Is Harvesting the Peroneus Brevis an Alternative in Anatomic Ankle Ligament Reconstruction

October 22, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
Severe ankle sprains are the most frequent reason for emergency trauma consultations. Between 30% and 80% of sprains result in sequelae such as pain, joint derangement or instability. Ankle instability can itself lead to osteoarthritis if left untreated (1st cause of post-traumatic ankle osteoarthritis). To treat instability, ligament reconstruction is performed by harvesting the tendon of the gracilis muscle (inserted at knee level) to replace the damaged ankle ligaments. This tendon is also used for other ligament reconstructions (anterior cruciate ligament), so is not always harvested. Moreover, it represents an invasive procedure at a distance from the site of interest (the ankle), and can cause sensory nerve damage (20-60% of cases). For a long time, half of the peroneus brevis tendon was harvested as part of a now-defunct ankle stabilization technique (Hemi-Castaing). This tendon does, however, play a role in stabilizing the ankle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before considering harvesting the peroneus brevis as an alternative to harvesting the gracilis, it is important to ensure that the peroneus brevis remains functional after harvesting. The aim of this study was to evaluate the potential for tendon regrowth after harvesting half of the peroneus brevis tendon after Hemi-Castaing-type ankle stabilization surgery.

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Priest-en-Jarez, France, 42270
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients at Saint-Etienne University Hospital who underwent Haemi-Castaing-type ankle stabilisation surgery.

Description

Inclusion Criteria:

  • Adult one year after peroneus brevis harvesting (Hemi-Castaing)

Exclusion Criteria:

  • No.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Harvested ankle
Other: MRI
Morphological data on the tendon (appearance) will be collected on the harvested side and on the healthy side from an MRI analysis carried out systematically after Haemi-Castaing-type surgery.
Other: Measure
Morphological data on the tendon (diameter) will be collected on the harvested side and on the healthy side from an MRI analysis carried out systematically after Haemi-Castaing-type surgery.
Native ankle
Other: MRI
Morphological data on the tendon (appearance) will be collected on the harvested side and on the healthy side from an MRI analysis carried out systematically after Haemi-Castaing-type surgery.
Other: Measure
Morphological data on the tendon (diameter) will be collected on the harvested side and on the healthy side from an MRI analysis carried out systematically after Haemi-Castaing-type surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peroneus brevis diameter of a native ankle and at one-year postoperative harvested ankle.
Time Frame: Year : 1
Cross section area (mm²) at 40, 30, 20mm above the tip of the fibula, and 20mm from 5th metatarsal basis.
Year : 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peroneus brevis MRI aspect of a native ankle and at one-year postoperative harvested ankle.
Time Frame: Year : 1
% T1 signal on the tendon at 40, 30, 20mm above the tip of the fibula, and 20mm from 5th metatarsal basis.
Year : 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Pierre-Henri VERMOREL, MD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2024

Primary Completion (Actual)

October 11, 2024

Study Completion (Actual)

October 11, 2024

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRBN752024/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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