NCT07470359

Comparison of Functional Outcomes Following Arthroscopic ACL Reconstruction With Peroneus Longus Autograft With and Without Intra-articular Platelet-Rich Plasma 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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Lahore General Hospital · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This prospective RCT investigates if a single 4 ml intra-articular PRP injection improves knee function after ACL reconstruction using peroneus longus autograft. In Pakistan's resource-limited context, 88 patients (18-50 years) with isolated ACL tears receive either PRP or saline during surgery, then randomized equally. KOOS4 scores compared at 3, 6, and 12 months via ANCOVA (adjusted baseline, α=0.05). Positive results could establish affordable enhancement for recovery and guide practice in similar settings.

Detailed description

Anterior cruciate ligament (ACL) injuries impair knee function, particularly in young athletes, with many failing to regain pre-injury performance post-reconstruction (ACLR). Peroneus longus autografts offer comparable strength to traditional grafts with reduced donor site morbidity, but early recovery remains challenging. Platelet-rich plasma (PRP) may enhance graft healing, yet its efficacy with peroneus longus autografts is understudied, especially in resource-limited settings like Pakistan, where costly PRP methods are impractical. This prospective randomized controlled trial (RCT) evaluates whether a single intra-articular PRP injection (4 ml, 2 ml per femoral/tibial tunnel) improves functional outcomes in ACLR with peroneus longus autograft. The hypothesis is that PRP will lead to superior knee functions. The study aims to compare KOOS4 scores at 3, 6, and 12 months between PRP and control groups. Eighty-eight patients (44 per group) aged 18-50 with isolated ACL tears will be randomized (1:1) to receive 4 ml PRP (from 15-20 ml blood, single-spin centrifugation at 3500 rpm) or saline during surgery at Lahore General Hospital. Assessments at baseline, 3, 6, and 12 months will use validated KOOS4 questionnaires, integrated into clinic visits to ensure low dropout (10%). Data will be analyzed using analysis of covariance (ANCOVA) for KOOS4 scores (α = 0.05) in SPSS, adjusting for baseline differences. Improved KOOS4 scores with PRP could validate a cost-effective approach, enhance recovery and inform clinical guidelines in resource-constrained settings, ultimately improving patient outcomes.

Conditions

• ACL Reconstruction
• Intraarticular Injection
• PRP

Interventions

Type	Name	Description
BIOLOGICAL	PRP injection	Platelets rich plasma from patients own blood

Timeline

• Start date: 2026-02-20
• Primary completion: 2027-08-31
• Completion: 2027-11-30
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: Pakistan