Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-17 @ 8:07 AM
Study NCT ID:
NCT00754520
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2008-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061825', 'term': 'Metal-on-Metal Joint Prostheses'}], 'ancestors': [{'id': 'D007595', 'term': 'Joint Prosthesis'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lisette.smid@zimmerbiomet.com', 'phone': '+31 62 395 6378', 'title': 'Clinical Project Lead', 'organization': 'Zimmer Biomet'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From surgery until the last study visit at 10 years post-op.', 'description': 'ISO definitions are applicable. 211 operative cases (110 COM and 101 MOM) were available for the analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Ceramic On Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 0, 'seriousNumAtRisk': 110, 'deathsNumAffected': 16, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'Metal on Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'deathsNumAffected': 13, 'seriousNumAffected': 38}], 'seriousEvents': [{'term': 'Revision', 'notes': 'One or more components revised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muculoskeletal problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Clinical Success (CCS) Rate as Defined in the Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceramic On Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.'}, {'id': 'OG001', 'title': 'Metal on Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years post-operatively', 'description': 'CCS is defined as:\n\na. Total Harris Hip Score \\> 80 points, and b. No acetabular or femoral revision or removal, and c. No pending acetabular or femoral revision or removal as defined in radiographic evaluation by: i. An acetabular radiographic assessment with all of the following:\n\n1. Migration \\< 4 mm, and\n2. Change in angle of inclination \\< 4o, and\n3. Absence of osteolysis, and ii. A femoral radiographic assessment with all of the following:\n\n1\\. Subsidence \\< 5 mm, and 2. Absence of osteolysis.\n\nThe HHS including a series of questions answered by the patient and physical examinations recorded by a qualified health care professional covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \\< 70', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to a lack of radiographic evaluation data, the overall number of participants analyzed is smaller than the actual number enrolled.'}, {'type': 'SECONDARY', 'title': 'Oxford Hip Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceramic On Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.'}, {'id': 'OG001', 'title': 'Metal on Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.'}], 'classes': [{'title': 'preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.7', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '22.1', 'spread': '7.3', 'groupId': 'OG001'}]}]}, {'title': '6 weeks postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.3', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '39.0', 'spread': '6.7', 'groupId': 'OG001'}]}]}, {'title': '6 months postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.0', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '44.8', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': '1 year postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.0', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '46.1', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': '2 years postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.6', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '45.9', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': '3 years postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '45.9', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': '4 years postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.8', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '46.0', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': '5 years postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.1', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '45.9', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': '10 years postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.0', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '42.1', 'spread': '10.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively', 'description': "The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \\> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \\< 27.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients were not included in analysis due to receiving a different articulation (not the study device). Other than that, the number of participants decreased over time due to several reasons, such as missing visits or lost to follow-up or withdrawn from the study for any reason.'}, {'type': 'SECONDARY', 'title': 'Womac Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceramic On Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.'}, {'id': 'OG001', 'title': 'Metal on Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.'}], 'classes': [{'title': 'Pain pre-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Pain 6 weeks post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Pain 6 months post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Pain 1 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Pain 2 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Pain 3 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Pain 4 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Pain 5 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Pain 10 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness pre-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness 6 weeks post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness 6 months post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness 1 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness 2 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness 3 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness 4 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness 5 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Stiffness 10 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'ADL pre-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.1', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '33.7', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'ADL 6 weeks post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'ADL 6 months post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'ADL 1 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'ADL 2 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'ADL 3 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'ADL 4 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'ADL 5 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'ADL 10 year post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '8.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively', 'description': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score) is a standardised patient reported outcome measure consisting of 24 items divided into 3 sub-sections: Pain (5 items), stiffness (2 items) and physical function or "Activities of Daily Living; ADL" (17 items). A higher score indicates a worse clinical outcome. The maximum score for each subsection is Pain: 20 - 0; Stiffness: 8 - 0; ADL: 68 - 0.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients were not included in analysis due to receiving a different articulation (not the study device). Other than that, the number of participants decreased over time due to several reasons, such as missing visits or lost to follow-up or withdrawn from the study for any reason.'}, {'type': 'SECONDARY', 'title': 'Metal Ion Concentrations in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceramic On Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.'}, {'id': 'OG001', 'title': 'Metal on Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.'}], 'classes': [{'title': 'Chromium 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'Chromium 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '32.5', 'groupId': 'OG001'}]}]}, {'title': 'Chromium 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '29.9', 'groupId': 'OG001'}]}]}, {'title': 'Chromium 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.3', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '-13.4', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Chromium 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'spread': '29.3', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '30.7', 'groupId': 'OG001'}]}]}, {'title': 'Cobalt 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '26.8', 'spread': '25.1', 'groupId': 'OG001'}]}]}, {'title': 'Cobalt 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '41.4', 'spread': '77.8', 'groupId': 'OG001'}]}]}, {'title': 'Cobalt 2 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '45.1', 'spread': '45.5', 'groupId': 'OG001'}]}]}, {'title': 'Cobalt 3 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '57.5', 'spread': '61.4', 'groupId': 'OG001'}]}]}, {'title': 'Cobalt 5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.7', 'spread': '46.4', 'groupId': 'OG000'}, {'value': '64.9', 'spread': '64.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post-operatively, 1, 2, 3 and 5 years post-operatively', 'description': 'Chromium and Cobalt concentrations in blood are measured in measurement unit nmol/L. The change from baseline analysis is presented.', 'unitOfMeasure': 'nmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Metal Ion analysis is only performed on a subset of the patients. Other than that, the number of participants fluctuates over time due to several reasons, such as missing visits or lost to follow-up or withdrawn from the study for any reason.'}, {'type': 'SECONDARY', 'title': 'Survivorship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceramic On Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.'}, {'id': 'OG001', 'title': 'Metal on Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 years post-op', 'description': 'Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 10 years post-operative is presented here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ceramic On Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.'}, {'id': 'FG001', 'title': 'Metal on Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '49'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ceramic On Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head.'}, {'id': 'BG001', 'title': 'Metal on Metal', 'description': 'Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.2', 'spread': '7', 'groupId': 'BG000'}, {'value': '65.3', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '65.2', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age (years) at date of surgery', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Finland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2008-09-23', 'size': 260253, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-27T11:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2008-09-16', 'resultsFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2008-09-16', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-01', 'studyFirstPostDateStruct': {'date': '2008-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Clinical Success (CCS) Rate as Defined in the Protocol', 'timeFrame': '2 years post-operatively', 'description': 'CCS is defined as:\n\na. Total Harris Hip Score \\> 80 points, and b. No acetabular or femoral revision or removal, and c. No pending acetabular or femoral revision or removal as defined in radiographic evaluation by: i. An acetabular radiographic assessment with all of the following:\n\n1. Migration \\< 4 mm, and\n2. Change in angle of inclination \\< 4o, and\n3. Absence of osteolysis, and ii. A femoral radiographic assessment with all of the following:\n\n1\\. Subsidence \\< 5 mm, and 2. Absence of osteolysis.\n\nThe HHS including a series of questions answered by the patient and physical examinations recorded by a qualified health care professional covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \\< 70'}], 'secondaryOutcomes': [{'measure': 'Oxford Hip Score', 'timeFrame': 'pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively', 'description': "The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \\> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \\< 27."}, {'measure': 'Womac Score', 'timeFrame': 'pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively', 'description': 'The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score) is a standardised patient reported outcome measure consisting of 24 items divided into 3 sub-sections: Pain (5 items), stiffness (2 items) and physical function or "Activities of Daily Living; ADL" (17 items). A higher score indicates a worse clinical outcome. The maximum score for each subsection is Pain: 20 - 0; Stiffness: 8 - 0; ADL: 68 - 0.'}, {'measure': 'Metal Ion Concentrations in Blood', 'timeFrame': '6 months post-operatively, 1, 2, 3 and 5 years post-operatively', 'description': 'Chromium and Cobalt concentrations in blood are measured in measurement unit nmol/L. The change from baseline analysis is presented.'}, {'measure': 'Survivorship', 'timeFrame': '10 years post-op', 'description': 'Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 10 years post-operative is presented here.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '31540737', 'type': 'DERIVED', 'citation': 'Higgins JE, Conn KS, Britton JM, Pesola M, Manninen M, Stranks GJ. Early Results of Our International, Multicenter, Multisurgeon, Double-Blinded, Prospective, Randomized, Controlled Trial Comparing Metal-on-Metal With Ceramic-on-Metal in Total Hip Arthroplasty. J Arthroplasty. 2020 Jan;35(1):193-197.e2. doi: 10.1016/j.arth.2019.08.002. Epub 2019 Aug 22.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.', 'detailedDescription': 'The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting with osteoarthritis and suitable for primary Total Hip Replacement\n* Patients preoperative Harris Hip Score \\<= 70 points\n* Patients aged over 18 and under 75\n* Patients with limited co-morbidity - ASA I-III\n* Patients with normal urea and electrolyte levels and creatinine levels\n* Patients must be able to understand instructions and be willing to return for follow-up\n* Patients willing to provide blood and urine samples for metal ion analysis at follow up\n\nExclusion Criteria:\n\n* Patients preoperative Harris Hip Score \\> 70 points\n* Previous prosthetic hip surgery\n* Patients with significant co-morbidity - ASA IV - V\n* Dementia and inability to understand and follow instructions\n* Neurological conditions affecting movement\n* Existing metal implant or fixation device\n* Pregnancy\n* Presence of symptomatic arthritis in other lower limb joints'}, 'identificationModule': {'nctId': 'NCT00754520', 'briefTitle': 'A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Multi-center Prospective Randomized Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic-on-metal and Metal-on-metal as Used in Cementless Primary Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'BMETEU.CR.EU11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ceramic On Metal', 'description': 'This arm utilizes the ceramic on metal articulation using the M2a-38™ mm cup.', 'interventionNames': ['Device: Ceramic On Metal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metal on Metal', 'description': 'This arm utilizes the metal on metal articulation using M2a-38™ mm cup.', 'interventionNames': ['Device: Metal on Metal']}], 'interventions': [{'name': 'Ceramic On Metal', 'type': 'DEVICE', 'description': 'Ceramic on Metal articulation using M2a-38™ mm cup', 'armGroupLabels': ['Ceramic On Metal']}, {'name': 'Metal on Metal', 'type': 'DEVICE', 'description': 'Metal on Metal articulation using M2a-38™ mm cup', 'armGroupLabels': ['Metal on Metal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jyväskylä', 'country': 'Finland', 'facility': 'Central Finland Central Hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'city': 'Kotka', 'country': 'Finland', 'facility': 'Kymenlaakso Central Hospital', 'geoPoint': {'lat': 60.4664, 'lon': 26.94582}}, {'zip': 'RG24 9NA', 'city': 'Basingstoke', 'country': 'United Kingdom', 'facility': 'North Hampshire Hospital', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}], 'overallOfficials': [{'name': 'G. Stranks, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Hampshire Hospital'}, {'name': 'M Pesola', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Finland Central Hospital'}, {'name': 'H Kauppinen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kymenlaakso Central Hospital Kotka Finland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}