Vol 4 | Issue 1 | Jan - Apr 2016 | page: 19-25 | Snigdha Kumari[1],  Ashok Kumar Biswas[1], Goutam Giri[1].

Author: Snigdha Kumari[1],  Ashok Kumar Biswas[1], Goutam Giri[1].

Department of obstetrics and gynecology. Vivekananda Institute of Medical Sciences, Ramakrishna Mission Seva Pratishthan, Kolkata-26, West Bengal, India.
Institute Where Research Was Conducted: Department Of Obstetrics & Gynaecology, Vivekananda Institute Of Medical Sciences, Rama Krishna Mission Seva Pratishthan, Kolkata, India.
University Affiliation: The West Bengal Institute Of Health Sciences .
Year Of Acceptance Of Thesis: 2014.

Address of Correspondence
Dr. Snigdha Kumari
Senior Resident, Department Of Obstetrics And Gynaecology, Postgraduate Institute Of Medical Education & Research, Chandigarh- 160012, India.
Email: snigdha.obs@gmail.com

 Abstract

Background: Induction of labour is the stimulation of uterine contractions before the spontaneous onset of labour with or, without ruptured membranes. In recent years, vaginal prostaglandins have become one of the most commonly used induction agents. These come with a variety of methods of administration, including gels, tablets, suppositories and pessaries. We conducted a randomized prospective clinical trial to compare the efficacy of intravaginal dinoprostone gel and misoprostol vaginal tablets in women undergoing induction of labour at term. 120 pregnant women were randomly chosen from our outpatients department and admitted during the period January 2011 to June 2012 as per the study protocol. Out of 120 pregnant women 60 subjects received dinoprostone gel and rest 60 received misoprostol vaginal tablets randomly as a method of induction of labour. The primary aim of this study was to compare the efficacy of intravaginal dinoprostone gel with misoprostol vaginal tablets in induction of labour and it was concluded that the administration of drugs and delivery interval was significantly higher in dinoprostone gel group than that of misoprostol tablets group and the mean duration of labour of misoprostol tablets group was significantly lower than that of dinoprostone gel group
Keywords : Induction of labour, Dinoprostone gel, Misoprostol tablets.

Introduction

Induction of labour is the stimulation of uterine contractions before the spontaneous onset of labour with or, without ruptured membranes. An intervention designed to initiate uterine contractions artificially leading to progressive effacement and dilatation of the cervix and birth of the baby. It is a common obstetric intervention employed in response to a wide range of conditions in which prompt delivery may be achieved to reduce the risk of maternal and neonatal morbidity and mortality [1]. The physiological processes surrounding the initiation and promotion of labour are complex, but a successful vaginal delivery is less likely if the cervix is unfavorable. There are several methods of labour induction, including administration of oxytocin, prostaglandins, prostaglandin analogues and smooth muscle stimulants such as herbs or, castor oil, or mechanical methods such as digital stretching of the cervix and sweeping of the membranes [2]. In recent years, vaginal prostaglandins have become one of the most commonly used induction agents. These come with a variety of methods of administration, including gels, tablets, suppositories and pessaries [2].  A successful induction is primarily dependent on the pre-induction condition of the cervix. When the cervix is favourable the usual method of induction is amniotomy and oxytocin, whereas with an unfavourable cervix vaginal prostaglandins are commonly used [6]. Dinoprostone is a synthetic analogue of ProstaglandinE2 (PGE2). It works by binding and activating the PGE2 receptor. The major clinical application of PGE2 relates to its effect on uterine smooth muscles. This property has led to its obstetrical use for term labour induction. Although the exact mechanisms are not fully understood, it is theorized that the pharmacologic action of PGE2 is related to its ability to regulate intracellular cyclic 3', 5'-cyclic adenosine monophosphate (cAMP) levels and cellular membrane calcium ion transport. It should be noted, however, that some effects of prostaglandins are independent of cAMP and are mediated through that of cGMP. Finally, Prostaglandins allow for an increase in intracellular calcium levels, causing contraction of myometrial muscle [7]. Misoprostol is a potential alternative to currently licensed labour induction agents. It is a prostaglandin E1 analogue. Misoprostol has been widely used in the prevention and treatment of gastrointestinal ulcers for more than 20 years, but it also has uterotonic properties and there is a growing body of literature exploring its 'off-label' use for cervical ripening and labour induction [1].

Material And Methods

STUDY DESIGN
This was a hospital based observational comparative study.

SAMPLE SIZE
This study was conducted on 120 indoor subjects. Sixty subjects were induced with intravaginal dinoprostone gel and rest were induced with misoprostol vaginal tablets on random basis.
INCLUSION CRITERIA
1) Women with cephalic presentation
2) 37 to 42 week's period of gestation
3) Maternal medical conditions- diabetes mellitus, pregnancy induced hypertension

EXCLUSION CRITERIA
1) Women who are hypersensitive to prostaglandins 2) Women with favourable cervix (modified bishop's score ≥8)
3) Certain circumstances where use is not recommended --
a) Multiple foetuses
b) Severe hydrocephalus
c) Malpresentation
d) Non reassuring fetal status
e) Prior uterine surgery (including caesarean section)
f) Contracted or distorted pelvic anatomy
g) Abnormal placentation (Placenta praevia, Vasa praevia)
h) Active genital herpes
I) Cervical cancer

METHODOLOGY
It was a randomized prospective clinical trial to compare the efficacy of intravaginal dinoprostone gel and misoprostol vaginal tablets in women undergoing induction of labour at term. Women meeting the study criteria were approached for participation and an informed consent was obtained. Participants in the randomized trial were admitted to the antenatal ward. A 30 minutes admission cardiotocogram was recorded. Eligible patients were randomly assigned by block randomization method to receive PGE2 gel or misoprostol vaginal tablets.
PGE2 vaginal gel contains 0.5mg of dinoprostone in 3 grams of thick clear gel in sterile translucent syringes stored at 2-8 degree Celsius. Misoprostol tablet contains 25mcg of misoprostol stored at room temperature.  Prior to the administration of the study drug, fetal heart sound was monitored for a period of 1 minute followed by vaginal examination if the FHR was within normal limits. The initial Bishop's score was recorded and the study drug (i.e. 1.5mg of PGE2 gel or 25mcg misoprostol tablet) was administered into the posterior vaginal fornix.  Cardiotocography (CTG) was performed after 1 hour of administration of the medication. If normal, then patient was reviewed 6 hours after the first administration of inducing agent. A further dose of 0.5mg dinoprostone gel or 25mcg misoprostol was repeated if necessary. Patient was again reviewed after 24 hours of administration of first dose of the study drug and further dose of 0.5mcg dinoprostone gel or 25mcg misoprostol was administered, if necessary. And likewise, application of study drug was followed by CTG after 1 hour. No further dose of either agent was administered to women who experienced three or, more uterine contractions per 10 minutes, had a Bishop ≥8 or, spontaneous rupture of membranes. Subsequent management was taken thereafter. Oxytocin augmentation was started in cases with unsatisfactory progress of labour or following amniotomy, at a rate of 1mU/minute. Oxytocin was not started for 6 hours following administration of vaginal prostaglandins and was increased at intervals of 30 minutes as needed to achieve an adequate contraction pattern. Surveillance of fetal heart rate and uterine activity was performed by CTG. This study protocol includes a standardized Bishop's Scoring System used for assessment of inducibility. It is one of the quantifiable methods used to predict outcomes of labour induction described by Bishop in 1964. A Bishop's score of 9 conveys a high likelihood for a successful induction. For research purposes, a Bishop score of 4 or less identifies an unfavorable cervix and may be an indication for cervical ripening. The data regarding secondary outcome measures recorded were: requirement of oxytocin, mode of delivery, abnormal CTG recordings, incidence of uterine contraction abnormalities, any complications during labour. The newborn was examined immediately after birth, the Apgar score being determined at 1 and 5 minutes. Any fetal abnormalities occurring in hospital were noted. All maternal side-effects were recorded, as was the administration of all drugs including analgesics, tranquillizers, anesthetics and antiemetics.

Results

The specific objective of the study was to compare the efficacy of intravaginal dinoprostone gel with misoprostol vaginal tablets in induction of labour (vaginal delivery within 24 hours). Having completed the result, analysis and the discussion on major issues, we finally present the following observations to arrive at a conclusion.
Overall views:
1. The mean age of Dinoprostone Gel group was 25.91 years with range 18-34 years and the median age was 26.0 years.
The mean age of Misoprostol Tablets group was 25.61 years with range 19-34 years and the median age was 25.5 years. Thus, in our study the subjects of the two groups are age matched.
2. In Dinoprostone Gel group 41.7% of the subjects whereas 26.7% of the subjects in Misoprostol Tablets group received education below higher secondary level. We observed that there is no significant association between level of education and groups.
3. The mean period of gestation on admission of the Dinoprostone Gel group was 272.53 days with range 259-280 days and the median was 276 days whereas in Misoprostol Tablets group it was 275.61 days with range 259-286 days and the median 278 days.
There is no significant difference between the mean period of gestation on admission of two groups (p>0.05).
4. Majority of the subjects in this study were primigravida.
5. In Dinoprostone Gel group 26.7% of the subjects had an associated medical history however, only 11.7% had an associated medical history in Misoprostol Tablets group but it is not statistically significant (p>0.05). Three subjects were β-thalassemia carrier, four individuals had a documented cholelithiasis, two subjects had a history of subfertility, four were HbE trait, two individuals contacted pulmonary tuberculosis and another two suffered from jaundice.
6. In Dinoprostone Gel group 23.7% of the subjects had a past surgical history however, only 16.7% had past surgical history in Misoprostol Tablets group but it is not statistically significant (p>0.05).
7. Among the subjects taken in the study 41% had prior MTP in Dinoprostone Gel group whereas 58.3% of the individuals had prior MTP in Misoprostol Tablet group. Also two subjects underwent prior forceps delivery in Dinoprostone Gel group.
8. The following were the major complications noted in both the groups during their antenatal visits viz; bleeding per vaginum, fever, GDM on insulin, GDM on MNT, GGI, hypothyroid, ICP, IUGR, less fetal movement, PIH and UTI. These complications were evenly noted in both the groups and there was no significant association between these complications during antenatal visit and groups (p>0.05).
9. We could not draw any significant difference between per abdomen findings of the subjects in the groups (p>0.05).
10. The mean Bishop's score at admission of the Dinoprostone Gel group was 4.59 with range 3-6 and the median was 5 whereas it was 4.58 in Misoprostol group with range 2-7 and the median was 5. There was no significant difference between the mean Bishop's score at admission of the two groups (p>0.05).
11. The mean period of gestation on day of induction of the Dinoprostone Gel group was 273.86 days with range 256-281 days and the median was 276 days however it was 276.78 days with range 260-287 days and the median was 279 days in Misoprostol Tablets group. There was no significant association between period of gestation on day of induction (in days) and groups (p=0.09).
12. The mean Bishop's score before administration of drugs in the Dinoprostone Gel group was 5.06 with range 3-6 and the median was 5 whereas it was 5.26 with range 3-8 and the median was 5.5 in Misoprostol Tablets group. There was no significant association between Bishop's score before administration of drugs and groups (p=0.12). t-test showed that there was no significant difference between the mean Bishop's score before administration of drugs to the two groups (p>0.05).
13. Several trials and study concluded that there was no significant difference in the incidence of abnormal fetal heart rate recordings [11, 12].Whereas our study correlated similarly to their findings in the way that we also found no significant association between CTG abnormalities and groups. We found that in the Dinoprostone Gel group the CTG findings 1 hour after administration of drug was normal in 95%, pathological in 1.7% and suspicious in 3.3% of the cases whereas it was normal in 98.3% and suspicious in 1.7% of the cases in Misoprostol Tablets group.
14. A randomized study of vaginal misoprostol (PGE1) and dinoprostone gel (PGE2) for induction of labor at term concluded that in the Dinoprostone Gel group, more women required repeated doses of the inducing agent before achieving active labour and were less likely to deliver following administration of a single dose [6]. Our study too inferred the similar observation. The subjects in Misoprostol Tablets group requiring single repeat dose of drug for induction of labour in 60% of the cases whereas 70% of the subjects needed repeat dose of drugs in Dinoprostone Gel group. The subjects in Misoprostol Tablets group requiring twice repeat dose of drug for induction of labour in 8.3% of the cases whereas 15% of the subjects needed twice repeat dose of drugs in Dinoprostone Gel group. The above findings showed that there was significant association between requirement of repeat dose and groups (p=0.0001). Test of proportion showed that subjects of the Dinoprostone Gel Group needed single as well as twice repeat dose significantly higher than the subjects of the Misoprostol Tablets Group (p<0.05).
15. The CTG findings 1 hour after re-administration of drugs were normal in 63.3%, pathological in 1.7% and suspicious in 3.3% of the subjects in Dinoprostone Gel group and it was normal in 78.3%, pathological in 1.7% and suspicious in 3.3% of the subjects in Misoprostol Tablets group. The above findings shows that there is no significant association between CTG 1hr. after re-administration of drugs and groups (p=0.29).
16. Several randomized studies opined that misoprostol may be more effective than other inducing agents, with a higher rate of vaginal delivery within 24hrs of induction [6].
Misoprostol is associated with a shorter duration of labour, higher rate of vaginal delivery within 24 hours from induction [6, 10].
Whereas in different studies, the number of women who delivered <24 hours was similar in both groups [11, 12]. In our study, the mean of administration of drugs and delivery interval in the Dinoprostone Gel group was 18.50 hours with range 5.0 – 56.0 hours and the median was 18.25 hours. The mean of administration of drugs and delivery interval of the Misoprostol Tablets group was 16.89 hours with range 4.5 - 41.08 hours and the median was 15 hours. There was a significant association between administration of drugs and delivery interval (in hours) and groups (p=0.04). t-test showed that the mean of administration of drugs and delivery interval (in hours) of Dinoprostone was significantly higher than that Misoprostol group (p<0.01).
17. In our study, the incidence of prelabour rupture of membranes was noted in 38.3% of subjects of Misoprostol Tablets group and 16.7% in Dinoprostone Gel group. Test of proportion showed that subjects of the Misoprostol Tablets group had prelabour rupture of membranes significantly higher than the subjects of the Dinoprostone Group (Z=2.65; p<0.01)
18. A comparative study on the efficacy of Dinoprostone versus Misoprostol found no significant difference between the two groups in mode of delivery [21]. Another study noted no significant difference in the rate of caesarean section between the two groups [10]. Few studies noted that there is no increase in the rate of caesarean section or maternal and neonatal morbidity between the Dinoprostone gel and Misoprostol Tablet group [6, 10]. Our study revealed that 65% of the subjects in the Dinoprostone Gel group and 75% of the subjects in the Misoprostol Tablets group underwent vaginal delivery respectively. The rate of caesarean section in our study in Dinoprostone Gel group and Misoprostol Tablets group was 31.7% and 25% respectively. 3.3% of the subjects had low forceps delivery in the Dinoprostone Gel group. The above findings in our study shows that there is no significant association between mode of delivery and groups (p=0.23), which corroborates with the above mentioned studies.
19. The mean duration of labour of the Dinoprostone Gel group was 5.06 hours with range 1-16 hours and the median was 4.0 hours whereas it was 3.22 hours with range 1-15 hours and the median was 4.5 hours in the Misoprostol Tablets group. The above findings inferred that there was no significant association between duration of labour and groups (p=0.12) although t-test showed that the mean duration of labour of Misoprostol Tablet group was lower than that of Dinoprostone Gel group.
20. Few studies reported that the number of women who delivered <24 hours was similar in both groups, as was the number requiring oxytocin augmentation [11, 12]. It was also concluded in some studies that a significantly smaller proportion of women in the misoprostol group required oxytocin augmentation during labour [6, 10]. In our study both the groups needed oxytocin augmentation for labour. It was needed in 60% subjects of Dinoprostone Gel group and in 58.3% of the subjects in the Misoprostol Tablets group. Hence, the requirement of oxytocin in both groups is similar with no significant association between the individual drugs.
21. There are studies that suggest that there is a role vaginal misoprostol for cervical ripening and induction of labour and found increased incidence of meconium-stained liquor [4]. However some other studies found no significant differences between the two groups in incidence of meconium [11, 12]. In our study, the incidence of meconium stained liquor was noted in 25% of the subjects of Dinoprostone Gel group and 45% of the subjects of Misoprostol Tablets group. Test of proportion showed that subjects of the Misoprostol Tablets Group had meconium stained liquor significantly higher than the subjects of the Dinoprostone Gel Group (Z=2.29; p<0.05).
22. We found that the Intrapartum CTG was normal in 66.7%, pathological in 1.7% and suspicious in 3.3% of the subjects on Dinoprostone Gel group whereas it was normal in 65%, pathological in 6.7% and suspicious in 5% of the subjects in the Misoprostol Tablets group. Test of proportion showed that subjects of the Misoprostol Group had pathological Intrapartum CTG significantly higher than the subjects of the Dinoprostone Group (Z=8.48; p<0.01).
23. Shellhaas18 et al and Kastner19 et al described the association between increased incidence of postpartum atony and hemorrhage in women undergoing induction or augmentation. Intractable atony was the indication for a third of all caesarean hysterectomies. This indication was more prevalent in women with induced or augmented labor.
We could not found any significant association between the incidence of PPH and the use of individual drugs needed for induction of labor. In our study 6.7% of the subjects of Dinoprostoen Gel group and 5% of the Misoprostol Tablets group suffered PPH. But there was no significant association between incidence of PPH and groups (p=0.69).
Among other observations, we noted equal number of subjects in both the groups whose fetus had one loose loop of cord around the neck, whereas two loose loop of cord around the neck was noted in two subjects of Dinoprostone Gel group and one subject of Misoprostol Tablets group. We noted an inc idence of tight loop of cord around neck, vulval hematoma, scanty liquor in Dinoprostone Gel group. In Misoprostol Tablets group one subject delivered a newborn with CTEV. High intrapartum blood pressure was noted in one subject in each of the two groups.
24. In our study the indication of caesarean section in Dinoprostone Gel group and Misoprostol Tablets group was as follows: FIOL in 9.6% and 8% respectively, Suspicious CTG and unfavourable cervix in 6.4% and 4.8% of cases respectively, MSL with unfavourable cervix in 2% cases in both the group, pathological CTG in 3% of cases in both group and PROM in 1.6% of cases in both the groups. The conclusion is that the proportion of FIOL (9.6%) and suspicious CTG and unfavourable cervix (6.4%) were higher in Dinoprostone Gel Group than Misoprostol Tablets Group but it was not statistically significant (p>0.05).
25. There was significant association between Apgar score at 1 minute and groups (p=0.03). The mean Apgar score at 1 minute of the Dinoprostone Gel group was 6.46 with range 3-7 and the median was 7.0. The mean Apgar score at 1 minute of the Misoprostol Tablets group was 6.10 with range 3-7 and the median was 6.0. t-test showed that the mean Apgar score at 1 minute of Dinoprostone Gel group was significantly higher than that of Misoprostol Tablets group (p<0.05).
26. Sarah Gregson11 et al in a randomized study concluded that there were no significant differences between the two groups in incidence of Apgar scores below 8 at 5 minutes or admission to the neonatal unit.
We found no significant association between Apgar score at 5 minute and groups (p=0.31). The mean Apgar score at 5 minutes of the Dinoprostone Gel group was 6.10 with range 6-9 and the median was 6.20.The mean Apgar score at 5 minutes of the Misoprostol Tablets group was 6.46 with range 6-9 and the median was 6.42. t-test showed that there was no significant difference in mean Apgar score at 5 minutes of Misoprostol tablets group and Dinoprostone Gel group (p>0.05).
27. G. K. Pandis6 and Paul Bernstein9 in their randomized and multicenter trial concluded that there was no significant difference between the two groups in serious maternal morbidity or perinatal outcome.
G. K. Pandis6 and Marjorie Meyer10 concluded that there is no increase in the rate of maternal and neonatal morbidity in the two groups.
In our study the Newborns of 6.7% of subjects in Dinoprostone Gel group and 11.7% in Misoprostol Tablets group got admitted to NICU but there was no significant association between NICU admission of baby and groups (p=0.34).The risk of NICU admission of baby was 1.84 times [OR-1.84(0.51, 6.68); p=0.34] more in Misoprostol group in comparison with Dinoprostone group but the risk was not significant. Our study findings were in accordance to the results of the above investigators.
Three newborns of the Dinoprostone Gel group got admitted in NICU because of the delayed cry and respiratory distress and one newborn in the same group for poor feeding whereas four newborns with delayed cry after stimulation and needing assisted bag mask ventilation, one with low forceps delivery with MSL, other with delayed cry with MSL and one depressed baby delivered by caesarean section due to non-progress of labour in the Misoprostol Tablets group needed NICU admission.
Women whose labour is induced have an increased incidence of chorioamnionitis compared with those in spontaneous labor (American College of Obstetricians and Gynecologists, 1999a).
28. 18.3% of newborn in the Dinoprostone Gel group and 8.3% of newborn in Misoprostol Tablets group suffered from neonatal jaundice in our study. There was no significant association between neonatal jaundice and groups (p=0.10). The risk of neonatal jaundice was 2.46 times (p=0.10) more in Dinoprostone group in comparison with Misoprostol group but the risk was not significant.
29. 6.7% of newborn in the Dinoprostone Gel group and 3.3% of newborn in Misoprostol Tablets group suffered from neonatal sepsis in our study. There was no significant association between neonatal sepsis and groups (p=0.10). The risk of neonatal sepsis was 2.11 times (p=0.39) more in Dinoprostone group in comparison with Misoprostol group but the risk was not significant.
30. There was no significant association between hospital stay of mother after delivery (in days) and groups (p=0.27). The mean hospital stay of mother after delivery (in days) of the Misoprostol Tablets group was 3.16 days with range 2-6 days and the median was 3.0 days .The mean hospital stay of mother after delivery (in days) of the Dinoprostone Gel group was 3.66 days with range 2-10 days and the median was 3.0 days. t-test showed that there was no significant difference in mean hospital stay of mother (delivery) of Misoprostol Tablets group and Dinoprostone Gel group (p>0.05).
31. The mean hospital stay of baby of the Misoprostol Tablets group was 2.98±1.20 days with range 2-7 days and the median was 3.0 days. The mean hospital stay of baby of the Dinoprostone Gel group was 3.36 days with range 2-10 days and the median was 3.0 days. t-test showed that the there was no significant difference in mean hospital stay of baby of Misoprostol Tablet and Dinoprostone Gel group (p>0.05).
The mean total hospital stay of mother of the Misoprostol Tablets group was 5.10 days with range 3-10 days and the median was 4.5 days. The mean hospital stay of mother of the Dinoprostone Gel group was 5.90 days with range 3-16 days and the median was 5.0 days. t-test showed that there was no significant difference in mean hospital stay of mother of Misoprostol group and Dinoprostone group (p>0.05).

Conclusion

The following inferences therefore can be clearly drawn from this study:
Subjects of the Dinoprostone Gel group needed single as well as twice repeat dose which is significantly higher than subjects of the Misoprostol Tablets group. There is no significant association between CTG 1hour after administration and 1hour after re-administration of drugs and groups. Administration of drugs and delivery interval (in hours) in vaginal delivery in subjects of Dinoprostone Gel group is significantly higher than that of Misoprostol Tablets group. The incidence of prelabour rupture of membranes after administration of drugs is significantly higher in subjects of the Misoprostol Tablets group than Dinoprostone Gel group. There is no significant association between duration of labour and groups. However, the mean duration of labour of Misoprostol Tablets group is significantly lower than that of Dinoprostone Gel group. The incidence of meconium stained liquor is significantly higher in subjects of Misoprostol Tablets group than Dinoprostone Gel group in both vaginal delivery as well as caesarean section. The subjects of Misoprostol Tablets group have Pathological Intrapartum CTG significantly higher than the subjects of the Dinoprostone Gel group. There is no significant association between mode of delivery and groups.
Proportion of FIOL necessitating caesarean section is higher in Dinoprostone Gel group than Misoprostol Tablets group but the comparison is not statistically significant. There is no significant association between the incidence of PPH and groups.
There is an association between Apgar score at 1 minute and groups. The mean Apgar score at 1 minute of Dinoprostone Gel group is higher than that of Misoprostol Tablets group which is statistically significant.
There is no significant association between NICU admission of baby and groups however; the risk of NICU admission of baby is 1.84 times more in Misoprostol Tablets group in comparison with Dinoprostone Gel group.
Neonatal jaundice is 2.46 times more observed in Dinoprostone Gel group than Misoprostol Tablets group but the observation is not significant.
The incidence of neonatal sepsis is 2.11 times more in Dinoprostone Gel group in comparison with Misoprostol Tablets group but the risk is not statistically significant.
There is no significant difference in mean hospital stay of mother after delivery and of baby in Dinoprostone Gel group and Misoprostol Tablets group.
Therefore, both Misoprostol Tablets given per vaginum as well as Intravaginal Dinoprostone gel can be considered as a method of induction of labor and their respective advantages and drawbacks should be assessed for the better maternal and fetal outcome.

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Vol 4 | Issue 1 | Jan - Apr 2016 | page: 13-18 | Guus M Vermeulen[1,2], Ruud W Selles[1], Harm Slijper[1,2], Reinier Feitz[2], Thybout M Moojen[2], Kim R Spekrijse[1,2], Sander M Brink[1], Hans Sluiter[1], Sjoerd G Elias[1], Kees H Emmelot[1], Peter Houpt[1], Steven ER Hovius[1].

Author: Guus M Vermeulen[1,2], Ruud W Selles[1], Harm Slijper[1,2], Reinier Feitz[2], Thybout M Moojen[2], Kim R Spekrijse[1,2], Sander M Brink[1], Hans Sluiter[1], Sjoerd G Elias[1], Kees H Emmelot[1], Peter Houpt[1], Steven ER Hovius[1].

[1] Department of Plastic Surgery and Hand Surgery, Erasmus MC University Medical Center Rotterdam, The Netherlands.
[2] Institute Where Research Was Conducted: Xpert Clinic Hilversum, The NetherlandsMedical Center Rotterdam, The Netherlands.
Institute Where Research Was Conducted: Xpert Clinic Hilversum, The Netherlands.
University Affiliation: Erasmus University Rotterdam, The Netherlands.
Year Of Acceptance Of Thesis: 2014.

Address of Correspondence
Dr. Guus Maarten Vermeulen
Roerstraat 117
1078 LM Amsterdam
The Netherlands
Email: g.vermeulen@xpertclinic.nl

 Abstract

Background: Hand Osteoarthritis (OA) is after knee and hip OA the most common presentation of OA in the human body. In the hand one of the most affected joint is the first carpometacarpal (CMC) joint. Surgical treatment of OA at first CMC joint is very common and a variety of surgical techniques have been described. However, there is lack of high-level studies comparing these techniques. Therefore, we planned this thesis in sequential stages that will systematically review the literature first and depending on these results randomised clinical trials (RCT) were planned and executed to determine the best modality of treatment for CMC joint OA.
Method: In the first stage a brief introduction and outline of the thesis was described (The aims of the thesis). The second stage performed a systematic review reviewing literature up to December 2009. Third stage was a prospective study of patients with primary thumb carpometacarpal osteoarthritis treated with Weilby interposition tendoplasty (20 thumbs). Fourth to sixth stage were RCTs comparing trapeziometacarpal arthrodesis with trapeziectomy with ligament reconstruction (fourth stage), trapeziectomy with total joint arthroplasty (fifth stage), Burton-Pellegrini technique (arthroplasty with a bone tunnel at the base of the first metacarpal) with the Weilby technique (sixth stage). The patients were assessed using clinical criteria's and functional scores appropriate to each study design. The Disabilities of the Arm, Shoulder, and Hand (DASH) outcome data collection instrument and the Patient Rated Wrist/Hand Evaluation (PRWHE) questionnaire were used as the most important outcome measures for pain and physical function.
Result: The first and second stage (introduction and systematic review) did not establish superiority of one technique over the other. However based on good results of some techniques we postulated that there could be differences between the various surgical procedures. Further prospective studies and RCTs were planned based on the results of this systematic review. Stage 3 prospective study found good results for most clinical parameters and DASH score for patients undergoing Weilby interposition tendonoplasty. In the fourth stage more complications and a higher revision rate was found in the arthrodesis group compared to trapeziectomy with LRTI and this RCT had to be prematurely terminated due to this reason. In both groups however, PRWHE and DASH significantly improved over time, but comparing both groups results were highly similar. In the fifth stage patients after total joint arthroplasty showed a statistically significant greater improvement on DASH and key-pinch force compared to the trapeziectomy group at one year follow up. In stage six the Burton-Pellegrini group showed a faster recovery of pain and function at three months compared to the Weilby group, however both group had similar results at the end of 1 year.
Conclusion: General discussion (stage 7): Updated systematic review with literature up to December 2012 combined with the results of the 3 RCTs (stage 4, 5, and 6): Based on the present evidence, patients with symptomatic OA only at the first CMC joint are best treated with trapeziectomy. If patients have clinical symptoms at both the first CMC and STT joint, we postulate that trapeziectomy with an additional LRTI (Burton Pellegrini technique) is the best treatment option.
Keywords: First carpometacarpal osteoarthritis, trapezeictomy, Trapeziometacarpal arthrodesis, Weilby interposition tendonoplasty, Trapeziectomy with total joint arthroplasty.
Thesis Question: The thesis had two main questions
1. Which surgical techniques (trapeziectomy, trapeziectomy with LRTI, CMC arthrodesis, total joint prosthesis) are preferred in the treatment of the different stages of primary OA at the base of the thumb?
2. Which suspensor ligament reconstruction (LRTI techniques) is most useful?
Thesis Answer: 1. First question is answered by the following recommendation: Based on the present evidence, patients with symptomatic OA only at the first CMC joint are best treated with trapeziectomy. CMC arthrodesis of the thumb should not be routinely used because of the high complication rate. Additionally, total joint prosthesis should only be performed in a trial setting. If patients have clinical symptoms at both the first CMC and STT joint, we postulate that trapeziectomy with an additional LRTI (Burton Pellegrini technique) is the best treatment option.
2. Answering the second research question, we conclude that different types of suspensory ligament reconstruction (LRTI techniques) have more or less the same objective outcomes at 1-year follow-up. However, if a LRTI technique is used we recommend the Burton Pellegrini technique (arthroplasty with a bone tunnel at the base of the first metacarpal) over the Weilby technique (arthroplasty that preserves the structural integrity of the base of the first metacarpal), because of the faster recovery at 3 months.

Introduction

Hand osteoarthritis (OA) is one of the most common OA phenotypes, after knee OA and hip OA. OA at the base of the thumb is, after distal interphalangeal joint OA, the most common affected joint in the hand and can cause severe pain, weakness and deformity, which can result in significant disabilities. Surgical treatment of OA at the base of the thumb is reserved for symptomatic patients not responding to conservative treatment and suffering from interference with occupational or recreational activities. Conservative treatment consists of splinting, exercises, physical therapy, NSAIDs, or intra-articular injections with steroids or hyaluronacid. During the last decades, a variety of surgical techniques has been described to restore function of the thumb, with pain relief, stability, mobility, and strength as the main goals of treatment The purpose of this thesis is to better understand which surgical techniques are preferred in the treatment of the different stages of primary OA at the base of the thumb.

Aims
- To investigate which surgical technique (trapeziectomy, trapeziectomy with LRTI, CMC arthrodesis, total joint prosthesis) is preferred in the treatment of the different stages of primary OA at the base of the thumb.
- To evaluate whether different types of suspensory ligament reconstruction (LRTI techniques) lead to different subjective and objective outcomes.
- To develop new treatment recommendations for patients with different stages of OA at the base of the thumb.

Materials And Methods
We performed this research in seven stages.
First stage: The introduction and outline of the thesis showed that the 8 most commonly used surgical procedures presented in literature to treat OA at the base of the thumb are: 1. volar ligament reconstruction, 2. metacarpal osteotomy, 3. CMC arthrodesis, 4. joint replacement, 5. trapeziectomy, 6. trapeziectomy with TI, 7. Trapeziectomy with LR, and 8. trapeziectomy with LRTI. Furthermore, the aims of the thesis were described.
The second stage was a systematic review of surgical techniques that were successful in treating primary OA at the base of the thumb. 35 articles were evaluated including articles on trapeziectomy or trapeziectomy with tendon interposition, trapeziectomy with ligament reconstruction or trapeziectomy with ligament reconstruction and tendon interposition, thumb carpometacarpal (CMC) arthrodesis and CMC total joint prostheses.
In third stage we describe the results of a prospective single-arm study of a trapeziectomy with LRTI procedure, i.e., the Weilby arthroplasty and compare it with other existing techniques. Nineteen patients (20 thumbs) with primary thumb carpometacarpal osteoarthritis were treated with Weilby interposition tendoplasty. For subjective assessment, the Disabilities of the Arm, Shoulder, and Hand (DASH) outcome data collection instrument was used to evaluate preoperative and postoperative outcomes at 0, 3, 6, and 12 months. A personal questionnaire and other relevant objective parameters were also assessed.
Fourth stage: A randomised controlled trial was performed to compare the results of trapeziometacarpal arthrodesis with trapeziectomy with ligament reconstruction in primary trapeziometacarpal osteoarthritis. Women aged 40 years or older were randomized to either trapeziectomy with LRTI or arthrodesis with plate and screws. Patients were evaluated preoperatively and postoperatively at 3 and 12 months by assessing pain, function (PRWHE and DASH questionnaires), ROM, strength, complication rate, and patients were asked if they would have the same surgery again under the same circumstances.
Fifth Stage: A randomised controlled trial was performed to compare trapeziectomy and total joint arthroplasty in primary thumb carpometacarpal osteoarthritis. Primary outcome measure was the Patient Rated Wrist/Hand Evaluation questionnaire (PRWHE). Secondary outcome measures were the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH), patient satisfaction, grip- and pinch force, active range of motion and complications. Patients were evaluated preoperatively and postoperatively at 3 and 12 months.
Stage 6: We conducted a randomised controlled trial comparing the Burton-Pellegrini technique (arthroplasty with a bone tunnel at the base of the first metacarpal) with the Weilby technique (arthroplasty that preserves the structural integrity of the base of the first metacarpal). Women aged 40 years or older with stage IV osteoarthritis were randomized to either of both treatments. Patients were evaluated preoperatively and postoperatively at 3 and 12 months by assessing pain, function (PRWHE and DASH questionnaires), ROM, strength, duration to return to work or activities, satisfaction with the results, and complication rate.

Results
Stage 1-. A brief introduction and outline of the thesis was described (The aims of the thesis).
Stage 2- Findings in the previous published systematic reviews showed no evidence of superiority of any of the surgical procedures to treat OA at the base of the thumb. Nine new articles were added (literature up to December 2009), but still none of the procedures showed superiority over another. However, based on good results of CMC arthrodesis and total joint prostheses, we postulate that there could be differences between the various surgical procedures. Therefore randomized clinical trials of CMC arthrodesis and total joint prostheses compared to trapeziectomy with long follow-up (>1 y) are warranted.
Stage3: The DASH score was significantly improved, and 17 of 19 patients were satisfied with the procedure. The interphalangeal joint flexion/extension, metacarpophalangeal joint flexion/extension, and carpometacarpal joint extension did not significantly change. Carpometacarpal joint palmar abduction and opposition were significantly improved at 12 months. The 3-point pinch and overall grip strengths were significantly improved at 12 months.
Stage 4: Forty-three patients were enrolled in this study. The study was prematurely terminated to significantly more complication and higher revision rate in the arthrodesis group as compared to trapeziectomy with LRTI (71% vs 29%, p = .016). In both groups, PRWHE and DASH scores significantly improved over time, but comparing both groups results were highly similar.
Stage 5: Fifty-five patients were enrolled in this study. Twenty-six patients underwent trapeziectomy and 29 patients total joint arthroplasty. Although in both groups the PRWHE scores significantly improved over time, there was no significant difference between both groups. Three month after surgery the total joint arthroplasty group was significantly more improved with respect to key- and three-point pinch, and IP extension compared to the trapeziectomy group. One year after surgery the total joint arthroplasty group showed a statistically significant greater improvement on DASH and key-pinch force compared to the trapeziectomy group. Furthermore, no significant difference in complications between both groups was observed.
Stage 6: Seventy-nine patients were enrolled in this study. Our main findings were that at 3 months PRWHE pain and PRWHE total were significantly more improved in the Burton-Pellegrini group compared to the Weilby group. At 12 months, however, no significant differences were found for all PRWHE and DASH scores between both groups. In addition, we observed no significant differences between groups in strength, duration to return to work or activities, patient satisfaction, and complication rates

General Discussion (Stage 7)
Because OA at the base of the thumb can result in significant disability, selecting the optimal surgical procedure is highly relevant. Patients should only be operated on when not responding to conservative treatment and when suffering from interference with occupational or recreational activities.
Patients with symptomatic OA only at the first CMC joint: Based on the best available evidence in literature and the results of this thesis we conclude that patients with symptomatic OA only at the first CMC joint are best treated with trapeziectomy. It has less complications reported by various authors. Additional value of an interposition after trapeziectomy is questionable and if planned only authologous T1 tissue should be used. Routine use of CMC arthrodesis in these patients is not recommended, because too many complications occur due to delayed union and non-union (regardless of the use of bone grafting). The results of total joint prosthesis are only slightly better in the short-term and because costs are inevitably higher, it should only be used in a trial setting. Patients with symptomatic OA at both the first CMC and scaphotrapeziotrapezoid (STT) joint: the available evidence says that there is no evidence for superiority of trapeziectomy with additional LR or LRTI, not even in the long-term. Since stage IV OA is characterized by more cartilage and soft-tissue damage (ligament wear) than stage II en III, we postulate that the thumb has an increased tendency to collapse in the palm, resulting in a typical zigzag deformity of the thumb. Therefore, we believe that an additional ligament reconstruction after trapeziectomy could still be a valuable treatment option in patients with stage IV OA (patients with symptomatic OA at the first CMC and STT joint). Performing additional LRTI in these patients is debatable, however based on our study we can say that if a LRTI technique is performed the Burton Pellegrini is preferable, because of the faster recovery. A recent meta-analysis reports that a higher probability of complications after an additional LRTI is due to the more comprehensive technique, but whether these complications are all clinically relevant is questionable, because present literature does not report the clinical relevance of the complications. Therefore, further research is warranted.

Conclusion
Based on the present evidence, patients with symptomatic OA only at the first CMC joint are best treated with trapeziectomy, because trapeziectomy has less complications compared to a trapeziectomy with LRTI or trapeziectomy with a nonautologous interposition. CMC arthrodesis of the thumb should not be routinely used because of the high complication rate caused by delayed and non-union, regardless the use of a bone graft. Additionally, total joint prosthesis should only be performed in a trial setting. If patients have clinical symptoms at both the first CMC and STT joint, we postulate that trapeziectomy with an additional LRTI (Burton Pellegrini technique) is the best treatment option.

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Download Full Text PDF   |  Download Full Thesis

Vol 4 | Issue 1 | Jan - Apr 2016 | page: 48-51 | Satish R Gawali[1], Pramod V Niravane[1], Raman O Toshniwal[1], Sachin Kamble[1].

Author: Satish R Gawali[1], Pramod V Niravane[1], Raman O Toshniwal[1], Sachin Kamble[1].

[1] Government Medical College & Hospital, Latur.
Institute Where Research Was Conducted: Government Medical College & Hospital, Latur.
University Affiliation: Maharashtra University of Health Sciences, Nashik.
Year Of Acceptance Of Thesis: 2015.

Address of Correspondence
Dr. Satish R Gawali
Associate Professor, Dept. of Orthopaedics, Government Medical College & Hospital, Latur.
Email:satishgawali61@gmail.com

 Abstract

Background: Fracture of shaft of humerus accounts for 3-5 % of all long bone fracture and 14 % of all fractures of humerus. There are several modalities for the management of diaphyseal humeral fractures. Most fracture can be treated by non-operatively Fracture shaft humerus is a major cause of morbidity in patients with upper extremity injuries Intramedullary nailing can be used to stabilize fractures that are 2 cm below the surgical neck to 3 cm proximal to the olecranon fossa. The aim of this study was to evaluate the outcome of interlocking nail in humeral shaft fractures.
Methods: This study was conducted in the Department of Orthopaedics of Govt. Medical College and Hospital, Latur, Maharashtra from November 2012 to June 2015. Forty six patients were followed prospectively admitted in department having a close fracture of humerus shaft. All patients were operated with closed reamed interlocking nailing. All patients were followed for 9 months.
Results: Out of 46 patients, 41 patients underwent union in 13 weeks –21.5 weeks with a mean of 15.8 weeks. Complications found in 02 patients who had non-union, and 03 patients had delayed union, which was treated with bone grafting. All the patients were assessed clinically And radiologically for fracture healing, joint movements and implant failure. The results were excellent in 88.46% and good in 6.41% patients. Complete subjective, functional, and clinical recovery had occurred in almost 100% of the patients.
Keywords: Humeral Shaft Fractures, rotational stability, Close Reamed Interlocking Nail, Union.
Thesis Question: What is the best modality of treatment of fracture of shaft of humerus in adults?
Thesis Answer: Locked intramedullary nailing is best treatment if basic surgical fixation principles and with proper implants & is sure way to achieve union and pre-trauma functional outcome.

Introduction

Fracture of shaft of humerus accounts for 3-5 % of all long bone fracture .Most fracture can be treated by non-operatively. Conservative methods like Closed reduction and application of U-Slab, abduction cast and splint, Hanging arm cast, Arm-Brace.
Serminto et al reported use of plastic sleeve with early introduction of functional activity. In review of 51 fractures, there was no non-union in 49 non-pathological fractures with good restoration of joint motion [1].Traditionally fractures of shaft of humerus are treated conservativelywith high union rate, but with significant rate of deformities; so also period of immobilisation required is 12 to 16 weeks.
In Today's, modern era, both, deformities and longer period of immobilisation are not accepted by patients.
Humerus is single bone in arm and surrounded by large muscle mass. With shoulder and elbow at risk of stiffness due to prolonged immobilization, there are certain clinical conditions and in these conditions primary or secondary operative treatment is indicated [2].
Following are indications for Surgery:-
1. Failure to Obtain Satisfactory reduction :
-LONG SPIRAL FRACTURES
-TRANSVERSE FRACTURES
-SHORT OBLIQUE FRACTURES.
2. Failure to Maintain Reduction (Unacceptable reduction) – Shortening >3 cm, Rotation>30 degrees & angulation >20 degrees.
3. Injuries to Chest Wall.
4. Bilateral Humerus Fractures.
5. Multiple Injuries / Vascular Lesions / Neurological Lesions.
6. Fracture of Shaft with Intra articular Extensions / with intra articular Fractures.
7. Open Fractures/ Pathological Fractures of the Humerus.
8. Floating elbow lesions and
9. Patients with obesity (risk of developing varus angulation).
Open reduction and internal fixation (ORIF) with plates and screws and intramedullary nailing are advocated for treating humerus fractures .In accordance with AO Principle of anatomical reduction and stable internal fixation, Plate and screw osteosynthesis seemed appropriate choice [3].
But due to obvious disadvantages of
- Extensive soft tissue dissection,
- Periosteal stripping,
- Opening of fracture hematoma,
- Contamination of fracture site and
- Risk of infection and non-union
- Less secure fixation in osteoporotic bones.
- Scar over arm.
- Dissection of radial nerve in middle third fracture, which may endanger the nerve
Intramedullary nailing is favoured. Biomechanically intramedullary nails are better implants .Nails are subject to smaller bending load and less likely to fail due to fatigue[4]. Also cortical osteopenia that occur adjacent to plate ends is rarely seen in internal fixation with intramedullary nail, and risk of re-fracture after implant removal is less likely.
Locked Closed Intramedullary Nails are preferably to be used in the treatment of Segmental and Complex fractures of Shaft, which are difficult to stabilize with plates and screws because of fracture morphology.
Additionally;
- Being intramedullary, they act as load sharing and stress shielding device.
- Advantage of controlled impaction.
- Two screws in proximal and one distal fragment give better rotational stability.
- Shorter operative time, less soft tissue dissection, less blood loss & hence reduced rate of infection.
- Very useful in the treatment of Pathological fractures of humerus.
- Shaft fracture with severe comminution or bone loss and in osteoporotic bone.
- Early mobilization.and Excellent functional outcome.
In view of these conditions, this study is taken up to evaluate clinical & radiological outcome of fractures of shaft of Humerus treated with closed interlocked intramedullary Nailing.

Material and Methods
We prospectively followed a series of 46 consecutive patients with closed humeral shaft fracture treated at our Hospital between November 2012 and March 2015 with closed reduction and Locked intra medullarynail fixation.

Aims and Objectives
1) To study incidence of fractures of shaft of humerus in tertiary care centre.
2) To study incidence of associated complications with fracture shaft humerus.
3) To study difficulties encountered in management of fracture of shaft humerus treated with intra-medullar implant (locked intra-medullar nail) under IITV control.
4) To study clinical and radiological outcome of fracture of shaft humerus treated with intra-medullary implant ( locked intra-medullary nail )

Inclusion criteria
Adult age groups patients of both sexes having fracture of humerus classified as according to AO classification.

Exclusion criteria
I. Unstable proximal fracture of shaft humerus.
ii. Fracture of distal part of humerus.
iii. Fracture of shaft humerus – below 18 years of age.
iv. Fracture dislocations of proximal humerus,
v. Pathological fractures, patients affected by mental impairment,
vi. Skeletally immature patients
vii. Patients with open fractures and fractures in the same limb.
viii. Patients with distal neurovascular deficit.
ix. Patients with non-union, malunion or delay in surgery(>10 days)

Technique
- For patients requiring surgical intervention, anaesthesia fitness and written valid informed consent shall be obtained prior to surgery.
- Under anaesthesia, closed reduction and internal fixation by ante grade intra-medullary locked nailing was done.
- The surgery is performed in the supine position, sandbag under medial aspect of scapula with the head rotated to contra lateral side on a radiolucent table.
-A longitudinal skin incision 2–3 cm over the antero-lateral edge of the acromion obliquely forward near the tip of the greater tuberosity. Deltoid is split longitudinally along its fibres to reveal subacromial bursa and the rotator cuff.
- Incise rotator cuff in the direction of supraspinatus muscle; an awl was passed just medial to the tip of the greater tuberosity, 0.5 cm posterior to biceptal groove to make an entry point. The direction of awl should d be slightly oblique, aiming towards medial cortex of humerus.
- The hand awl must penetrate for at least 4 to 5 cm to create pathway for guide wire.
- The correct alignment was obtained by closed reduction maneuvur of Traction, Supination of forearm, and 90 Degrees elbow flexion applied and maintained by assistant.
- Close reduction achieved and confirmed under C‑arm guidance and guide wire was passed, the length of the nail was measured by subtracting exposed guide wire from the total length of the guide wire. In two cases, where closed reduction failed minimum open reduction was done.
- While maintaining the reduction, guide wire was removed, and the nail of proper length and diameter was passed till its proximal end was beneath the bone by 0.5 cm to avoid sub-acromial impingement, and its tip should lie 1.5-2.0cm proximal to olecranon fossa.
- Proximal and distal locking was done. The type of nailing is static ante grade interlocking nails.Before distal locking the fracture site is compressed by placing axial load on elbow(Gentle thumping on elbow) Dressing done and the limb was kept in collar and cuff support. Check X‑ray was taken of the full humeral length.
- Three antibiotic shots, one pre operative, intra operative and post operative each, will be given and broad spectrum IV antibiotics for five days were administered.
- Patient treated with surgery will be discharged on 11th post operative day after suture removal.
- Rehabilitation Protocol.
- Patient were followed up at regular intervals at 4 , 6 12 wks and 3 ,6 12 months.
- Assessment was done based on clinical assessment and radiological examination with particular advices regarding active assisted shoulder and elbow exercises.
- Passive flexion abduction exercises of shoulder and flexion extension exercises of elbow was started on 3rd post op day after first check dressing and subsidence of local swelling and oedema.
- Active exercises were instructed after 2 weeks, and after visualisation of soft callus rotational exercises were advised.
- Union was defined as mature callus formation bridging across fracture visible in two radiographic views & Non union is defined as when fracture is not united at the end of 9 months of surgery.
- Clinical assessment was done based on severity of pain on operated limb and active range of motion of shoulder And elbow
- Functional assessment as per system of American Shoulder and Elbow Surgeons shoulder score.
The collected data was statistically analysed.

Results
Our study comprises of 46 patients of fracture of shaft of humerus.
There were 44 patients with 46 fractures (01 male and 01 female sustained bilateral fracture).and 32 males and 12 females.
04(8.69%) were upper third, 34(73.91%) were middle third and 08(17.39%) were lower third in location.
35 patients (76.08%) achieved union and 07(15.21%) had delayed union and 02 (4.34%) had malunion, So overall 44 patients (95.66 %)achieved union.
02(4.34%) went into nonunion and were treated by bone grafting.
Union was achieved between 91(13 wks) to 140(20 wks) days in 44 fractures out of which 07 were delayed union(which was diagnosed if a fracture had not united within four months[16 weeks] of injury (Stern et al. 1984).
Delayed union was treated with removal of distal locking screw (Bone grafting was not performed), and active movement was encouraged after operation.
In this study, 02 (4.34%) fractures went into non-union & were treated by bone-Grafting.
Functional outcome was Excellent in 39 fractures (84.78%)& Good in 5fractures(10.86%) i.e Excellent to Good fracture union in 44 fractures (95.64%).
And by end of 9 month assessment of functional and clinical outcome was done and found to be satisfactory in all 100% patients.

Outcome of Result
39 patients (84.78%) had Excellent result and 05 patients (10.86%) had Good outcome on final assessment. 02 (4.34%) had Fair result. Clinical assessment was based on severity of pain in operated limb and active range of motion of shoulder and elbow, functional assessment was done as per system of American Shoulder and Elbow Surgeons shoulder score as adopted by McCormack et al[5]. They were followed‑up after surgery, they were clinically and radiologically assessed for fracture healing, joint movements and implant failure.
According to the criteria the results are graded as excellent when the fractures unites within 16 weeks without any complication, good when union occur within 24 weeks with treatable complications like superficial infection and shoulder stiffness and poor when union occur before or after 24 weeks with one or more permanent complications like infection (osteomyelitis), implant failure, nonunion, limb shortening and permanent shoulder stiffness.
Follow‑up was done according to these criteria. As part of a subjective assessment, patients were asked in the questionnaire if they were very satisfied, satisfied or not satisfied with the outcome of treatment.

Conclusion
Essentially all closed humerus shaft fractures extending between 2 cm from surgical neck to 3 cm proximal to olecranon fossa can be stabilized by ante grade closed intramedullary interlock nailing.
It is excellent method of managing comminuted and unstable humerus shaft fracture. Long butterfly fragment consolidate early at 4-6 weeks as closed nailing isdone.
It is best surgical method available to fix humerus shaft fracture in patients with poly trauma and osteoporosis where reduction in operating time and early rehabilitation are the primaryobjectives
Interlocking nailing gives rotational stability; decreases need for post-op bracing and allow early mobilization of extremity.
In available surgical modalities, closed nailing is the least invasive surgical technique and has got the least chance of post- operative infection. It reduces hospitalstay.
Since closed nailing preserves fracture hematoma, it appreciable decreases the time required for fracture to consolidate and achieves high rate of fractureunion.
Complications like delayed union can be effectively cured by dynamization (which is helpful to achieve compression at fracturesite).
Non-union can be avoided by Intraoperative compression and avoiding distraction at fracture site. We believe that distraction can be prevented during ante grade nailing by pushing /thumping at flexed elbow after proximallocking.Technical aspect like, burying nail end in bone at the entry portal are essential in avoiding impingement and to gain better shoulderfunction.
Early intensive physiotherapy hastens the recovery of shoulder.

Reference
1. Sarmiento A, Kinman PB, Galvin EG, Schmitt RH, Phillips JG. Functional bracingof fractures of the shaft the humerus. J Bone Joint Surg 1977; 59A:596-601.
2. Christos Garnavas, Humeral shaft fractures in Rockwood and Green's Fractures in Adults Eighth Edition Page 1301 Charles M.Court –Brown, James D.Heckman, Margaret M.Mcqueen, Wiliam M.Ricci, and Paul Tornetta. :Editors.
3. Pol M Rommens, Donald P. Endrizzi. Jochen Blum, Raymond R. White AO Manual Of fracture Fixation .4.2.2 Humerus Shaft Page291-305.
4. Dalton JE, Salkeld SL, Satterwhite YE, Cook SD. A biomechanical comparison of intramedullary nailing systems for the humerus. J Orthop Trauma. 1993;7(4):36774.
5. McCormack RG, Brien D, Buckley RE, McKee MD, Powell J, Schemitsch EH. Fixation of fractures of shaft of the humerus by dynamic compression plate or intramedullary nail .A prospective randomized trial. J Bone Joint Surg2000; 82B:p.336-339.

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Vol 4 | Issue 1 | Jan - Apr 2016 | page: 43-47 | Vikas P Birla[1],  Raju Vaishya[1], Vipul Vijay[1].

Author: Vikas P Birla[1],  Raju Vaishya[1], Vipul Vijay[1].

[1] Department Of Orthopaedics, Indraprastha Apollo Hospital, Sarita Vihar, New Delhi-110076.
Institute Where Research Was Conducted: Indraprastha Apollo Hospital, Sarita Vihar, New Delhi.
University Affiliation: National Board Of Examinations.
Year Of Acceptance Of Thesis: 2015.

Address of Correspondence
Dr. Vikas P Birla
Room no. 1210, Department Of Orthopaedics, Indraprastha Apollo Hospital, Sarita Vihar, New Delhi-110076.
Email:vpbirla86@gmail.com

 Abstract

Background: Total knee arthroplasty is now a commonly performed surgery with successful outcomes. Larger number of patients expected to undergo this procedure in future. Shortcomings with conventional jigs have led to development of patient specific instruments, with the aim to improve mechanical alignment after total knee arthroplasty. This study compared the outcomes of surgery with use of patient specific instruments and conventional jigs.
Material and Method: Total 80 knees were included in the study, 40 in each group. We compared mechanical alignment achieved, blood loss, surgical time, postoperative pain, and length of hospital stay.
Results: There was significant improvement in postoperative mechanical alignment (p value - 0.001), surgical time (p value – 0.004) and postoperative pain (p value – 0.001) in patient specific instruments group. Lesser blood loss and shorter hospital stay was also noticed in patient specific instruments group but this difference was not statistically significant.
Conclusions: Patient specific instruments improve mechanical alignment after total knee arthroplasty, compared to conventional jigs. It also decreases surgical time and blood loss. Postoperative pain is also less with patient specific instrument. With lesser complications and faster rehabilitation it also shortens length of hospital stay.
Keywords: Total knee arthroplasty, Patient specific instruments, conventional jigs.

Introduction

Total Knee Arthroplasty (TKA) is now a very commonly done procedure for end stage arthritis of knee. Although TKA, a highly successful orthopaedic procedure that gives long lasting good results, but short term failure have also been reported in some cases, which are worrisome for arthroplasty surgeons. It has been recognized that accurate limb alignment is one of the important factor responsible for successful outcome in TKA. Thus a surgeon aims to achieve neutral mechanical alignment (180°) of lower limb postoperatively through properly oriented bone cuts. Currently, the commonly used instruments for TKA are extramedullary (EM) alignment guide for the tibial resection and intramedullary (IM) alignment guide for the distal femoral resection. However, these have demonstrated some fallacies and limited degree of accuracy. Inaccuracies with conventional instruments could be due to several factors like a) relying on assumption about the difference between the femoral mechanical and anatomical axis, b) the accuracy of guide is dependent on a rigid fit of the IM rod in the femoral canal and on the position of the entrance hole. The invasion of the IM canal has been implicated to cause increased pulmonary pressures, fat embolism and increased blood loss in TKA.
Patient Specific Instruments (PSI) was introduced as an alternative to conventional ones, with the aim of improving postoperative alignment and implant positioning. It uses anatomical data obtained from preoperative computed tomography (CT) images to create disposable cutting jigs individualized to the unique anatomy of the patient. It seem to offer added advantages of preoperative planning, accurate mechanical alignment, decreased surgical time, lesser trays of instruments, less blood loss, and shorter hospital stay. These advantages come with caveats of increased cost (imaging and PSI block fabrication), exposure to radiation and waiting period for the manufacturing of blocks. We studied a comparative group of patients to identify whether the use of PSI has any advantages over conventional technique in primary TKA.

Aims and Objectives
A) Primary -
To assess and compare the mechanical alignment of the operated limb with Patient specific instruments (PSI) and Conventional jigs for TKA.
B) Secondary -
To asses and compare
Operative Time
Post-op Pain
Blood loss
Length of stay.

Materials and Methodology
Study type: Prospective comparative cohort study.
Sample size: Total 80 knees with 40 in each group (PSI and conventional jigs).
Study population: Patients with advanced arthritis of knee joint requiring TKA. All the patients were operated by the same surgeon, with same approach and in the same hospital set up. Patients who fulfilled the inclusion criteria for PSI were operated with PSI (group 1) and remaining patients were operated with conventional jigs (group 2).
Inclusion criteria (PSI):
1. Patient having severe arthritis of knee joint (Ahlback's Grade 3, 4 or 5)
2. Patient willing to undergo CT scan.
3.Patient who were willing to bear the extra cost of manufacturing these jigs and CT scan (approx. Rs 25000 per knee).
4.Patient who could wait for 1 week to undergo TKA (manufacturing time for PSI jigs).
5. Patient who consented to undergo TKA with PSI.
Exclusion criteria (PSI):
1. Mild arthritis (Ahlback's Grade 1 and 2).
2. Patient not willing for CT scan.
3. Patient who couldn't wait for 1 week.
4. Patient who couldn't bear extra cost.
All patients were thoroughly clinically evaluated and necessary blood investigations were done as per general protocol.
Special planning for patients of Group 1 (PSI):
1. Preoperative CT scannogram of lower limb was done and the data was sent in CD to jigs manufacturing unit.
2.Virtual 3-D anatomical bone model was constructed from the data obtained through CT scannogram.
3. Cuts made were checked virtually and then jig design was changed according to the bone cuts desired.
4. After approval from surgeon, manufacturing unit prepared the final block specific to the patient's knee.
5. Patient specific cutting blocks were prepared in a manufacturing unit and were transferred to the hospital before the day of surgery.
6. These blocks were autoclaved and then used intra-operatively for taking the bone cuts for TKA surgery, after appropriate exposure.

Method of assessment:
1. Mechanical alignment– Mechanical axis (MA) is a load bearing axis of the lower limb. Normally it is a straight line passing from the center of femoral head to the center of ankle and through center of the knee. It is measured in the form of mechanical femoral tibial angle (MFT angle). Thus with neutral MA, MFT angle is 180°. We measured and analyzed MA postoperatively by measuring MFT angle on long leg radiograph, done on one of the follow up visit, using picture archiving and communication system (PACS).
2. Operative time – We measured tourniquet time (in minutes) to assess and represent operative time required for TKA.
3. Postoperative pain – Postoperative pain after TKA was recorded on 1st and 2nd POD using Visual analogue score (VAS).
4. Blood loss – To assess the total blood loss in TKA we recorded fall in hemoglobin (Hb) after TKA on 1st POD and collection in drain on 1stand 2ndPOD.It is a general presumption that larger the blood loss more is the chance of requirement of blood. Thus we also measured frequency of patient requiring blood transfusion postoperatively. We only transfused blood (Packed red cells) to patients with Hb level less 8 gm/dl.
5. Length of hospital stay – All patients were admitted in hospital a day before the surgery and were discharged after TKA when patients were stable and mobilized with support comfortably.

Follow up visit:
Minimum two follow up visit were done. First on 10th day of surgery and second after 3 weeks of surgery. Further follow up visits were done as per convenience and need of patients.

Result
1. There was no statistically significant difference in both groups with respect to age, sex and side wise distribution and so both the groups were matched.
2. Mean postoperative MFT angle in group 1 (PSI) was 178.23° compared to 175.73° in group 2 (conventional jigs). This improvement in MFT angle in group 1 was found statistically significant (p value - 0.001).
3. In unilateral TKA mean drop in Hb in group 1 was 1.90gm/dl while in group 2 it was 2.07gm/dl. Whereas in bilateral TKA mean drop in Hb in group 1 was 2.76 gm/dl while in group 2 it was 3.31 gm/dl. Though there was no statistically significant difference in fall of Hb in both the groups but results showed lesser fall in Hb level in group 1 compared to group 2 in both unilateral and bilateral TKA.
4. On assessing collection in drain we found mean collection on 1st and 2nd postop day (POD) in group 1 was 232.5 ml and 110 ml while in group 2 it was 290 ml and 100 ml respectively. Thus mean total collection in drain postoperatively was less in group 1 compared to group 2 but the difference was not statistically significant.
5. From the assessment of fall in Hb level and collection in drain we expected less blood loss and lesser requirement of blood transfusion in group 1. This was confirmed by our observation that fewer patient in group 1 required blood transfusion postoperatively compared to group 2. No unilateral TKA patient required blood transfusion in either group while in group 1 only 3 out of 13 (18.7%) bilateral TKA patient required blood transfusion compared to 6 out of 17 (35.3%) total bilateral TKA patient in group 2. Although difference was not found statistically significant.
6. Mean tourniquet time in group 1 was 43.3 minutes while in group 2 it was 48.82 minutes. This difference in tourniquet time was found to be statistically significant (p value- 0.004).
7. We also observed significantly lesser pain postoperatively in group 1 compared to group 2 (p value < 0.001). Mean VAS score on 1st and 2nd POD in group was 1.87 and 1.17 compared to group 2 where it was as high as 2.52 and 2 respectively.
8. Mean length of hospital stay in unilateral TKA patient was found to be 5.38 days in group 1 and 6 days in group 2 while in bilateral TKA patient it was 7.25 days in group 1 and 7.47 days in group 2. However this decrease in length of hospital stay in group 1 was not found statistically significant.

Conclusion
In this study we found that PSI significantly improved mechanical alignment of the lower limb after TKA compared to conventional jigs. There was significant decrease in operative time required for surgery with lesser postoperative pain with the use of PSI. A decreased blood loss and blood transfusion requirement was found in PSI group. Shorter surgery time (thus lesser anesthesia) and lesser invasive nature of PSI resulted in faster rehabilitation and thus decreasing the hospital stay.

Clinical Importance

PSI is an innovative technique in the field of TKA promising added advantages not only to patients but also to the surgeons and to the hospitals.

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39. Spencer BA, Mont MA, McGrath MS, Boyd B, Mitrick MF. Initial experience with custom-fit total knee replacement: intra-operative events and long-leg coronal alignment. IntOrthop 2009;33:1571–1575.
40. Noble JW Jr, Moore CA, Liu N. The value of patient matched instrumentation in total knee arthroplasty. J Arthroplasty 2012;27:153–155.
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42. Vincent Y. Ng , Jeffrey H. DeClaire ,Keith R. Berend , Bethany C. Gulick RT , Adolph V. Lombardi Jr . Improved Accuracy of Alignment With Patient-specific Positioning Guides Compared With Manual Instrumentation in TKA. ClinOrthopRelat Res (2012) 470:99–107.
43. Thomas J. Heyse, Carsten O. Tibesku. Improved femoral component rotation in TKA using patient-specific instrumentation. The Knee.2012:04.
44. N. Kharwadkar , R.E. Kent , K.H. Sharara , S. Naique. 5- to 6- of distal femoral cut for uncomplicated primary total knee arthroplasty : Is it safe? The Knee 13 (2006) 57 – 60.
45. Luc Renson, Pascal Poilvache, Hans Van den Wyngaert. Improved alignment and operating room efficiency with patient-specific instrumentation for TKA. The Knee 21 (2014) 1216–1220.
46. Emmanuel Thienpont, Frederic Paternostre, Martin Pietsch, Mahmoud Hafez, Stephen Howell. Total knee arthroplasty with patient-specific instruments improves function and restores limb alignment in patients with extra-articular deformity. The Knee 20 (2013) 407–411.
47. William Barrett, Daniel Hoeffel, David Dalury, J. Bohannon Mason, Jeff Murphy, Sam Himden. In-Vivo Alignment Comparing Patient Specific Instrumentation with both Conventional and Computer Assisted Surgery (CAS) Instrumentation in Total Knee Arthroplasty. The Journal of Arthroplasty 29 (2014) 343–347.
48. Thanainit Chotanaphuti, Wangwittayakul, Saradej Khuangsirikul, Trakul Foojareonyos. The accuracy of component alignment in custom cutting blocks compared with conventional total knee arthroplasty instrumentation: Prospective control trial. The Knee 21 (2014) 185–188.
49. L. Abane, P. Anract, S. Boisgard, S. Descamps, J. P. Courpied, M. Hamadouche. A comparison of patient-specific and conventional instrumentation for total knee arthroplasty. Bone Joint J 2015;97-B:56–63.
50. David R. Lionberger, Catherine L. Crocker, Vincent Chen. Patient Specific Instrumentation. The Journal of Arthroplasty 29 (2014) 1699–1704.
51. Daniilidis K, Tibesku CO. A comparison of conventional and patient-specific instruments in total knee arthroplasty.IntOrthop. 2014 Mar;38(3):503-8.
52. Klatt BA, Goyal N, Austin MS, Hozack WJ. Custom-fit total knee arthroplasty (OtisKnee) results in mal-alignment. J Arthroplast 2008;23(1):26–29.
53. Chen JY, Yeo SJ, Yew AK, Tay DK, Chia SL, Lo NN, Chin PL. The radiological outcomes of patient-specific instrumentation versus conventional total knee arthroplasty. KneeSurg Sports Traumatol Arthrosc.2014 Mar;22(3):630-5.
54. Parratte S, Blanc G, Boussemart T, Ollivier M, Le Corroller T, Argenson JN.Rotation in total knee arthroplasty: no difference between patient- specific and conventional instrumentation.KneeSurg Sports TraumatolArthrosc. 2013 Oct;21(10):2213-9.
55. Hamilton WG, Parks NL, Saxena A. Patient-specific instrumentation does not shorten surgical time: a prospective, randomized trial. J Arthroplasty. 2013 Sep;28(8 Suppl):96-100.
56. Chareancholvanich K, Narkbunnam R, Pornrattanamaneewong C. A prospective randomised controlled study of patient-specific cutting guides compared with conventional instrumentation in total knee replacement. Bone Joint J. 2013 Mar; 95-B(3):354-9.
57. Lotke PA, Ecker ML. Influence of positioning of prosthesisin total knee replacement. J Bone Joint Surg Am 1977;59(1):77–9.
58. Nunley RM, Ellison BS, Ruh EL, et al. Are patient specific cutting blocks cost effective for total knee arthroplasty? Clin Orthop Relat Res 2012;470(3):889–94.
59. Lionberger DR, Crocker CL, Chen V. Customized cutting jigs improve OR efficiency, but not accuracy. Proceedings of the American Association of Hip and Knee Surgeons Annual Meeting. Dallas, November 2011.
60. Watters TS, Mather RC 3rd, Browne JA, et al. Analysis of procedure-related costs and proposed benefits of using patient-specific approach in total knee arthroplasty. J Surg Orthop Adv 2011;20(2):112–6.
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Vol 4 | Issue 1 | Jan - Apr 2016 | page: 10-12 | Pradnya Patil[1],  Anand Gangwal[1].

Author: Pradnya Patil[1],  Anand Gangwal[1].

[1] Department of Musculoskeletal Physiotherapy, Sancheti Healthcare Academy, Sancheti Institute College of Physiotherapy, Thube Park, Shivaji Nagar, Pune, Maharashtra, India.
Institute Where Research Was Conducted: Sancheti Institute of Orthopaedics and Balewadi.
University Affiliation: Maharashtra University of Health Sciences ,Nashik.
Year Of Acceptance Of Thesis: 2014.

Address of Correspondence
Dr. Anand Gangwal
Sancheti Healthcare Academy, Sancheti Institute College of Physiotherapy, 12, Thube Park, ShivajiNagar, Pune - 411005, Maharashtra.
Email: anandgangwal@gmail.com

 Abstract

Background: Overhead racquet sports place high amount of stress on the dominant shoulder. Over a period of time, to allow for the extra degrees of movement necessary for an effective stroke or serve, the shoulder girdle on the dominant side of such players undergo certain postural adaptations. At the same time, it has to be firm enough to prevent any hyper mobility and injury. Thus, 'throwers paradox' i.e., a fragile balance exists between mobility and stability. [1, 2] If this balance is disturbed it can lead to injuries. Hence, to assess whether lack of spinal mobility, posture and scapular symmetry are being reason for shoulder pain hence the spinal mobility and posture and scapular symmetry needs to be evaluated in the racquet players, especially between players with and without shoulder pain and non-players. Also, comparison between dominant and non dominant side of the players may help us determine the postural adaptations that is likely to occur in these players due to the strenuous, repetitive and biomechanically challenging demands of the game. Present study is a cross-sectional observational study enrolling 150 (50 per group) racquet players with shoulder pain (Group A) and racquet players with no shoulder pain (Group B) and non-players (Group C).
Hypothesis: It is hypothesised that spinal mobility, posture and scapular symmetry in racquet players without shoulder pain will be better than racquet players with shoulder pain and non-players.
Clinical Importance: There is need to improve spinal mobility, posture and scapular symmetry in overhead racquet sports to prevent shoulder injuries.
Future Direction: A similar study but of an interventional study design, comparing the above parameters in the same set of overhead racquet players, will help derive more conclusive results.
Keywords: Shoulder pain, spinal mobility, over head racquet sport.

Introduction

The most popular overhead racquet sports in Asian countries like India are lawn tennis and badminton. These sports are not only popular but have also been studied to have an increase in the injury rate. Tennis shows an inconsistent injury rate of 0.04 injuries/1000 hours to 21.5 injuries/1000 hours [3] with 25% to 45.7% injuries affecting the shoulder joint. [4] Hence, prevention of injuries in the elite athletes playing these sports has become an integral part. The transfer of energy in the kinetic chain is said to be “broken” if the characteristics of the chain are not present, or the sequential timing incorrect. In a broken kinetic chain the energy that is normally generated and accumulated by many segments is altered or even not transferred at all to the next segment, hence other body parts must compensate to create the same performance. The USTA states that “if the trunk does not rotate to provide force to the shoulder, it requires a 34% increase in the shoulder velocity to achieve the same ball velocity”[5]. Anatomically shoulder joint is very unstable joint, dynamic stabilization is provided by balance between the agonist and antagonist muscle group.[6,7] The stability of gleno-humeral joint is reliant on the scapulo-thoracic joint as scapula provides a stable base for movement of humerus during an overhead motion.[8] Scapular asymmetry, in the form of excessive protraction, internal rotation and anterior tilt develops on the striking side of overhead athletes using their dominant shoulder repetitively in a forceful manner. [9] Asymmetry of scapula can be described as the acronym SICK scapula (Scapular malposition, Inferior medial border prominence, Coracoid pain and malposition and dyskinesis).[10] Tennis and badminton have distinctiveness peculiar to the individual game; however, both games subject the dominant shoulder of the player to repetitive overhead movement pattern.[4] A racquet serve/stroke biomechanically can be broken down into five phases: wind up, early cocking, late cocking, acceleration and follow through.[11] The cocking phase maintains the dominant arm in 90° abduction and external rotation which reaches a maximum of 172° to 180° during the late cocking phase.[12,13] This is a combination of true gleno-humeral rotation, scapulo-thoracic motion and trunk hyperextension.[12] It ends with internal rotation and forward flexion of the dominant shoulder along with upper torso and pelvic rotation during the follow through phase. Each phase places an asymmetric load between the two shoulders, and maximum stress is exposed to the dominant shoulder. [8] In tennis activities normal shoulder biomechanical function requires an integral kinetic chain to create energy, produce force and stabilize the joint. [5]

Hypothesis
Shoulder injuries are much more common in overhead racquet professional players and today, they are even seen in junior teenage players who compete regularly, due to the increase in the number of tournaments they have to play around the year, and of course due to the long hours of training they need. They have regular training and specific physical preparation in order to prepare their muscles and bones properly. There is evidence that reduced mobility of upper thoracic segments is related to neck and/or shoulder pain.[14,15] Thus, it becomes necessary to introduce the correlation between shoulder pain and spinal mobility in overhead racquet sports.
The present study is a cross-sectional observational study. 150 subjects will be recruited from different racquet sports tournaments and sports clubs located in Pune, India. The participants will be screened using the following inclusion criteria; Players playing overhead racquet sports (lawn tennis and badminton) at district level and above, minimum 3 years of training, players participating in only one kind of sport, age group 13-19 years, both male and female players, Players with/without shoulder pain, Players with/without a past history of symptoms, Non-players without shoulder and any other musculoskeletal involvement. And recreational players, history of trauma, fracture, or surgery to the scapula, humerus, rib cage, thoracic spine, or abdomen, subjects diagnosed with any upper body, trunk, musculoskeletal problems, and neuromuscular disorder will be excluded. The subjects will be assessed for pain with (Numerical Pain Rating Scale) NRS, spinal mobility of cervical, thoracic and lumbar spine by using dual inclinometer, thoracic and lumbar posture by using flexicurve, and scapular symmetry by doing lateral scapular slide test.
Group A: Racquet players with shoulder pain
Group B: Racquet players with no shoulder pain
Group C: Non-players
Number of badminton and lawn tennis players will be same in Group A and Group B. All the procedure was approved by the Institutional Ethics Committee on Human Research and conducted in conformity with ethical and principles of research.
Paired t- test shall be used for intra-group assessment of all parameters. Unpaired t- test shall be used for inter-group assessment of all parameters. One way ANOVA test shall be used to compare all three groups.

Discussion
Sports like badminton and lawn tennis innately place demands on the dominant shoulder as it requires repetitive and forceful movements of the dominant extremity which render the shoulder vulnerable to injuries. Elite tennis players are observed to have rotational velocities as high as up to 1700 degrees/ second. Increased moment of inertia of the upper extremity from holding a tennis racquet may result in greater stress at the dominant shoulder joint [16]. The stability of an overhead athlete's shoulder is maintained by the active and the passive restraints of the joint [9, 11].
During the follow through phase or deceleration phase of an overhead motion, the shoulder joint undergoes distractive forces of up to 750N or 0.5 to 0.75 times the body weight [7, 19]. This force is primarily resisted by the eccentric contraction of the rotator cuff muscles [7]. However, with repetitive activity, these muscles start to fatigue and convey the load on the posterior capsule to provide further restraint [20]
With such recurring loading, the posterior capsule is said to endure micro trauma [9].The posterior capsule reacts to this trauma with hypertrophy and increased fibroblastic activity during the healing process , leading to contracture and thickening of the capsule [9, 17]. This reduces the capsular pliability causing restriction of internal rotation ultimately leading to GIRD (gleno-humeral internal rotation deficit) in the throwing or serving shoulder. [7, 9, 11, 21]
Several studies have used a regional interdependence examination and treatment approach to demonstrate the effectiveness of including cervicothoracic and upper rib manual physical therapy interventions into the treatment plan for subjects with a primary complaint of shoulder pain. [22, 23]
As there is regional interdependence between spine and shoulder, thus even if spinal mobility is improve the shoulder pain in overhead racquet sports can be minimized.

Clinical Importance
There is need to improve spinal mobility, posture and scapular symmetry to prevent shoulder injuries in overhead racquet sports.

Future Direction
A similar study but of an interventional study design, comparing the above parameters in the same set of overhead racquet players, will help derive more conclusive results.

References
1. Norkin CC, White DJ. Introduction to goniometry. In:Measurement of Joint Motion:A Guide to Goniometry. Philadelphia,PA:FA Davis;1985:1–7.
2. Ellenbecker TS, Davies GJ. The application of isokinetics in testing and rehabilitation of the shoulder complex. J. Athl. Train.2000; 35(3):338-350.
3. Pluim BM,et al. Tennis injures:Occurrence, aetiology, and prevention. Br J Sports Med 2006:40; 415-423.
4. Wilk KE.,Meister K., Andrews JR.Current concepts in the rehabilitation of the overhead throwing athlete. Am J Sports Med. 2002;30:131-151
5. Kibler WB. Biomechanical analysis of the shoulder during tennis activities. Clin Sports Med. 1995 Jan; 14(1):79-85.
6. Burkhart S., Morgan C., Kibler W. The disabled throwing shoulder of pathology part: 1: pathoanatomy and biomechanics. Arthroscopy2003; 19(4):404-420.
7. Wilk K.,et al. Shoulder injuries in the overhead athlete. J Orthop Sports Phys Ther.2009; 39(2):38-54.
8. Fleisig GS et al. Biomechanics of overhand throwing with implications for injuries. Sports Med. 1996 Jun; 21(6):421-37.
9. Oyama S. et al. Asymmetric resting scapular posture in healthy overhead athletes. J Athl Train2008; 43(6):565-570.
10. BurkhartS.,MorganC.,Kibler W.The disabled throwing shoulder: Spectrum of pathology Part Three: The SICK scapula, scapular dykinesia, the kinetic chain and rehabilitation. Arthroscopy.2003; 19(6):641-661.
11. Downer J., Sauers E. Clinical measures of shoulder mobility in the professional baseball players. J Athl Train 2005;40(1):23-29
12. Craig A. The shoulder complex. In: Maria Z.,Christopher B., John c.,et al.Sports physiotherapy Applied science and practice (1st edition), Churchill Livingstone,1995:Pp:365).
13. Hoeven H.,Kibler W. Shoulder injuries in tennis players. Br J Sports Med 2006; 40:435-440.
14. Norlander S, Gustavsson B-A, Lindell J, Nordgren B. Reduced mobility in the cervico- thoracic motion segment—a risk factor for musculoskeletal neck-shoulder pain: A two-year prospective follow-up study. Scand J Rehab Med 1997; 29:167–174.)
15. ( Norlander S, Nordgren B. Clinical symptoms related to musculoskeletal neck-shoulder pain and mobility in the cervico-thoracic spine. Scand J Rehab Med 1998; 30: 243– 251.)
16. Torres RR., Gomes EL. Measurement of gleno-humeral internal rotation in asymptomatic tennis players and swimmers. Am J Sports Med. 2009; 37(5):1017-1023.
17. Thomas SJ, Swanik K., Swanik C., et al. Internal rotation and scapular position difference: a comparison of collegiate and high school baseball players. J Athl Train 2010; 45(1): 44-50.
18. Hoeven H., Kibler W. Shoulder injuries in tennis players. Br J Sports Med 2006; 40: 435-440.
19. Ellenbecker TS, Roetert EP, Kibler WB, et al. Applied biomechanics of tennis. In: Magee Dj, Manske RC, Zachazewski JE, et al. Athletic And sports issues in musculoskeletal rehabilitation. St. Louis, MO: Saunders 2010: chapter 11.
20. Burkhart S., Morgan C., Kibler W. The disabled throwing shoulder: Spectrum of pathology Part Three: The SICK scapula, scapular dykinesia, the kinetic chain and rehabilitation. Arthroscopy. 2003; 19(6): 641-661.
21. As cited by- Almeida GPL, Silveria PF, Rosseto NP, et al. Glenohumeral range of motion in handball players with and without throwing related shoulder pain. J Shoulder Elbow Surg. 2013; 22: 602-607.
22. Bang MD, Deyle GD. Comparison of supervised exercise with and without manual physical therapy for patients with shoulder impingement syndrome. J Orthop Sports Phys Ther 2000; 30:126–137.
23. (Winters JC, Sobel JS, Groenier KH, Arendzen HJ, Meyboom-de Jong B. Comparison of physiotherapy, manipulation, and corticosteroid injection for treating shoulder complaints in general practice: Randomised, single blind study. BMJ 1997; 314:1320–1325.)

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Vol 4 | Issue 1 | Jan - Apr 2016 | page: 31-36 | Bipul Borthakur[1], Birseek Hanse[2], Russel Haque[3], Saurabh Jindal[4], Manabjyoti Talukdar[5].

Author: Bipul Borthakur[1], Birseek Hanse[2], Russel Haque[3], Saurabh Jindal[4], Manabjyoti Talukdar[5].

[1] Department of Orthopaedics, Assam Medical College, Barbari, Dibrugarh,  PIN - 786 002, Assam, India.
Institute Where Research Was Conducted: Assam Medical College, Dibrugarh, Assam.
University Affiliation: Srimanta Sankaradeva University of Health Sciences, Guwahati.
Year Of Acceptance Of Thesis: 2013.

Address of Correspondence
Dr. Russel Haque
Department of Orthopaedics, Assam Medical College, Barbari, Dibrugarh,
PIN - 786 002, Assam, India.
Email- russelhaq@gmail.com

 Abstract

Background: Distal femoral fractures represents a challenging problem in orthopaedic practice. Open reduction with Internal fixation replaces previous trend of closed conservative management and external fixation. Distal femoral locking compression plate (DF-LCP) requires both locking and compression screw fixation of the femur shaft. This study was conducted to examine the short-term results, early complications and healing rate of distal femoral fractures treated with the DF-LCP.
Materials and Method: 32 patients were included in the study. Lateral approach was performed as standard surgical technique. Functional results evaluated using knee society score.
Results: There were 24 males and 8 female patients of mean age 48.84 years. Road traffic Accident (59.38%) was the commonest mode of injury and 33A3 was the commonest fracture type (25%). Most were closed fractures (78.12%). Late complications seen in 4 cases of implant failure (broken plate and screw breakage) and 2 wound infections. 100% union rate seen with an average union time 14.40 weeks. Knee society score was Excellent in 13 (40.63%), good in 17 (53.12%) and failure in 2 (6.25 %) patients.
Conclusion: DF-LCP is an important armamentarium in treatment of Distal femur fractures especially when fracture is closed, severely comminuted and in situations of osteoporosis.

Introduction

The incidence of distal femoral fractures is 4-7% of all femur fractures. Distal femoral fractures, especially AO Type C fractures are difficult to treat as diastasis of 3 or more millimetres cause Osteoarthritis. The problems associated with conservative management as was done previously are the limitation of reduction and difficulty of maintaining reduction with associated complications of prolonged immobilisation and economic considerations of increased hospital stay. Pin tract infections and joint contractures are common complications with external fixation with devices such as the hybrid external fixator and the Ilizarov external fixator. Internal fixation devices used earlier such as 95° angled blade plate, dynamic condylar screw plate, condylar buttress plate and retrograde supra-condylar inter-locking nail etc. but these implants may not be ideal for complex inter-condylar and metaphyseal comminuted fracture types. Distal femoral locking compression plate (DF-LCP) has a smaller application device and allows both locking and compression screw fixation of the femur shaft. This study was conducted to examine the short term results, early complications and healing rate of distal femoral fractures treated with the distal femoral locking compression plate.

Aim and Objectives
Aim: To study and analyse the results of Locking compression plate (LCP) in Distal Femur Fracture.

Objectives:
1) To Analyse the clinical profile of the patient in regards to age, sex, mode of injury and any other relevant features.
2) To evaluate the Radiological union in treated patients.
3) To evaluate the complications.
4) To evaluate the functional outcome in treated patient based on knee findings.
5) To Assess any factors influencing the results.

Materials And Method
This study was petrformed in Assam Medical College & Hospital, Dibrugarh from July, 2012 to June, 2013 and 32 patients eligible for inclusion were selected who were admitted either through the Outpatient Department (OPD) or the Emergency Department (Casualty). All the fractures were post-traumatic. No pathological fracture was included in the study Patients with distal neurovascular injury is not included in this study. Inclusion Criteria: were Fresh cases of Closed fractures or Type1 open (Gustilo and Anderson) in skeletally mature patients. Exclusion Criteria: were who do not gave consent, unable to take part in post- operative rehabilitation. Open infected wound like Compound fracture(type 2 or 3), Pathological Fractures and Malunited fractures or Long standing cases(>3wks) or patients with Definite major illness like malignancy,chronic major system illness etc. Drug or alcohol abuse were also excluded. After admission into the hospital general and systemic examination as well as local examination along with thorough assessment of patient to rule out other systemic injuries was done followed by evaluation of patients in terms of age ,sex , mode of trauma and period between injury and arrival. Thereafter patient is stabilized with intravenous fluids, oxygen and blood transfusion as and when required. Careful assessment of injured limb as regards to neurovascular status was noted. Primary immobilization done with a Thomas splint and Antero-posterior and true lateral views of injured limb including Hip joint and Knee joint were done. CT scan was done as and when required. Traction given over Thomas splint for complex fractures. Analgesics were administered as required. Preoperative preparation include prophylactic antibiotics (3rd generation cephalosporin) on the evening before surgery and just before skin incision. Either Spinal aneasthesia or General anesthesia were used. Operating field washed with savlon , povidone iodine and was draped separately. PROCEDURE: Lateral approach as standard surgical technique was followed in all patients. The incision should start as proximal as necessary and distally, should extend across the midpoint of the lateral condyle anterior to the fibular collateral ligament, across the knee joint, and then gently curve anteriorly to end distal and lateral to the tibial tubercle. The fascia lata is incised in line with the skin incision. At the knee, the iliotibial tract will need to be incised, and the incision will continue down through the joint capsule and synovium to expose the lateral femoral condyle. The superior geniculate artery will need to be identified and ligated. Care was taken not to incise the lateral meniscus at the lateral joint margin. The vastus lateralis muscle is carefully elevated from the intermuscular septum and is retracted anteriorly and medially. Fractures were reduced under direct vision using manual traction. A knee roll assisted the procurement and maintenance of reduction. The plate length, axial and rotational alignment were checked under image intensifier (IITV).Temporary fixation was achieved through the use of Kirschner- wires. Inter-condylar type fractures were converted to a single condylar block before DF-LCP. Appropriate lengths of the plates were selected intra-operatively. Fixation of plates done. In minimally invasive technique, of selected distal femur fractures,a5-6cm lateral incision limited to the area of the lateral condyle and distal metaphysis was used. The incision was placed more distal to allow for retrograde sub-muscular plate insertion. Condylar screws are placed through the incision used for plate insertion. Adequate length of LCP was taken and placed on distal femur and temporarily fixed with k-wires. Locking compression screws were applied sequentially, followed by proximal screws. Reduction was viewed under IITV. Wound was washed thoroughly with normal saline. Drain was given to every patient. Closure was done in layers after Haemostasis was achieved, followed by Dressing. Posterior plaster slab above knee was applied. Considering the patient's condition and the stability of the internal fixation, mobilization using a walker was done as soon as possible with the help of supervised physiotherapy. Crutch walking given but weight bearing was not allowed. . In case of unstable fracture immobilization was upto 3 weeks. Weight bearing was allowed only after clinical and functional assessment. Patients were followed up clinically at 2, 6, 12 and 24 weeks and radiologically at 6,12 and 24 weeks. Further radiological assessment was done at 6 weeks,3 months, 6 months and 12 months.

Results
Among 32 patients the mean age was 48.84 years ( youngest 18 years and oldest 78 years ), 24 males and 8 females were among the subjects. Slight preponderance of Left side was noted. Road traffic Accident (RTA) (59.38%) was the Commonest mode of injury. Five cases had fractures in other parts of the body. One case had Associated head injury with other parts fracture. Most of the patient were closed fracture 25 Patients (78.12%) and 7 patients (21.88%) were open fractures. Majority (87.50%) were operated in 8–14 days following injury. There were no intraoperative and immediate post-operative complications. Late complications encountered were 2 cases of implant failure (broken locking plate and screw breakage) and 2 wound infections. Broken implants were safely removed and treated with other method. The union rate was 100% in the study group with average union rate 14.40 weeks, with no delayed or non-unions in the study, except 2 failure case treated with other implants. The union rate was 100% in our study group with average union time of 14.40 weeks, with no delayed or non-unions in the study, except 2 failure case treated with other implants. Based on the assessment criteria of knee society score for the present study, the final outcome for all cases was Excellent in 13 (40.63%) patients, good in 17 (53.12%) patients and failure in 2 (6.25 %).

Conclusion
The final outcome of the study based on the assessment criteria of knee society score was Excellent in 13 (40.63%) patients, good in 17 (53.12%) patients and failure in 2 (6.25 %). Thus, Locking Compression Plate is an important armamentarium in treatment of the Distal femur fractures especially when fracture is closed, severely comminuted and in situations of osteoporosis. Further study in large number of patients is required to comment regarding disadvantages and complications.

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Vol 4 | Issue 1 | Jan - Apr 2016 | page: 26-30 | Abhishek Vaish[1],  Sandeep Patwardhan[1], Ashok Shyam[1], Parag Sancheti[1].

Author: Abhishek Vaish[1],  Sandeep Patwardhan[1], Ashok Shyam[1], Parag Sancheti[1].

[1] Sancheti Institute for Orthopedics and Rehabilitation, Shivajinagar, Pune.
Institute Where Research Was Conducted: Sancheti Institute for Orthopedics and Rehabilitation, Shivajinagar, Pune 411005.
University Affiliation: MUHS(Maharashtra university of health sciences),Nashik.
Year Of Acceptance Of Thesis: 2015.

Address of Correspondence
Dr. Abhishek Vaish
Healing Touch Clinic, 94 Sukhdev Vihar
New delhi 110025.
Email: drabhishekvaish@gmail.com

 Abstract

Background: Titanium elastic nail (TEN) fixation was originally meant as an ideal treatment method for femoral fractures, but was gradually applied to other long bone fractures in children. We assessed outcomes in 50 Indian patients.
Material and Methods: Children with long bones fractures between 3-16 years were included and patients pathological fractures excluded. Functional outcome was assessed by using LEFS and DASH scoring and clinical by Flynn and Daruwala scoring. Radiological union was assessed by Anthony score. All patients were assessed upto 1 year or till implant removal .
Results: Excellent in 73%, satisfactory in 27% cases based on Flynn score. Based on Daruwala forearm score Excellent in 53%,Good in 27% and Fair in 20% cases.Percentage of functionality based on LEFS Score was 89.15% and Percentage of disability according to Quick DASH was 6.6 for both bones and 7.4 for humerus. Grade 3 callus formation according to Anthony et al scale was seen at 6 weeks in 70% and 28% cases at 12 weeks.
Conclusion: Based on our results, we conclude that flexible intramedullary nailing is an effective way of fixation with excellent functional results and minimal complications in diaphyseal fractures in skeletally immature patients.
Keywords: ESIN, TEN, Diaphyseal Fracture, Flynn.
Thesis Question: Is flexible elastic nailing an effective treatment modality in skeletally immature children?
Thesis Answer: Based on our results, we conclude that flexible intramedullary nailing is an effective way of fixation with excellent functional results and minimal complications in diaphyseal fractures in skeletally immature patients.

Introduction

Treatment of paediatric fractures dramatically changed in 1982, when Métaizeau and the team from Nancy( France), developed the technique of flexible stable intramedullary pinning (FSIMP) using titanium pins [1,2].Since then there have been tremendous advances in the surgical options available to treat paediatric fractures. Pediatric orthopedists have increasingly recognized the advantages of fixation and rapid mobilization.
Between 6 to 16 years, there are several available treatment options like traction followed by hip spica, external fixation, flexible stable intramedullary nails (ender or titanium), plate fixation, and locked intramedullary nailing[3,4,5,6,7] . Systematic review of literature provides little evidence to support one method of treatment over the other [8]. The treatment of long bone fractures in children less than 6 years and adolescents older than 16 years is straight forward. Titanium elastic nail (TEN) fixation was originally meant as a gold standard treatment method for femoral fractures[9], but was gradually applied to other long bone fractures in children, as it represents a midpath between conservative and surgical modality with satisfactory results and minimal complications.[10,11,12,13]. Much of the indexed publications and literature available on titanium elastic nailing is based on studies conducted outside the Indian subcontinent where the demographics like body weight on an average is different. The aim of this study is to evaluate the results of operative treatment of paediatric diaphyseal fractures in the age group between 6 to 16 years using titanium elastic nailing system (TENS).

Aims and Objectives
1. To study the surgical and functional outcomes of titanium elastic nailing in diaphyseal fractures in children between the age of 6-16 years.
2. To study the complications associated with titanium elastic nailing.

Material and Methods
Type of Study: Prospective study.

Duration of Study: May 2012 to November 2014
Case Selection Criteria: During this period all patients posted for titanium elastic nailing were screened using the inclusion and exclusion criteria. Informed consent was taken from all patients that fit the inclusion criteria and all patients willing to undergo the study were included after approval from the ethics committee.

Inclusion Criteria:
• Children with diaphyseal fractures of long bones.
• Age between 6-16 years.

Exclusion criteria:
• Congenital disorders.
• Patients with pathological fractures.

Study Method
All patients diagnosed with fractures of long bones were assessed clinically and radiographs were taken. Patients who fell into the eligibility criteria were included in the study and followed up at 2 weeks, 6 weeks, 12 weeks and till maximum 1 year or till implant removal whichever was earlier. They were assessed clinically, radiographically and functionally using Flynn outcome scoring65(Table 1- Annexure), Daruwala scoring66 (Table 2-Annexure)for forearm fractures. Radiographs were analysed in which the Limb alignment, delayed or non union(using Anthony scoring67-Table 5 annexure) were seen. Functional outcome was assessed by using quick Disability Arm, Shoulder, Hand scoring(Table 3-Annexure) for upper limbs and Lower Extremity Functional Score (Table 4-Annexure) for lower limbs at final follow up. Protocol was approved by Institutional review board. All patients were consented prior to inclusion in the study. Displaced fractures were immobilized using skin traction with Thomas splint (femur / tibia) or slab support till the day of surgery. Various demographic, clinical, investigative and operative findings were recorded from the hospital case file. Postoperative data collected was number of nails, postoperative immobilization, period of hospital stay, period of radiological union , return to normal work/daily activities, any complication , time to nail removal. Radiographs were evaluated for alignment, callus formation, nail position, and measurement of fracture location. Final outcome was graded excellent, satisfactory or poor based on criteria described by Flynn et al.

Results
Excellent in 73%, satisfactory in 27% cases based on Flynn score. Based on Daruwala forearm score Excellent in 53%,Good in 27% and Fair in 20% cases.Percentage of functionality based on LEFS Score was 89.15% and Percentage of disability according to Quick DASH was 6.6 for both bones and 7.4 for humerus. Grade 3 callus formation according to Anthony et al scale was seen at 6 weeks in 70% and 28% cases at 12 weeks.

Conclusion
Based on our results, we conclude that flexible intramedullary nailing is an effective way of fixation with excellent functional results and minimal complications in diaphyseal fractures in skeletally immature patients.

Clinical message
Titanium elastic nailing is a good modality of treatment with excellent results in the hands of experience surgeons with good surgical skills.
Hence this should be undertaken after proper training as the learning curve is high.
Keywords: ESIN, TEN, diaphyseal fracture,Flynn

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43. Gaid M, Jeer P. Cost analysis of managing paediatric femoral shaft fractures: flexible intramedullary nailing versus non-operative management. Acta Orthop Belg 2006 April; 72(2): 170-5.
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Vol 4 | Issue 1 | Jan - Apr 2016 | page:3-6 | Dr Shimpi Apurv P (PT).

Author: Dr Shimpi Apurv P (PT).

Associate Professor and Head Department of Community Physiotherapy, Sancheti Institute College of Physiotherapy, Pune.
Email: apurvshimpi@sha.edu.in

Introduction to Physiotherapy Research
Physiotherapy is a Health care profession concerned with human function & movement aimed at maximizing its potential. It uses physical approaches to promote, maintain & restore physical, psychological & social wellbeing, taking account of variations in health status. The role of a Physiotherapist involves administration and interpretation of tests related to bodily functions and structures, and the provision of a range of therapeutic and preventive measures to patients suffering from disabilities, dysfunctions and pain. But by large, Physiotherapy is still a non-dosage specific field where still lot of researches are being done to understand the exact or specific dosages required in the treatments/ restoration/ prevention of various conditions.

Challenges faced by the novice researcher
New PG Physiotherapy candidates are full of concerns regarding the application of research knowledge in practice for their PG thesis. Although few of the universities in India have incorporated research at an under-graduation level, this is expected to be an observational research, more or less limited to a retrospective study. Thus, many times, they may neither be exposed to, nor be interested in research. Although the thesis in PG is mandatory, most of the young learners consider clinical learning devoid of research and Evidence Based Physical Therapy (EBPT). EBPT incorporates the application of the learners' clinical Physiotherapy knowledge backed by latest evidences favouring the same considering the patients' needs and necessities. This requires a thorough knowledge of the client's functional aspects backed by the latest trends in the practice of that condition at a global level. This also necessitates the formulation of a clinical research question in current practice.

The Research Question
The Research Question is the soul of every thesis. It not only directs the end point of the thesis, but also marks the pathway to be taken towards completion of the thesis. Research question helps to understand contents of the thesis, including the methodology, tools, outcome measures and statistical tests that may be used in the particular thesis. It helps choose an appropriate protocol to be followed in completion of the thesis and let the researcher understand the need for the study. A good research question should guide towards appropriate references; explain about the condition to be studied and treatments currently available. It should note the gaps present in the current chain of evidences and the specific treatment to be studied and guide towards collection of preliminary data in the condition to be studied. It should also help the researcher anticipate results and potential pitfalls and describe the significance of the research including potential benefit for individual subjects or society at large.

Hypothesis
The hypothesis directs the methodology which considers the measures of exposure and outcome. It should be tested by making a comparison between the two or more groups. It guides the authors to develop a plan for data collection and management, determine the statistical methods for analysis and also estimate the magnitude of the expected difference between the two groups, as a basis for determining sample size (power calculation). This will guide to assess study feasibility, sample recruitments and analysis.

Study Title
This is the most important part of every research as the title forms the face of the study. An improper title will be a deterrent for any study and shall not arouse interest in the readers. The title should be descriptive of the study and should be concise, clear and non-ambiguous.

Challenges in writing Introduction
The introduction is the prima facia of the research. The introduction should be of the current study, rather than about the known knowledge of the conditions and diseases. It should always be in the funnel format, i.e. from broad global concerns to small local concern. Many times, the young researcher writes in great lengths about everything else other than their own study which may turn down the review board and readers. Introduction should be short and specific incorporating the need for conducting the present research in around 2–3 pages maximum. Bold statements like “such evidences do not exist” or “there have been no studies on this topic” etc. should be avoided.

Conducting the Review
The next challenge faced is collecting literature for reviewing. Although textbooks do give some baseline information, they can only answer background questions. For understanding research in its better aspect, answers to the foreground questions must be sought for which reading latest literature is mandatory. This can be obtained by subscribing to various peer reviewed, indexed journals or going through online databases. Database like the Google scholar may be useful to find articles, but specific databases like Pubmed, Cochrane, PEDro and CINAHL are also useful in Physiotherapy thesis. But the reader should be clear in understanding methods to navigate through them e.g., using the key words, filters, bullions, truncation symbols, MeSH terms etc. Documentation of the reviewed literature is also an art. A review should always have a story and a flow to it. This may be from the historical to the newer perspectives or may be compartmentalised based on the research question/s. Writing briefly about the authors, their study, design, results, conclusion and applicability is desired.

Aim and Objectives
Generally PG thesis may have a single aim to answer to a specific research question. The study objectives should be clearly and precisely stated. They should be simple, specific, and stated in advance to performing the research and should be attainable, measurable and realistic.

Research design and Statistics
The research design should be identified and should be appropriate to answer the research question/s under study. The researcher may describe the type of research proposed (e.g. experimental, correlational, survey, qualitative) and specific study design that will be used (e.g. pre-posttest, control group, cross-sectional; prospective longitudinal, cohort; blinded randomized control). The research design, methods and procedures should help answer the specific research question/s as mentioned in the study objectives. The sampling procedures should be specific and scientific. The researcher should always describe the sampling approach including determination and justification for sample size. A larger sample size may increase the cost and duration of the study and will be unethical to expose human subjects to any potential unnecessary risk without additional benefit. A smaller sample size can also be unethical if it exposes human subjects to risk with no benefit to scientific knowledge. Calculation of sample size has been made easy by computer software programs. The principles underlying the estimation of the software sample size should be well understood. The researchers have to identify the procedures that will be used to recruit, screen and follow study volunteers as well as specifically define the study sample (number and characteristics of subjects to be included and excluded). In intervention studies, clarification of subject allocation to treatment and comparison groups and criteria for discontinuation should be defined. Another challenge faced is on statistics which is considered as a huge hurdle. Thus, involving the statistician from the earliest part of the research is an excellent idea. Statisticians can help in understanding the basis of statistical tools, data variables and tests before actual exploration of data. Choosing good and appropriate, valid and reliable outcome measures is also an important step to a successful thesis.

Why conduct the Pilot Study?
Before the actual research, performing the pilot study is another crucial step in Physiotherapy thesis. It is useful in multiple ways. In observational studies, it may help understand the outcome measure or may help in validating the research tools. In experimental studies, it may help in rectification and finalization of the processes and the procedures which may be used in the study. Pilot study is never meant to analyse the end results. It will help the researcher understand if he is on the right track. This also helps rectify any lacunae that may weaken the study as well as prevent any potential confounders that may cause bias in the study. Permissions for obtaining/ using outcome measures can also be done in this phase.

Materials and Methods
The methodology should be elaborate to explain every procedural detail to the level of replication of the entire study in the similar given environment. Processes of sampling, consent, measures, tests, and data entry need to be provided in elaborate details. A very important consideration in the thesis methodology is following the universal guidelines for the procedure documentation. Researchers are advised to go through CONSORT guidelines (CONsolidated Standards Of Reporting Trials) for experimental, STROBE guidelines (STrengthening the Reporting of OBservational studies in Epidemiology) for observational and STARD guidelines (STAtement for Reporting studies of Diagnostic accuracy) for diagnostic studies.

Ethical Clearance and Research Registration
Another important step, before actual initiation of the study, is getting clearance from the Ethics Committee. This is mandatory for any medical research, including Physiotherapy research to ensure that the researcher shall not violate the rights and dignity of their subjects. It is advisable for every researcher to be certified in Good Clinical Practices, in order to ensure safeguarding of their subjects. Methods for data collection and for avoiding/ minimizing subject risks should be included. Always include a timeline for subject evaluations, duration of intervention and tentative budget for the project. The researcher should document the methods for maintaining subject confidentiality (plans for coding data and for securing written and electronic subject records) and should indicate duration of storage of personal information post study completion. These methods will vary with the research type (qualitative, quantitative) and thus should sufficiently describe justification of the approach for answering the defined research question. Methods should also be described in adequate detail so that IEC members may assess the potential study risks and benefits. Also it is important to register the study with national clinical trials registry (Clinical Trials Registry of India, CTRI). Many Physiotherapy researchers are still unaware of the importance of registering their studies to safeguard their intellectual rights. CTRI does register Post graduation Physiotherapy thesis and also observational studies. Also, it is advantageous to publish of your hypothesis as a defensive publications. Journals like 'Journal of Medical Thesis' does publish Research Hypothesis which helps protect intellectual property of the researchers.

The master chart and Scientific Misconduct
Although the master chart seems to be the last and inconspicuous part of the research, fact is that it is the most important piece of evidence in every research. The basic analysis of the entire study data is done from the master chart and thus, it should be created properly without any fallacies. The PG candidate should be clear with the data being analysed and should make the master chart elaborately. Avoid making single headings for multiple components. E.g., for male/ female, yes/ no options, make 2 different columns rather than a single column and enter '1' for every 'yes' or 'no'. This is extremely important in summation and averaging. In experimental studies, it is advised to make different sheets for control and experimental groups. MS Excel has multiple, user friendly options and tools which should be learnt before making the master chart. Also, many statistical tests for parametric data can be performed in Excel, including descriptive statistics, paired and unpaired t test, ANOVA, Correlations, covariance etc. For all other tests, including non-parametric tests and Correlations etc., using statistical packages like the SPSS is beneficial. Taking guidance from a good statistician always helps but learn your own basic test procedures as well. Few of the researchers tend to indulge in research malpractices during this phase by falsification and fabrication of their data. This is strongly condemned and the researchers have to understand that such malpractices can easily be detected by basic analysis of the master-chart. Also ensure that the master chart does not disclose the identity of the subjects in any way as this is considered as breach of confidentiality. Hence, coding of the case report forms before making the master chart is a good practice.

Results, Discussion and Conclusion of the Study
This is another crucial part of any Physiotherapy thesis. Often good studies lose their value due to improperly interpreted and explained results. The PG candidate should choose appropriate, self-explanatory graphs and tables for explanation of their results. The discussion should focus on the important findings and rationalisation of these findings and should avoid repetition of results. Utilising a good reviewed literature is extremely helpful in this stage. Also, the confounders of the study should be well identified and expressed in the discussion (unless they are being written separately as limitations). The conclusion should be a good amalgamation of the aim, objectives, research question and hypothesis. Any conclusion, whether it accepts or rejects the null hypothesis, is an important contribution to Physiotherapy research. Conclusion should only be based on the results obtained and should not have any comments outside the preview of the study, including indirect study implications. Any suggestions or added information can be written as a scope for further study.

References Guidelines
References should always be recent, complete and preferably in the Vancouver format. The details can be found in most of the standard journal and sites. References should be given to all the published articles, books, websites (mentioning the date of viewing them), and even to unpublished but accepted works.

Summary
Thesis has been an integral part of every Post Graduate Physiotherapy candidate and is associated with them for a lifetime. In today's electronic era, every published or unpublished thesis can utilised by future researchers as a reference. But it should be remembered that every research is completed only when published in a good peer reviewed indexed journal. Thus, it becomes not only important and ethical, but even legal to lay down all the facts associated with the study in a truthful and honest manner. Malpractices like plagiarism, although may seem easy, but are deterrents in the future prospects of the candidate. Almost all of the universities and journals run anti-plagiarism software's and getting indulged in such act may not only cause rejection of this wonderful piece of literature, but may also blacklist the candidate for life. Research is all about a bit of dedication, understanding, honesty and hard work on the researchers' side and about a lot of truth, facts and probabilities of the findings for verification of these facts, which under any costs, must not be altered, but be expressed with all its integrity. Only then can the candidate truly contribute to his professions growth and stability in a noble way.

References

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6.Writing a Research Policy – WHO. Recommended format for a Research Protocol. Available at http:// www.who.int/rpc/research_ethics/format_rp/en/ [Viewed on February 22, 2016].
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8. Amezcua M. [Myths, challenges, and fallacies in nursing research]. Rev Enferm. 2003 Sep;26(9):36-44. Spanish.
9. Babu AS, Veluswamy SK, Rao PT, Maiya AG. Clinical trial registration in physical therapy journals: a cross-sectional study. Phys Ther. 2014 Jan;94(1):83-90.
10. Shyam AK. Editorial: Hypothesis, Intellectual Property and Journal of Medical Thesis: Concept of Defensive Publication. Journal Medical Thesis 2014 Jan- April: 2(1); 1-2.

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