Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-29 @ 8:21 PM
Study NCT ID:
NCT01156558
Status:
COMPLETED
Last Update Posted:
2011-03-31
First Post:
2010-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2011-03-30', 'unreleaseDateUnknown': True}, {'resetDate': '2011-04-28', 'releaseDate': '2011-03-31'}, {'resetDate': '2011-12-07', 'releaseDate': '2011-11-07'}], 'estimatedResultsFirstSubmitDate': '2011-03-30'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-30', 'studyFirstSubmitDate': '2010-07-01', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2011-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant survivorship 2 years following revision TKA'}], 'secondaryOutcomes': [{'measure': 'Knee Society Score'}, {'measure': 'KOOS score'}, {'measure': 'Radiographic assessment 1 and 2 years following revision surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Revision Total Knee Replacement']}, 'descriptionModule': {'briefSummary': 'Metaphyseal sleeves, through their design, could allow reconstruction of the knee in cases of severe bone loss by allowing rigid internal fixation and proper alignment of the extremity and components.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sequential assessment of 100 patients who have received a revision knee surgery for which metaphyseal sleeve was used in femoral and/or tibial side starting August 2007. Patients must meet inclusion/exclusion criteria for enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Revision knees with bone defect for which metaphyseal sleeve in femoral and/or tibial side is used\n2. Cases with at least 2 year follow-up\n3. Cases with regular follow-up visits completed\n\nExclusion Criteria:\n\n1. Cemented sleeves\n2. Patients with less than two year follow-up completed\n3. Cases lost to follow-up'}, 'identificationModule': {'nctId': 'NCT01156558', 'briefTitle': 'Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Early Outcome Assessment of Revision Total Knee Arthroplasty Using Metaphyseal Sleeves', 'orgStudyIdInfo': {'id': '10FA01'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy Orthopaedics', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Matthew Austin, MD', 'oldOrganization': 'Rothman Institute'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-03-31', 'type': 'RELEASE'}, {'date': '2011-04-28', 'type': 'RESET'}, {'date': '2011-11-07', 'type': 'RELEASE'}, {'date': '2011-12-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rothman Institute (Matthew Austin, MD)'}}}}