Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-29 @ 7:02 AM
Study NCT ID:
NCT01176292
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2010-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'research@aori.org', 'phone': '703-619-4411', 'title': 'Dr. William Hamilton', 'organization': 'Anderson Orthopaedic Research Institute'}, 'certainAgreement': {'otherDetails': 'Any paper drafted by authors regarding project results should be sent to sponsor at least 30 days before being submitted for publication. An abstract should be sent to the sponsor at least 10 days before being submitted. The sponsor will inform the authors of any changes deemed necessary to preserve the confidentiality of proprietary information or to insure scientific accuracy.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year follow-up', 'description': 'Collected according to standard protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Rotating Platform High-Flex Cruciate Substituting TKA', 'otherNumAtRisk': 71, 'otherNumAffected': 9, 'seriousNumAtRisk': 71, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Rotating Platform Cruciate Substituting TKA', 'otherNumAtRisk': 71, 'otherNumAffected': 3, 'seriousNumAtRisk': 71, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'postoperative pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'patellar crepitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'infection', 'notes': 'Infection/polyethylene exchange', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'stiffness', 'notes': 'manipulation for stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'patellar fracture', 'notes': 'Repair of patellar fracture due to a fall.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'quadriceps tendon rupture', 'notes': 'Extensor mechanism reconstruction from a quadriceps tendon rupture.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'symptomatic patellar crepitus', 'notes': 'Arthroscopic nodule debridement for patellar crepitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Flexion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotating Platform High-Flex Cruciate Substituting TKA'}, {'id': 'OG001', 'title': 'Rotating Platform Cruciate Substituting TKA'}], 'classes': [{'title': 'Clinical flexion - preoperative', 'categories': [{'measurements': [{'value': '119.1', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '120.3', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': 'Clinical flexion - 4 week', 'categories': [{'measurements': [{'value': '112.0', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '111.3', 'spread': '15.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative, 4-6 weeks', 'description': 'Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with available data at the preoperative and 4-6 week intervals.'}, {'type': 'SECONDARY', 'title': 'Radiographic Flexion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotating Platform High-Flex Cruciate Substituting TKA'}, {'id': 'OG001', 'title': 'Rotating Platform Cruciate Substituting TKA'}], 'classes': [{'title': 'preoperative', 'categories': [{'measurements': [{'value': '116.8', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '116.6', 'spread': '15.5', 'groupId': 'OG001'}]}]}, {'title': '4-6 weeks', 'categories': [{'measurements': [{'value': '104.7', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '102.1', 'spread': '16.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'preoperative, 4-6 weeks', 'description': 'Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with available data at the preoperative and 4-6 week intervals.'}, {'type': 'SECONDARY', 'title': 'Radiographic Flexion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotating Platform High-Flex Cruciate Substituting TKA'}, {'id': 'OG001', 'title': 'Rotating Platform Cruciate Substituting TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '117.6', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '117.9', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with available data at the 1-year interval.'}, {'type': 'SECONDARY', 'title': 'Knee Society Score (KSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotating Platform High-Flex Cruciate Substituting TKA'}, {'id': 'OG001', 'title': 'Rotating Platform Cruciate Substituting TKA'}], 'classes': [{'title': 'Clinical KSS', 'categories': [{'measurements': [{'value': '95.0', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '94.9', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Functional KSS', 'categories': [{'measurements': [{'value': '87.7', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '90.9', 'spread': '16.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. The minimum score is 0 and the highest score is 100. A higher score represents a better outcome.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with available KSS data at the 1-year interval.'}, {'type': 'SECONDARY', 'title': 'Oxford Knee Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotating Platform High-Flex Cruciate Substituting TKA'}, {'id': 'OG001', 'title': 'Rotating Platform Cruciate Substituting TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '41.8', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'A patient reported questionnaire for assessing the outcome of knee surgery. The minimum score is 0 and the maximum score is 48. A higher score represents a better outcome.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with available Oxford Knee Score data at the 1-year interval.'}, {'type': 'PRIMARY', 'title': 'Clinical Flexion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotating Platform High-Flex Cruciate Substituting TKA'}, {'id': 'OG001', 'title': 'Rotating Platform Cruciate Substituting TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '122.5', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '121.3', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-6 months', 'description': 'Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with available data at the 4-6 month interval.'}, {'type': 'PRIMARY', 'title': 'Clinical Flexion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotating Platform High-Flex Cruciate Substituting TKA'}, {'id': 'OG001', 'title': 'Rotating Platform Cruciate Substituting TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '124.2', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '124.0', 'spread': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with available data at the 1-year interval.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rotating Platform High-Flex Cruciate Substituting TKA'}, {'id': 'FG001', 'title': 'Rotating Platform Cruciate Substituting TKA'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Has not scheduled one-year visit yet', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subject enrollment began August 2007 and ended April 2009, with a total of 142 patients enrolled at an orthopaedic clinic.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rotating Platform High-Flex Cruciate Substituting TKA'}, {'id': 'BG001', 'title': 'Rotating Platform Cruciate Substituting TKA'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '7', 'groupId': 'BG000'}, {'value': '62', 'spread': '7', 'groupId': 'BG001'}, {'value': '64', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2010-07-26', 'resultsFirstSubmitDate': '2013-07-23', 'studyFirstSubmitQcDate': '2010-08-05', 'lastUpdatePostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-31', 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Flexion', 'timeFrame': 'Preoperative, 4-6 weeks', 'description': 'Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.'}, {'measure': 'Clinical Flexion', 'timeFrame': '4-6 months', 'description': 'Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.'}, {'measure': 'Clinical Flexion', 'timeFrame': '1 year', 'description': 'Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.'}], 'secondaryOutcomes': [{'measure': 'Radiographic Flexion', 'timeFrame': 'preoperative, 4-6 weeks', 'description': 'Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.'}, {'measure': 'Radiographic Flexion', 'timeFrame': '1 year', 'description': 'Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.'}, {'measure': 'Knee Society Score (KSS)', 'timeFrame': '1 year', 'description': 'A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. The minimum score is 0 and the highest score is 100. A higher score represents a better outcome.'}, {'measure': 'Oxford Knee Score', 'timeFrame': '1 year', 'description': 'A patient reported questionnaire for assessing the outcome of knee surgery. The minimum score is 0 and the maximum score is 48. A higher score represents a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['total knee replacement', 'high flexion', 'range of motion', 'rotating platform', 'TKA'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 40 to 75 years old\n* Primary diagnosis of osteoarthritis of the knee\n* Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA.\n* Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments.\n\nExclusion Criteria:\n\n* Pregnant or lactating female subjects\n* Patients with post-traumatic or inflammatory arthritis\n* Patients with a fixed flexion contracture of greater than 20 degrees\n* Patients with advanced hip, spine, or ankle disease\n* Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues"}, 'identificationModule': {'nctId': 'NCT01176292', 'briefTitle': 'Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)', 'organization': {'class': 'OTHER', 'fullName': 'Anderson Orthopaedic Research Institute'}, 'officialTitle': 'A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'AORI2010-0104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Rotating Platform High-Flex Cruciate Substituting TKA', 'interventionNames': ['Device: Rotating Platform High-Flex Cruciate Substituting TKA']}, {'type': 'OTHER', 'label': 'Rotating Platform Cruciate Substituting TKA', 'interventionNames': ['Device: Rotating Platform Cruciate Substituting TKA']}], 'interventions': [{'name': 'Rotating Platform High-Flex Cruciate Substituting TKA', 'type': 'DEVICE', 'armGroupLabels': ['Rotating Platform High-Flex Cruciate Substituting TKA']}, {'name': 'Rotating Platform Cruciate Substituting TKA', 'type': 'DEVICE', 'armGroupLabels': ['Rotating Platform Cruciate Substituting TKA']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'William G Hamilton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anderson Orthopaedic Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anderson Orthopaedic Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy Orthopaedics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'William G. Hamilton, MD', 'investigatorAffiliation': 'Anderson Orthopaedic Research Institute'}}}}