Actively Recruiting

Phase 2
Age: 18Years - 50Years
All Genders
ID07470359

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

Led by Lahore General Hospital · Updated on 2026-03-13

60

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether a single 4 ml injection of platelet-rich plasma (PRP) inside the knee can improve function after anterior cruciate ligament (ACL) reconstruction using a peroneus longus autograft. This randomized controlled trial involves 88 patients aged 18 to 50 years in Pakistan, a setting where cost-effective treatments are important. The study compares PRP with a saline placebo to see if PRP helps recovery and improves knee function scores over time. Participants receive arthroscopic ACL reconstruction with a peroneus longus autograft. During surgery, half of the patients are randomly assigned to get a 4 ml PRP injection (2 ml in each femoral and tibial tunnel), while the other half receive a saline injection as a placebo. PRP is prepared from the patient's own blood using a single-spin centrifugation. The study measures knee function using KOOS4 scores at 3, 6, and 12 months after surgery. Patients will be assessed at baseline before surgery and then followed up at 3, 6, and 12 months with questionnaires to measure knee function and recovery. The study uses statistical methods to compare the groups while adjusting for baseline differences. Results could help guide affordable treatment options in similar resource-limited settings. The total participation lasts about one year, and the study monitors patient adherence to the rehabilitation and follow-up visits to ensure data quality.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo arthroscopic ACL reconstruction with peroneus longus autograft and receive either a single intra-articular platelet-rich plasma (PRP) injection or saline during surgery.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 12 months

Participants are assessed for functional outcomes and recovery using validated KOOS4 questionnaires integrated into clinic visits.

Visits at baseline, 3 months, 6 months, and 12 months (in-person)

Trial Site Locations

Total: 1 location

1

Lahore General Hospital

Lahore, Punjab Province, Pakistan, 54000

Actively Recruiting

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Research Team

H

Hafiz Sohail Ahmad, Dr

A

Abdul Subhan Zahid, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

The Efficacy of Platelet-Rich Plasma for Ligament Injuries: A Systematic Review of Basic Science Literature With Protocol Quality Assessment.

Kyle N Kunze, Jeevana J Pakanati, Amar S Vadhera...

https://pubmed.ncbi.nlm.nih.gov/35155701

Clinical Use of Platelet-Rich Plasma to Promote Tendon-Bone Healing and Graft Maturation in Anterior Cruciate Ligament Reconstruction-A Randomized Controlled Study.

Heng Gong, Bin Huang, Zhuozhao Zheng...

https://pubmed.ncbi.nlm.nih.gov/35103026