Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:39 PM
Study NCT ID:
NCT00289094
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2006-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'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'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], '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': 'TOdell2@its.jnj.com', 'phone': '574-372-7104', 'title': "Tammy O'Dell, EMT, CCRA", 'organization': 'DePuy Orthopaedics, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Rotating Platform', 'description': 'P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Fixed Bearing', 'description': 'P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Femoral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Cardiacvascular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Knee Society Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotating Platform', 'description': 'P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.'}, {'id': 'OG001', 'title': 'Fixed Bearing', 'description': 'P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.'}], 'classes': [{'title': 'Pre-operative', 'categories': [{'measurements': [{'value': '40.8', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '43.4', 'spread': '23.0', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '84.3', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '77.8', 'spread': '14.9', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '86.4', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '86.4', 'spread': '10.0', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '89.7', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '88.1', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '92.3', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '87.1', 'spread': '10.4', 'groupId': 'OG001'}]}]}, {'title': '48 months', 'categories': [{'measurements': [{'value': '94.3', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '86.0', 'spread': '14.7', 'groupId': 'OG001'}]}]}, {'title': '60 months', 'categories': [{'measurements': [{'value': '95.0', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '95.5', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.', 'description': 'The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \\< 60 = poor.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications/Revisions', 'timeFrame': 'On-going to end of study.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Medical Imaging', 'timeFrame': 'Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'SF-12 Patient Outcomes', 'timeFrame': 'Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rotating Platform', 'description': 'P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.'}, {'id': 'FG001', 'title': 'Fixed Bearing', 'description': 'P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}]}]}], 'recruitmentDetails': 'Two US clinical centers performed 99 primary knee replacements in 86 subjects. Recruitment was based on the inclusion and exclusion criteria as specified in the clinical investigation plan.', 'preAssignmentDetails': 'Immediately before surgery, the implant type was determined according to the randomization schedule. Before treatment assignment, consented subjects could be excluded from the trial based on results of pre-operative clinical evaluations and/or radiographs, as per the exclusion criteria in the CIP.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rotating Platform', 'description': 'P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.'}, {'id': 'BG001', 'title': 'Fixed Bearing', 'description': 'P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.7', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '66.9', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '65.3', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2007-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2006-02-07', 'resultsFirstSubmitDate': '2010-09-29', 'studyFirstSubmitQcDate': '2006-02-07', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-11-12', 'studyFirstPostDateStruct': {'date': '2006-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Society Scores', 'timeFrame': 'Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.', 'description': 'The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \\< 60 = poor.'}], 'secondaryOutcomes': [{'measure': 'Complications/Revisions', 'timeFrame': 'On-going to end of study.'}, {'measure': 'Medical Imaging', 'timeFrame': 'Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.'}, {'measure': 'SF-12 Patient Outcomes', 'timeFrame': 'Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Rheumatoid Arthritis', 'Post-traumatic Arthritis', 'Juvenile Rheumatoid Arthritis', 'Avascular Necrosis of Bone']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.', 'detailedDescription': 'This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoarthritis\n* Rheumatoid Arthritis\n* Other inflammatory arthritis\n* Avascular necrosis of bone\n\nExclusion Criteria:\n\n* Prior ipsilateral TKA\n* Metabolic disorders\n* Joint replacement due to autoimmune disorders'}, 'identificationModule': {'nctId': 'NCT00289094', 'briefTitle': 'Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy Orthopaedics'}, 'officialTitle': 'Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases', 'orgStudyIdInfo': {'id': 'SRP-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System', 'interventionNames': ['Device: Total Knee Replacement']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System', 'interventionNames': ['Device: Total knee replacement']}], 'interventions': [{'name': 'Total Knee Replacement', 'type': 'DEVICE', 'otherNames': ['P.F.C.® Sigma™ RP Cruciate Retaining Knee System'], 'description': 'Rotating Platform (RP) Cruciate Retaining Knee System', 'armGroupLabels': ['1']}, {'name': 'Total knee replacement', 'type': 'DEVICE', 'otherNames': ['P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System'], 'description': 'Fixed Cruciate Retaining Knee System', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '98664', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}], 'overallOfficials': [{'name': "Tammy L O'Dell, EMT, CCRA, CCRC", 'role': 'STUDY_DIRECTOR', 'affiliation': 'DePuy Orthopaedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}