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NCT Number: NCT07470359

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lahore General Hospital

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Lahore General Hospital

CONTACT

[email protected]

+9242992688019

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

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Treatment and study plan

PRP injection

Biological

Platelets rich plasma from patients own blood

Primary outcomes

  1. KOOS4 score

    Time frame: 12 months

    To compare knee-related functional outcomes, as measured by the KOOS4 score, between patients undergoing arthroscopic ACL reconstruction with peroneus longus autograft and intra-articular PRP injection versus those undergoing ACL reconstruction with peroneus longus autograft alone at 3-, 6-, and 12-months post-surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdul Subhan Zahid, Dr

CONTACT

[email protected]

+923104052587

Hafiz Sohail Ahmad, Dr

CONTACT

[email protected]

+923204085069

Sponsors and collaborators

Lead sponsor

Lahore General Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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