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CTRI Number  CTRI/2019/08/020531 [Registered on: 02/08/2019] Trial Registered Prospectively
Last Modified On: 09/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Factors affecting return to professional competitive sports after surgery for knee ligament injury using a muscle harvesting technique 
Scientific Title of Study   Factors affecting return to professional competitive sports after Anterior Cruciate Ligament Reconstruction using Semitendinosus-Gracillis graft with preserved tibial insertion 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Ravi Gupta 
Designation  Professor, Orthopaedics 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Room 3208, B-Block Level 3, Orthopaedics OPD, Government Medical College and Hospital, Sector 32, Chandigarh.

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121592  
Fax    
Email  ravikgupta2000@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Ravi Gupta 
Designation  Professor, Orthopaedics 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Room 3208, B-Block Level 3, Orthopaedics OPD, Government Medical College and Hospital, Sector 32, Chandigarh.

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121592  
Fax    
Email  ravikgupta2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rohli Mehta 
Designation  PG Resident 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Orthopaedics, Government Medical College and Hospital, Sector 32, Chandigarh.

Chandigarh
CHANDIGARH
160030
India 
Phone  9535316135  
Fax    
Email  rohil.mart11@gmail.com  
 
Source of Monetary or Material Support  
Department of Orthopaedics 
 
Primary Sponsor  
Name  Department of Orthopaedics 
Address  GMCH-32, Chandigarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Dr Ravi Gupta  Department of Orthopaedics  Room 343, Level 3, D-block, Government Medical College and Hospital, Sector-32, Chandigarh.
Chandigarh
CHANDIGARH 
9646121592

ravikgupta2000@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Age 18-35 years
Sportsperson
ACL tear
ACL reconstruction with STG graft using Preserved Insertion technique (STGPI) 
 
ExclusionCriteria 
Details  Bilateral ACL tear
Any other ligament injury in ipsilateral/contralateral knee presently or in the past
ACL reconstruction with Bone Patellar Tendon Bone (BPTB) graft
ACL re-rupture
Past surgery on the knee 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Co-relation of factors affecting return to sports after ACL reconstruction using Semitendinosus-Gracilis graft with preserved tibial insertion  6 months to 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of age, thigh wasting, duration of injury before surgery, graft size, socio-economic status, type of sports, pre-op rehabilitation and fear of re-injury on timing of Return to Sports

To find out efficacy of STGPI technique in terms of return to sports after ACL injury 
6 months to 1 year 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/08/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Anterior Cruciate Ligament (ACL) tear is a common orthopaedic injury in sportspersons. ACL reconstruction (ACLR) is the treatment of choice for the same. The goal of ACL reconstruction surgery is to restore the normal function of the knee and allow a subsequent return to sports as early as possible. However, despite improvement of surgical techniques and better method of fixation of graft, return to sports (RTS) is still not guaranteed in all the patients. Various studies have shown that return to sports after ACLR has been possible in 55-80% of cases. 
The most commonly used autografts in ACLR are Bone Patellar tendon Bone (BPTB) autograft and Semitendinosus-Gracilis (hamstring) free autograft (STGF). BPTB graft has been reported to have the advantage of good mechanical stability and low rupture rate but disadvantages of donor site morbidity and anterior knee pain. STGF autograft has advantages of not having donor site morbidity and having a good functional outcome but has the disadvantage of high rupture rate. Semitendinosus-Gracillis graft with preserved tibial insertion (STGPI) is another option in the clinical setting with low graft failure rate like that of BPTB graft and with the added advantage of not having significant donor site morbidity. In STGPI, because we are not severing the insertions of the hamstring tendons from the tibia, the blood supply of the tendons remains preserved. Hence preserving the insertions in this technique preserves the biology to a greater extent than the severed insertions in the case of STGF and potentially promotes superior healing of the graft; this may minimize the risk of graft elongation, and preserve the mechanoreceptors in the graft tissue and has been reported to have better results in terms of proprioception.6,8 However, there is no statistically significant difference amongst the three grafts in terms of return to sports and mechanical stability. Since STGPI has comparable outcomes in terms of RTS with BPTB, and factors affecting RTS have not been studied extensively in ACLR with STGPI, we aim to find out the co-relation of these factors with RTS using STGPI.
So far there is no consensus on as to what should be the ideal time for RTS after ACLR, which is the most frequent and important question from the sportsperson’s point of view. A number of factors have been suggested by several authors on which the outcome of ACLR depends. There are studies co-relating certain parameters like thigh wasting, type of sports and duration of injury with RTS after ACLR, but most of them do not concern the more important factor, that is the return to competition (RTC) after ACLR, which means returning
to the same level of competitive sports as the pre-injury state, especially in the context of sportspersons. There are very few studies showing a relation of younger age group of presentation with an increased rate of graft failure after ACLR, but there is no study showing a direct relation between age at the time of injury and RTS. Similarly there is not enough literature on the co-relation between socio-economic status of a patient, and the outcome of ACLR, and through our study we also aim to find out if socio-economic status also has an impact on RTS after ACLR. We hypothesize that lower is the socio-economic score of the sportsperson, higher is the tendency to avoid re-injury due to economic reasons.
Graft size has also been co-related with graft failure post ACLR, but none of the studies show a direct co-relation between graft size and RTS.14 We also aim to study fear of re-injury as a factor for preventing RTS. There have been a few studies stressing on the importance of fear of re-injury having a negative impact on the outcome of ACLR in terms of RTS, but none of the studies have been undertaken on ACLR using STGPI which has a better result in terms of proprioception.
Our study becomes unique due to the fact that, although these factors have been studied in relation to ACLR in many studies individually, there is very scant literature showing the relation of a combination of these factors in a single study. Also majority of the literature in the past has been studied on either BPTB or STG free grafts, and since we hypothesize that STGPI has a similar outcome to BPTB, this study will help us determine the outcome of STGPI in terms of RTS as a technique for ACLR.
The purpose of this study is to find out the co-relation of parameters such as age, thigh wasting, duration of injury before surgery, graft size, socio-economic status, type of sports, and fear of re-injury with both RTS and returning to the same level of sports.
 
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