Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-25 @ 1:46 PM
Study NCT ID:
NCT06559592
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2022-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Internal Unicompartmental Arthroplasty After Tibial Valgization Osteotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Give the functional results using the Oxford score, for patients who underwent this procedure.', 'timeFrame': 'from 4 to 185 months', 'description': 'Oxford Knee Scale (OKS) score results after a mean follow-up of 79 months after unicompartmental internal arthroplasty, and a mean follow-up of 185 months after tibial valgization osteotomy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['orthopedic surgery', 'unicompartmental knee arthroplasty', 'high tibial osteotomy'], 'conditions': ['Knee Arthritis']}, 'descriptionModule': {'briefSummary': 'This retrospective, monocentric study is about outcomes concerning patients who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. This previous high tibial osteotomy was performed because of genu varum.\n\nClinical, funtionnal and radiological outcomes were examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged of at least18 years old, who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. The high tibial osteotomy was made because of genu varum.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* operated between January 2005 and June 2019\n* HTO followed by implantation of medial UKA (Oxford Partial Knee, Zimmer Biomet, Bridgend, UK) in the same knee\n* medial knee osteoarthritis with healthy lateral compartment\n* patellofemoral pain\n* coronal plane deformity of less than 15°\n\nExclusion Criteria:\n\n* death\n* lost to follow-up\n* medial UKA implant other than the Oxford Partial Knee'}, 'identificationModule': {'nctId': 'NCT06559592', 'acronym': 'ArOs', 'briefTitle': 'Internal Unicompartmental Arthroplasty After Tibial Valgization Osteotomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Internal Unicompartmental Arthroplasty After Tibial Valgization Osteotomy', 'orgStudyIdInfo': {'id': 'ArOs (29BRC21.0209)'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after the publication of result and ending five years maximum following the last visit of the last patient', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}