About this trial
This is a prospective, single-blinded, randomized controlled trial. Sixty patients (≥18 years) with an isolated ACL injury will be randomly assigned to receive an ACL reconstruction using either a Peroneus Longus Tendon (PLT) autograft or a Hamstring Tendon (HST) autograft. The primary objective is to compare early functional outcomes between the two groups at 6 weeks and 3 months post-surgery, using the Lysholm Knee Score. The study aims to demonstrate the non-inferiority of the PLT graft. All surgeries will be performed arthroscopically at Khyber Teaching Hospital, Peshawar, followed by a standardized rehabilitation protocol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older.
Isolated, primary Anterior Cruciate Ligament (ACL) injury confirmed by clinical assessment and Magnetic Resonance Imaging (MRI).
Provides written informed consent for the surgical procedure and study participation, including follow-up assessments.
Disqualifiers
Multiligament knee injuries (e.g., concomitant PCL, MCL, or LCL injuries).
Previous surgery or history of fracture in the involved lower limb.
Radiographic evidence of osteoarthritis in the affected knee.
Presence of any neuromuscular disease.
Trial design
Parallel
Treatments tested in this trial
Hamstring Tendon Autograft Harvest and ACL Reconstruction
Procedure/SurgeryArthroscopic anterior cruciate ligament (ACL) reconstruction performed under spinal anesthesia, utilizing an autograft harvested from the patient's own ipsilateral semitendinosus and gracilis (hamstring) tendons. The harvested tendons are prepared as a quadrupled graft. Reconstruction follows a standard single-bundle technique with graft fixation using an Endobutton on the femoral side and an adjustable button system on the tibial side.
Peroneus Longus Tendon Autograft Harvest and ACL Reconstruction
Procedure/SurgeryArthroscopic anterior cruciate ligament (ACL) reconstruction performed under spinal anesthesia, utilizing an autograft harvested from the patient's own ipsilateral peroneus longus tendon (PLT). The tendon is harvested through a 2-3 cm incision proximal to the lateral malleolus, with a tenodesis of the peroneus brevis performed at the donor site. Reconstruction follows a standard single-bundle technique with graft fixation using an Endobutton on the femoral side and an adjustable button system on the tibial side.
Treatment groups
Trial outcomes
Primary outcomes
Knee instability
A Lysholm Knee Score validated patient-reported outcome measure assessing knee function, symptoms, and instability. Scores range from 0 to 100, with higher scores indicating better function. Outcomes are categorized as Excellent (\>90), Good (65-89), or Poor (\<64).
Knee function
A Lysholm Knee Score validated patient-reported outcome measure assessing knee function, symptoms, and instability. Scores range from 0 to 100, with higher scores indicating better function. Outcomes are categorized as Excellent (\>90), Good (65-89), or Poor (\<64).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Khyber Medical University Peshawar
Lead sponsor
Khyber Medical College, Peshawar
Collaborator