalbuminuria diabetic cases than without microalbuminuria (p<0.0001). Furthermore, hs-CRP was poorly correlated with urinary albumin excretion (p=0.002). This study concludes that inflammation is involved in the pathogenesis of microalbuminuria. The significance of these findings emphasizes the early detection of MAU combined with glycemic control and improved lipid profile which are fundamentals in prevention and control of diabetic complications.
Sudhindra Rao M, et al in 2012 [30], have reported that high serum levels of uric acid are strongly associated with prevalent health conditions such as obesity, insulin resistance, metabolic syndrome, essential hypertension and renal disease. This study aimed to investigate the level of serum uric acid in Type II diabetes mellitus, pre-diabetics and non diabetics (controls) in south Indian population. Uric acid level was measured by uricase-PAP methodology in patients with diabetes (n=71)/pre diabetes (n=12)/control groups (n=34). Using ANOVA test, uric acid levels in the above three groups were compared based on age, sex and other factors which can affect uric acid level. The mean serum uric acid level was lower in control group (3.84 mg/dl), rose in pre-diabetics (4.88 mg/dl) and again decreased in diabetics (3.78 mg/dl). P value comparing control and pre-diabetes was 0.009, p-value comparing pre-diabetes and diabetes was 0.003 and p-value comparing control and diabetes was 0.982 (p value <0.05 being significant).They found that, the serum uric acid level being higher in pre-diabetes than controls and lower in diabetes mellitus than pre-diabetes may serve as a potential inexpensive biomarker of deterioration of glucose metabolism.
Gurprit Grover, et. al. in another study conducted in year 2012 [31],, found that, diabetes affects more than 170 million people worldwide and the number will rise to 370 million people by 2030. About one third of those affected, will eventually have progressive deterioration of renal function. To estimate progression of renal disease among type II diabetic population, with serum creatinine, in the presence of covariates: fasting blood glucose, systolic BP, diastolic BP and LDL, duration of disease and age at which diabetes was diagnosed. Retrospective data collected from 132 patients, who were diagnosed as diabetic as per ADA standards with or without diabetic complications. Multiple linear regression (MLR) and logistic regression models were adopted to estimate and predict serum creatinine, a well-accepted marker for the progression of diabetic nephropathy. The fitted multiple linear regression models were found to be statistically significant, with p <0.001, fitted logistic models have 88.5% and 84.7% predictive power to assess the renal disease based on mean values of predictors and last record of predictors, respectively. It was concluded from the models, which were based on mean values of records, that high blood glucose and high blood pressure along with duration of diabetes are the main contributors for estimating serum creatinine and predicting diabetic nephropathy.
Sangeeta Kapoor, et. al. in 2014 [13], observed that, Diabetic nephropathy is a leading cause of end stage renal damage, characterized by decreased GFR and proteinuria in patients of Type II diabetes mellitus. In order to device a means to protect kidneys at an early stage, this study has examined micro total protein (MTP) in 24 hrs urine along with eGFR by modification of diet in renal disease (MDRD) and Cockroft-Gault (CG) prediction equations as predictor of early renal damage in type II diabetes mellitus. They examined the eGFR and MTP in 24 hrs urine sample as independent predictors of renal damage in type II diabetes mellitus patients and also to study the additive value of eGFR and MTP in diagnosing incipient diabetic nephropathy. Urinary 24 hrs proteinuria was assessed by pyrogallol red dye method and GFR estimated using MDRD and CG prediction equations. The mean ± standard deviation of MTP was compared between diabetic patients (1913.3 ± 2084.15 mg/24 hrs) and non-diabetic controls (189.5 ± 66.72 mg/24 hrs), found significant proteinuria in diabetic patients. The eGFR estimated by MDRD equation compared between diabetics (75.44 ± 30.85 mL/min/1.73 m2) and non-diabetic controls (103.52 ± 24.69 mL/min/1.73 m2) and eGFR by CG compared between diabetics (71.34 ± 32.63 mL/min) and non-diabetic controls (99.44 ± 25.37 mL/min) were found significantly decreased in diabetic patients. MTP correlated with eGFR estimated by both the equations (rMTP−MDRD = −0.544 and rMTP−CG = −0.452) and found to be significant at P <0.01 and <0.05, respectively. It has also been seen that MTP correlation with eGFR (MDRD) is better than MTP correlation with eGFR (CG).They finally concluded that, there is an additive value of MTP estimation along with eGFR assessment in diagnosing incipient nephropathy and hence, increasing the chances of detecting renal damage at initial stages in type II diabetes mellitus patients.
Geetha Bhaktha, et. al. in 2014 [32], found that, C-reactive protein is considered as one of the most sensitive markers of systemic inflammation. Studies have found that increase in the levels of C-reactive protein is associated with the vascular complications. Hence the author aimed in finding the correlation of hs-CRP with other risk factors like BMI, FBS and HbA1c in diabetic subjects who have still not developed any micro and macrovascular complications. 229 cases of type II diabetics and 205 healthy individuals were selected as per the criteria. BMI was calculated, FBS was estimated by glucose-oxidase-peroxidase method. hs-CRP was estimated by immunoturbidometric technique. The group was divided into low risk and high risk group as per their hs-CRP level. Correlation was seen with other factors like BMI, FBS and HbA1c. The level of hs-CRP was high in diabetic subjects when compared to normal individuals. Further when the diabetic subjects were divided into high risk and low risk groups, the difference between the groups were statistically significant. hs-CRP failed to show any correlation with BMI, FBS and HbA1c. Diabetes is considered as an inflammatory disease hence they observed an increase in the hs-CRP level in diabetes than in the normal. Since the vascular complication was totally absent hs-CRP failed to show any correlation with BMI, FBS and HbA1c.
Yasuaki Hayashino, et. al. in 2014 [15], assessed the prospective association between baseline serum hs-CRP concentration and the subsequent risk of development or progression of diabetic nephropathy. Longitudinal data was obtained from 2,518 patients with type II diabetes registered in a Japanese diabetes registry. To assess the independent correlations between serum baseline hs-CRP and either the development or progression of diabetic nephropathy 1 year later, the Cox proportional hazards model was used and adjusted for potential confounders. The mean patient age, BMI, and HbA1c level were 66.1 years, 24.6 kg⁄m2, and 7.5% (57.6 mmol/mol), respectively. Baseline serum hs-CRP levels were significantly associated with the urinary albumin-to-creatinine ratio at baseline (P <0.001). Multivariable adjusted hazard ratio for the development from normoalbuminuria to microalbuminuria was 1.31 (95% CI 0.80–2.17; P = 0.286), 1.55 (1.16–2.08; P = 0.003), and 1.57 (1.22–2.03; P = 0.001), respectively, for the second, third, and fourth quartiles of serum hs-CRP levels, showing a statistically significant linear trend across categories (P < 0.001). They did not observe a significant association between hs-CRP levels and the subsequent risk of diabetic nephropathy progression (P for trend = 0.575). They concluded that, serum hs-CRP levels, independent of possible confounders, were associated with a subsequent risk of developing, not progressing, diabetic nephropathy in type II diabetic patients. Serum hs-CRP may be useful for predicting the future risk of developing diabetic nephropathy.
Anwarullah, et. al. in another study of 2014 [33], discovered that, microalbuminuria is often the first sign of renal dysfunction (nephropathy) in diabetes mellitus. The current study was aimed at determining the microalbuminuria levels in type II diabetes and to correlate changes in microalbuminuria levels with the HbA1c levels in type II diabetic patients. The study was conducted at the Islamabad Diagnostic Centre, Islamabad, Pakistan. Patients with type II diabetes aged between 30-60 years were included in the study. Patients with systemic diseases like cardiovascular diseases, cerebrovascular diseases and urinary tract infection was excluded from the study. Fasting blood samples were used to analyze HbA1c levels for the estimation of diabetic control and subsequently random urine specimens to investigate microalbumin level of all the individuals under study. The study showed that microalbuminuria levels were linearly correlated to those of HbA1c levels. They found that, impaired glycemic control is associated with significant elevations in urinary microalbumin levels which suggest that the monitoring of microalbuminuria levels at the early stages of diabetes can avert and reduce the clinical and economic burden of auxiliary complications (nephropathy etc.) in the developing countries like Pakistan.
Ritika Kumar Tandon et. al. in 2014 [12], studied that, nephropathy is a common complication of diabetes mellitus that could lead to End Stage Kidney Disease (ESKD). Microalbuminuria is important as an ‘early marker’ of renal disease as it represents a time when renal biopsy shows no or minimal changes. HbA1c represents the average glucose concentration over the period of 2-3 months and is accepted as a useful index of mean blood glucose. The purpose of the study was to study the relationship between HbA1c and urinary microalbumin in patients of type II diabetes mellitus. A prospective study was conducted on 200 known diabetics. Detailed history was taken and thorough physical examination of all the patients was done followed by HbA1c estimation by Bio Rad D10 HPLC machine and microalbumin by Nyco Card Microalbumin test kit. 56.5% of the cases were males and 43.5% females. 43.5% cases were positive for microalbumin, of which 47% had duration of diabetes between 5 to 10 years (p<0.05). 35% cases had HbA1c in the range of 8.1-10% of which 67% had microalbuminuria (p<0.05) . Microalbuminuria showed a significant correlation with HbA1c and duration of diabetes, thus serving as an invaluable tool in monitoring of glycemic status and screening for diabetic nephropathy.
Sanjeev Kumar et. al. in the year 2014 [34], stated that, insulin resistance is characterized by a subnormal response to a given concentration of insulin and can be measured indirectly by a fasting insulin level. The prevalence of diabetes continues to grow worldwide, disease-related morbidity and mortality is emerging as major healthcare problems. Clearly, type II diabetes has a strong genetic component. Diabetic nephropathy is the leading cause of ESRD in US and a leading cause of diabetes mellitus related morbidity and mortality. Nephropathy complicates approximately 30% of type II diabetic patients. However no study has been performed that compared the HbA1c in type II diabetes mellitus with nephropathy to without nephropathy. Therefore aim of the study was to evaluate the glycosylated hemoglobin and their association with diabetic nephropathy in a western Uttar Pradesh. Venous blood was collected after 12 hours fasting into two test tubes; with no anticoagulant for serum creatinine, and with Ethylene Diamine Tetra Acetic Acid (EDTA) for HbA1c. They observed that Incidence of microalbuminuria increases with age as well as with increased duration of diabetes mellitus. Their study also evaluated relationship between diabetic retinopathy and nephropathy and found a significant correlation.
Thomas Vijatha et. al. in 2014 [35], studied the prevalence of DM and found that it has been increasing worldwide including India, both in rural and urban dwellers. Studies have shown prevalence rate of DM to be 2-4% in rural and 4-11% among urban dwellers. In parallel with increase in diabetes a dramatic increase in prevalence of diabetic nephropathy has been noted which is the single most common cause of ESRD. HbA1c is currently accepted as the most diagnostic and prognostic biomarker of glycemic control in subjects with diabetes. However, in diabetic patients with CKD, HbA1c may not be the most informative biomarker of glycemic index. Therefore objective of the study was to assess whether HbA1c is a reliable indicator of diabetic status in CKD patients in the advancing stage. 120 diabetic subjects with CKD, who were not on maintenance hemodialysis, were included in the study. They were divided into 4 groups depending on eGFR: Group I (n=30, eGFR ≥60ml/min/1.73m2), Group II (n=30, eGFR: 60-30ml/min/1.73m2), Group III (n=30, eGFR: 30-15ml/min/1.73m2), Group IV (n=30, eGFR <15ml/min/1.73m2). Their blood samples were used to measure glucose, HbA1c, serum creatinine and hemoglobin. eGFR was estimated using the four-variable MDRD formula using electronic abstraction. A significant correlation (p value of 0.00) was found between HbA1c and eGFR. Also significant change is seen in hemoglobin with change in eGFR. Significantly lower HbA1c values were seen in diabetic patients with advancing stage of CKD who were not on maintenance hemodialysis.
Akihiro Tsuda, et. al. in 2014 [14], found that, serum creatinine levels are lower in diabetic patients compared with their nondiabetic counterparts. Therefore, eGFR is higher in the former than in the latter group. Factors associated with overestimation of renal function in diabetic patients were examined and new formulae reflecting precise eGFR were created. Eighty subjects (age 56.5615.4years; 35 males[43.8%]; 40 patients with diabetes and 40 nondiabetic subjects) were enrolled. GFR was evaluated by inulin clearance (Cin). eGFR values were calculated based on serum creatinine and/or serum cystatin C levels. The factors related to the dissociation between eGFR and Cin in diabetic patients and the agreement among each of three eGFR and Cin were compared. Although Cin was not significantly different between the diabetic and nondiabetic subjects (P =0.2866), each of three eGFR measures from the diabetic patients was significantly higher than that of the nondiabetic subjects (P <0.01). There were significant and positive correlations between the ratio of each eGFR/Cin, HbA1c, and glycated albumin. The intraclass correlation coefficients in diabetic patients were weaker than those in the nondiabetic subjects and the intercepts of the regression lines between each eGFR measure and Cin in the diabetic patients were significantly higher than those of the nondiabetic subjects. New formulae for the calculation of eGFR corrected by the glycemic control indices were better than the original eGFR, particularly in diabetic patients. So, they concluded that, eGFR overestimates Cin as glycemic controls worsen. eGFR corrected by HbA1c is considered to be clinically useful and feasible.
Rohitash Kumar et. al. in 2014 [36], stated that, high values of renal function tests are associated with type II diabetes mellitus. But there are studies that found that the levels of creatinine and uric acid are low in cases of diabetes mellitus. Comparative studies related to serum renal function tests with eGFR and blood glucose in type II DM is less. Hence the study was undertaken to study the renal function test and its correlation with blood glucose and eGFR in type II DM. 25 freshly diagnosed cases of type II diabetes mellitus and 25 healthy controls were studied. It is found that mean serum urea levels were 25.80±6.75 mg/dl in controls and 34.08±9.62 in cases, which was statistically highly significant. Mean serum creatinine and uric acid values were also highly significant (p=0.0002) in cases, as compared to controls. Significant positive correlation was found between FBS (p<0.001) and PPBS (p<0.0001) with the eGFR and renal function tests in both cases and controls. Their study showed that, urea, creatinine and uric acid levels are towards higher reference limits in cases compared to controls.
Jay Prakash Sah, et. al. in the year 2015 [16], found that, hs-CRP is an α globulin produced by liver as a marker of inflammation. It may play a role as predictor of inflammation in diabetic nephropathic patients. The aim of present study was to estimate hs-CRP levels and blood uric acid and to determine association between them. The relationship between inflammation and blood uric acid level in type II diabetes has not yet been reported in Nepalese population. So a quantitative, analytical study were done by enrolling 89 type II diabetic patients conducted at Tertiary care Hospital. They analyzed serum concentrations of hs-CRP, serum uric acid, blood glucose and family history of the patients. In their study, they found the significant association between serum hs-CRP and serum uric acid level (P values=0.001). They also found the significant association between serum hs-CRP and blood glucose level (P values <0.01). Furthermore, serum hs-CRP was not correlated with family history of patients (P >0.599) and sex (P >0.08). They concluded that the increase in serum hs-CRP value in type II diabetic patients increase the risk of diabetic nephropathy and thus increase the value of serum uric acid level. And there is no correlation of both serum hs-CRP and uric acid level with the risk factors especially sex and family history of type II diabetes. The significance of these findings emphasizes to choose these association for early screening of diabetic nephropathy in type II diabetic patients to prevent from further complication.
Suryawanshi K.S, et. al. in 2015 [18], studied that, type II diabetes mellitus is one of the major cause of the mortality and morbidity in the world. Type II diabetes mellitus is a chronic disease characterized by relative deficiency of insulin, resulting in glucose intolerance. Their study was planned to understand more about hyperuricemia and microalbuminuria and its complications in type II diabetes mellitus patients. In present study, 565 patients of type II diabetes mellitus and age and sex matched controls were included. They found increased levels of serum uric acid and urine microalbumin in type II diabetic patients as compared to controls (p<0.001). They observed the positive correlation between serum uric acid and urine microalbumin (p<0.001). They finally concluded that, serum uric acid and urine microalbumin are not only early diagnostic markers for atherogenic cardiovascular disease and renal disease but also prognostic monitoring of the disease in type II diabetes mellitus patients.

Aim & objectives
Aim
To assess the risk of renal microvascular involvement in patients of type II diabetes mellitus.

Objectives
1. To study the usefulness of various biochemical parameters as marker of renal microvascular damage in patients of type II diabetes mellitus. 2. To study the relationship of inflammatory marker (hs-CRP) with renal microvascular damage, in all the three groups.

Material and methods
A prospective, observational study, “Assessing the Risk of Renal Microvascular Involvement in Patients of Type II Diabetes Mellitus” was carried out at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi (Meghe), Wardha, during the period between January 2014 to August 2015. Permission from the college ethical committee was taken for the conduct of study. Informed written consent was obtained from each patient.
Source Population: The patients coming to the central clinical laboratory from different outpatient department (O.P.D.) of AVBRH were selected.
Study Population: Amongst the above, subjects coming particularly for plasma glucose estimation were selected.
Design of study: Prospective, analytical, case control study.

Inclusion criteria
1) Subjects coming for plasma glucose estimation
2) Age group >20 years
3) Patients willing to give informed consent.

Exclusion criteria
1) Type I diabetes mellitus
2) Known case of diabetic nephropathy
3) Known case of congestive heart failure
4) Patients having prostate disease or any infection.
Enrollment of patients: Informed consent of all patients for blood and urine investigations was taken. Name, age, sex, height and weight was noted. 5 ml of fasting venous blood and morning urine samples, were collected from the patients for assessment of parameters mentioned in table 1. Investigations like fasting and post meal plasma glucose, glycosylated hemoglobin, microalbumin serum urea, creatinine, uric acid, eGFR and hs-CRP were done.

Parameters:
Parameter Method
Plasma Glucose GOD-POD method
Glycated Haemoglobin Latex Agglutination Inhibition Assay
Microalbumin Immunoturbidimetric method
Serum Urea Urease Kinetic Method
Serum Creatinine Modified Jaffe’s Kinetic method
Serum Uric acid Uricase-PAP method
Egfr Cockcroft-Gault equation
hs-CRP Turbidimetric Immunoassay
method
Methods of Estimation
1. Plasma glucose estimation by god-pod method [37]: Glucose oxidase catalyzes the oxidation of glucose to gluconic acid and hydrogen peroxide (H2O2).
Addition of the enzyme peroxidase and a chromogenic oxygen acceptor, such as o-dianisidine, results in the formation of a colored compound that is measured.

2. Glycated Haemoglobin by Latex Agglutination Inhibition Assay [38]: The agglutinator, a synthetic polymer containing multiple copies of the immunoreactive portion of HbA1C, binds the anti- HbA1C monoclonal antibody that is attached to latex beads. This agglutination produces light scattering, measured as an increase in absorbance. HbA1C in the patient’s sample competes for the antibody on the latex, inhibiting agglutination, thereby, decreasing light scattering.

3. Microalbumin estimation by Immunoturbidimetric method [33]: The multigent microalbumin immunoturbiditimetric that uses polyclonal antibodies against human albumin was used for the determination of urine microalbumin urea. The specimen was mixed with the reagents. Albumin in the specimen combined with the anti-human albumin antibody, in the reagent to yield an insoluble aggregate that causes increased turbidity in the solution. The degree of turbidity is proportional to the albumin in the specimen, which was measured optically.

4. Serum Urea by Urease Kinetic Method [39]: Method for the measurement of urea is based on preliminary hydrolysis of urea with Urease (urea with amidohydrolase), to generate ammonia which is then quantified.

5. Serum Creatinine by Modified Jaffe’s Kinetic method [40]: Creatinine reacts with picrate ion in alkaline medium to yield an Orange coloured complex (Creatinine picrate).

6. Uric acid estimation by Uricase-PAP Method [41]: Uricase oxidoreductase is used either as a single step or as the initial step to oxidize uric acid. Uricase acts on the uric acid to produce allantoin, hydrogen peroxide or carbon dioxide.

7. eGFR by Cockcroft-Gault equation [42]: Estimated GFR (eGFR; ml/min/1.73 m ) was calculated using the following CG(Cockcroft-Gault) formula:-
CG = [(140-age) x weight {x 0.85 if female}] / (72 x serum creatinine)

8. hs CRP by Turbidimetric Immunoassay (Latex) method [43]: The Latex method uses particle-enhanced technology. In this method, the specific antibodies coated to polystyrene particles formed a complex with CRP present in the measured study sample. The amount of scattered light was directly proportional to the size of the antigen-antibody complex and reflected the hs-CRP concentration present in the study sample.

Sample size: Total 150 subjects were studied and divided into three groups, depending upon their glycosylated hemoglobin level as follows:-

Group 1 (Normal subjects: 50 patients): HbA1c level <6%.
Group 2 (Well controlled diabetes: 50 patients): HbA1c level 6-8%.
Group 3 (Poorly controlled diabetes: 50 patients): HbA1c level >8%.
Statistical data: 1. Data was expressed as Mean ± SD. 2. For statistical analysis, SPSS Version 16 was done. 3. Anova test was applied for comparison between more than two groups & student ‘t’ test for comparison between two groups. 4. Pearson’s correlation was applied for correlating two parameters. 5. ‘p’ value of less than 0.05 was considered statistically significant.

Discussion
Diabetes mellitus (DM) comprises of a group of common metabolic disorders that share the phenotype of hyperglycemia. Several distinct types of DM exist and are caused by a complex interaction of genetics, environmental factors, and life-style choices. Depending on the etiology of the DM, factors contributing to hyperglycemia may include reduced insulin secretion, decreased glucose utilization, and increased glucose production. [44]
Type II DM is characterized by three pathophysiologic abnormalities: impaired insulin secretion, peripheral insulin resistance, and excessive hepatic glucose production. Obesity, particularly visceral or central (as evidenced by the hip-waist ratio), is very common in type II DM. Adipocytes secrete a number of biologic products (leptin, tumor necrosis factor-α, free fatty acids, resistin, and adiponectin) that modulate insulin secretion, insulin action, and body weight which may contribute to the insulin resistance.
In the early stages of the disorder, glucose tolerance remains normal, despite insulin resistance, because the pancreatic beta cells compensate by increasing insulin output. As insulin resistance and compensatory hyperinsulinemia progress, the pancreatic islets in certain individuals are unable to sustain the hyperinsulinemic state. Impaired glucose tolerance(IGT), characterized by elevations in postprandial glucose, then develops. A further decline in insulin secretion and an increase in hepatic glucose production lead to overt diabetes with fasting hyperglycemia. Ultimately, beta cell failure may ensue. Markers of inflammation such as IL-6 and C-reactive protein are often elevated in type II diabetes. [44]
DM can result into acute or chronic complications. Diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar state (HHS) are acute complications of diabetes. Both disorders are associated with absolute or relative insulin deficiency, volume depletion and acid-base abnormalities. DKA and HHS exist along a continuum of hyperglycemia, with or without ketosis. Both disorders are associated with potentially serious complications if not promptly diagnosed and treated.
The chronic complications of DM affect many organ systems and are responsible for the majority of morbidity and mortality associated with the disease. Chronic complications can be divided into vascular and nonvascular complications of DM are further subdivided into microvascular and macrovascular complications. [44]
Diabetic nephropathy is the leading cause of ESRD in the United States and a leading cause of DM-related morbidity and mortality. Proteinuria in individuals with DM is associated with markedly reduced survival and increased risk of cardiovascular disease.
The pathogenesis of diabetic nephropathy is related to chronic hyperglycemia. The mechanisms by which chronic hyperglycemia leads to ESRD, though incompletely defined, involve the effects of soluble factors (growth factors, angiotensin II, endothelin, advanced glycated end products), hemodynamic alterations in the renal microcirculation (glomerular hyperfiltration or hyperperfusion, increased glomerular capillary pressure), and structural changes in the glomerulus (increased extracellular matrix, basement membrane thickening, mesangial expansion, fibrosis). Some of these effects may be mediated through angiotensin II receptors.
The natural history of diabetic nephropathy is characterized by a fairly predictable sequence of events that was initially defined for individuals with type I DM but appears to be similar in type II DM.
Glomerular hyperperfusion and renal hypertrophy occur in the first years after the onset of DM and cause an increase of the glomerular filtration rate (GFR).
During the first 5 years of DM, thickening of the glomerular basement membrane, glomerular hypertrophy and mesangial volume expansion occur as the GFR returns to normal.
After 5 to 10 years of type I DM, 40% of individuals begin to excrete small amounts of albumin in the urine. Microalbuminuria is defined as 30 to 300 mg/d in a 24-h collection or 30 to 300 μg/mg creatinine in a spot collection (preferred method). The appearance of microalbuminuria (incipient nephropathy) in type I DM is an important predictor of progression to overt proteinuria (>300 mg/d) or overt nephropathy. Blood pressure may rise slightly at this point but usually remains in the normal range. Once overt proteinuria is present, there is a steady decline in GFR, and 50% of individuals reach ESRD in 7 to 10 years. The early pathologic changes and albumin excretion abnormalities are reversible with normalization of plasma glucose. However, once overt nephropathy develops, the pathologic changes are likely irreversible.
The nephropathy that develops in type II DM differs from that of type I DM in the following respects: (1) microalbuminuria or overt nephropathy may be present when type II DM is diagnosed, reflecting its long asymptomatic period;(2) hypertension more commonly accompanies microalbuminuria or overt nephropathy in type II DM; and (3) microalbuminuria may be less predictive of diabetic nephropathy and progression to overt nephropathy in type II DM. Finally, it should be noted that albuminuria in type II DM may be secondary to factors
unrelated to DM, such as hypertension, congestive heart failure, prostate disease, or infection.
Type IV renal tubular acidosis (hyporeninemic hypoaldosteronism) also occurs in type I or II DM. These individuals develop a propensity to hyperkalemia, which may be exacerbated by medications [especially angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs)]. Patients with DM are predisposed to radio contrast-induced nephrotoxicity. [44]
The optimal therapy for diabetic nephropathy is prevention. As part of comprehensive diabetes care, microalbuminuria should be detected at an early stage when effective therapies can be instituted. The recommended strategy for detecting microalbuminuria is outlined below: [44]
Plasma glucose is a continuous variable, rising and falling about two-fold throughout the day in people without diabetes and up to some 10-folds in people with diabetes, given by Saudek CD, et al. [405 Rohitash Kumar, et al [36] showed a positive correlation existing between FPG and PMPG with eGFR, which may be due to the hyperfiltration of glomerulus during the early stage of diabetes, which at later stage is known to decrease eGFR with development of nephropathic changes. [2] In the study shown by Suryawanshi K.S., et al [18], FPG, PMPG, serum uric acid and urine microalbumin were markedly increased in diabetic patients as compared to healthy controls.
Our study shows that, FPG values are more in poorly controlled group(173.66 ± 52.73), as compared to normal(92.82 ± 8.43) and well controlled group(117.3 ± 22.67), which is statistically highly significant(<0.0001). Similarly, PMPG values are also found on a higher side in poorly controlled group(289.8 ± 83.58), compared to normal(136.82 ± 20.52) and well controlled group(185.72 ± 40.37), which is also statistically highly significant(<0.0001). As poor glycemic control increases UAE, rise in FPG and PMPG could be responsible for renal microvascular damage. Therefore, good control of plasma glucose level is absolute requirement to prevent progressive renal impairment.
It was reported by Shehnaz A Sheikh, et al [10] that, HbA1c can be used as a diagnostic test for Type II diabetes instead of relying only on FPG. The complications of both Type I and II diabetes do not develop or progress for 6–9 years when the average HbA1c level is kept at <7%, stated by Brownlee M, et al. [46] Marked increase in HbA1c level was found in diabetic patients with microalbuminuria, as compared to without microalbuminuria, which could be attributed to uncontrolled/ persistent higher blood sugar level as indicated by excessive glycosylation of hemoglobin. HbA1c is a good indicator of glycemic control in initial stages but, its reliability in advancing stage is questioned, as given by Thomas Vijatha, et al. [35]
In our study, HbA1c values are found to be more in poorly controlled group(10.32 ± 1.52), in comparison with normal(5.10 ± 0.42) and well controlled group(7.00 ± 0.52), which is statistically highly significant(<0.000`). Thus, tighter glycemic control will lead to greater reduction in the risk for microvascular complications. Also, substantial reductions in HbA1c level at an early stage have a long-lasting implications for reducing the risk of future microvascular complications.
Previous three studies by Dinneen SF, Borch-Johnsen K and Remuzzi G, et al established microalbumin as a powerful independent predictor of microvascular lesions, cardiovascular disease, cardiovascular mortality and kidney disease including endstage renal failure in patients with diabetes, hypertensive subjects and even in the general population. [47, 48, 2] H-H Parving, et al showed a clear association of higher levels of albuminuria with an increased frequency of renal insufficiency. [22] The frequency of microalbuminuria increased with the increase in duration of diabetes, was shown by Naz S, et al. [49]
Giunti S, et al [50] stated that, microalbuminuria is related to hyperglycemia and control of blood glucose level has been shown to prevent the development of nephropathy in Type I & II diabetes. A rapid decline in renal function can be predicted for patients having poor glycemic control and microalbuminuria, as given by Araki S and Wright J, et al in two separate studies. [51, 52] According to Derakhshan A, et al [53], minimizing microalbuminuria and having a tight glycemic control is an important treatment goal for patients with diabetes. Study by Shehnaz A Sheikh [10], et al concluded that, microalbuminuria and HbA1c testing should be done in both, newly diagnosed as well as already diagnosed Type II diabetic patients as an early marker of cardiovascular and renal risk factor.
A Study by Francisco Javier del Canizo Gomez, et al [26] concluded that UAE levels >12 mg/24hrs are the most significant independent risk factor for development of nephropathy and/or retinopathy in the type II DM patients studied. However, according to current guidelines, the UAE cut-off level for progression to nephropathy is 30 mg/24 hrs. [19] In addition, Hoefi eld RA, et al [54] found that, individuals with microalbuminuria also have an increased rate of decline of eGFR compared with people with normoalbuminuria.
The study by Anwarullah, et al [33] explicitly indicated that poor diabetic control is the leading cause of diabetic nephropathy as evidenced by elevated microalbuminuria. Many complications arise due to uncontrolled or poorly controlled diabetes mellitus amongst which the most destructive is diabetic nephropathy, found by Battisti WP, et al. [55] Chowta NK, et al [56] discovered that, the level of glycemic control also plays an important role in the transition from normoalbuminuria to microalbuminuria to macroalbuminuria. Jha P, et al [57] suggested that, to maximize prevention of microalbuminuria development, blood pressure should be maintained at less than 130/80 mm Hg, and HbA1c should be kept below 7%.
In our study, Microalbumin values are very high in poorly controlled group(164.18 ±41.95), in contrast with normal(15.21± 5.35) and well controlled group(81.55 ±26.82) and found to be statistically highly significant(<0.0001). Therefore, a screening criteria like microalbuminuria applied either at a single time or serially, should be used to identify individuals at high risk of ESRD. In this way, using screening tests of microalbuminuria to prevent multiple outcomes of interest such as ESRD, will improve the efficacy of screening, recognizing that the presence of microalbuminuria may have important predictive validity for future renal microvascular complications.
There is strong relationship of blood sugar level with urea level. An increase in urea level is seen when there is damage to the kidney or the kidney is not functioning properly. Increment of blood urea level with the increment of blood sugar level clearly indicates that the increase blood sugar level causes damage to the kidney. A research by Anjaneyulu, et al [58] has found that increase urea and serum creatinine in diabetic rats indicates progressive renal damage.
According to Deepa K, et al [28], the plasma urea and creatinine are estabished markers of GFR, though plasma creatinine is a more sensitive index of kideny function. Blood urea and creatinine is widely accepted to assess the renal functions. Another observations of Deepa K, et al were in accordance with various studies which showed raised plasma creatinine and urea levels in diabetic patients, which may indicate a pre-renal problem. [59, 60]
The measurement of serum creatinine concentration is widely used clinically as an index of renal function, given by Justesen TI, et al. [60] Adler AI, et al [61] stated that, the rate of rise in SrCr , a well-accepted marker for the progression of diabetic nephropathy, (creatinine value 1.4 to 3.0 mg/dl) is the indicator for impaired renal function.
Mitch WE and Schutte JE, et al [62, 63] in separate studies found that, serum creatinine and urea concentration change inversely with changes in GFR and therefore useful in gauging the degree of renal dysfunction. Also, microalbuminuria and serum creatinine increase significantly in Type II diabetes as reported in an earlier study by Justesen TI. [60] Some patients have a substantial decrease in glomerular filtration rate, while their serum creatinine concentration remains within the normal range and thus it is a poor screening test for mild kidney disease, observed by Hebert CJ, et al. [64]
In our study, serum urea values are found to be more in poorly controlled group (52.08 ± 9.96), as compared to normal (25.52 ± 6.26) and well controlled group (35.38 ± 10.07), which is statistically highly significant (<0.0001). Creatinine values are also found on a higher side in poorly controlled group (2.74 ± 0.83), compared to normal(1.06 ± 0.18) and well controlled group(1.58 ± 0.67) and which is also statistically highly significant(<0.0001). Serum urea & creatinine measurement is a convenient and inexpensive method of assessing renal function and a consistently elevated level indicates chronic kidney disease. Thereby, urea, not alone but alongwith creatinine must be assessed in type II diabetic patients, to prevent or postpone renal damage.
According to Abbas Dehghan, et al [24] one quarter of diabetic cases can be attributed to a high serum uric acid level. Recognition of high serum uric acid as a risk factor for diabetes has been a matter of debate for a few decades, since hyperuricemia has been presumed to be a consequence of insulin resistance rather than its precursor, concluded in a study by Butler R, et al. [65]
Hyperuricemia has been found to be associated with obesity and insulin resistance and consequently with type II diabetes mellitus, given by Idonije , et al. [66] Hyperuricemia indues endothelial dysfunction which results in nephropathy in type II DM patients [67] and study done by Tseng also says that, even mild hyperuricemia will results in kidney injury. [68] Fukui M and Chin-Hsiao Tseng, et al [69, 70], discovered separately that, the long duration of diabetes may cause hyperuricemia and microalbuminuria which in turn lead to micro and macrovascular complication. The uric acid and urine microalbumin are very good diagnostic markers for detection of kidney injury in initial stage of disease, stated by both CAI Xiao-ling and Saeed Behradmanesh. [71, 72]
We also found more uric acid levels in poorly controlled group(5.65 ± 0.50), compared to normal(4.22 ± 0.39) and well controlled group(4.9 ± 0.46) & which is also statistically highly significant(<0.0001). Increased levels of uric acid can be injurious to kidneys, therefore, uric acid levels should be estimated in patients with type II diabetes mellitus.
eGFR is the most rational noninvasive method of assessing the renal status in patients, according to two studies done by Gross JL and Mykkanen L, et al. [73, 74] The eGFR estimated from both the equations were found to be decreased in DM patients compared to non-diabetic controls, which show that eGFR decrease in diabetic patients more than non-diabetic controls. It has been suggested by Sangeeta Kapoor, et al that, using eGFR as a screening tool may also potentially predict and reduce the incidence of CKD, which is associated with increased risk of death.
Sangeeta Kapoor, et al [13] also observed that, micro total protein in 24 hrs urine sample and eGFR were examined as independent predictors for renal damage in Type II DM patients and their additive values have also been assessed to diagnose incipient diabetic nephropathy. Average GFR values determined by either the 24- hour creatinine clearance method or by the Cocroft-Gault formula were found to be lower not only in patients with macroalbuminuria but in normoalbuminuria and microalbuminuria as well. In order to avoid variations of protein concentration in urine, assessment of micro total protein in 24 hrs urine sample along with the eGFR by the prediction equations suggested by National Kidney Foundation, which are MDRD and CG equations must be advocated.
Another observation noted in a study by Rohitash Kumar, et al [36] was a positive correlation existing between FPG and PMPG with eGFR. On the other hand, Doyle M. Cummings, et al [27] used a novel approach to explore the association of patterns of HbA1c fluctuation with changes in eGFR and stage of CKD. Another finding by Molnar M, et al [19] told that, with the development of diabetic nephropathy, serum creatinine level starts to increase and GFR starts to fall.
Our study revealed eGFR values lower in poorly controlled group(40.13±3.83), in comparison with normal(98.63± 5.86) and well controlled group(78.45±5.04), which is statistically highly significant(<0.0001). We can thereby, come to the conclusion that, kidney functions are well-preserved in the normoalbuminuria stage of type II diabetes and the decrease in eGFR starts only during the transition from normoalbuminuria to microalbuminuria. eGFR estimation is one of the renal parameter which can provide a picture of the actual renal status of Type II DM patients at any duration irrespective of other parameters. Since, it is important to take steps to protect the kidneys before the problem advances, eGFR assessment must be done at an early stage of Type II DM in oreder to prevent overt diabetic nephropathy.
hs-CRP levels >3 mg/L were an independent risk factor for development not only of diabetic nephropathy, but also of diabetic retinopathy. As per observations done by Yasuaki Hayashino, et al [15], there is a temporal association between elevated levels of hs-CRP and the subsequent risk of developing, not progressing, diabetic nephropathy in a large registry of patients with diabetes, even after adjusting for possible confounders, including medication use, which may influence the natural course of renal function. Francisco Javier del Canizo Gomez, et al [26] suggested that, hs-CRP may be a marker of vascular disease, which indicates impaired self-regulation of glomerular pressure and/or dysfunction of glomerular endothelium. Both these factors may increase microalbuminuria.
Mohd. Idrees Khan, et al [11] made an attempt to test the hypothesis that systemic inflammation as indicated by hs-CRP and uncontrolled blood sugar level as indicated by HbA1C are associated with type II diabetic nephropathy which signify occurrence of significant microalbuminuria. Interestingly, hs-CRP level in microalbuminuria diabetic patients was many fold increased than without microalbuminuria. There is convincing evidence that type II diabetes mellitus presented with inflammatory component has been related to such diabetic complication as nephropathy. Inflammatory markers in early diabetic nephropathy in patients with type II diabetes are elevated and are independently associated with UAE. Therefore, screening of hs-CRP level in diabetics could be established as biomarker of vascular complications.
We found in our study that, hs-CRP values are high in poorly controlled group(7.12±0.57), in comparison with normal(1.96 ±0.52) and well controlled group(4.71±0.29) and it is statistically highly significant(<0.0001). It should be noted that, corrections of conditions like hyperglycemia may halt inflammation in type II diabetic patients and burden of ESRD. Hence, screening of hs-CRP must be considered under screening of type II DM, inflammatory marker like hs-CRP play a pivotal role in the development and progression of diabetic complications.
In our study, no correlations of hs-CRP with microalbumin(r value: -0.1372), as well as hs-CRP with eGFR (r value: -0.0898), was found in well controlled diabetic group, with no statistical significance of hs-CRP with microalbumin (p value: 0.3419) & eGFR (p value: 0.5350), respectively. Also, in our study, no correlations of hs-CRP with microalbumin (r value: 0.0435), as well as hs-CRP with eGFR (r value: 0.1280), was found in poorly controlled diabetic group, with no statistical significance of hs-CRP with microalbumin (p value: 0.7641) and eGFR (p value: 0.3758). Similar results were found in a study conducted by Mohd. Idrees Khan, et al, who established a poor correlation between UAE and inflammatory parameter in patients with type II DM at an early stage of diabetic nephropathy in north Indians.

Summary
Our study “Assessing the Risk of Renal Microvascular Involvement in Patients of Type II Diabetes Mellitus” is a prospective, analytical, case control study. We conducted our study at AVBRH, Sawangi (Meghe), Wardha. The subjects coming particularly for plasma glucose estimation, aged >20 years and those willing to give informed consent were included in the study. Patients of type I DM, known case of diabetic nephropathy, congestive heart failure and those with prostate disease or any infection, were excluded from the study.
Total 150 subjects were studied and divided into three groups (50 each), depending upon their HbA1c levels i.e. Group 1 (normal subjects): HbA1c <6%, Group 2 (well controlled diabetes): HbA1c =6-8% and Group 3 (poorly controlled diabetes): HbA1c >8%. List of investigations were done in all the patients by different methods: FPG and PMPG by GOD-POD method, HbA1c by latex agglutination inhibition assay, microalbumin by mmunoturbidemetric method, serum urea by urease kinetic method, serum creatinine by modified Jaffe’s kinetic method, serum uric acid by uricase-PAP method, eGFR by Cockcroft-Gault equation & hs-CRP by turbidimetric immunoassay method.
Amongst the above listed parameters, FPG and PMPG values were significantly raised in group III, compared to groups I and II. HbA1c also showed a significant increase in group III, than group II and normal in group I. In addition, urinary marker i.e. microalbumin was markedly elevated in group III, in contrast to groups I and II. Since, HbA1c is a better marker for assessing the glycemic status of the patient, its screening must be done on a routine basis in all the patients of type II DM, to prevent or postpone overt diabetic nephropathy.
Also, other serum markers like serum urea, creatinine and uric acid were found to be significantly increased in group III, than the other two groups. Another important urinary marker included in our study was eGFR, which was significantly decreased in group III and raised in I and II groups. It should be noted that, serum urea and creatinine are poor screening tools for assessing renal damage. Thus, eGFR estimation by Cockroft-Gault equation, should be done in all the type II DM patients, especially in the early stage of diabetic nephropathy.
hs-CRP, an inflammatory marker used in our study was observed to be on a higher side in group III, than groups I and II. Since, hs-CRP acts as a vascular component too, its assay must be considered, in order to prevent renal microvascular complications in patients of type II DM.

Conclusion
From this study it can be concluded that, the serum markers i.e. FPG, PMPG and HbA1c, are good predictors of renal microvascular damage in type II diabetes mellitus. Poor glycemic control directs to the development of diabetic nephropathy. Thus, a strict glycemic control, having a healthy lifestyle and maintaining standard body weight is especially important for diabetic patients and for those with a family history of diabetes.
There is a direct association of serum urea and creatinine with altered kidney function in type II DM. In addition, there could be an association of raised serum uric acid levels with the onset of diabetic nephropathy. Thereby, it is mandatory to include serum urea, creatinine and uric acid as a potential risk factors, especially in chronic diabetics with poor glycemic control.
Moreover, rise of both the urinary markers i.e. microalbumin and eGFR in type II diabetic patients have an important predictive value for future microvascular complications. Microalbuminuria & eGFR are considered as early predictors for renal dysfunction, either at glomerular or proximal tubular level. The screening for microalbuminuria and eGFR is a pre-requisite for preventing diabetic nephropathy. Therefore, microalbuminuria and eGFR testing should be done in both, newly diagnosed as well as already diagnosed type II diabetic patients.
In addition, raised level of hs-CRP in blood might not predict the progression, but the development of nephropathy in type II DM. Hence, screening of inflammatory marker like hs-CRP in diabetics could be established as biomarker of renal microvascular complications. Thereby, hs-CRP must be used as a powerful screening tool, in order to prevent and/or postpone renal microvascular damage in type II DM patients with poor glycemic control.


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How to Cite this Article: Panbude SP, Chalak AS, Panbude PA, Malla R. Assessing the Risk of Renal Microvascular Involvement in Patients with Type II Diabetes Mellitus. Journal Medical Thesis 2024 January-June; 10(1):13-29.

 


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Renewing Our Commitment: Embracing a New Era for the Journal of Medical Thesis


Vol 10 | Issue 1 | January-June 2024 | page: 03-04 | Ashok Shyam, Sachin Kale, Arvind Vatkar

https://doi.org/10.13107/jmt.2024.v10.i01.211


Author: Ashok Shyam [1], Sachin Kale [2], Arvind Vatkar [3]

[1] Department of Orthopaedics, Sancheti Institute for Orthopaedics and Rehabilitation, Pune, Maharashtra, India.
[2] Department of Orthopaedics, D Y Patil Hospital, Navi Mumbai, Maharashtra, India.
[3] Department of Orthopaedics, MGM Medical College, Navi Mumbai, Maharashtra, India.

Address of Correspondence
Dr. Ashok Shyam,
Department of Orthopaedics, Sancheti Institute for Orthopaedics and Rehabilitation, Pune, Maharashtra, India.
E-mail: drashokshyam@gmail.com


Editorial

With a sense of renewed purpose, we are delighted to announce a new chapter in the life of the Journal of Medical Thesis. As the world’s only journal dedicated exclusively to publishing theses in the medical sciences, we remain committed to our founding vision: ensuring that the rich, original research conducted by postgraduate scholars does not languish in obscurity, but rather finds a permanent, accessible place in the global body of medical knowledge. It is with great pleasure that we also welcome Dr. Sachin Kale and Dr. Arvind Vtkar to our editorial team. Their expertise, dedication, and fresh perspectives will help guide the journal toward an even more impactful future.

Why Publishing Your Thesis Matters
The medical thesis stands as the culmination of years of rigorous study, painstaking research, and thoughtful analysis. Yet, despite the academic intensity that goes into their creation, many theses remain locked away on library shelves or confined to institutional archives. By publishing your thesis, you extend its life and reach, transforming it from a solitary academic exercise into a scholarly contribution that can influence patient care, inform medical policy, and inspire future investigations. Through publication, your work moves from the periphery of knowledge into the heart of ongoing scientific dialogue.

Enriching Global Scholarship
Our journal has a singular mission: to provide a platform where theses—irrespective of geographic origin, area of specialization, or unconventional research focus—can find an audience. Unlike general medical journals, which often prioritize certain study designs or high-profile research, the Journal of Medical Thesis embraces a diversity of topics. From niche local health concerns to innovative therapeutic interventions, every thesis published adds to a more inclusive and representative tapestry of medical literature. By bringing these studies to light, we nurture an environment where new ideas can flourish, cross-pollinate, and ultimately contribute to better health outcomes worldwide.

Advancing Your Career
Publication is a key milestone in any medical professional’s journey. Beyond fulfilling academic requirements, a published thesis bolsters your curriculum vitae and signals your readiness to engage with the global scientific community. Such publications can open doors to competitive residency programs, fellowships, research grants, and faculty appointments. By establishing yourself as a contributing scholar—one who values both the generation and dissemination of knowledge—you set the stage for continued growth, collaboration, and recognition.

A Global Repository of Ideas
As the world’s only specialized repository of medical theses, our journal is steadily building a knowledge base that is both timeless and borderless. Whether you are a clinician seeking evidence-based guidance for patient care, a researcher looking for novel approaches to an old problem, or a policymaker searching for data to inform healthcare strategies, the Journal of Medical Thesis provides a unique and authoritative resource.

A Future of Growth and Excellence
We are committed to improving every aspect of our publication process. From streamlining peer review and enhancing editorial support, to strengthening our indexing and widening our global reach, we are continuously working to make the path from thesis to publication more accessible, transparent, and rewarding. With the collective expertise and dedication of our team—now fortified by the insights of Dr. Kale and Dr. Vtkar—we are confident that the journal’s next chapter will be one of growth, innovation, and excellence.

An Invitation to All
We call upon postgraduate researchers, established academicians, and medical practitioners from every corner of the world to submit their theses for publication. Your findings may hold the key to solving perplexing clinical challenges, improving patient safety, or enhancing public health. By contributing to the Journal of Medical Thesis, you join a community committed to advancing healthcare through rigorous scholarship, open exchange of ideas, and unwavering dedication to quality science.

The Path Forward
With our rejuvenated platform, we are investing in improved review processes and enhanced accessibility. Our editorial board is dedicated to helping authors navigate the often-challenging journey from thesis completion to publication. We welcome submissions from all corners of the globe and from every stage of medical specialization. Our goal is to celebrate the diversity and richness of postgraduate research, promoting it as a foundation upon which the future of medicine is built.

In this era of rapid clinical advances, complex public health challenges, and unprecedented global connectivity, medical scholarship cannot afford to remain siloed. By publishing your thesis with us, you give your work the audience, influence, and longevity it warrants—and you join a community committed to advancing healthcare through rigorous, inclusive, and forward-thinking research.

We look forward to your contributions, your innovations, and your discoveries. Together, let’s ensure that no valuable thesis is lost to dusty shelves, and that every insight has the opportunity to inform, inspire, and improve medical practice worldwide.

 

Dr. Ashok Shyam, Dr. Sachin Kale, Dr. Arvind Vatkar
Editor
Journal of Medical Thesis


How to Cite this Article: Shyam A, Kale S, Vatkar A. Renewing Our Commitment: Embracing a New Era for the Journal of Medical Thesis. Journal Medical Thesis 2024 January-June ; 10(1):03-04.

 


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Comparative Study Between Functional Outcome of Mini Open Latarjet Versus Arthroscopic Bankart Repair in the Management of Recurrent Anterior Shoulder Instability


Vol 10 | Issue 1 | January-June 2024 | page: 09-12 | Bharadwaj Marrapu, Sasi Bhushana Rao Sasapu, Yeshwanth Thonangi, Jalapati Sairam, Rithika Reddy

https://doi.org/10.13107/jmt.2024.v10.i01.214


Author: Bharadwaj Marrapu [1], Sasi Bhushana Rao Sasapu [1], Yeshwanth Thonangi [1], Jalapati Sairam [1], Rithika Reddy [2]

[1] Department of Orthopaedics, MIMS Hospital, Nellimarla, Andhra Pradesh, India.
[2] Department of Radiology, MIMS Hospital, Nellimarla , Andhra Pradesh, India.

Address of Correspondence
Dr. Bharadwaj Marrapu,
Senior Resident, Department of Orthopaedics, MIMS Hospital, Nellimarla, Andhra Pradesh, India.
E-mail: bharadwajmarrapu@gmail.com


Abstract

Background: Anterior shoulder dislocations are frequent, affecting 2% of people annually. Arthroscopic Bankart repair is used for soft tissue lesions or minor bone loss, while the open Latarjet procedure is preferred for significant bone loss. This study compares functional outcomes of these surgical methods.
Materials and methods: This prospective interventional study, approved by the Institutional Ethical Committee, was conducted at Maharajah Institute of Medical Sciences from January 2023 to June 2024. It included 30 patients with recurrent anterior shoulder instability, managed with either arthroscopic Bankart repair or Latarjet procedure, based on specific criteria.
Results: In an 18-month study comparing mini-open Latarjet and arthroscopic Bankart repair, 30 patients were analyzed. Age distribution was similar between groups. There were no significant differences in functional scores, recurrence rates, or overall satisfaction. The Bankart group had 13.3% recurrence, while the Latarjet group experienced 13.3% superficial infections, which resolved with treatment.
Conclusion: Both techniques were effective, but the arthroscopic Bankart repair had a higher recurrence of shoulder dislocation, while the Latarjet procedure offered better functional outcomes. In developing countries like India, the Latarjet procedure may be preferred due to its potentially better long-term results and the financial burden of repeated treatments with the Bankart repair.
Keywords: Anterior shoulder dislocation, Arthroscopic Bankart repair, Open Latarjet procedure, Recurrent shoulder instability, Functional outcomes, Bone loss, Soft tissue lesions, Financial constraints, Mini-open Latarjet.


Thesis Question
To Compare Functional Outcome of Arthroscopic bankart repair vs Mini open Iatarjet in management of recurrent anterior shoulder instability.

Thesis Answer
The mini-open Latarjet procedure showed better long-term outcomes and lower recurrence rates compared to arthroscopic Bankart repair for recurrent anterior shoulder instability. Despite being more invasive and costly, Latarjet may be more effective in developing countries due to its superior stability and patient satisfaction.

Introduction
Anterior shoulder dislocations are highly prevalent, with an incidence rate of 23.9 per 100,000 people, affecting about 2% of the population [1, 2]. Surgery is often necessary for recurrent dislocations due to a high risk of recurrence with nonoperative methods [3, 4].
Arthroscopic Bankart repair, utilizing suture anchors, is typically used for patients with soft tissue Bankart lesions or up to 25% glenoid bone loss. For significant Hill-Sachs defects (>25% engagement), an additional remplissage procedure is recommended [5, 6, 7]. The open Latarjet procedure is generally preferred for cases with substantial glenoid bone loss. Although there is debate over the benefits of each technique, surgical success is ultimately measured by clinical outcomes and recurrence rates [8–14].
In resource-limited settings like Nepal, cost is a significant factor. Many patients cannot afford the expensive suture anchors needed for arthroscopic repair, and insurance often does not cover these costs [15, 16].
This study aims to compare the functional outcomes of patients undergoing arthroscopic Bankart repair versus those receiving open Latarjet treatment for recurrent anterior shoulder dislocation.

Aim & Objectives
Aim
To compare the functional outcomes of arthroscopic Bankart repair versus mini open Latarjet in the management of recurrent anterior shoulder instability.

Objectives
1. To evaluate and compare the functional outcomes of arthroscopic Bankart repair versus mini open Latarjet for recurrent anterior shoulder instability.
2. To analyze prognostic factors that may predict the outcomes of these surgical interventions.

Materials & Methods
This prospective interventional study was conducted at Maharajah Institute of Medical Sciences, Vizianagaram, over 18 months, from January 2023 to June 2024. The study protocol was approved by the Institutional Ethics Committee (IEC).
Study Design: Prospective interventional study
Study Period: January 2023 to June 2024
Study Setting: Maharajah Institute of Medical Sciences, Vizianagaram, affiliated with Dr. YSR UHS

Ethical Considerations
• Approval was obtained from the Institutional Ethics Committee.
• Participation was voluntary, with informed consent obtained from all participants.
• Participant confidentiality was maintained.
• No participants were subjected to potential harm.
Study Subjects: Patients with recurrent anterior shoulder instability admitted to Maharajah Institute of Medical Sciences and managed with arthroscopic surgery.

Inclusion Criteria:
• History of recurrent shoulder dislocations
• Age between 20-40 years
• Willingness to participate
• Soft tissue glenoid lesions and bone loss less than 10% for arthroscopic Bankart repair
• Glenoid bone loss of 10-25% or less than 10% with a Hill-Sachs lesion for Latarjet surgery

Exclusion Criteria:
• First-time dislocation
• Age ≥65 years
• Bony Bankart lesions >25% of glenoid
• Voluntary dislocators
• Psychiatric disorders
• Neuropathic joint
• Refusal to provide written/informed consent
Sample Size: 30 patients
Sampling Technique: Simple random sampling

Results
This study at Maharajah Institute of Medical Sciences evaluated the effectiveness of mini open Latarjet versus arthroscopic Bankart repair for recurrent anterior shoulder instability. The participants, mostly young males with a predominance of right-sided injuries and frequent prior dislocations, were equally divided between the two surgical methods.
Both techniques showed comparable functional outcomes in terms of ASES, Rowe, Quick DASH scores, and external rotation. Patient satisfaction was high for both groups, with the Latarjet group reporting slightly better satisfaction. Notably, the Bankart group experienced two cases of re-dislocation, whereas the Latarjet group had two cases of superficial wound infection. Overall, while both procedures were effective, Latarjet showed a slight advantage in patient satisfaction and fewer recurrent dislocations.
In the Bankart group, two patients had re-dislocation; one underwent an open Latarjet revision. In the Latarjet group, two patients had superficial wound infections, which resolved with treatment. No additional complications were reported in either group.

Figures and X-Rays
• Age Groups: Distribution by age range.
• Gender Distribution: Predominantly male.
• Side of Involvement: Predominantly right-sided.
• Mode of Injury: Most common was road traffic accidents.
• Bankart Lesion Types: Various types and locations.
• Hill-Sachs Lesions: Mostly medium and small sizes.
• Track Status: Majority off track.

Discussion
his study, conducted over 18 months at Maharajah Institute of Medical Sciences, compared the functional outcomes of mini open Latarjet versus arthroscopic Bankart repair for recurrent anterior shoulder instability. The Latarjet procedure is well-regarded for its triple-stabilizing effect—capsular repair, anterior glenoid augmentation, and sling effect—which can enhance stability and reduce recurrence rates compared to the Bankart repair [10 , 12 , 28].
Findings from this study support the Latarjet technique's superior performance, with lower recurrence rates and higher functional satisfaction. Specifically, the Bankart group experienced a 13.3% recurrence rate, while the Latarjet group reported no recurrences [10]. This is consistent with previous research demonstrating the Latarjet's effectiveness in improving stability and patient outcomes [11, 12]. The Bankart repair, though less invasive and cosmetically preferred, was associated with a higher recurrence rate and slightly lower patient satisfaction [ 25, 27].
Complications were noted in both procedures. Graft-related issues, including fractures and nonunion, were common, with arthroscopic methods possibly having a higher risk due to technical complexities [19]. Despite these challenges, no significant differences in complication rates were observed between the techniques in this study [30]. The open Latarjet method has been associated with concerns about wound infections and neurological injuries, but these complications were managed effectively in this cohort [16].
Both techniques resulted in minor increases in cartilage wear at the 3-month follow-up, indicating the need for longer-term monitoring [16]. This study's findings align with the broader literature, which often highlights the Latarjet procedure's superior long-term outcomes compared to Bankart repair [14]. However, the technical demands of both procedures suggest that patient-specific factors and surgeon expertise are crucial in achieving optimal outcomes.

Conclusion
• Both arthroscopic Bankart repair and the Latarjet procedure showed positive clinical outcomes for managing recurrent anterior shoulder instability. Despite the advantages of arthroscopic Bankart repair, such as being minimally invasive and having aesthetic benefits, it was associated with a higher tendency for recurrent shoulder dislocations compared to the Latarjet procedure. In contrast, the Latarjet procedure offered superior functional satisfaction and a lower recurrence rate.
• Given these findings, the Latarjet procedure may be more suitable in developing countries like India. This recommendation is based on the procedure’s potentially better long-term outcomes and its ability to minimize the financial burden associated with recurrent treatments. While arthroscopic Bankart repair is less invasive, its higher recurrence rate and the financial implications of repeated surgeries make Latarjet a more viable option in resource-constrained settings.

Clinical message
In this study comparing Mini Open Latarjet to Arthroscopic Bankart Repair for recurrent anterior shoulder instability, both techniques demonstrated positive clinical outcomes. However, the Arthroscopic Bankart Repair was associated with a higher rate of recurrence, while the Latarjet procedure provided superior functional satisfaction and lower recurrence rates. These findings suggest that, despite its invasiveness, the Mini Open Latarjet may offer better long-term stability and patient outcomes, particularly in resource-constrained settings where repeated treatments could be financially burdensome. Future studies with longer follow-ups are needed to confirm these results and guide optimal treatment choices.


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How to Cite this Article: Marrapu B, Sasapu ABR, Thonangi Y, Sairam J, Reddy R. Comparative Study Between Functional Outcome of Mini Open Latarjet Versus Arthroscopic Bankart Repair in the Management of Recurrent Anterior Shoulder Instability. Journal Medical Thesis 2024 January-June ; 10(1):09-12.

 

 

 


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