Comparative Study of Functional Outcomes Between Peroneus Longus and Hamstring Tendon Autografts in Arthroscopic ACL Reconstruction

Official title

Comparative Study of Functional Outcomes Between Peroneus Longus and Hamstring Tendon Autografts in Arthroscopic ACL Reconstruction: A Randomized Controlled Trial

Overview

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

• Procedure Hamstring 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.
• Procedure Peroneus 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

Primary outcome measures

• Knee instability [Time frame: 6 weeks, 3 months after surgery]
• Knee function [Time frame: 6 weeks, 3 months after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Khyber Teaching Hospital — Peshawar

Publications

• Corry IS, Webb JM, Clingeleffer AJ, Pinczewski LA. Arthroscopic reconstruction of the anterior cruciate ligament. A comparison of patellar tendon autograft and four-strand hamstring tendon autograft. Am J Sports Med. 1999 Jul-Aug;27(4):444-54. doi: 10.1177/03635465990270040701. PMID 10424213
• Adachi N, Ochi M, Uchio Y, Sakai Y, Kuriwaka M, Fujihara A. Harvesting hamstring tendons for ACL reconstruction influences postoperative hamstring muscle performance. Arch Orthop Trauma Surg. 2003 Nov;123(9):460-5. doi: 10.1007/s00402-003-0572-2. Epub 2003 Aug 14. PMID 12920536
• Rhatomy S, Asikin AIZ, Wardani AE, Rukmoyo T, Lumban-Gaol I, Budhiparama NC. Peroneus longus autograft can be recommended as a superior graft to hamstring tendon in single-bundle ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2019 Nov;27(11):3552-3559. doi: 10.1007/s00167-019-05455-w. Epub 2019 Mar 15. PMID 30877316
• He J, Tang Q, Ernst S, Linde MA, Smolinski P, Wu S, Fu F. Peroneus longus tendon autograft has functional outcomes comparable to hamstring tendon autograft for anterior cruciate ligament reconstruction: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2021 Sep;29(9):2869-2879. doi: 10.1007/s00167-020-06279-9. Epub 2020 Sep 27. PMID 32984919
• Asif N, Khan MJ, Singhal U, Anwer A, Firoz MA, Rashid M. Randomized Controlled Study Comparing Hamstring Graft and Peroneus Longus Tendon Graft in Arthroscopic ACL Reconstruction. J Orthop Case Rep. 2024 Nov;14(11):240-245. doi: 10.13107/jocr.2024.v14.i11.4980. PMID 39524299

Identifiers

NCT: NCT07346326 · KMU/DIR/CTU/2025/12

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗