Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-29 @ 12:26 PM
Study NCT ID:
NCT04726566
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2021-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Ankle Instability Return to Sport
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2021-01-22', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of return to main sport at the expected level in both groups', 'timeFrame': '10 months', 'description': 'The main objective is to evaluate the rate of patients who returned to sport at the level before the injury, according to their evaluation, 10 months after arthroscopic stabilization according to the surgical technique used (repair by suture or reconstruction by tendon graft).'}], 'secondaryOutcomes': [{'measure': 'Factors associated with the lack of resumption of sport at the level before the injury', 'timeFrame': '10 months', 'description': 'Factors associated with the lack of resumption of sport at 10 months at the level before the injury'}, {'measure': 'Time taken to resume sport after arthroscopic stabilization', 'timeFrame': '10 months', 'description': 'Evaluate the time taken to resume sport after arthroscopic stabilization according to the surgical technique used'}, {'measure': 'Functional state of the ankle', 'timeFrame': '10 months', 'description': 'Evaluate the functional state of the ankle and the level of activity of the patients during the follow-up according to the surgical technique used'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Ankle Instability']}, 'descriptionModule': {'briefSummary': 'Real-life, observational, monocentric, prospective, longitudinal study, carried out at the European Center for Sports Rehabilitation (CERS), France.', 'detailedDescription': 'The data will be collected through an electronic Case Report Form completed by the physician, and some auto-questionnaire completed by the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated in rehabilitation at the European Sports Rehabilitation Center after anatomical surgery for chronic lateral ankle instability.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 15 years;\n* Patient treated at the European Sports Rehabilitation Center after a first arthroscopic surgery on the external lateral ligament of the ankle for chronic instability by anatomical reconstruction:\n\n * With tendon graft;\n * By suture with biological reinforcement;\n* Non-opposition of the patient and his/her parents (if minor) to the collection of his/her personal data.\n\nExclusion Criteria:\n\n\\- Minor patient (age \\<18 years) not accompanied by one of his/her parents or legal representative during the inclusion visit;\n\n* History of surgery on the same ankle;\n* Associated complex osteochondral or internal ligament damage, syndesmosis, fracture;\n* Non-anatomical reconstruction;\n* Inability of the patient to understand the study protocol;\n* Vulnerable person whose inclusion is not justified by the purposes of the research: pregnant woman, person undergoing psychiatric care, or adult person subject to legal protection.'}, 'identificationModule': {'nctId': 'NCT04726566', 'acronym': 'CAIRTS', 'briefTitle': 'Chronic Ankle Instability Return to Sport', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Return to Sport and Functional Assessment After Surgery for Chronic Lateral Ankle Instability', 'orgStudyIdInfo': {'id': '2020-A00154-35'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arthroscopic stabilization', 'description': 'Patient will have an anatomical surgery of chronic lateral ankle instability under arthroscopy', 'interventionNames': ['Procedure: Tendon graft', 'Procedure: Suture with biological reinforcement']}], 'interventions': [{'name': 'Tendon graft', 'type': 'PROCEDURE', 'description': 'Anatomical surgery for chronic lateral ankle instability under arthroscopy with tendon graft', 'armGroupLabels': ['Arthroscopic stabilization']}, {'name': 'Suture with biological reinforcement', 'type': 'PROCEDURE', 'description': 'Anatomical surgery for chronic lateral ankle instability under arthroscopy by suture with biological reinforcement', 'armGroupLabels': ['Arthroscopic stabilization']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Capbreton', 'country': 'France', 'facility': 'European sports rehabilitation center', 'geoPoint': {'lat': 43.64238, 'lon': -1.43123}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'collaborators': [{'name': 'Euraxi Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}