Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT04741269
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2021-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Asymmetric Lack of Knee Flexion as a Symptom of DLM in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Meniscal posterior shift per-operative', 'timeFrame': 'During surgery for MCA-type DLM', 'description': 'Visualization of a dislocated posterior meniscus during arthroscopy, before any reduction or meniscoplasty procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['discoid lateral meniscus', 'children', 'instability', 'arthroscopy', 'repair', 'lack of flexion', 'flexion block knee'], 'conditions': ['Highlights a New Clinical Sign Which Point Out a Meniscus Posterior Luxation Because of a MCA-type DLM']}, 'descriptionModule': {'briefSummary': 'Highlighted during the clinical examination of a knee flexion asymmetry, and related to the intraoperative meniscal observations on DLM.\n\nSearch for a link between asymmetric bending defect and posterior shift in MCA-type DLM.\n\nAnalysis of all patients with symptomatic DLM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children with a discoid lateral meniscus symptomatic and surgical care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\< 18 yo\n* Symptomatic discoid lateral meniscus\n\nExclusion Criteria:\n\n* Osteochondritis dissecans (OCD)\n* Asymptomatic and partial DLM observed during arthroscopic exploration for other reasons\n* Revision knee surgery'}, 'identificationModule': {'nctId': 'NCT04741269', 'briefTitle': 'Asymmetric Lack of Knee Flexion as a Symptom of DLM in Children', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Asymmetric Lack of Knee Flexion as a Symptom of DLM in Children', 'orgStudyIdInfo': {'id': '69HCL20_1241'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lack of knee flexion', 'description': 'During preoperative clinical exam, highlight of a lack of knee flexion. The lack of knee flexion consists in an asymmetric heel-bottom distance or an asymmetric goniometric measure of knee flexion.\n\nAll others characteristics are also analyzed like in group 2, as : rest of knee motion, MRI meniscus shift, arthroscopic shift', 'interventionNames': ['Diagnostic Test: Find a link between lack of knee flexion and meniscal posterior luxation fixed']}, {'label': 'Full knee flexion', 'description': "During preoperative clinical exam, highlight of a lack of knee flexion. The lack of knee flexion consists in an asymmetric heel-bottom distance or an asymmetric goniometric measure of knee flexion. Patients in group 2 don't have any asymmetric full knee flexion.\n\nAll others characteristics are also analyzed like in group 2, as : rest of knee motion, MRI meniscus shift, arthroscopic shift"}], 'interventions': [{'name': 'Find a link between lack of knee flexion and meniscal posterior luxation fixed', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measure the full flexion angle of the knee using a goniometer. Measure the heel-buttom distance. All measurements are carried out in bilateral and comparative ways.\n\nSearch for the meniscal position on MRI and intraoperatively: no shift, anterior, medial, posterior shift.', 'armGroupLabels': ['Lack of knee flexion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69005', 'city': 'Lyon', 'country': 'France', 'facility': 'Paediatric orthopaedic - Femme Mère Enfant Hospital (HFME)', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Nicolas CANCE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Paediatric orthopaedic - Femme Mère Enfant Hospital (HFME)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}