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CTRI Number  CTRI/2025/02/080953 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 28/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Which graft is better for ACL reconstruction in athletes: peroneus longus or hamstring? 
Scientific Title of Study   A prospective randomised study comparing isokinetic strength recovery and return to sports following arthroscopic anterior cruciate ligament reconstruction using peroneus longus graft versus hamstring graft in athletes. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Devbrath Manna 
Designation  Postgraduate resident 
Affiliation  Pt. B.D. Sharma PGIMS, Rohtak. 
Address  Department of Sports Medicine, Pt. B.D. Sharma PGIMS, Rohtak.

Rohtak
HARYANA
124001
India 
Phone  7008461949  
Fax    
Email  devbrathmanna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rajesh Kumar Rohilla 
Designation  Senior Professor and Head 
Affiliation  Pt. B.D. Sharma PGIMS, Rohtak. 
Address  Department of Sports Medicine, Pt. B.D. Sharma PGIMS, Rohtak.

Rohtak
HARYANA
124001
India 
Phone  9812662814  
Fax    
Email  drrajeshrohilla@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Rajesh Kumar Rohilla 
Designation  Senior Professor and Head 
Affiliation  Pt. B.D. Sharma PGIMS, Rohtak. 
Address  Department of Sports Medicine, Pt. B.D. Sharma PGIMS, Rohtak.

Rohtak
HARYANA
124001
India 
Phone  9812662814  
Fax    
Email  drrajeshrohilla@rediffmail.com  
 
Source of Monetary or Material Support  
Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India,124001. 
 
Primary Sponsor  
Name  Devbrath Manna 
Address  Department of Sports Medicine, Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India,124001. 
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 
Devbrath Manna  Pt. B.D. Sharma PGIMS,Rohtak  Department of sports medicine
Rohtak
HARYANA 		 7008461949

devbrathmanna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt. B. D. Sharma PGIMS/UHS, Rohtak  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  Hamstring autograft.   The comparator group will undergo arthroscopic ACL reconstruction using the hamstring graft. This procedure will involve harvesting tendons from the hamstring muscles to replace the damaged ACL. The outcomes of this group will be compared with those of the peroneus longus graft group to evaluate differences in isokinetic strength recovery and return to sports. 
Intervention  Peroneus longus autograft.   The intervention in this study involves arthroscopic anterior cruciate ligament (ACL) reconstruction using the peroneus longus graft. Athletes who will undergo this procedure will have their torn ACL repaired using a graft harvested from the peroneus longus tendon, which is located in the lower leg. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Athletes with symptomatic anterior cruciate ligament injury grade 2 and grade 3 with or without meniscus injuries.  
 
ExclusionCriteria 
Details  1-Patients who do not give consent.
2-Patients with ACL injury grade 1.
3-Patients with bilateral ACL injury.
4-Patients with multi ligament knee injury.
5-Patients undergoing revision ACL surgery.
6-Patients with any other arthropathy affecting knee.
7-Patients with neuromuscular disorders.
8-Patients with any psychiatric disorders.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the isokinetic strength recovery of knee joint at 4 months and 6 months following arthroscopic anterior cruciate ligament reconstruction.   At 4 months and 6 months following arthroscopic anterior cruciate ligament reconstruction.  
 
Secondary Outcome  
Outcome  TimePoints 
1-To evaluate return to sports.
2-To evaluate the ankle donor site morbidity after harvesting ipsilateral hamstrings tendon.  		 At 4 months and 6 months following arthroscopic anterior cruciate ligament reconstruction.  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   25/02/2025 
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="1"
Months="6"
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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 10-07-2026 and end date provided 09-07-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Study Objective-
The study evaluates the isokinetic strength recovery of the knee joint at 4 months and 6 months following arthroscopic anterior cruciate ligament reconstruction using different grafts (peroneus longus vs. hamstrings). It aims to evaluate and compare isokinetic strength recovery and return to sports following arthroscopic anterior cruciate ligament reconstruction using peroneus longus versus hamstring autograft.
Study Design-Prospective Randomised Comparative Study.
Study Centre:-The Study Will be conducted at Department Of Sports Medicine, Pt. B. D. Sharma PGIMS, Rohtak.
Study period- From January 2025 to December 2025
Study population-All patients fulfilling inclusion criteria attending Sport Medicine OPD at Pt. B. D. Sharma PGIMS, Rohtak.
Randomisation and Group Allocation-
Patients attending Sports Medicine OPD at Pt. B.D. Sharma, PGIMS, Rohtak with anterior cruciate ligament injuries planning to undergo arthroscopic anterior cruciate ligament reconstruction will be randomly allocated to one of the following two groups using computer-generated random numbers.
Group A- Arthroscopic anterior cruciate ligament reconstruction using peroneus longus tendon autograft (n=25).
Group B- Arthroscopic anterior cruciate ligament reconstruction using hamstring autograft (n=25).
Inclusion-
1. Athletes with age group between 18-45 years of either sex. 
2. Athletes with symptomatic Anterior Cruciate Ligament injury (Grade 2 and 3) with or without Meniscus injuries.
Exclusion: Strict adherence to exclusion criteria.
Postoperative Protocol-ACL rehabilitation physiotherapy protocol is followed.
Measurements and Assessments-
Isokinetic Strength Testing:
Conducted preoperatively, 4 months, and 6 months postoperatively.
Measurements include knee extension (Ex) and flexion (Flx) at angular velocities of 60°/s and 180°/s using a Biodex dynamometer.
H/Q ratios recorded to assess muscle strength symmetry.
Outcome Evaluation:
Return to sports criteria:H/Q ratio ≥60% at 60°/s.
Less than 10% deficit in quadriceps/hamstring strength compared to the healthy side.
Less than 10% deficit in limb symmetry on single-leg hop testing.
Subjective assessments using Lysholm Knee Score and AOFAS Ankle Score.
Donor Site Morbidity:
Assessed through physical performance and subjective evaluations.
Key Results Expected-
Comparison of functional outcomes (e.g., muscle strength, Return to sports timing) between graft types.
Understanding rehabilitation needs and donor site morbidity.
 
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