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OpenTrials
Completed

NCT Number: NCT06655350

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No.

Treatment and study plan

MRI

Other

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.

Measure

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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