Arthroscopic ACL reconstruction with peroneus longus graft with or without a platelet-rich plasma (PRP) injection
Comparison of Functional Outcomes Following Arthroscopic ACL Reconstruction With Peroneus Longus Autograft With and Without Intra-articular Platelet-Rich Plasma Injection: A Randomized Controlled Trial
This test sees if a single 4 ml intra-articular PRP injection given during ACL reconstruction with a peroneus longus graft helps adults (18–50) with isolated ACL tears recover better over 12 months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Lahore General Hospital Government |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07470359 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective randomized controlled Phase 2 trial in Lahore, Pakistan will randomize 88 adults with isolated complete ACL tears to receive either a single 4 ml intra-articular PRP injection or saline at the time of arthroscopic ACL reconstruction with a peroneus longus autograft. PRP is prepared from 15–20 ml venous blood using a single-spin centrifugation (3500 rpm) and delivered as 2 ml per femoral/tibial tunnel during surgery. Functional recovery will be measured using KOOS4 questionnaires at baseline, 3, 6, and 12 months with primary comparisons made by ANCOVA adjusting for baseline scores. The trial is designed to be feasible in a resource-limited setting and integrates follow-up into routine clinic visits to minimize dropout.
Who should consider this trial
Good fit: Adults aged 18–50 with a primary, complete isolated ACL tear planning arthroscopic reconstruction with a peroneus longus autograft who are active in sports or regular physical activity and can attend follow-up visits are ideal candidates.
Not a fit: Patients with prior surgery on the affected knee, multi-ligament injuries, significant cartilage damage or knee osteoarthritis, systemic inflammatory disease, bleeding disorders, current anticoagulant use, or recent intra-articular corticosteroid injection are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding a single PRP injection could improve knee function and speed recovery after ACL reconstruction with peroneus longus grafts while remaining affordable for resource-limited settings.
How similar studies have performed: Prior ACL reconstruction studies of PRP have reported mixed results with some signs of improved graft healing and function, but findings are inconsistent and PRP use specifically with peroneus longus autografts is not well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age between 18 and 50 years. Diagnosis of a primary, complete ACL tear requiring reconstruction. Willingness to undergo arthroscopic ACL reconstruction with peroneus longus autograft. Active individuals participating in sports or regular physical activity. Willingness to provide informed consent and adhere to the study protocol, including follow-up visits and rehabilitation. Ability to understand and complete study questionnaires. - Exclusion Criteria: Previous knee surgery on the affected limb. Concomitant ligamentous injuries requiring additional reconstruction (e.g., PCL, MCL, LCL Grade III). Significant chondral damage (Outerbridge grade \> 2 on pre-operative MRI or intra-operative assessment). Pre-existing knee osteoarthritis (Kellgren-Lawrence grade \> 2). Systemic inflammatory conditions (e.g., rheumatoid arthritis). Bleeding disorders or coagulopathies. Current use of anticoagulants. Corticosteroid injection into the knee within 6 weeks prior to surgery. Pregnancy or lactation. Inability to comply with the rehabilitation protocol. Infection or history of infection in the affected knee. History of previous contralateral ACL injury (to isolate primary injury outcomes). \-
Where this trial is running
Lahore, Punjab Province
- Lahore General Hospital — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Hafiz Sohail Ahmad, Dr
- Email: Hafiz.sohail.315@gmail.com
- Phone: +923204085069
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.