| CTRI Number |
CTRI/2025/10/095561 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
02/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison of Two Techniques for Securing ACL Grafts in Knee Surgery Using the Peroneus Longus Tendon |
|
Scientific Title of Study
|
Comparison of functional and radiological outcomes of bioscrew vs loop washer for tibial site fixation in arthroscopic anterior cruciate ligament reconstruction using peroneus longus autograft. |
| 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 Koustav Roy |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Department of Orthopaedics, All India Institute of Medical Sciences, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
6296803547 |
| Fax |
|
| Email |
roykoustav2104@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Department of Orthopaedics, All India Institute of Medical Sciences, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9911278806 |
| Fax |
|
| Email |
vivekkumar.shah@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Koustav Roy |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Department of Orthopaedics, All India Institute of Medical Sciences, Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
6296803547 |
| Fax |
|
| Email |
roykoustav2104@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Gorakhpur, District Gorakhpur, PIN 273008, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Kunraghat, Gorakhpur, Uttar Pradesh, PIN 273008 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Nepal |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Koustav Roy |
All India Institute of Medical Sciences, Gorakhpur |
Department of Orthopaedics
Gorakhpur
UTTAR PRADESH |
6296803547
roykoustav2104@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, AIIMS Gorakhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arthroscopic anterior cruciate ligament reconstruction using bioscrew |
Arthroscopic ACL reconstruction using peroneus longus autograft with tibial fixation by bioscrew (bioabsorbable interference screw). The screw is placed within the tibial tunnel to compress the graft against the tunnel wall, ensuring initial stability. |
| Intervention |
Arthroscopic anterior cruciate ligament reconstruction using loop washer |
Arthroscopic ACL reconstruction using peroneus longus autograft with tibial fixation by loop washer (suspensory cortical fixation device). The loop washer suspends the graft extracortically over the tibial cortex, distributing forces across the tunnel and minimizing graft compression. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 to 40 years undergoing primary arthroscopic anterior cruciate ligament reconstruction.
2. No previous history of injury or surgery in the knee and normal contralateral knee.
3. No concomitant injury to lateral collateral ligament, medial collateral ligament or posterior cruciate ligament.
4. No systemic disease or illness that may affect the surgery. |
|
| ExclusionCriteria |
| Details |
1. Revision anterior cruciate ligament surgery.
2. Concomitant ligament injuries requiring repair.
3. Severe chondral damage (Outerbridge grade III/IV)
4. History of knee infection or systemic inflammatory disease
5. Patient who refuses to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| We would be able to compare the functional and radiological outcomes of bioscrew versus loop washer for tibial site fixation of peroneus longus graft in patients undergoing arthroscopic ACL reconstruction using validated scoring systems such as the IKDC (International Knee Documentation Committee) score, Tegner and Lysholm Knee Score and radiological outcomes using MRI. |
All patient enrolling in the study will be periodically assessed by various internationally accepted knee scoring systems and using MRI at various predefined intervals –
1) Post operative period during hospital stay
2) At 2 weeks when sutures will be removed
3) At 3 months
4) At 6 months
5) At 12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We would be able to assess complication rates (e.g., graft failure, tunnel widening, hardware irritation, infection) between bioscrew & loop washer fixation. |
1) Post operative period during hospital stay
2) At 2 weeks when sutures will be removed
3) At 3 months
4) At 6 months
5) At 12 months
|
| We would be able to determine patient satisfaction & return-to-activity levels following each fixation method. |
1) Post operative period during hospital stay
2) At 2 weeks when sutures will be removed
3) At 3 months
4) At 6 months
5) At 12 months
|
We would be able to evaluate & compare the radiological evidence of graft integration using MRI during the follow up at 6 months & 1 year.
|
1) Post operative period during hospital stay
2) At 2 weeks when sutures will be removed
3) At 3 months
4) At 6 months
5) At 12 months
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/10/2025 |
| 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)
|
Open to Recruitment |
| 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 - NO
|
|
Brief Summary
|
This thesis titled “A Comparative Study Between Bioscrew and Loop Washer for Tibial Site Fixation in Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction Using Peroneus Longus Autograft” aims to evaluate two widely used fixation methods for ACL reconstruction. ACL injuries are common among young active individuals, and tibial fixation plays a critical role in ensuring graft stability and successful outcomes. While bioscrews are traditionally preferred for their direct compression and ease of use, loop washers offer suspensory fixation with potential benefits such as reduced tunnel widening and better graft integration.
This study is designed as a prospective, randomized cohort trial involving 64 patients aged 18–40 years, who will undergo ACL reconstruction with peroneus longus autograft at AIIMS Gorakhpur. Patients will be randomized into two groups: Group A (bioscrew fixation) and Group B (loop washer fixation). Outcomes will be assessed using validated functional scores (IKDC, Lysholm, Tegner) and radiological evaluation by MRI at 6 and 12 months. Secondary outcomes include complication rates, graft incorporation, patient satisfaction, and return to activity.
The study hypothesizes that both fixation methods provide comparable functional and radiological outcomes. Findings are expected to bridge the current evidence gap regarding tibial fixation with peroneus longus grafts and may guide future surgical decision-making for improved patient outcomes in ACL reconstruction. |