Comparative Study of Functional Outcomes Between Peroneus Longus and Hamstring Tendon Autografts in Arthroscopic ACL Reconstruction
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2026
CompletedFirst Submitted
Initial submission to the registry
January 8, 2026
CompletedFirst Posted
Study publicly available on registry
January 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 15, 2026
January 16, 2026
January 1, 2026
7 months
January 8, 2026
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
6 weeks, 3 months after surgery
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).
6 weeks, 3 months after surgery
Study Arms (2)
Hamstring Tendon (HST) Autograft Group
EXPERIMENTALParticipants 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.
Peroneus Longus Tendon (PLT) Autograft Group
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Khyber Teaching Hospital
Peshawar, KPK, 25100, Pakistan
Related Publications (5)
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: 10424213BACKGROUNDAdachi 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: 12920536BACKGROUNDRhatomy 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: 30877316BACKGROUNDHe 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: 32984919BACKGROUNDAsif 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: 39524299BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Syed Dil Bagh Ali Shah, MBBS
Khyber Teaching Hospital
- PRINCIPAL INVESTIGATOR
Dr Rao Erbaz Hassan, MBBS
Khyber Teaching Hospital
- PRINCIPAL INVESTIGATOR
Dr Imtiaz, MBBS
Khyber Teaching Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2026
First Posted
January 16, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
July 28, 2026
Study Completion (Estimated)
September 15, 2026
Last Updated
January 16, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will become available beginning 6 months after the publication of the primary results manuscript. Data will be available for a minimum of 5 years.
- Access Criteria
- Data access requests will be reviewed by the trial's principal investigator and steering committee. Requestors will be required to submit a methodologically sound research proposal. Access will be granted following the execution of a data use/sharing agreement that commits the requestor to: 1) using the data only for the approved research, 2) securing the data appropriately, 3) destroying the data after analyses are complete, 4) not attempting to re-identify participants, and 5) acknowledging the data source in any publications. Proposals must also obtain approval from an authorized Institutional Review Board (IRB) or Ethics Committee.
De-identified individual participant data (IPD) that underlie the results reported in the primary publication will be made available to researchers upon reasonable request, following the completion of the trial and primary analysis. This includes demographic data, baseline clinical characteristics, surgical details, and outcome measures (Lysholm Knee Scores at all time points).