Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
Study NCT ID:
NCT06655350
Status:
COMPLETED
Last Update Posted:
2024-10-23
First Post:
2024-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Is Harvesting the Peroneus Brevis an Alternative in Anatomic Ankle Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peroneus brevis diameter of a native ankle and at one-year postoperative harvested ankle.', 'timeFrame': 'Year : 1', 'description': 'Cross section area (mm²) at 40, 30, 20mm above the tip of the fibula, and 20mm from 5th metatarsal basis.'}], 'secondaryOutcomes': [{'measure': 'Peroneus brevis MRI aspect of a native ankle and at one-year postoperative harvested ankle.', 'timeFrame': 'Year : 1', 'description': '% T1 signal on the tendon at 40, 30, 20mm above the tip of the fibula, and 20mm from 5th metatarsal basis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankle instability', 'Graft', 'Peroneus brevis', 'Ankle ligament reconstruction'], 'conditions': ['Ankle Disease', 'Ankle (Ligaments); Instability (Old Injury)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at Saint-Etienne University Hospital who underwent Haemi-Castaing-type ankle stabilisation surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult one year after peroneus brevis harvesting (Hemi-Castaing)\n\nExclusion Criteria:\n\n* No.'}, 'identificationModule': {'nctId': 'NCT06655350', 'briefTitle': 'Is Harvesting the Peroneus Brevis an Alternative in Anatomic Ankle Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Is Harvesting the Peroneus Brevis an Alternative in Anatomic Ankle Ligament Reconstruction', 'orgStudyIdInfo': {'id': 'IRBN752024/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Harvested ankle', 'interventionNames': ['Other: MRI', 'Other: Measure']}, {'label': 'Native ankle', 'interventionNames': ['Other: MRI', 'Other: Measure']}], 'interventions': [{'name': 'MRI', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Harvested ankle', 'Native ankle']}, {'name': 'Measure', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Harvested ankle', 'Native ankle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}], 'overallOfficials': [{'name': 'Pierre-Henri Vermorel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}