Anterior Cruciate Ligament InjuriesNCT07346326
Comparative Study of Functional Outcomes Between Peroneus Longus and Hamstring Tendon Autografts in Arthroscopic ACL Reconstruction
A study testing Hamstring Tendon Autograft Harvest and ACL Reconstruction and Peroneus Longus Tendon Autograft Harvest and ACL Reconstruction in people with Anterior Cruciate Ligament Injuries, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Hamstring Tendon Autograft Harvest and ACL Reconstruction and Peroneus Longus Tendon Autograft Harvest and ACL Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Functional Outcomes Between Peroneus Longus and Hamstring Tendon Autografts in Arthroscopic ACL Reconstruction: A Randomized Controlled 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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Hamstring Tendon Autograft Harvest and ACL Reconstruction, Peroneus Longus Tendon Autograft Harvest and ACL Reconstruction
- Keywords
- ACL reconstruction, Hamstring tendon autograft, Functional outcomes, Arthroscopy
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamstring Tendon Autograft Harvest and ACL ReconstructionProcedure or surgery
Also called HST autograft; Quadrupled semitendinosus-gracilis autograft
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 Autograft Harvest and ACL ReconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Hamstring Tendon (HST) Autograft Group | Experimental | 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. Receives: Procedure: Hamstring Tendon Autograft Harvest and ACL Reconstruction |
| Peroneus Longus Tendon (PLT) Autograft Group | Active comparator | 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. Receives: Procedure: Peroneus Longus Tendon Autograft Harvest and ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 6 weeks, 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Jan 2026
- Primary completion28 Jul 2026
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to one of two parallel groups receiving a different type of tendon autograft.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- Khyber Medical College, Peshawar
- Responsible party
- Sponsor
- Investigators
- Dr Syed Dil Bagh Ali Shah, MBBS, Principal investigator, Khyber Teaching HospitalDr Rao Erbaz Hassan, MBBS, Principal investigator, Khyber Teaching HospitalDr Imtiaz, MBBS, Principal investigator, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346326
- Sponsor's protocol ID
- KMU/DIR/CTU/2025/12
- Status last verified
- Aug 2026
- First submitted
- 8 Jan 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
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.
PubMed 10424213Adachi 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.
PubMed 12920536Rhatomy 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.
PubMed 30877316He 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.
PubMed 32984919Asif 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.
PubMed 39524299
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Functional Outcomes Between Peroneus Longus and Hamstring Tendon Autografts in Arthroscopic ACL Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07346326
- Acronym / sponsor ID
- KMU/DIR/CTU/2025/12
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- ACL reconstruction, Hamstring tendon autograft, Functional outcomes, Arthroscopy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Collaborators
- Khyber Medical College, Peshawar
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two parallel groups receiving a different type of tendon autograft.
| Arm | Type | Receives |
|---|---|---|
| Hamstring Tendon (HST) Autograft Group | Experimental | Procedure: Hamstring Tendon Autograft Harvest and ACL ReconstructionParticipants 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 comparator | Procedure: Peroneus Longus Tendon Autograft Harvest and ACL ReconstructionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hamstring Tendon Autograft Harvest and ACL ReconstructionAlso: HST autograft; Quadrupled semitendinosus-gracilis autograftArthroscopic 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 or surgery | Hamstring Tendon (HST) Autograft Group |
| Peroneus Longus Tendon Autograft Harvest and ACL ReconstructionArthroscopic 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. | Procedure or surgery | Peroneus Longus Tendon (PLT) Autograft Group |
Primary outcome
Knee instability
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 10424213Corry 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.
- Background: PubMed 12920536Adachi 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.
- Background: PubMed 30877316Rhatomy 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.
- Background: PubMed 32984919He 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.
- Background: PubMed 39524299Asif 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.
- Individual participant dataSharing planned: Yes. 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).
Related trials for Anterior Cruciate Ligament Injuries
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
RecruitingObservational study
Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
Anterior Cruciate Ligament Injury, Tunneling Technique
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Syed Dil Bagh Ali Shah, MBBS principal investigator
Khyber Teaching Hospital
Dr Rao Erbaz Hassan, MBBS principal investigator
Khyber Teaching Hospital
Dr Imtiaz, MBBS principal investigator
Khyber Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hamstring Tendon Autograft Harvest and ACL Reconstruction and Peroneus Longus Tendon Autograft Harvest and ACL Reconstruction in people with Anterior Cruciate Ligament Injuries, run by Khyber Medical University Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee instability (time frame: 6 weeks, 3 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07346326, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.