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CTRI Number  CTRI/2024/04/065472 [Registered on: 09/04/2024] Trial Registered Prospectively
Last Modified On: 08/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing quadriceps tendon autograft with hamstring tendon autograft used in anterior cruciate ligament reconstruction in Knee in terms of better outcome and return to pre injury level: a randomised control trial 
Scientific Title of Study   Functional Outcome comparing quadriceps tendon autograft with hamstring tendon autograft in anterior cruciate ligament reconstruction: a randomised control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhay Tyagi 
Designation  Post graduate resident 
Affiliation  KIMS, Bhubaneswar, odisha 
Address  Department of Orthopaedics, Kalinga institute of medical science, Bhubaneswar, Odisha

Khordha
ORISSA
751024
India 
Phone  9779777677  
Fax    
Email  abhay20tyagi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Debashish Mishra 
Designation  Professor (HOD) 
Affiliation  KIMS, Bhubaneswar, odisha 
Address  Department of Orthopaedics, kalinga institute of medical sciences

Khordha
ORISSA
751024
India 
Phone  9437043323  
Fax    
Email  drdmishraortho@gmail.com  
 
Details of Contact Person
Public Query  
Name  Saurav Narayan Nanda 
Designation  Assistant Professor 
Affiliation  KIMS, Bhubaneswar, odisha 
Address  Department of Orthopaedics, kalinga institute of medical sciences

Khordha
ORISSA
751024
India 
Phone  9853178656  
Fax    
Email  saurav.scb@gmail.com  
 
Source of Monetary or Material Support  
Self funded, Kalinga institute of medical sciences 
 
Primary Sponsor  
Name  Abhay Tyagi  
Address  Kims Bhubaneswar odisha 
Type of Sponsor  Other [SELF] 
 
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 
Dr Abhay Tyagi  Kalinga Institute of medical science(Kalinga Super speciality and Pradyuman Bal Memorial Hospital )  Room 112 department of orthopaedics Kalinga Institute of Medical Sciences Kushabhadra Campus, 5, KIIT Rd, Bhubaneswar, Odisha 751024
Khordha
ORISSA 		 9779777677

abhay20tyagi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee Kalinga institute of medical sciences(KIMS) Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hamstring tendon autograft  Patient with anterior cruciate ligament injury patient’s own hamstring tendon autograft will be used for reconstruction. 
Intervention  Quadriceps tendon autograft  Patient with anterior cruciate ligament injury patient’s own quadriceps tendon autograft will be used for reconstruction. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1 18-35 Years
2 Isolated ACL injury
3 Patient active in sporting related activity 
 
ExclusionCriteria 
Details  1. Arthritic knee.
2 Injury ot any other body part.
3 Patient with multiple comorbidities
4 Patient having inflammatory diseases (Rheumatoid arthritis, Ankylospondolytis)
5 Patient with open wound. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
How early patients return to pre injury status   6th month 9th month 12th month 
 
Secondary Outcome  
Outcome  TimePoints 
Functional outcome in term of knee society score,lysholm score  1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 4 
Date of First Enrollment (India)   20/04/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [abhay20tyagi@gmail.com].

  6. For how long will this data be available start date provided 13-03-2024 and end date provided 13-03-2050?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
Anterior cruciate ligament (ACL) is crucial ligament for knee stability in rotation and forward motion of knee. ACL injury is most common ligament injury in knee occurring in people involved in sporting activities. One of the commonly employed grafts for repair of ACL rupture in current practice involves using hamstring tendon (HT) autograft. Now a days an alternative option for ACL repair is the quadriceps tendon (QT) autograft. This study seeks to compare functional outcome between patients with ACL injury treated with either QT or HT autografts in term of return to pre injury level. Following approval from our institution’s
ethics and research Committee, patients will be randomly assigned to two groups: one receiving QT autograft and the
other HT autograft. Evaluation will occur preoperatively and
postoperatively, utilizing the Lysholm and knee society score and questionnaire at the 1st month, 6th, 9th, and 12th months aiming to prove the hypothesis of using QT graft in ACL reconstruction which may lead to an earlier return to sporting activity compared to a HT graft.
 
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