Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-14 @ 9:00 AM
Study NCT ID:
NCT03308760
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2017-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-09', 'studyFirstSubmitDate': '2017-10-04', 'studyFirstSubmitQcDate': '2017-10-09', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '6 months', 'description': 'measured on the healthy and injured side using an isokinetic dynamometer'}, {'measure': 'Postural parameters measured using a stabilometry platform', 'timeFrame': '6 months', 'description': 'measured using a stabilometry platform'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Unilateral Rupture of the Achilles Tendon']}, 'descriptionModule': {'briefSummary': 'Acute rupture of the Achilles tendon is a very frequent sports injury. Surgical repair is the usual treatment in young subjects, and although the optimal technique is still a matter of debate, conventional surgery with a direct approach is still the reference technique in young sportsmen and women. Studies investigating the evolution of ankle muscle strength following surgery for a ruptured Achilles tendon are rare, even though it is a crucial criterion to determine the possibility of returning to the sport. This project thus proposes to study, in comparison with the healthy ankle:(1) the evolution of muscle strength in the flexors/extensors and invertors/evertors of the injured ankle, evaluated using an isokinetic dynamometer, and (2) the evolution of stabilometry parameters, at 6 months, then at 12 months, following surgery for acute unilateral rupture of the Achilles tendon, operated on using the conventional technique in young sportsmen and women and in comparison with the healthy side.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients followed at the Convalescence and Rehabilitation Unit of Dijon CHU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* persons informed about the research\n* sportsmen and women (competition or leisure, practiced \\> 3h/week)\n* Between 18 and 45 years old\n* First episode of acute traumatic unilateral rupture of the Achilles tendon\n* Open surgery in the Orthopaedic and Traumatology Department of Dijon University Hospital\n* Identical post-operative immobilisation programme for 6 weeks\n* Absence of major post-operative complications delaying the rehabilitation\n\nExclusion Criteria:\n\n* persons without national health insurance cover\n* concomitant joint disease that could be aggravated by the tests\n* heart disease/contra-indication to effort required during the isokinetic test\n* management other than open surgery (orthopaedic, functional, percutaneous surgery, …)\n* Rupture of the contralateral tendon\n* Contra-indication for the use of the Biodex S4 pro'}, 'identificationModule': {'nctId': 'NCT03308760', 'acronym': 'ACHILLE', 'briefTitle': 'Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Analytical and Functional Evaluation of Recovery Following Acute Rupture of the Achilles Tendon and Surgical Repair in Young Patients', 'orgStudyIdInfo': {'id': 'GREMEAUX 2013'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Interview concerning the post-operative rehabilitation programme and a functional analysis using the American Orthopaedic Foot and Ankle Society questionnaire'}, {'name': 'Static stabilometry', 'type': 'OTHER', 'description': 'on a force plate, in a double- then single-foot stance, with the eyes open and then closed'}, {'name': 'Isokinetic test', 'type': 'OTHER', 'description': 'Isokinetic test of the flexors/extensors and invertors/evertors of the ankle'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}