Ankle DiseaseNCT06655350
Is Harvesting the Peroneus Brevis an Alternative in Anatomic Ankle Ligament Reconstruction
An observational study of Ankle Disease and Ankle (Ligaments); Instability (Old Injury), run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Disease, Ankle (Ligaments); Instability (Old Injury)
- What is being tested?
- MRI and Measure
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2024to 11 Oct 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Saint-Etienne University Hospital who underwent Haemi-Castaing-type ankle stabilisation surgery.
Who may be able to join
- Adult one year after peroneus brevis harvesting (Hemi-Castaing)
Who cannot join
- No.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- MRI, Measure
- Keywords
- Ankle instability, Graft, Peroneus brevis, Ankle ligament reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
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.
MeasureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Harvested ankle | Not described Receives: Other: MRI; Other: Measure | |
| Native ankle | Not described Receives: Other: MRI; Other: Measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peroneus brevis diameter of a native ankle and at one-year postoperative harvested ankle.
Cross section area (mm²) at 40, 30, 20mm above the tip of the fibula, and 20mm from 5th metatarsal basis.
Measured: Year : 1
Secondary outcomes (1)
Peroneus brevis MRI aspect of a native ankle and at one-year postoperative harvested ankle.
% T1 signal on the tendon at 40, 30, 20mm above the tip of the fibula, and 20mm from 5th metatarsal basis.
Measured: Year : 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start6 Sep 2024
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Henri Vermorel, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655350
- Sponsor's protocol ID
- IRBN752024/CHUSTE
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 23 Oct 2024
- 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Harvesting the Peroneus Brevis an Alternative in Anatomic Ankle Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06655350
- Acronym / sponsor ID
- IRBN752024/CHUSTE
- Keywords
- Ankle instability, Graft, Peroneus brevis, Ankle ligament reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 23 Oct 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Harvested ankle | – | Other: MRI, Other: Measure |
| Native ankle | – | Other: MRI, Other: Measure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Saint-Etienne University Hospital who underwent Haemi-Castaing-type ankle stabilisation surgery.
Key inclusion criteria (1 listed)
- Adult one year after peroneus brevis harvesting (Hemi-Castaing)
Key exclusion criteria (1 listed)
- No.
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 |
|---|---|---|
| MRIMorphological 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 | Harvested ankle, Native ankle |
| MeasureMorphological 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. | Other | Harvested ankle, Native ankle |
Primary outcome
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.
1 secondary outcome
Peroneus brevis MRI aspect of a native ankle and at one-year postoperative harvested ankle.
Time frame: Year : 1
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 23 Oct 2024.
- 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.
Pierre-Henri Vermorel, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Disease and Ankle (Ligaments); Instability (Old Injury), run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 1 inclusion and 1 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 23 Oct 2024. 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 France. 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?
Peroneus brevis diameter of a native ankle and at one-year postoperative harvested ankle. (time frame: Year : 1). 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 23 Oct 2024.