Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-27 @ 12:21 AM
Study NCT ID:
NCT01806766
Status:
COMPLETED
Last Update Posted:
2013-03-07
First Post:
2013-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-06', 'studyFirstSubmitDate': '2013-03-05', 'studyFirstSubmitQcDate': '2013-03-06', 'lastUpdatePostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris hip score', 'timeFrame': 'Pre-op, last follow-up(11-13 years)', 'description': 'Comparing harris hip score before and after the intervention, and at the final follow-up, between two sides.'}], 'secondaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)', 'timeFrame': 'preop, last follow-up(11-13 years)', 'description': 'WOMAC index before, and after the intervention, and between sides at the last follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cementless total hip arthroplasty', 'ceramic on ceramic bearing', 'ceramic on highly cross linked polyethylene', 'young patient'], 'conditions': ['Osteonecrosis', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective, randomized study was to compare the clinical and radiographic results and the prevalence of osteolysis of the cementless total hip arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked polyethylene bearings on the other side in the young and active patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary hip osteoarthritis\n* Secondary hip osteoarthritis\n* Avascular necrosis of femoral head\n\nExclusion Criteria:\n\n* Previous surgical history of hip'}, 'identificationModule': {'nctId': 'NCT01806766', 'briefTitle': 'Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings in Primary Cementless Total Hip Arthroplasty in the Same Patients', 'orgStudyIdInfo': {'id': 'XPECCC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ceramic on Ceramic', 'description': 'Ceramic on Ceramic bearing coupled side of a single patient undergoing bilateral total hip arthroplasty', 'interventionNames': ['Procedure: Ceramic on Ceramic bearing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ceramic on HXPE', 'description': 'Ceramic on HIghly crosslinked polyethylene bearing coupled side of a single patient undergoing bilateral total hip arthroplasty', 'interventionNames': ['Procedure: Ceramic on Highly crosslinked polyethylene bearing']}], 'interventions': [{'name': 'Ceramic on Ceramic bearing', 'type': 'PROCEDURE', 'description': 'cementless Total Hip Arthroplasty with Ceramic on ceramic bearing', 'armGroupLabels': ['Ceramic on Ceramic']}, {'name': 'Ceramic on Highly crosslinked polyethylene bearing', 'type': 'PROCEDURE', 'description': 'Cementless Total Hip Arthroplasty with Ceramic on Highly crosslinked polyethylene bearing', 'armGroupLabels': ['Ceramic on HXPE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '158-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young-Hoo Kim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ewha Womans University Mokdong Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young Hoo Kim', 'investigatorAffiliation': 'Ewha Womans University'}}}}