- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05991557
Peroneus Longus Graft :Effect in Foot and Ankle Function
Peroneus Longus Autograft Use in Knee, Shoulder, Elbow Ligaments Reconstruction Surgery : Effect On Ankle And Foot Function
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Assiut, Egypt, 71515
- Assiut University Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- clinical and radiological diaginsis of joint ligament injury and needs to ligament reconstruction .
- people with asymptomatic ankle and foot pre and post injury
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: treatment arm
peroneus longus autograft
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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peronei muscle strength testing using handheld dynamometer
Time Frame: preoperative, three months postoperative and six months postoperative
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power of plantar flexion and eversion of foot and ankle
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preoperative, three months postoperative and six months postoperative
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
- 2- Rudy ME, Phatama KY (2017) Tensile strength comparison between peroneus longus and hamstring tendons: a biomechanical study. Int J Surg Open 9:41-44
- 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 32:804-811
- -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 43:38-43
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- peroneus longus graft
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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