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

NCT ID: NCT07346326

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-09-15

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized to one of two parallel groups receiving a different type of tendon autograft.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Hamstring Tendon (HST) Autograft Group

Participants will undergo arthroscopic anterior cruciate ligament (ACL) reconstruction using an autograft harvested from their own ipsilateral hamstring tendons (semitendinosus and gracilis). The tendons will be harvested, prepared as a quadrupled graft, and fixed using an Endobutton on the femoral side and an adjustable button system (ABS) on the tibial side via a standard single-bundle technique.

Group Type EXPERIMENTAL

Hamstring Tendon Autograft Harvest and ACL Reconstruction

Intervention Type PROCEDURE

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.

Peroneus Longus Tendon (PLT) Autograft Group

Participants will undergo arthroscopic anterior cruciate ligament (ACL) reconstruction using an autograft harvested from their own ipsilateral peroneus longus tendon (PLT). The tendon will be harvested through a 2-3 cm incision proximal to the lateral malleolus, with a tenodesis of the peroneus brevis performed at the donor site. The graft will be prepared and fixed using an Endobutton on the femoral side and an adjustable button system (ABS) on the tibial side via a standard single-bundle technique.

Group Type ACTIVE_COMPARATOR

Peroneus Longus Tendon Autograft Harvest and ACL Reconstruction

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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 the tibial side.

Intervention Type PROCEDURE

Other Intervention Names

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HST autograft; Quadrupled semitendinosus-gracilis autograft

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khyber Medical College, Peshawar

OTHER

Sponsor Role collaborator

Khyber Medical University Peshawar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Syed Dil Bagh Ali Shah, MBBS

Role: PRINCIPAL_INVESTIGATOR

Khyber Teaching Hospital

Dr Rao Erbaz Hassan, MBBS

Role: PRINCIPAL_INVESTIGATOR

Khyber Teaching Hospital

Dr Imtiaz, MBBS

Role: PRINCIPAL_INVESTIGATOR

Khyber Teaching Hospital

Locations

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Khyber Teaching Hospital

Peshawar, KPK, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Dr Syed Dil Bagh Ali Shah, MBBS

Role: CONTACT

+92-91-9217701

Dr Syed Muhammad Shabbir Ali Naqvi, MSPT

Role: CONTACT

+923460113227

Facility Contacts

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Dr Syed Dil Bagh Shah, MBBS

Role: primary

+92-91-9217701

Dr Syed Muhammad Shabbir Ali Naqvi

Role: backup

+923460113227

References

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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.

Reference Type BACKGROUND
PMID: 10424213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12920536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30877316 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32984919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39524299 (View on PubMed)

Other Identifiers

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KMU/DIR/CTU/2025/12

Identifier Type: -

Identifier Source: org_study_id

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