Anterior Cruciate Ligament Injuries
Conditions
Keywords
ACL reconstruction, Hamstring tendon autograft, Functional outcomes, Arthroscopy
Brief summary
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.
Detailed description
This study compares two autograft sources for anterior cruciate ligament (ACL) reconstruction. While the hamstring tendon (HST) is a widely used standard, it is associated with donor-site complications such as anterior knee pain and weakness. The peroneus longus tendon (PLT) has emerged as a potential alternative, offering similar biomechanical strength with the possibility of reduced donor-site morbidity. However, robust comparative data, particularly focusing on early functional recovery, remain limited, creating a need for high-quality evidence to guide surgical decision-making. To this end, the trial is designed as a single-center, prospective, randomized controlled study. Sixty patients will be randomly assigned to receive ACL reconstruction using either a PLT or HST autograft, with functional outcomes assessed via the Lysholm Knee Score at six weeks and three months postoperatively. The methodology includes rigorous allocation concealment, blinding of the outcome assessor, and an intention-to-treat statistical analysis to robustly test the non-inferiority of the PLT graft. The trial has received ethical approval, and all participants will provide informed consent. The findings aim to contribute meaningful evidence to clinical practice and will be disseminated through peer-reviewed publications and scientific conferences, with the goal of informing safer and more effective surgical choices for patients with ACL injuries.
Interventions
PROCEDUREHamstring Tendon Autograft Harvest and ACL Reconstruction
Arthroscopic 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.
PROCEDUREPeroneus Longus Tendon Autograft Harvest and ACL Reconstruction
Arthroscopic 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.
Sponsors
Khyber Medical University Peshawar
Khyber Medical College, Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the surgical intervention, the participating surgeons and patients cannot be blinded to the group assignment. However, the independent assessor responsible for collecting the primary outcome (Lysholm Knee Score) will be blinded to which graft type the participant received.
Intervention model description
Participants are randomized to one of two parallel groups receiving a different type of tendon autograft.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee instability | 6 weeks, 3 months after surgery | 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 | 6 weeks, 3 months after surgery | 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). |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORDr Syed Dil Bagh Ali Shah, MBBS
Khyber Teaching Hospital
PRINCIPAL_INVESTIGATORDr Rao Erbaz Hassan, MBBS
Khyber Teaching Hospital
PRINCIPAL_INVESTIGATORDr Imtiaz, MBBS
Khyber Teaching Hospital
Outcome results
None listed