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CTRI Number  CTRI/2025/06/089726 [Registered on: 27/06/2025] Trial Registered Prospectively
Last Modified On: 26/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An assessment of the functional outcome of the knee and ankle joints after ACL Reconstruction with Peroneus Longus Autograft v/s Hamstring Autograft: A Randomized Control Trial 
Scientific Title of Study   An assessment of the functional outcome of knee and ankle after ACL Reconstruction with Peroneus Longus Autograft v/s Hamstring Autograft: A Randomized 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  Dr Sharad Prabhakar 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Professor, Dept of Orthopaedics, PGIMER, Sec 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9781716119  
Fax    
Email  sumukha.249@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sharad Prabhakar 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Professor, Dept of Orthopaedics, PGIMER, Sec 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8762293404  
Fax    
Email  sumukha.249@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumukha Sringeri V S 
Designation  Junior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Junior Resident, Dept of Orthopaedics, PGIMER, Sec 12, Chandigarh
No 1265, KUMARS, Sec 15B Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9901307944  
Fax    
Email  sumukha.249@gmail.com  
 
Source of Monetary or Material Support  
Dept of Orthopaedics, PGIMER 
 
Primary Sponsor  
Name  Dept of Orthopaedics 
Address  PGIMER, Sec 12 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 
Dr Sharad Prabhakar  Dept of Orthopaedics  Dept of Orthopaedics, PGIMER, Sec 12 Chandigarh
Chandigarh
CHANDIGARH 		 8762293404

sumukha.249@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(intramural) PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ACL reconstruction using Hamstring autograft  Participants who will have ACL reconstruction using Hamstring autograft are used to compare functions status of ankle and knee in participants who undergo ACL reconstruction using PLT autograft 
Intervention  ACL Reconstruction with Peroneus Longus Autograft v/s Hamstring Autograft  Randomised controlled study to compare functional outcome between 2 groups after ACL reconstruction Group 1 will have ACL reconstruction using Peroneus Longus Tendon autograft and Group 2 will get ACL Reconstruction using Hamstring autograft Functional outcome of both knee and ankle joints will be assessed in both of them 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All skeletally mature adults of either sex, aged 18 to 75 years with ACL injury of either degenerative or traumatic aetiology.  
 
ExclusionCriteria 
Details  1. Arthritis of KNEE joint(osteoarthritis, rheumatoid arthritis )
2. Multi ligamentous knee Injury
3. Bony ACL injury
4. Recurrent ACL tear
5. Patient who withholds consent.
6. Any patient who cannot provide the necessary data due to any disability.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The effect on Ankle eversion and Ankle function in patients who undergo Peroneus Longus Tendon autograft vs Hamstring
autograft in ACL reconstruction using
i) Ankle eversion strength measurement using Hand held push pull dynamometer
ii) Pedobarography
iii) FAAM score
iv). IKDC score
v0 SF12 score

 		 6 weeks, 12 weeks, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
The functional outcome of knee in Peroneus Longus Tendon autografted patients vs Hamstring autograft in ACL Reconstruction using IKDC 2000 score.   6 weeks, 12 weeks, 6 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 4 
Date of First Enrollment (India)   10/07/2025 
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="0"
Months="6"
Days="15" 
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-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

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

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sumukha.249@gmail.com].

  6. For how long will this data be available start date provided 16-06-2025 and end date provided 16-05-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A Randomised controlled trail where in the functional outcome of the knee and ankle joints are assessed in partic who will have ACL Reconstruction using Peroneus longus autograft is compared with those with hamstring autograft 
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