Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-01 @ 7:02 PM
Study NCT ID:
NCT00894361
Status:
TERMINATED
Last Update Posted:
2020-09-07
First Post:
2009-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs
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': 'tjgioe@gmail.com', 'title': 'Terence J. Gioe, M.D.', 'organization': 'PI/study coordinator retired due to personal family health matters and study sponsor then withdrew funding. Study terminated and no data was collected or analyzed from any participant.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'PI/study coordinator retired due to personal family health matters and study sponsor then withdrew funding. Study terminated and no data was collected or analyzed from any participant.'}}, 'adverseEventsModule': {'timeFrame': '2 Years', 'description': 'PI/study coordinator retired due to personal family health matters and study sponsor then withdrew funding. Study terminated and no data was collected or analyzed from any participant.', 'eventGroups': [{'id': 'EG000', 'title': 'Rotating-platform Design Total Knee Arthroplasty (TKA)', 'description': 'patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design', 'otherNumAtRisk': 200, 'otherNumAffected': 0, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)', 'description': 'patients who were randomized to receive the all-polyethylene tibial component design', 'otherNumAtRisk': 200, 'otherNumAffected': 0, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Knee Postoperative Range of Motion (ROM) at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotating-platform Design Total Knee Arthroplasty (TKA)', 'description': 'patients who were randomized to receive the rotating platform mobile-bearing TKA design'}, {'id': 'OG001', 'title': 'All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)', 'description': 'patients who were randomized to receive the all-polyethylene tibial component design'}], 'classes': [{'categories': [{'measurements': [{'value': '110.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '111.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'range of motion of the knee postoperatively at 2 years', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival of the Implants to Subject Death or Implant Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotating-platform Design TKA', 'description': 'patients who were randomized to receive the rotating platform mobile-bearing TKA design\n\nTKA surgery with the rotating platform mobile-bearing knee design: Depuy Sigma RP rotating platform design'}, {'id': 'OG001', 'title': 'All-polyethylene Tibia Design TKA', 'description': 'patients who were randomized to receive the all-polyethylene tibial component design\n\nTKA surgery with the all-polyethylene tibia knee design: Depuy Sigma fixed-bearing design with all-polyethylene tibia'}], 'timeFrame': '10 or more years', 'reportingStatus': 'POSTED', 'populationDescription': 'PI/study coordinator retired due to personal family health matters and study sponsor withdrew funding. Study was terminated and no data was collected or analyzed from any participant for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rotating-platform Design Total Knee Arthroplasty (TKA)', 'description': 'patients who were randomized to receive the rotating platform mobile-bearing TKA design'}, {'id': 'FG001', 'title': 'All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)', 'description': 'patients who were randomized to receive the all-polyethylene tibial component design'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '64'}]}], 'dropWithdraws': [{'type': 'deaths and less than 2 years followup', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '64'}]}]}], 'recruitmentDetails': 'October 1, 2001 to January 1, 2007 recruitment period from the Minneapolis VAMC Orthopaedic Clinic', 'preAssignmentDetails': 'Patients that were recruited but not enrolled either failed the inclusion criteria or elected not to participate'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rotating-platform Design Total Knee Arthroplasty (TKA)', 'description': 'patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design'}, {'id': 'BG001', 'title': 'All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)', 'description': 'patients who were randomized to receive the all-polyethylene tibial component design'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'range of motion of knee', 'classes': [{'categories': [{'measurements': [{'value': '113.7', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '111.9', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '112.8', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'degrees', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'whyStopped': 'PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-03', 'studyFirstSubmitDate': '2009-03-24', 'resultsFirstSubmitDate': '2009-03-24', 'studyFirstSubmitQcDate': '2009-03-24', 'lastUpdatePostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-03-24', 'studyFirstPostDateStruct': {'date': '2009-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Postoperative Range of Motion (ROM) at 2 Years', 'timeFrame': '2 years', 'description': 'range of motion of the knee postoperatively at 2 years'}], 'secondaryOutcomes': [{'measure': 'Survival of the Implants to Subject Death or Implant Removal', 'timeFrame': '10 or more years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['knee arthritis', 'total knee arthroplasty', 'total knee replacement', 'mobile bearing design', 'all-polyethylene tibia'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '19723986', 'type': 'RESULT', 'citation': 'Gioe TJ, Glynn J, Sembrano J, Suthers K, Santos ER, Singh J. Mobile and fixed-bearing (all-polyethylene tibial component) total knee arthroplasty designs. A prospective randomized trial. J Bone Joint Surg Am. 2009 Sep;91(9):2104-12. doi: 10.2106/JBJS.H.01442.'}]}, 'descriptionModule': {'briefSummary': "This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will afford the investigators information in the following areas:\n\n1. Does a RP design offer improvement in range of motion over a AP design?\n2. Does a RP design have improved wear characteristics over a nonmodular AP design?\n3. Is there a clear clinical advantage to the RP design that justifies its increased cost?\n\nAnswering these questions will allow surgeons to use RP designs appropriately in different demand populations.\n\nThis study was designed to address the questions of whether an RP design offers improvement in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators' primary hypothesis was that there would be no difference in these outcome measures at a minimum two year followup. A secondary hypothesis based on the anticipated long-term followup of this group was that there would be no difference in implant survival."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* generally accepted clinical and radiographic criteria for primary total knee arthroplasty\n\nExclusion Criteria:\n\n* substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator\n* patients whose mental function precluded them from responding to our standard questionnaires'}, 'identificationModule': {'nctId': 'NCT00894361', 'briefTitle': 'Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs', 'organization': {'class': 'FED', 'fullName': 'Minneapolis Veterans Affairs Medical Center'}, 'officialTitle': 'A Randomized Prospective Comparison of Mobile-Bearing and Fixed-Bearing (All-Polyethylene Tibia) Cruciate-Substituting Total Knee Arthroplasty (TKA) Designs', 'orgStudyIdInfo': {'id': 'MVA-3028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rotating-platform design TKA', 'description': 'patients who were randomized to receive the rotating platform mobile-bearing TKA design', 'interventionNames': ['Procedure: TKA surgery with the rotating platform mobile-bearing knee design']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'all-polyethylene tibia design TKA', 'description': 'patients who were randomized to receive the all-polyethylene tibial component design', 'interventionNames': ['Procedure: TKA surgery with the all-polyethylene tibia knee design']}], 'interventions': [{'name': 'TKA surgery with the rotating platform mobile-bearing knee design', 'type': 'PROCEDURE', 'description': 'Depuy Sigma RP rotating platform design', 'armGroupLabels': ['rotating-platform design TKA']}, {'name': 'TKA surgery with the all-polyethylene tibia knee design', 'type': 'PROCEDURE', 'description': 'Depuy Sigma fixed-bearing design with all-polyethylene tibia', 'armGroupLabels': ['all-polyethylene tibia design TKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VAMC', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Terence J Gioe, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis VAMC, Dept. of Orthopaedic Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minneapolis Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Depuy, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Dept. of Orthopaedic Surgery, Minneapolis VAMC', 'investigatorFullName': 'Terence J. Gioe, M.D.', 'investigatorAffiliation': 'Minneapolis Veterans Affairs Medical Center'}}}}