Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-01-01 @ 5:21 AM
Study NCT ID:
NCT00175500
Status:
UNKNOWN
Last Update Posted:
2011-09-22
First Post:
2005-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Conventional and Large Diameter Femoral Heads for the Prevention of Hip Dislocation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006617', 'term': 'Hip Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-09-20', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the difference in dislocation rate between those receiving a large ball (36/40 mm femoral head) versus those receiving a 32 mm femoral head in patients who undergo revision hip arthroplasty', 'timeFrame': 'at two years'}], 'secondaryOutcomes': [{'measure': 'To compare polyethylene wear in the two groups'}, {'measure': 'To compare the difference in functional and quality of life measures in the two groups', 'timeFrame': 'at 3, 12 and 24 months post surgery'}, {'measure': 'To compare radiographic findings in the two groups'}, {'measure': 'To estimate the rate of re-revision in the two groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post-Arthroplasty Hip Dislocation'], 'conditions': ['Hip Dislocation']}, 'descriptionModule': {'briefSummary': 'About ten percent of revision hip replacements will dislocate. Although dislocation is not a life-threatening problem, it is stressful and costly and requires hospitalization to treat. Subjects who have repeated dislocations live with the constant fear of another dislocation. The purpose of this study is to test the effectiveness of a large ball prosthesis in preventing post-surgical dislocation. A large diameter ball has greater freedom of movement before it impinges; therefore, theoretically, it should not dislocate as easily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Eligible patients will be those undergoing revision hip arthroplasty, either first revision or subsequent re-revision.\n2. Revision must require replacement of both the acetabular component and femoral component, except when revising femur only with well-fixed Trilogy socket.\n3. The acetabular component must have a minimum outer diameter of 50 mm.\n4. The femoral component inserted should be a Zimmer Versys™ beaded full-coated stem or Zimmer ZMR™ stem or collarless polished taper (CPT™)\n5. Patients must be able to reply to questionnaires in either French or English.\n\nExclusion Criteria:\n\n1. Patients who are undergoing revision for recurrent dislocation.\n2. Revision of the acetabulum requiring structural allograft or reconstruction ring.\n3. Revision of the acetabulum requiring the use of cemented all-polyethylene cups.\n4. Revision of the acetabulum using a liner cemented into an existing metal shell.\n5. Intra-operative decision to use a constrained liner.'}, 'identificationModule': {'nctId': 'NCT00175500', 'briefTitle': 'Comparison of Conventional and Large Diameter Femoral Heads for the Prevention of Hip Dislocation', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'A Randomized Multi-Centre Controlled Trial of Large Diameter (36/40 mm) Versus Conventional Diameter (32 mm) Femoral Heads for the Prevention of Post Revision Arthroplasty Dislocation', 'orgStudyIdInfo': {'id': 'C02-0530'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Large Diameter Femoral Head', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1L8', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Donald Garbuz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}