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CTRI Number  CTRI/2022/10/046620 [Registered on: 19/10/2022] Trial Registered Prospectively
Last Modified On: 10/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of graft healing between two standard methods of taking graft in knee ACL ligament surgery by MRI and functional outcome 
Scientific Title of Study   Comparative clinico radiological evaluation of graft maturation between two methods of graft harvesting in arthroscopic ACL reconstruction 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SKAND SINHA 
Designation  PROFESSOR 
Affiliation  Orthopaedics department,SPORTS INJURY CENTRE 
Address  Room no 3 Orthopaedics department SPORTS INJURY CENTRE VMMC and Safdarjung hospital
VMMC and Safdarjung hospital New delhi
New Delhi
DELHI
110029
India 
Phone  9868428689  
Fax    
Email  skandsinha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SKAND SINHA 
Designation  PROFESSOR 
Affiliation  Orthopaedics department,SPORTS INJURY CENTRE 
Address  Room no 3 Orthopaedics department SPORTS INJURY CENTRE VMMC and Safdarjung hospital
VMMC and Safdarjung hospital New delhi
New Delhi
DELHI
110029
India 
Phone  9868428689  
Fax    
Email  skandsinha@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR KARTHI CUMARAN 
Designation  FNB TRAINEE 
Affiliation  Orthopaedics department,SPORTS INJURY CENTRE 
Address  Orthopaedics department SPORTS INJURY CENTRE VMMC and Safdarjung hospital
VMMC and Safdarjung hospital New delhi
New Delhi
DELHI
110029
India 
Phone  9940389287  
Fax    
Email  stanleycumaran@gmail.com  
 
Source of Monetary or Material Support  
VMMC and Safdarjung hospital New delhi 
 
Primary Sponsor  
Name  Sports injury centre 
Address  VMMC and Safdarjung hospital New delhi 
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 
DR SKAND SINHA  SPORTS INJURY CENTRE  Sports injury centre VMMC AND SAFDARJUNG HOSPITAL, NEW DELHI.
South
DELHI 		 9868428689

skandsinha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee,VMMC and safdarjung hospital,Newdelhi  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, (2) ICD-10 Condition: S835||Sprain of cruciate ligament of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HAMSTRING ATTACHMENT SPARING ACL RECONSTRUCTION  Arthroscopic ACL reconstruction done using hamstring graft with attachment preserved on the tibial side ( intervention duration -one day on surgery day).MRI and clinical outcome measured at various intervals( outcome follow up duration - 2 years) 
Comparator Agent  FREE HAMSTRING GRAFT ACL RECONSTRUCTION  Arthroscopic ACL reconstruction done using free hamstring graft with attachment detached on both sides ( intervention duration -one day on surgery day).MRI and clinical outcome measured at various intervals( outcome follow up duration - 2 years) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1)All consecutive cases of ACL Tear with or without meniscal tear

2)Unilateral ACL injury 
 
ExclusionCriteria 
Details  1)Age <18 years and >30 years
2)Smoking history
3)Endocrine disorders (DM/Hypothyroidism)
4)PVD/Malignancy/sepsis
5)Metabolic bone disease
6)Connective tissue disorders
Collagen disorders
Inflammatory arthritis
Muscular dystrophy
Associated Multi-ligament injury/Bilateral injury
Associated chondral injury
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
MRI Scoring
Lysholm , IKDC and Tegner scoring
KT arthrometer and objective anterior translation
Return to sport scoring 		 3,6,9,12 and 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Lysholm , IKDC and Tegner scoring
KT arthrometer and objective anterior translation
Return to sport scoring 		 3 months,6 months,9 months,12 months,24 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   01/11/2022 
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)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 The aim of the study is to assess the difference in graft maturation between two methods of graft harvesting in arthroscopic ACL reconstruction .Our hypothesis is tibial attachment sparing hamstring graft results in early graft maturation than free hamstring graft .Th early graft maturation allows early rehabilitation and early reurn to sports in young athlete. 
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