Ligament InjuryNCT05991557
Peroneus Longus Graft :Effect in Foot and Ankle Function
A study testing peroneus longus autograft in people with Ligament Injury, run by Assiut University at 1 site in Egypt.
Trial summary
The purpose of this study is to report the ankle and foot functions via American orthopedic foot and ankle society score (AOFAS), peronei muscle testing ,handheld dynamometer and radiological outcomes after harvesting autogenous peroneus longus tendons for ligaments reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ligament Injury
- What is being tested?
- peroneus longus autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical and radiological diaginsis of joint ligament injury and needs to ligament reconstruction .
- people with asymptomatic ankle and foot pre and post injury
Who cannot join
- Associated ankle and/or foot fractures.
- Associated hip or pelvic fractures
- Abnormal ankle function pre-injury.
- Contralateral limb fractures
- Traumatic brain injury (TBI) that limits their ability to participate in their post-operative care;
- Presence of neurological condition that result in spasticity or any abnormal lower limb muscles tone.
- Any condition that would preclude the ability to comply with post-operative guidelines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peroneus Longus Autograft Use in Knee, Shoulder, Elbow Ligaments Reconstruction Surgery : Effect On Ankle And Foot Function
The purpose of this study is to report the ankle and foot functions via American orthopedic foot and ankle society score (AOFAS), peronei muscle testing ,handheld dynamometer and radiological outcomes after harvesting autogenous peroneus longus tendons for ligaments reconstruction.
Read the detailed description
Using a Peroneus longus tendon (PLT) as an autograft is a common procedure and has been used previously for deltoid ligament reconstruction in flatfoot deformity correction . Recently, (PLT) is gaining popularity as a graft option in primary anterior cruciate ligament (ACL) reconstruction surgeries with biomechanical studies showing tensile strength and clinical outcomes comparable to quadrupled hamstring grafts.
In addition to using PLT for isolated (ACL), it is also used in posterior cruciate ligament (PCL) reconstruction, medial collateral ligament reconstruction, posterolateral corner reconstruction of the knee, or knee multiple ligament injuries . The partial-thickness of the tendon has been used variably in knee ligament surgery..
Being a powerful muscle in plantar flexion and eversion of the foot, there might be associated ankle functional impairment. To the authors knowledge, there is a gap in science evaluating donor site morbidity. The aim of this study is to report the clinical and functional outcome of the donor site for better explanation of the cons and pros of using PLT as a graft in joint ligamentous injury .
- Conditions
- Ligament Injury
- Being tested
- peroneus longus autograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peroneus longus autograftProcedure or surgery
Peroneus longus tendon graft will be harvested with a longitudinal skin incision at 2 to 3 cm (2 finger-breadths) above and 1 cm (1 finger-breadth) behind the lateral malleolus, followed by superficial fascia incision in line with skin incision followed by incision of the tendon sheath proximal to the retinaculum. The peroneus longus and peroneus brevis tendons will be then identified. The tendon division location marked at 2 to 3 cm above the level of the lateral malleolus.The peroneus longus tendon will be exposed on its posterolateral surface through the incision after carefully incising the fascia
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | peroneus longus autograft Receives: Procedure: peroneus longus autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
peronei muscle strength testing using handheld dynamometer
power of plantar flexion and eversion of foot and ankle
Measured: preoperative, three months postoperative and six months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Sabra Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991557
- Sponsor's protocol ID
- peroneus longus graft
- Status last verified
- Jun 2025
- First submitted
- 6 Aug 2023
- Last updated
- 20 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroneus Longus Autograft Use in Knee, Shoulder, Elbow Ligaments Reconstruction Surgery : Effect On Ankle And Foot Function
- ClinicalTrials.gov ID
- NCT05991557
- Acronym / sponsor ID
- peroneus longus graft
- Conditions
- Ligament Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 14 Aug 2023 (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.
The purpose of this study is to report the ankle and foot functions via American orthopedic foot and ankle society score (AOFAS), peronei muscle testing ,handheld dynamometer and radiological outcomes after harvesting autogenous peroneus longus tendons for ligaments reconstruction.
Detailed description
Using a Peroneus longus tendon (PLT) as an autograft is a common procedure and has been used previously for deltoid ligament reconstruction in flatfoot deformity correction . Recently, (PLT) is gaining popularity as a graft option in primary anterior cruciate ligament (ACL) reconstruction surgeries with biomechanical studies showing tensile strength and clinical outcomes comparable to quadrupled hamstring grafts.
In addition to using PLT for isolated (ACL), it is also used in posterior cruciate ligament (PCL) reconstruction, medial collateral ligament reconstruction, posterolateral corner reconstruction of the knee, or knee multiple ligament injuries . The partial-thickness of the tendon has been used variably in knee ligament surgery..
Being a powerful muscle in plantar flexion and eversion of the foot, there might be associated ankle functional impairment. To the authors knowledge, there is a gap in science evaluating donor site morbidity. The aim of this study is to report the clinical and functional outcome of the donor site for better explanation of the cons and pros of using PLT as a graft in joint ligamentous injury .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Procedure: peroneus longus autograftperoneus longus autograft |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- clinical and radiological diaginsis of joint ligament injury and needs to ligament reconstruction .
- people with asymptomatic ankle and foot pre and post injury
Key exclusion criteria (7 listed)
- Associated ankle and/or foot fractures.
- Associated hip or pelvic fractures
- Abnormal ankle function pre-injury.
- Contralateral limb fractures
- Traumatic brain injury (TBI) that limits their ability to participate in their post-operative care;
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 |
|---|---|---|
| peroneus longus autograftPeroneus longus tendon graft will be harvested with a longitudinal skin incision at 2 to 3 cm (2 finger-breadths) above and 1 cm (1 finger-breadth) behind the lateral malleolus, followed by superficial fascia incision in line with skin incision followed by incision of the tendon sheath proximal to the retinaculum. The peroneus longus and peroneus brevis tendons will be then identified. The tendon division location marked at 2 to 3 cm above the level of the lateral malleolus.The peroneus longus tendon will be exposed on its posterolateral surface through the incision after carefully incising the fascia | Procedure or surgery | treatment arm |
Primary outcome
peronei muscle strength testing using handheld dynamometer
Time frame: preoperative, three months postoperative and six months postoperative
power of plantar flexion and eversion of foot and ankle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2025.
- 2- Rudy ME, Phatama KY (2017) Tensile strength comparison between peroneus longus and hamstring tendons: a biomechanical study. Int J Surg Open 9:41-44Link provided by the sponsor.
- Shi F-D, Hess DE, Zuo J-Z et al (2019) Peroneus longus tendon autograft is a safe and effective alternative for anterior cruciate ligament reconstruction. J Knee Surg 32:804-811Link provided by the sponsor.
- -Setyawan R, Soekarno NR, Asikin AIZ, Rhatomy S (2019) Posterior cruciate ligament reconstruction with peroneus longus tendon graft: 2-years follow-up. Ann Med Surg 43:38-43Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peroneus longus autograft in people with Ligament Injury, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 20 Jun 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
peronei muscle strength testing using handheld dynamometer (time frame: preoperative, three months postoperative and six months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2025.