Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-07-05 @ 5:58 PM
Study NCT ID:
NCT03409666
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2018-01-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lisette.smid@zimmerbiomet.com', 'phone': '+31 62 395 6378', 'title': 'Lisette Smid', 'organization': 'Zimmer Biomet'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'A limitation of the study was that 14 patients had to be excluded for RSA analysis due to insufficient bone markers or not meeting other criteria to perform an accurate RSA migration calculation. However, as Valstar et al. (2005) stated that at least 15-25 patients are needed per group, we believe that the results of this study are still valuable.'}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Taperloc Complete Microplasty Stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.\n\nTaperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Taperloc Complete Reduced Distal Stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.\n\nTaperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 9, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Stem Subsidence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Periarticular Ossification', 'notes': 'Other hip related radiographic finding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pedestal Sign', 'notes': 'Other hip related radiographic finding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taperloc Complete Microplasty Stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.\n\nTaperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner'}, {'id': 'OG001', 'title': 'Taperloc Complete Reduced Distal Stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.\n\nTaperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner'}], 'classes': [{'categories': [{'measurements': [{'value': '3.15', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '3.90', 'spread': '4.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years postoperatively', 'description': 'Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RSA data from 35 patients (20 Taperloc Complete Reduced Distal \\& 15 Taperloc Complete Microplasty) is available for the comparison of migration between the investigated stems.'}, {'type': 'SECONDARY', 'title': 'Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taperloc Complete Microplasty Stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.\n\nTaperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner'}, {'id': 'OG001', 'title': 'Taperloc Complete Reduced Distal Stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.\n\nTaperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner'}], 'classes': [{'title': 'Stem malalignment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Incorrect sizing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Subsidence', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years postoperatively', 'description': 'Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Early Survival Assessed by Counting the Number of Implant Revisions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taperloc Complete Microplasty Stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.\n\nTaperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner'}, {'id': 'OG001', 'title': 'Taperloc Complete Reduced Distal Stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.\n\nTaperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively', 'description': 'Assessed by counting the number of implant revisions', 'unitOfMeasure': 'implant revisions', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taperloc Complete Microplasty Stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.\n\nTaperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner'}, {'id': 'OG001', 'title': 'Taperloc Complete Reduced Distal Stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.\n\nTaperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner'}], 'classes': [{'title': 'pre-op', 'categories': [{'measurements': [{'value': '63.9', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '65.1', 'spread': '13.9', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'categories': [{'measurements': [{'value': '79.9', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '82.4', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '96.7', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '95.7', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': '2 year', 'categories': [{'measurements': [{'value': '98.3', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '97.6', 'spread': '4.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively', 'description': 'Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis.\n\nThe score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taperloc Complete Microplasty Stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.\n\nTaperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner'}, {'id': 'OG001', 'title': 'Taperloc Complete Reduced Distal Stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.\n\nTaperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner'}], 'classes': [{'title': 'Stress shielding', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Radiolucency', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'stem alignment (between <5 valgus and <5 varus)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks, 1 year and 2 years postoperatively', 'description': 'Assess radiographs for signs of stress shielding, radiolucency and stem alignment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taperloc Complete Microplasty Stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.\n\nTaperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner'}, {'id': 'OG001', 'title': 'Taperloc Complete Reduced Distal Stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.\n\nTaperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '94.2', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '92', 'spread': '9.2', 'groupId': 'OG001'}]}]}, {'title': 'Symptoms', 'categories': [{'measurements': [{'value': '89.8', 'spread': '12', 'groupId': 'OG000'}, {'value': '85.5', 'spread': '13.3', 'groupId': 'OG001'}]}]}, {'title': 'Activity limitations daily living', 'categories': [{'measurements': [{'value': '92.7', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '90.8', 'spread': '10.1', 'groupId': 'OG001'}]}]}, {'title': 'Sport/Recreation', 'categories': [{'measurements': [{'value': '80.7', 'spread': '24.1', 'groupId': 'OG000'}, {'value': '79.6', 'spread': '20.2', 'groupId': 'OG001'}]}]}, {'title': 'Quality of life', 'categories': [{'measurements': [{'value': '89.7', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '84.4', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years postoperatively', 'description': 'The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Performance Measured by Patient Based Outcome EQ5D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taperloc Complete Microplasty Stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.\n\nTaperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner'}, {'id': 'OG001', 'title': 'Taperloc Complete Reduced Distal Stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.\n\nTaperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner'}], 'classes': [{'title': 'EQ-5D', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Health status', 'categories': [{'measurements': [{'value': '81.0', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '81.0', 'spread': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years postoperatively', 'description': 'Each question in the EQ5D assessment can be answered in three ways, indicating no, moderate or extreme problems. Index scores are created with a weight for each dimension, ranging from 0 (health state equivalent to death) to 1 (perfect health). The EQ5D also includes a question about health status, ranging from 0 (worst health) to 100 (best health).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taperloc Complete Microplasty Stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.\n\nTaperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner'}, {'id': 'OG001', 'title': 'Taperloc Complete Reduced Distal Stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.\n\nTaperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner'}], 'classes': [{'title': 'pre-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.1', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '25.6', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': '6 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.3', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.6', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '43.1', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': '2 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.7', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively', 'description': 'The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of analyzed patients differs between the time points due to missing values'}, {'type': 'SECONDARY', 'title': 'Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Taperloc Complete Microplasty Stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.\n\nTaperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner'}, {'id': 'OG001', 'title': 'Taperloc Complete Reduced Distal Stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.\n\nTaperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner'}], 'classes': [{'title': '6 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.8', 'spread': '30', 'groupId': 'OG000'}, {'value': '43.2', 'spread': '26.1', 'groupId': 'OG001'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.9', 'spread': '29.2', 'groupId': 'OG000'}, {'value': '61.7', 'spread': '29.6', 'groupId': 'OG001'}]}]}, {'title': '2 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.3', 'spread': '30.5', 'groupId': 'OG000'}, {'value': '80.3', 'spread': '26.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks, 1 year and 2 years postoperatively', 'description': 'The Forgotten Joint Score (FJS) is a questionnaire, which focuses on the awareness of having a joint prosthesis.\n\nThe rationale of this questionnaire is that the ultimate goal in joint arthroplasty resulting in the greatest possible patient satisfaction is the ability to forget the artificial joint. The outcome is scored on a 0 to 100 scale, with a total score of 0 indicating the highest level of awareness of having a joint prosthesis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of analyzed patients differs between the time points due to missing values'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Taperloc Complete Microplasty Stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.\n\nTaperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner'}, {'id': 'FG001', 'title': 'Taperloc Complete Reduced Distal Stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.\n\nTaperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Taperloc Complete Microplasty Stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.\n\nTaperloc Complete Microplasty stem: Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner'}, {'id': 'BG001', 'title': 'Taperloc Complete Reduced Distal Stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.\n\nTaperloc Complete Reduced Distal stem: Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.6', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '63.7', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem.\n\n25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem.\n\n25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).'}, {'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.'}], 'populationDescription': 'These numbers represent the subjects who received either the Taperloc Complete Microplasty stem or the Taperloc Complete Reduced Distal stem.\n\n25 patients were enrolled in the TCM group, and 25 in the TCRD group. In the TCM group, 1 patient was withdrawn before surgery. In the TCRD group, 3 received a different device, and 1 the TCM. For clarity, we decided to report based on the actual implantation (i.e. 25 TCM and 21 TCRD).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-01', 'size': 244380, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-24T08:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 assignment of treatment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-21', 'studyFirstSubmitDate': '2018-01-08', 'resultsFirstSubmitDate': '2022-01-19', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-21', 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)', 'timeFrame': '2 years postoperatively', 'description': 'Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)'}], 'secondaryOutcomes': [{'measure': 'Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty', 'timeFrame': '2 years postoperatively', 'description': 'Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation.'}, {'measure': 'Early Survival Assessed by Counting the Number of Implant Revisions', 'timeFrame': 'Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively', 'description': 'Assessed by counting the number of implant revisions'}, {'measure': 'Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)', 'timeFrame': 'pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively', 'description': 'Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis.\n\nThe score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)'}, {'measure': 'Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation', 'timeFrame': '6 weeks, 1 year and 2 years postoperatively', 'description': 'Assess radiographs for signs of stress shielding, radiolucency and stem alignment.'}, {'measure': 'Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)', 'timeFrame': '2 years postoperatively', 'description': 'The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms.'}, {'measure': 'Clinical Performance Measured by Patient Based Outcome EQ5D', 'timeFrame': '2 years postoperatively', 'description': 'Each question in the EQ5D assessment can be answered in three ways, indicating no, moderate or extreme problems. Index scores are created with a weight for each dimension, ranging from 0 (health state equivalent to death) to 1 (perfect health). The EQ5D also includes a question about health status, ranging from 0 (worst health) to 100 (best health).'}, {'measure': 'Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)', 'timeFrame': 'pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively', 'description': 'The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score.'}, {'measure': 'Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)', 'timeFrame': '6 weeks, 1 year and 2 years postoperatively', 'description': 'The Forgotten Joint Score (FJS) is a questionnaire, which focuses on the awareness of having a joint prosthesis.\n\nThe rationale of this questionnaire is that the ultimate goal in joint arthroplasty resulting in the greatest possible patient satisfaction is the ability to forget the artificial joint. The outcome is scored on a 0 to 100 scale, with a total score of 0 indicating the highest level of awareness of having a joint prosthesis.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Total Hip Arthroplasty', 'Medical Device', 'Performance', 'Safety', 'Hip prosthesis', 'Roentgen Stereophotogrammetric Analysis'], 'conditions': ['Hip Osteoarthritis', 'Noninflammatory Degenerative Joint Disease', 'Avascular Necrosis', 'Correction of Functional Deformity', 'Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.', 'detailedDescription': 'A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner.\n\nAll potential study subjects will be required to participate in the Informed Consent process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.\n* Correction of functional deformity.\n* Male or female\n\n -≥ 18 and ≤ 70 years of age\n* Subjects willing to return for follow-up evaluations.\n* Subjects able to read and understand Dutch language.\n\nExclusion Criteria:\n\n* active Infection (or within 6 weeks after infection)\n* Sepsis\n* Osteomyelitis\n* Uncooperative patient or patient with neurologic disorders who are incapable of following directions\n* diagnosed Osteoporosis or Osteomalacia\n* Metabolic disorders which may impair bone formation\n* Distant foci of infections which may spread to the implant site\n* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram\n* Vascular insufficiency, muscular atrophy or neuromuscular disease.'}, 'identificationModule': {'nctId': 'NCT03409666', 'briefTitle': 'Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.', 'orgStudyIdInfo': {'id': 'ORTHO.CR.GH60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Taperloc Complete Microplasty stem', 'description': 'Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.', 'interventionNames': ['Device: Taperloc Complete Microplasty stem']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Taperloc Complete Reduced Distal stem', 'description': 'Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.', 'interventionNames': ['Device: Taperloc Complete Reduced Distal stem']}], 'interventions': [{'name': 'Taperloc Complete Microplasty stem', 'type': 'DEVICE', 'otherNames': ['Total hip arthroplasty'], 'description': 'Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner', 'armGroupLabels': ['Taperloc Complete Microplasty stem']}, {'name': 'Taperloc Complete Reduced Distal stem', 'type': 'DEVICE', 'otherNames': ['Total hip arthroplasty'], 'description': 'Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner', 'armGroupLabels': ['Taperloc Complete Reduced Distal stem']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Roosendaal', 'country': 'Netherlands', 'facility': 'Bravis', 'geoPoint': {'lat': 51.53083, 'lon': 4.46528}}], 'overallOfficials': [{'name': 'Paola Vivoda, BSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zimmer Biomet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}