Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 7:44 AM
Study NCT ID:
NCT00435357
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2007-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Fixed- Versus Mobile-bearing TKA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092462', 'term': 'Patella Fracture'}], 'ancestors': [{'id': 'D000092443', 'term': 'Knee Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-20', 'studyFirstSubmitDate': '2007-02-13', 'studyFirstSubmitQcDate': '2007-02-13', 'lastUpdatePostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Knee Society Score', 'timeFrame': '2, 6 and 12 monthes after surgery'}], 'secondaryOutcomes': [{'measure': 'Patellofemoral tilt on skyline view, measurement of two angles :', 'timeFrame': '2 and 12 monthes after surgery'}, {'measure': 'patellar tilt', 'timeFrame': '2 and 12 monthes after surgery'}, {'measure': 'patellar displacement from the center of the trochlear groove', 'timeFrame': '2 and 12 monthes after surgery'}]}, 'conditionsModule': {'keywords': ['Mobile-bearing', 'arthroplasty', 'fixed-bearing', 'knee', 'patella', 'posterior stabilized TKA'], 'conditions': ['Knee Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to analyse the clinical and radiological results of a postero-stabilized TKA by using a mobile bearing versus fixed. Only patients with medial femorotibial arthritis will be included. The consequences on the patellofemoral joint will be thoroughly analysed on skyline view.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medial medial femorotibial arthritis requiring an arthroplasty\n* Age between 50y and 90y\n\nExclusion Criteria:\n\n* Lateral femorotibial arthritis\n* Inflammatory disease\n* Stiff knee with flexion under 90°\n* Revision TKA\n* Previous surgery (except meniscectomy)'}, 'identificationModule': {'nctId': 'NCT00435357', 'briefTitle': 'Comparison Between Fixed- Versus Mobile-bearing TKA', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Comparison Between Fixed- Versus Mobile-bearing TKA : a Randomized Prospective Study', 'orgStudyIdInfo': {'id': '2005.407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mobile-bearing TKA', 'interventionNames': ['Device: mobile-bearing TKA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fixed- bearing TKA', 'interventionNames': ['Device: fixed- bearing TKA']}], 'interventions': [{'name': 'mobile-bearing TKA', 'type': 'DEVICE', 'armGroupLabels': ['mobile-bearing TKA']}, {'name': 'fixed- bearing TKA', 'type': 'DEVICE', 'armGroupLabels': ['fixed- bearing TKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69300', 'city': 'Lyon', 'country': 'France', 'facility': 'Sebastien Lustig', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Philippe Neyret, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Philippe NEYRET', 'oldOrganization': 'Hospices Civils de Lyon'}}}}