Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-02-20 @ 3:51 PM
Study NCT ID:
NCT01336595
Status:
COMPLETED
Last Update Posted:
2011-10-05
First Post:
2011-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-04', 'studyFirstSubmitDate': '2011-04-14', 'studyFirstSubmitQcDate': '2011-04-15', 'lastUpdatePostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Knee Society Knee Score', 'timeFrame': 'Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery', 'description': 'change in knee score will be compared with initial score, until mean follow up of 20 years.'}], 'secondaryOutcomes': [{'measure': 'Improvement in the range of motion', 'timeFrame': 'Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery', 'description': 'change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 20 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'oxidized zirconium', 'genesis II', 'femoral component', 'cobalt chrome'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '15534531', 'type': 'BACKGROUND', 'citation': "Ezzet KA, Hermida JC, Colwell CW Jr, D'Lima DD. Oxidized zirconium femoral components reduce polyethylene wear in a knee wear simulator. Clin Orthop Relat Res. 2004 Nov;(428):120-4. doi: 10.1097/01.blo.0000148576.70780.13."}, {'pmid': '14652400', 'type': 'BACKGROUND', 'citation': 'Good V, Ries M, Barrack RL, Widding K, Hunter G, Heuer D. Reduced wear with oxidized zirconium femoral heads. J Bone Joint Surg Am. 2003;85-A Suppl 4:105-10. doi: 10.2106/00004623-200300004-00013. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if there are any clinical or radiographic differences in cemented total knee arthroplasty with an oxidized zirconium and a cobalt-chromium femoral knee component.', 'detailedDescription': 'Although it has been claimed that total knee arthroplasties with an oxidized zirconium femoral knee component had beneficial wear properties in vitro, there are conflicting clinical results. The purpose of the present study was to compare the clinical, subjective, and radiographic results as well as the weight, size and shape of polyethylene wear particles in the patients with an oxidized zirconium and a cobalt-chromium femoral knee component.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease\n\nExclusion Criteria:\n\n* Inflammatory disease\n* patient with other Lower extremity disease which may affect functional outcome\n* Neurologic disease effecting patients lower extremity\n* Revision surgery\n* Patient not medically cleared for bilateral surgery'}, 'identificationModule': {'nctId': 'NCT01336595', 'briefTitle': 'Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components in the Same Patients: A Prospective, Double Blinded, and Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'TKRzirconium'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zirconium Femoral Component', 'description': 'Oxidized zirconium femoral component of Genesis II TKR system is used.', 'interventionNames': ['Device: Zirconium (Zirconium Genesis II)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cobalt Chrome', 'description': 'Cobalt-Chromium Femoral component of Genesis II system is used.', 'interventionNames': ['Device: Cobalt-Chrome (Cobalt Chrome Genesis II)']}], 'interventions': [{'name': 'Zirconium (Zirconium Genesis II)', 'type': 'DEVICE', 'otherNames': ['Zirconium Genesis II'], 'description': 'Oxidized Zirconium femoral component of Genesis II TKR system is used.', 'armGroupLabels': ['Zirconium Femoral Component']}, {'name': 'Cobalt-Chrome (Cobalt Chrome Genesis II)', 'type': 'DEVICE', 'otherNames': ['Cobalt Chrome Genesis II'], 'description': 'Cobalt Chrome Femoral Component of Genesis II TKR system is used', 'armGroupLabels': ['Cobalt Chrome']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hosptial', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jang-Won Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ewha Womans University Mokdong Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director', 'investigatorFullName': 'Young Hoo Kim', 'investigatorAffiliation': 'Ewha Womans University'}}}}