Tag Archives: Fusion
Prospective Comparative Study of Stand-Alone versus Zero-Profile Anchored Cages in Single-Level ACDF: Radiological and Clinical Outcomes
Vol 11 | Issue 1 | January-June 2025 | page: 21-24 | Niharika Virkar, Chetan Pradhan, Atul Patil, Chetan Puram, Darshan Sonawane, Ashok Shyam, Parag Sancheti
https://doi.org/10.13107/jmt.2025.v11.i01.242
Author: Niharika Virkar [1], Chetan Pradhan [1], Atul Patil [1], Chetan Puram [1], Darshan Sonawane [1], Ashok Shyam [1], Parag Sancheti [1]
[1] Department of Orthopaedics, Sancheti Institute of Orthopaedics and Rehabilitation, Pune, Maharashtra, India.
Address of Correspondence
Dr. Niharika Virkar
Department of Orthopaedics, Sancheti Institute of Orthopaedics and Rehab-ilitation, Pune, Maharashtra, India.
E-mail: niharikavirkar@yahoo.in
Abstract
Background: Anterior cervical discectomy and fusion (ACDF) is a well-established surgery for symptomatic cervical disc disease. Interbody devices—stand-alone PEEK cages and zero-profile anchored PEEK cages—restore disc height, decompress neural elements and promote fusion. This study compares clinical and radiological outcomes after single-level ACDF using these two implant types.
Methods: In a retro-prospective cohort from September 2019 to September 2021, sixty-two patients with single-level degenerative cervical pathology underwent ACDF with either a stand-alone PEEK cage (n=31) or an anchored zero-profile PEEK cage (n=31). Clinical assessments included VAS, Neck Disability Index and modified JOA scores. Radiographic evaluation recorded segmental and global lordosis, fused segment height, disc heights and subsidence (>2 mm). Follow-up was immediate, 3, 6, 12 and 24 months.
Results: Both groups experienced significant clinical improvement in pain and function at final follow-up, with comparable gains in VAS, NDI and mJOA. Radiographically, anchored cages showed lower subsidence rates and better maintenance of segmental height and lordosis. Dysphagia was mostly mild and transient.
Conclusion: Single-level ACDF produces reliable clinical improvement with both implant types. Anchored zero-profile cages may better preserve radiographic alignment and reduce subsidence without compromising early clinical outcomes and patient satisfaction postoperatively.
Keywords: ACDF, PEEK cage, Zero-profile, Subsidence, Dysphagia, Fusion
Introduction
Anterior cervical discectomy and fusion (ACDF) is an established operation for symptomatic degenerative cervical disease and compressive myelopathy, with early foundational descriptions that laid the groundwork for modern anterior approaches. Classic anterior techniques have demonstrated consistent decompression and symptom relief. [1][2] The anterior route permits direct disc removal and placement of structural graft or spacer to restore disc height, maintain foraminal dimensions and promote arthrodesis. [3][4] Historically, autologous iliac crest graft provided reliable fusion but carried donor-site morbidity that motivated the search for alternative materials and constructs. [5][6] Interbody cage technology progressed from early metallic cages to the more recently favoured PEEK spacers, chosen for radiolucency and a modulus closer to bone, which may reduce stress shielding and facilitate radiographic fusion assessment. [7][8]
Plated constructs showed early advantages in immediate stability and fusion rates in some series, but the anterior plate has also been implicated in higher rates of early postoperative dysphagia and anterior soft-tissue irritation. [9][10] This trade-off inspired low-profile and zero-profile anchored devices designed to provide fixation while reducing anterior profile and soft-tissue contact. [11][12] The literature contains mixed findings on whether the choice of implant significantly alters long-term clinical outcomes despite radiographic differences such as subsidence and segmental alignment. [13][14] Factors intrinsic to surgery — including endplate preservation, cage sizing and avoidance of over-distraction — remain central to reducing subsidence irrespective of implant design. [15][16] Given continued debate about the relative radiographic behaviour of stand-alone versus anchored constructs and the clinical significance of those differences, focused comparative studies are needed. [17-20]
Aims and objectives
1. To evaluate, quantify and compare radiographic parameters of single-level ACDF treated with a stand-alone PEEK cage versus an anchored (zero-profile) PEEK cage.
2. To assess and compare clinical outcomes and functional recovery (VAS, NDI, mJOA) between the two groups.
3. To determine the incidence of complications including subsidence, dysphagia and absence of radiographic fusion and to analyse their relationship with implant type and level of fusion.
4. To provide practical recommendations on implant selection and technique to minimise adverse radiographic events while optimizing patient-reported results.
Review of literature
Seminal clinical reports established ACDF as a reliable method for decompression and fusion in cervical degenerative disease, demonstrating early and sustained symptomatic improvement across varied patient cohorts. [1][2] Over decades researchers compared autograft, allograft and synthetic cages; while fusion rates tended to be comparable, each choice carried differing profiles for complications and radiographic visibility. [3][4] Titanium cages were introduced early but concerns about imaging artefact and stress shielding encouraged wider adoption of PEEK devices, both for radiographic assessment and for mechanical compatibility with bone. [5][6] Comparative series examining plated versus plate-less constructs found that anterior plating may better preserve immediate sagittal alignment in some circumstances but can increase anterior soft tissue contact and early dysphagia. [7][8]
Zero-profile anchored spacers were developed to couple fixation with a lower anterior profile, with multiple retrospective and prospective series reporting reduced early dysphagia compared with traditional plate-and-cage constructs while maintaining satisfactory fusion rates. [9][10] Subsidence remains variably reported across studies — a product of inconsistent definitions, surgical technique, implant geometry and patient bone quality. [11][12] Some authors conceptualise modest subsidence as benign settling that does not impair patient outcomes, whereas others report a threshold beyond which subsidence produces segmental kyphosis and potential clinical sequelae. [13][14] Meta-analyses and systematic reviews suggest implant choice influences radiographic parameters and perioperative morbidity but that patient-reported outcomes are often similar across contemporary devices when appropriate technique is used. [15][16] The literature therefore supports a nuanced approach: implant selection should be informed by the balance between radiographic preservation and soft-tissue morbidity, while meticulous surgical technique remains the most reproducible determinant of favourable outcomes. [17-20]
Materials and methods
Study design: Retro-prospective, non-randomised cohort study at a tertiary centre. Ethics approval and informed consent were obtained.
Study period and sample: September 2019 to September 2021. Sixty-two consecutive patients fulfilling inclusion criteria were enrolled. Inclusion criteria comprised symptomatic cervical radiculopathy refractory to 4–6 weeks of conservative management, progressive neurological deficit, Nurick grade ≥2, or single-level cervical myelopathy. Exclusion criteria included active spinal infection, inflammatory spondyloarthropathy, traumatic or pathological fractures, cervical spinal tumours, developmental canal stenosis, and ossification of the posterior longitudinal ligament, prior cervical surgery, C7–T1 pathology and congenital block vertebrae. Patients were allocated to two groups: Group A (stand-alone PEEK cage) and Group B (anchored zero-profile PEEK cage), each containing thirty-one patients.
Clinical assessment: Baseline and follow-up evaluations included VAS for neck and arm pain, Neck Disability Index (NDI) and modified Japanese Orthopaedic Association (mJOA) score. Neurological examination and patient-reported outcomes were recorded preoperatively and at scheduled postoperative intervals.
Radiographic assessment: Standard AP, lateral and flexion–extension radiographs and preoperative MRI were used. Radiographic parameters measured included global cervical lordosis (C2–C7), segmental lordosis at the fused level, fused segment height, anterior and posterior disc heights, anterior cage distance and adjacent disc heights. Subsidence was defined as a decrease >2 mm in anterior or posterior disc height. Fusion was judged by bridging trabeculae, absence of motion on dynamic views and implant stability.
Surgical technique and follow-up: Standard anterior Smith-Robinson exposure was used. In the stand-alone group a PEEK cage packed with demineralised bone matrix was inserted; in the anchored group a zero-profile PEEK cage with integrated fixation screws was used. Patients were followed at immediate post-op, 3, 6, 12 and 24 months. Data collection included operative time, blood loss, perioperative complications including dysphagia (Bazaz score), and radiographic outcomes. Statistical analysis used appropriate comparative tests with p<0.05 considered significant.
Results
Sixty-two patients were included: forty-seven men and fifteen women, mean age 47.82 years. The most frequently treated level was C5–6 (43.5%). Each implant group contained thirty-one patients. Operative time predominantly ranged from 120 to 180 minutes; blood loss was generally minimal across the cohort. Both groups demonstrated significant improvement from baseline in VAS, mJOA and NDI scores at final follow-up with comparable magnitudes of change between groups. Immediate postoperative radiographs documented restored segmental height and increased segmental lordosis in most patients; over time there was a tendency for some reduction in segmental lordosis compared with the immediate postoperative measurements. Subsidence, defined as >2 mm decrease in anterior or posterior disc height, occurred in six patients overall (9.6% of cohort): two in the anchored group and four in the stand-alone group. Fusion as judged radiographically by bridging trabeculae and lack of motion on dynamic views was achieved in the majority of patients by 6–12 months. Dysphagia was reported in several patients but was predominantly mild and transient; severe persistent dysphagia was uncommon. There were no implant migrations or major neurological complications recorded in this series.
Discussion
This study demonstrates that single-level ACDF reliably improves pain, neurological status and function whether performed with a stand-alone PEEK cage or an anchored zero-profile PEEK cage. Both implant groups showed comparable and significant clinical improvement, which aligns with prior literature indicating that modern interbody constructs produce consistent symptomatic relief when appropriate decompression and alignment are achieved. [15] Radiographically, anchored cages in this cohort showed a lower incidence of subsidence and a better capacity to maintain segmental height and lordosis over time. [16] Although modest subsidence has been described as part of implant settling and may not always impair clinical outcomes, our observations and other reports caution that pronounced subsidence and consequent local kyphosis can adversely influence mechanical loading of adjacent segments and potentially affect long-term function. [17]
The lower subsidence observed with anchored devices may relate to immediate fixation through anchoring screws that distribute load and reduce micromotion, together with preservation of the subchondral endplate during insertion. [18] Technique remains critical: endplate preservation, avoidance of overdistraction and appropriate cage sizing are key modifiable factors to reduce subsidence risk. [19] Dysphagia rates were low and predominantly mild in both groups, supporting the premise that zero-profile low-profile fixation mitigates anterior soft-tissue irritation while not compromising stability. [20] It is important to note that differences in radiographic behaviour may not translate to early differences in patient-reported outcomes; longer follow-up will determine whether improved radiographic preservation confers sustained clinical benefits or reduces adjacent segment degeneration.
Limitations of this study include its non-randomised design, the modest sample size and follow-up limited to the early mid-term. Nevertheless, the findings support considering anchored zero-profile constructs when radiographic maintenance of segmental height and minimising subsidence are priorities, while recognising that both constructs deliver meaningful clinical improvement when surgery is performed thoughtfully.
Conclusion
Single-level anterior cervical discectomy and fusion reliably reduces pain and improves neurological function. Both stand-alone PEEK cages and anchored zero-profile PEEK cages produced significant and comparable improvements in VAS, NDI and mJOA scores. Radiographically, anchored cages displayed lower subsidence rates and better maintenance of fused segment height and segmental lordosis in this series. Clinical outcomes, however, were similar between implant types during the follow-up period reported. Surgical technique that preserves endplate integrity, avoids over distraction and ensures correct cage sizing is essential to minimise subsidence and maintain alignment. Anchored constructs may offer a radiographic advantage without negatively affecting early clinical recovery. Longer-term follow-up and larger, ideally randomized studies would clarify whether the radiographic benefits translate to sustained clinical advantage or reduced adjacent segment disease.
References
1. Aronson N, Filtzer DL, Bagan M. Anterior cervical fusion by the smith-robinson approach. J Neurosurg. 1968; 29(4):396-404. doi:10.3171/jns.1968.29.4.0397
2. S M, FP G, AA S, et al. National trends in anterior cervical fusion procedures. Spine (Phila Pa 1976). 2010; 35(15):1454-1459. doi:10.1097/BRS.0B013E3181BEF3CB
3. M P, J S, N G, et al. Anterior discectomy and fusion for the management of neck pain. Spine (Phila Pa 1976). 1999; 24(21):2224-2228. doi:10.1097/00007632-199911010-00009
4. Eck JC, Humphreys SC, Hodges SD, Levi P. A comparison of outcomes of anterior cervical discectomy and fusion in patients with and without radicular symptoms. J Surg Orthop Adv. 2006; 15(1):24-26.
5. Chong E, Pelletier MH, Mobbs RJ, Walsh WR. The design evolution of interbody cages in anterior cervical discectomy and fusion: A systematic review Orthopedics and biomechanics. BMC Musculoskelet Disord. 2015; 16(1):1-11. doi:10.1186/s12891-015-0546-x
6. Xiao SW, Liang Z De, Wei W, Ning JP. Zero-profile anchored cage reduces risk of postoperative dysphagia compared with cage with plate fixation after anterior cervical discectomy and fusion. Eur Spine J. 2017; 26(4):975-984. doi:10.1007/s00586-016-4914-5
7. A F-B, JK H, B O, et al. Swallowing and speech dysfunction in patients undergoing anterior cervical discectomy and fusion: a prospective, objective preoperative and postoperative assessment. J Spinal Disord Tech. 2002; 15(5):362-368. doi:10.1097/00024720-200210000-00004
8. H T, M N, ER L, et al. Dysphonia and dysphagia after anterior cervical decompression. J Neurosurg Spine. 2007; 7(2):124-130. doi:10.3171/SPI-07/08/124
9. M Q, H C, Y L, Y Z, L L, W Y. The use of a zero-profile device compared with an anterior plate and cage in the treatment of patients with symptomatic cervical spondylosis: A preliminary clinical investigation. Bone Joint J. 2013; 95-B (4):543-547. doi:10.1302/0301-620X.95B4.30992
10. Hofstetter CP, Kesavabhotla K, Boockvar JA. Zero-profile anchored spacer reduces rate of dysphagia compared with ACDF with anterior plating. J Spinal Disord Tech. 2015; 28(5):E284-E290. doi:10.1097/BSD.0b013e31828873ed
11. JS S, DG A, SD D, et al. Donor site morbidity after anterior iliac crest bone harvest for single-level anterior cervical discectomy and fusion. Spine (Phila Pa 1976). 2003; 28(2):134-139. doi:10.1097/00007632-200301150-00008
12. Wang ZD, Zhu RF, Yang HL, et al. Zero-profile implant (Zero-p) versus plate cage benezech implant (PCB) in the treatment of single-level cervical spondylotic myelopathy. BMC Musculoskelet Disord. 2015; 16(1):1-7. doi:10.1186/s12891-015-0746-4
13. RB C. The anterior approach for removal of ruptured cervical disks. J Neurosurg. 1958; 15(6):602-617. doi:10.3171/JNS.1958.15.6.0602
14. SMITH GW, ROBINSON RA. The treatment of certain cervical-spine disorders by anterior removal of the intervertebral disc and interbody fusion. J Bone Joint Surg Am. 1958; 40-A (3):607-624.
15. Shedid D, Benzel EC. Cervical spondylosis anatomy: pathophysiology and biomechanics. Neurosurgery. 2007; 60(1 Suppl 1):S7-13. doi:10.1227/01.NEU.0000215430.86569.C4
16. Frost BA, Camarero-Espinosa S, Foster EJ. Materials for the Spine: Anatomy, Problems, and Solutions. Mater (Basel, Switzerland). 2019; 12(2). doi:10.3390/ma12020253
17. Fakhoury J, Dowling TJ. Cervical Degenerative Disc Disease. StatPearls. August 2021. Accessed November 3, 2021.
18. Connell MD, Wiesel SW. Natural history and pathogenesis of cervical disk disease. Orthop Clin North Am. 1992; 23(3):369-380.
19. Okada E, Matsumoto M, Ichihara D, et al. aging of the cervical spine in healthy volunteers: a 10-year longitudinal magnetic resonance imaging study. Spine (Phila Pa 1976). 2009; 34(7):706-712. doi:10.1097/BRS.0b013e31819c2003
20. Nordin M, Carragee EJ, Hogg-Johnson S, et al. Assessment of neck pain and its associated disorders: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008; 33(4 Suppl):S101-22. doi:10.1097/BRS.0b013e3181644ae8
| How to Cite this Article: Virkar N, Pradhan C, Patil A, Puram C, Sonawane D, Shyam A, Sancheti P. Prospective Comparative Study of Stand-Alone versus Zero-Profile Anchored Cages in Single-Level ACDF: Radiological and Clinical Outcomes. Journal of Medical Thesis. 2025 January-June; 11(1): 21-24. |
Institute Where Research was Conducted: Department of Orthopaedics, Sancheti Institute of Orthopaedics and Rehabilitation, Shivajinagar, Pune, Maharashtra, India.
University Affiliation: MUHS, Nashik, Maharashtra, India.
Year of Acceptance of Thesis: 2022
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Hypothesis of Improved Fusion Rates with Anchored PEEK Cages Compared to Standalone Constructs in ACDF
Vol 11 | Issue 1 | January-June 2025 | page: 13-16 | Niharika Virkar, Chetan Pradhan, Atul Patil, Chetan Puram, Darshan Sonawane, Ashok Shyam, Parag Sancheti
https://doi.org/10.13107/jmt.2025.v11.i01.238
Author: Niharika Virkar [1], Chetan Pradhan [1], Atul Patil [1], Chetan Puram [1], Darshan Sonawane [1], Ashok Shyam [1], Parag Sancheti [1]
[1] Department of Orthopaedics, Sancheti Institute of Orthopaedics and Rehabilitation, Pune, Maharashtra, India.
Address of Correspondence
Dr. Niharika Virkar
Department of Orthopaedics, Sancheti Institute of Orthopaedics and Rehabilitation, Pune, Maharashtra, India.
E-mail: niharikavirkar@yahoo.in
Abstract
Background: Anterior cervical discectomy and fusion (ACDF) is a trusted operation for patients with single-level cervical disc disease who continue to have pain, numbness, weakness, or signs of nerve compression despite treatment. The main purpose of this surgery is to remove the damaged disc, free the compressed nerve structures, and restore stability to the cervical spine. In recent years, surgeons have increasingly used low-profile cages to support the operated level after disc removal. Standalone cages are simple and less prominent, while anchored cages add extra fixation and are expected to hold the correction more securely. Both are commonly used, but their effect on disc height, cervical alignment, and subsidence remains an important concern.
Hypothesis: This study was based on the belief that both standalone and anchored cages would improve symptoms after ACDF, but the anchored cage would give better structural support. It was expected to reduce cage settling, preserve disc height, and maintain cervical lordosis more effectively than the standalone cage. At the same time, the two groups were expected to show similar clinical improvement, since pain relief after surgery mainly depends on proper decompression of the affected nerve or spinal cord.
Clinical Importance: The study is useful for surgical decision-making because the choice of implant can affect how well the reconstructed segment holds its shape over time. Both cages helped patients recover well and improved pain and function after surgery. However, the anchored cage showed better maintenance of alignment and less subsidence, which may make it a better choice when stronger support is needed. The low-profile design of both implants also helped keep swallowing problems low after surgery.
Future Research: Further studies with more patients, longer follow-up, and multiple centers are needed to confirm these findings. Future work should also look at fusion rates, bone quality, and outcomes at different cervical levels.
Keywords: Anterior cervical discectomy and fusion, Standalone cage, Anchored cage, Cervical disc disease, Subsidence, Cervical lordosis, Dysphagia, Clinical outcome.
Background
Anterior cervical discectomy and fusion (ACDF) has remained one of the most dependable procedures for treating cervical disc disease because it directly addresses the source of compression and instability in a single operation. The anterior cervical approach was first described in the classic works of Cloward and later Smith and Robinson, and these reports laid the foundation for modern anterior cervical fusion surgery [1, 2]. Since then, ACDF has continued to evolve, but its basic purpose has remained the same: remove the diseased disc, decompress the neural structures, and restore stability to the cervical spine [3].
The cervical spine is a highly mobile region, and degeneration in this area can produce neck pain, radiculopathy, sensory loss, weakness, or myelopathic symptoms. The degenerative process affects the disc, facets, and supporting soft tissues, and the resulting biomechanical changes may gradually reduce disc height, alter alignment, and narrow the neural foramina [4-7]. Because symptoms do not always match imaging perfectly, surgical treatment is usually reserved for patients with clear clinical correlation and failure of conservative care [6, 7, and 9].
Over time, the choice of fusion material and implant design has changed significantly. Iliac crest bone graft was used widely in the past, but it carried donor-site pain and added morbidity [10]. Cages later became popular because they avoided graft harvest and helped maintain disc space height [5, 11]. However, standalone cages can sometimes settle into the vertebral endplates, leading to subsidence and partial loss of correction [11, 13]. Anchored cages were developed to improve stability while keeping the implant low profile. The idea was simple: add fixation to reduce motion and better preserve cervical lordosis without the bulk of a traditional plate [8, 12, and 14].
This study was therefore important because it compared two commonly used strategies in single-level ACDF: a standalone cage and an anchored cage. The real question was whether the added fixation of the anchored cage would lead to better radiological maintenance without sacrificing clinical improvement [8, 12, and 14]. That question is relevant in day-to-day surgical practice, where the surgeon must balance simplicity, stability, dysphagia risk, and long-term alignment [8, 9, 12, and 14].
Hypothesis
The working hypothesis of this study was that both implants would improve pain and function after single-level ACDF, but the anchored cage would perform better in preserving radiological alignment and preventing subsidence. This expectation was based on the mechanical design of the two constructs. A standalone cage depends mainly on cage-endplate contact for stability, and that can be enough in many cases, but it may be less resistant to collapse when the endplates are weak or when the segment is highly mobile [11,13,17]. By contrast, an anchored cage adds internal fixation, which should improve initial stability and reduce the chance of settling over time [12, 14, and 18].
The study also assumed that symptom relief would be similar in both groups. In ACDF, most of the clinical benefit comes from removal of the compressive disc and relief of pressure on the nerve root or spinal cord [3, 6, and 9]. For that reason, both groups were expected to show improvement in pain scores, disability scores, and neurological function, even if the radiological profile differed slightly [6, 9, 18, and 19]. In other words, the implant might influence alignment more than symptoms in the short term.
Another part of the hypothesis was that dysphagia would remain low in both groups because both devices are low profile compared with plate-based constructs [8, 12, 14, 23, and 24]. Dysphagia is a known issue after anterior cervical surgery, but lower-profile implants are generally designed to reduce that risk [8, 14, and 23]. Since the surgery in this study was limited to one level, the expectation was that postoperative swallowing problems would be mild and not meaningfully different between groups.
The study also considered cervical lordosis. Lordosis is more than just a number on an X-ray; it reflects the shape and mechanical balance of the cervical spine [4, 7, and 19]. The anchored cage was expected to preserve segmental and overall alignment better because fixation should reduce micromotion and lower the risk of cage settling [11, 12, and 18]. This may matter especially at the lower cervical levels, where mechanical stress is usually greater [7, 13, and 19].
Overall, the hypothesis was practical and clinically grounded. It asked whether anchored cages truly provide a mechanical advantage over standalone cages in routine single-level ACDF, or whether both methods achieve similar results with only a small difference in radiological behavior [8,12,14,20].
Discussion
The findings of this study show that both standalone cages and anchored cages are effective for single-level ACDF, but the anchored cage appears to offer better radiological stability. Both groups improved clinically after surgery, which supports the well-established role of ACDF in relieving cervical radiculopathy and myelopathic symptoms [3, 6, 9, and 19]. Pain reduction and functional improvement were seen in both groups, showing that decompression remains the main reason for clinical success, regardless of the exact cage design [3, 6, and 9].
The more interesting difference was seen in subsidence and alignment. The anchored cage showed less subsidence, which is important because settling of the implant can reduce disc height, narrow the foramina, and gradually affect segmental lordosis [11, 13, 17, and 21]. This finding fits the known mechanical advantage of fixation. A standalone cage may work well, but when the implant is held only by endplate contact, there is always some risk of gradual sinking [11, 13, 21]. Anchored fixation appears to reduce that risk and help preserve the correction achieved during surgery [12, 14, and 18].
Lordosis was also better maintained in the anchored cage group. That is clinically meaningful because cervical alignment influences biomechanics and, over time, may affect adjacent levels and overall spinal balance [4, 7, 19, and 22]. The immediate postoperative gain in alignment is often easy to obtain, but holding that gain over months is more difficult. The study suggests that anchored cages may do a better job of maintaining the reconstructed cervical shape, especially in the lower cervical spine where mechanical load is greater [7, 13, and 19].
The dysphagia findings were reassuring. Both groups had low rates of swallowing difficulty, and there was no major difference between them. This is consistent with the idea that low-profile devices are less irritating to the esophagus and surrounding soft tissues than traditional plate constructs [8, 14, 23, and 24]. Dysphagia remains one of the most important postoperative complaints after anterior cervical surgery, so even a small reduction is meaningful in patient comfort and satisfaction [8, 23, and 24]. The relatively low dysphagia burden in this study supports the use of compact constructs when possible.
The results also show that implant choice should be individualized. A standalone cage is simpler and remains a good option in many patients, especially when the bone quality is adequate and the surgeon wants to avoid extra fixation. The anchored cage, however, offers more mechanical security and may be preferred when alignment preservation is a priority or when there is greater concern about subsidence [11, 12, 18, and 21]. In practical terms, the difference between the two methods is not in early symptom relief, but in how well the surgical correction is maintained over time [12, 18, and 20].
This study fits well with the broader evolution of anterior cervical fusion. ACDF has moved from iliac crest grafting to cage-based reconstruction and then toward low-profile systems that try to combine stability with less soft-tissue irritation [5, 10, 11, 14]. That evolution reflects an ongoing effort to improve both patient comfort and mechanical durability. The present findings support that direction and suggest that anchored cages may be a useful middle ground between stability and low implant prominence [12, 14, and 25].
Clinical Importance
For everyday surgical practice, this study suggests that both implants work well, but the anchored cage may be the better choice when preserving disc height and lordosis is especially important. At the same time, the low rate of dysphagia supports the use of low-profile anterior cervical implants in suitable patients.
Future Direction
Future studies should include a larger sample, longer follow-up, and multicenter data. It would also be useful to compare fusion quality, bone density, and outcomes at different cervical levels to better define which patients benefit most from anchored fixation.
References
1. Cloward RB. The anterior approach for removal of ruptured cervical disks. J Neurosurg. 1958;15(6):602-617.
2. Smith GW, Robinson RA. The treatment of certain cervical-spine disorders by anterior removal of the intervertebral disc and interbody fusion. J Bone Joint Surg Am. 1958;40-A(3):607-624.
3. Aronson N, Filtzer DL, Bagan M. Anterior cervical fusion by the Smith-Robinson approach. J Neurosurg. 1968;29(4):396-404.
4. Shedid D, Benzel EC. Cervical spondylosis anatomy: pathophysiology and biomechanics. Neurosurgery. 2007;60(1 Suppl 1):S7-S13.
5. Frost BA, Camarero-Espinosa S, Foster EJ. Materials for the spine: anatomy, problems, and solutions. Materials (Basel). 2019;12(2):253.
6. Fakhoury J, Dowling TJ. Cervical Degenerative Disc Disease. StatPearls. Treasure Island (FL): StatPearls Publishing; 2021.
7. Connell MD, Wiesel SW. Natural history and pathogenesis of cervical disk disease. Orthop Clin North Am. 1992;23(3):369-380.
8. Xiao SW, Liang ZD, Wei W, Ning JP. Zero-profile anchored cage reduces risk of postoperative dysphagia compared with cage and plate fixation after anterior cervical discectomy and fusion. Eur Spine J. 2017;26(4):975-984.
9. Caridi JM, Pumberger M, Hughes AP. Cervical radiculopathy: a review. HSS J. 2011;7(3):265-272.
10. Sasso RC, Smucker JD, Hacker RJ, Heller JG. Donor site morbidity after anterior iliac crest bone harvest for single-level anterior cervical discectomy and fusion. Spine. 2003;28(2):134-139.
11. Chong E, Pelletier MH, Mobbs RJ, Walsh WR. The design evolution of interbody cages in anterior cervical discectomy and fusion: a systematic review. BMC Musculoskelet Disord. 2015;16:1-11.
12. Hofstetter CP, Kesavabhotla K, Boockvar JA. Zero-profile anchored spacer reduces rate of dysphagia compared with ACDF with anterior plating. J Spinal Disord Tech. 2015;28(5):E284-E290.
13. Cunningham BW, Kotani Y, McNulty P, Cappuccino A, Kanayama M, McAfee PC. Cage subsidence in the cervical spine after anterior cervical discectomy and fusion: a biomechanical analysis. Spine. 2000;25(19):2446-2451.
14. Wang ZD, Zhu RF, Yang HL, et al. Zero-profile implant versus plate-cage construct in the treatment of single-level cervical spondylotic myelopathy. BMC Musculoskelet Disord. 2015;16:1-7.
15. Okada E, Matsumoto M, Ichihara D, et al. Aging of the cervical spine in healthy volunteers: a 10-year longitudinal magnetic resonance imaging study. Spine. 2009;34(7):706-712.
16. Nordin M, Carragee EJ, Hogg-Johnson S, et al. Assessment of neck pain and its associated disorders: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine. 2008;33(4 Suppl):S101-S122.
17. Wu WJ, Jiang LS, Liang Y, et al. Long-term radiological and clinical outcomes of stand-alone titanium cage in degenerative cervical disc disease. Spine. 2012;37(16):1285-1293.
18. Vanek P, Bradac O, de Lacy P, Benes V. Clinical and radiological efficacy of anterior cervical microdiscectomy and fusion using a low-profile interbody spacer. Eur Spine J. 2013;22(1): Song KJ, Taghavi CE, Hsu MS, Lee KB, Kim GH, et al. Efficacy of anterior cervical discectomy and fusion with cage alone compared with cage and plate construct. Spine J. 2009;9(8):647-653.
19. Lied B, Roenning PA, Sundseth J, Helseth E. Anterior cervical discectomy and fusion with tricortical iliac crest graft or PEEK cage: a prospective outcome study. Acta Neurochir (Wien). 2010;152(12):
20. Gereck B, Ringel F, Reinke A, et al. Subsidence in anterior cervical discectomy and fusion with stand-alone titanium cage. Acta Neurochir (Wien). 2003;145(10
21. Lawrence BD, Zhou H, Brotman SG, et al. Risk of adjacent segment pathology after cervical fusion surgery: a systematic review. Spine. 2012;37(22 Suppl):.
22. Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine. 2002;27(22):2453-2458.
23. Fountas KN, Kapsalaki EZ, Nikolakakos LG, et al. Anterior cervical discectomy and fusion associated complications. Spine. 2007;32(21):2310-2317.
24. Thomé C, Krauss JK, Zevgaridis D. A prospective clinical comparison of rectangular titanium cages and iliac crest autografts in anterior cervical discectomy and fusion. Neurosurg Rev. 2003;27(1):34-41.
| How to Cite this Article: Virkar N, Pradhan C, Patil A, Puram C, Sonawane D, Shyam A, Sancheti P. Hypothesis of Improved Fusion Rates with Anchored PEEK Cages Compared to Standalone Constructs in ACDF. Journal of Medical Thesis. 2025 January-June; 11(1): 13-16. |
Institute Where Research was Conducted: Department of Orthopaedics, Sancheti Institute of Orthopaedics and Rehabilitation, Shivajinagar, Pune, Maharashtra, India.
University Affiliation: MUHS, Nashik, Maharashtra, India.
Year of Acceptance of Thesis: 2022
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Validation of a Novel Clinico-Radiological Scoring System to Decide on the Need for Fusion in cases of Lumbar Degenerative Spondylolisthesis
Vol 10 | Issue 2 | July-December 2024 | page: 20-23 | Shashank Omprakashji Jajoo, Shailesh Hadgaonkar, Ajay Kothari, Siddharth Aiyer, Pramod Bhilare, Parag Sancheti, Ashok Kumar Shyam Murari, Darshankumar Sonawane
https://doi.org/10.13107/jmt.2024.v10.i02.242
Author: Shashank Omprakashji Jajoo [1], Shailesh Hadgaonkar [1], Ajay Kothari [1], Siddharth Aiyer [1], Pramod Bhilare [1], Parag Sancheti [1], Ashok Kumar Shyam Murari [1], Darshankumar Sonawane [1]
[1] Department of Orthopaedics, Sancheti Institute for Orthopaedics and Rehabilitation, Pune - 411005, Maharashtra, India.
Address of Correspondence
Dr. Shashank Omprakashji Jajoo,
Department of Orthopaedics, Sancheti Institute for Orthopaedics and Rehabilitation, Pune - 411005, Maharashtra, India
E-mail: shankrocks139.sj@gmail.com
Abstract
Background: Degenerative spondylolisthesis is a common cause of lower back pain, creating challenges in determining the best treatment approach—either standalone decompression or fusion. The absence of a standardized scoring system complicates decision-making. This study intends to validate a clinico-radiological scoring system to guide treatment decisions and improve patient outcomes.
Material & Methods: A cohort of 112 patients with degenerative lumbar spondylolisthesis was evaluated using the new scoring system. Independent assessments by spine consultants, fellows, and residents determined whether patients required standalone decompression or fusion. Inter- and intra-observer variability was measured. Patients' recovery and functional outcomes were tracked using VAS score (for back pain & leg pain), Oswestry Disability Index (ODI) and SF-36 score.
Results: A total of 112 cases were divided into four groups: Group 1A (8.9%), 1B (71.4%), 2A (13.4%), and 2B (6.3%). Complications were minimal, and re-surgery rates were low. Significant improvements were observed in back pain, leg pain, and ODI scores, with no major differences in postoperative outcomes across groups.
Conclusions: The scoring system effectively guides surgical decision-making in degenerative spondylolisthesis, reducing unnecessary fusion and improving outcomes. Further research should explore its broader application.
Keywords: Degenerative spondylolisthesis, Standalone decompression, Fusion, Scoring system, Reliability study
Introduction:
Degenerative spondylolisthesis has become a prominent cause of lower back pain and disability, especially as the global population ages and adopts more sedentary lifestyles. The management of this condition presents significant challenges for both patients and healthcare providers. A critical decision in treatment involves choosing between non-surgical approaches such as physical therapy, medications, or lifestyle changes, and opting for surgical intervention.[1] This decision is influenced by clinical, radiological, and patient-specific factors. However, a widely accepted standardized scoring system to guide these decisions is lacking. Furthermore, there is ongoing debate regarding the most appropriate surgical approach, with some advocating for decompression alone[2–10] and others supporting decompression combined with spinal fusion[2,11–13].
Several classification systems, including the Meyerding classification[14], Wiltse classification[15], and Clinical and Radiographic Degenerative Spondylolisthesis Classification (CARDS)[16], have been introduced to assist in surgical decision-making for degenerative lumbar spondylolisthesis. While these systems offer insights into spinal instability and the severity of the condition, they often fail to account for the complexities of individual cases. A key issue is the tendency to treat degenerative spondylolisthesis as a homogenous condition, leading to potential overtreatment or undertreatment[7]. For instance, the widely used Meyerding classification is limited as degenerative spondylolisthesis slips rarely exceed grade I or 30%[14]. This study seeks to validate a new clinico-radiological scoring system proposed by Kulkarni et al. in 2020[7] aimed at addressing these limitations and offering a more comprehensive, patient-centered approach to surgical decision-making in degenerative lumbar spondylolisthesis.
Aims and Objectives:
Aim: Validation of a Novel Clinico-Radiological Scoring System to Decide on the Need for Fusion in cases of Lumbar Degenerative Spondylolisthesis
Objectives: 1) Calculate the score for all patients with degenerative lumbar spondylolisthesis using the new scoring system. 2)Analyze and assess the functional outcomes of surgically treated patients. 3)Study the reliability of variables used in the new clinico-radiological scoring system. 4)Compare interobserver and intraobserver reliability of the new scoring system.
Materials and Methods:
This prospective study was conducted at a tertiary care center between October 2022 and December 2024. After receiving institutional ethical and scientific committee approval, patients were selected based on specific inclusion and exclusion criteria. Thorough explanations of the study's nature were provided to patients and their relatives, and informed consent was obtained from all participants. The sample size comprised approximately 112 skeletally mature patients diagnosed with degenerative lumbar spondylolisthesis.
Eligibility Criteria
Inclusion criteria: 1) Skeletally mature patients diagnosed with lumbar degenerative spondylolisthesis. 2) Patients who failed conservative treatment. 3) Patients with spondylolisthesis at one or two levels. 4) Patients who provided written informed consent.
Exclusion criteria: 1) Patients under 18 years of age. 2) Patients diagnosed with spondylolisthesis subtypes other than degenerative (e.g., dysplastic, isthmic, traumatic). 3) Patients previously managed surgically.
A new clinico-radiological scoring system proposed by Kulkarni et al. in 2020[7] was applied to calculate scores for all patients. Patients scoring <5.5 were classified as stable and advised standalone decompression. Scores ≥5.5 indicated instability, requiring fusion surgery[7].
Patients were divided into two main groups:
Group 1: Operated according to the new scoring system (Group 1A: standalone decompression, Group 1B: decompression with fusion).
Group 2: Operated based on the surgeon's preference, contrary to the scoring system (Group 2A: decompression with fusion, Group 2B: standalone decompression).
Postoperative follow-ups were conducted at 6 weeks, 3 months, 6 months, and 1 year. Functional outcomes were measured using VAS, ODI, and SF-36 Health Survey scores. Intra-operative and post-operative complications were monitored.
Seven independent observers were selected to evaluate a set of clinical cases twice, at intervals of 2-3 months, for interobserver and intraobserver reliability. Observers were blinded to each other’s assessments and their prior evaluations. The data was analyzed using Cohen’s Kappa statistic[16] to assess both inter-observer and intra-observer reliability. Kappa (k) values, expressed with 95% confidence intervals, ranged from -1 to 1, with higher values indicating better agreement.
Statistical analysis was performed using SPSS version 24.0. Comparisons were conducted using the Chi-Square test for categorical data and ANOVA for continuous variables, with Bonferroni post-hoc tests for multiple comparisons[17–19].
Results:
A total of 112 cases were analyzed and categorized into four groups: Group 1A (10 cases), Group 1B (80 cases), Group 2A (15 cases), and Group 2B (7 cases). The majority of cases belonged to Group 1B (71.4%), followed by Group 2A (13.4%), Group 1A (8.9%), and Group 2B (6.3%). The highest mean age was observed in Group 2A (67.80 ± 8.15 years), with a significant age difference between Group 2A and Group 1B (P<0.05). The male-to-female ratio in the study was 0.75:1. Group 2B had a significantly higher proportion of male patients (85.7%), while Group 1B had the largest proportion of female patients (61.2%).
BMI varied across the groups, ranging from 24.91 ± 4.45 kg/m² in Group 1A to 26.15 ± 2.94 kg/m² in Group 2B, but no significant differences were found (P>0.05). Co-morbidities such as hypertension, diabetes, ischemic heart disease (IHD), and hypothyroidism were prevalent.
Intra-operative complications occurred in 8.8% of Group 1B cases and 20% of Group 2A cases, primarily dural tears. Post-operative complications, including infection and cage migration, were minimal, occurring in 6.2% of Group 1B and 6.7% of Group 2A cases. No complications were reported in Groups 1A and 2B. Re-surgery was required in 2.5% of Group 1B and 6.7% of Group 2A cases, while Groups 1A and 2B had no re-surgeries.
Back pain, leg pain, Oswestry Disability Index (ODI), and SF36 scores were analyzed to assess outcomes. Group 1A had significantly lower pre-operative back pain scores (Mean = 3.70, SD = 3.09) compared to other groups (P<0.05). However, post-operative scores showed no significant differences at 6 weeks, 3 months, 6 months, and 1 year (P>0.05). The percentage improvement in back pain scores at 1 year ranged from 64.95% in Group 1A to 78.11% in Group 1B, with no significant differences between groups (P>0.05).
For leg pain, Group 1A had significantly higher pre-operative scores (Mean = 8.60, SD = 0.84) than Group 1B (Mean = 6.76, SD = 1.59), with no significant differences between other groups. At the 1-year follow-up, leg pain scores were significantly lower in Groups 1B and 2B compared to Group 2A (P<0.05), with percentage improvement ranging from 64.64% in Group 2A to 88.76% in Group 2B.
ODI scores were similar across all groups pre-operatively. At the 1-year follow-up, Groups 1A and 1B had significantly better scores compared to Group 2A (P<0.05), with percentage improvement ranging from 46.52% in Group 2A to 54.50% in Group 1B.
SF36 pain scores showed no significant pre-operative differences between the groups (P>0.05). At 1 year, Group 2B had the greatest improvement, with a 398.89% increase in pain scores, followed by Group 1A (368.15%), Group 1B (330.83%), and Group 2A (264.81%). Physical functioning scores also improved significantly across all groups post-operatively, with Group 2B showing the greatest improvement at 1 year (257.14%).
The interobserver agreement for parameters such as Mechanical Back Pain, age, and activity showed very high reliability, with Cohen's kappa values ranging from 0.999 for MBP and activity to 0.687 for Arvind’s score. Segmental Kyphosis and Facet Effusion had substantial agreement (kappa values ranging from 0.630 to 0.946). However, variability was noted in the assessment of Segmental Dynamic Spondylolisthesis (kappa values of 0.379 to 0.682), and technical factors showed the lowest agreement (kappa range 0.323 to 0.718). Intraobserver reliability mirrored these trends, with high agreement across most parameters, though certain parameters like Arvind's score and technical factors displayed slight variability.
Conclusion:
The results of the study showed significant improvements in patients who underwent surgical treatment, whether it was standalone decompression or decompression with fusion. The study further compared these findings with Kulkarni's study[7], highlighting similar trends in the reduction of pain scores, though with varying degrees of improvement. The inter-observer reliability of the scoring systems used in this study is generally high, certain parameters, particularly those involving more subjective assessments, could benefit from further refinement to enhance consistency. The robust agreement in most parameters underscores the reliability of the scoring systems, yet highlights the importance of continuous evaluation and training to ensure the highest standard of clinical assessments. In conclusion, the study validates the efficacy of the new clinico-radiological scoring system, which could potentially standardize the decision-making process in surgical treatment of degenerative spondylolisthesis, ensuring better patient outcomes and minimizing unnecessary fusion surgeries.
Clinical Message:
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.
References
1. 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.
2. Chan AK, Bisson EF, Bydon M, Glassman SD, Foley KT, Potts EA, et al. Laminectomy alone versus fusion for grade 1 lumbar spondylolisthesis in 426 patients from the prospective Quality Outcomes Database. J Neurosurg Spine. 2019 Feb;30(2):234–41.
3. 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.
4. Cheung JPY, Cheung PWH, Cheung KMC, Luk KDK. Decompression without Fusion for Low-Grade Degenerative Spondylolisthesis. Asian Spine J. 2016;10(1):75.
5. Inose H, Kato T, Yuasa M, Yamada T, Maehara H, Hirai T, et al. Comparison of Decompression, Decompression Plus Fusion, and Decompression Plus Stabilization for Degenerative Spondylolisthesis: A Prospective, Randomized Study. Clin Spine Surg Spine Publ. 2018 Aug;31(7):E347–52.
6. Dijkerman ML, Overdevest GM, Moojen WA, Vleggeert-Lankamp CLA. Decompression with or without concomitant fusion in lumbar stenosis due to degenerative spondylolisthesis: a systematic review. Eur Spine J. 2018 Jul;27(7):1629–43.
7. 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.
8. Ha DH, Kim TK, Oh SK, Cho HG, Kim KR, Shim DM. Results of Decompression Alone in Patients with Lumbar Spinal Stenosis and Degenerative Spondylolisthesis: A Minimum 5-Year Follow-up. Clin Orthop Surg. 2020;12(2):187.
9. 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.
10. Wei FL, Zhou CP, Gao QY, Du MR, Gao HR, Zhu KL, et al. Decompression alone or decompression and fusion in degenerative lumbar spondylolisthesis. eClinicalMedicine. 2022 Sep;51:101559.
11. 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.
12. Kleinstueck FS, Fekete TF, Mannion AF, Grob D, Porchet F, Mutter U, et al. To fuse or not to fuse in lumbar degenerative spondylolisthesis: do baseline symptoms help provide the answer? Eur Spine J. 2012 Feb;21(2):268–75.
13. 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.
14. Meyerding HW. Meyerding HW. Spondylolisthesis. Surg Gynecol Obstet. 1932;54: 371–377. In p. 371–7.
15. Wiltse LL, Newman PH, Macnab I. Classification of spondylolisis and spondylolisthesis. Clin Orthop. 1976 Jun;(117):23–9.
16. McHugh ML. Interrater reliability: the kappa statistic. Biochem Medica. 2012;22(3):276–82.
17. Rosner BA. Fundamentals of biostatistics. 5. ed. Pacific Grove, Calif.: Duxbury; 2000. 80–240 p.
18. Riffenburgh RH. Statistics in medicine. 2nd ed. Amsterdam: Elsevier Academic Press; 2006. 85–125 p.
19. Sundar Rao PSS, Richard J. An introduction to biostatistics: a manual for students in health sciences. 3 ed., 8. print. New Delhi: Prentice Hall of India; 2003. 86–160 p. (Eastern economy edition).
| How to Cite this Article: Jajoo SO, Hadgaonkar S, Kothari A, Aiyer S, Bhilare P, Sancheti P, Murari AS, Sonawane D. Validation of a Novel Clinico-Radiological Scoring System to Decide on the Need for Fusion in cases of Lumbar Degenerative Spondylolisthesis. Journal of Medical Thesis. 2024 July-December ; 10(2): 20-23. |
Institute Where Research was Conducted: Department of Orthopaedics, Sancheti Institute for Orthopaedics and Rehabilitation, Pune, Maharashtra, India.
University Affiliation: Maharashtra University Of Health Sciences (MUHS), Nashik, Maharashtra, India.
Year of Acceptance of Thesis: 2024
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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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