Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-03 @ 7:30 AM
Study NCT ID:
NCT01751334
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2012-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-13', 'studyFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2012-12-13', 'lastUpdatePostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tibial anteroposterior axis relative to femoral anteroposterior axis', 'timeFrame': 'postoperative 2 weeks', 'description': 'Tibial anteroposterior axis relative to femoral anteroposterior axis on Computed tomogram images'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arthroplasty', 'Replacement', 'Knee', 'Rotational Alignment'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its variability was investigated in this study in order to determine whether a certain landmark could be employed as a reference axis for the proximal tibia after rotating platform mobile bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).', 'detailedDescription': 'Reference of tibial AP axis for implanting tibial component in total knee arthroplasty have not been concluded. This study can suggest appropriate method for alingning the tibial component to accurate tibial AP axis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary osteoarthritis\n\nExclusion Criteria:\n\n* infection\n* inflammatory arthritis\n* reoperation\n* severe deformity'}, 'identificationModule': {'nctId': 'NCT01751334', 'briefTitle': 'Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'SNUHOSKNEE01-RPFLPSF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile Bearing', 'description': 'Mobile bearing total knee arthroplasty', 'interventionNames': ['Device: total knee arthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fixed Bearing', 'description': 'Fixed Bearing total knee arthroplasty', 'interventionNames': ['Device: total knee arthroplasty']}], 'interventions': [{'name': 'total knee arthroplasty', 'type': 'DEVICE', 'otherNames': ['Sigma® RP-F Knee System, Depuy J&J, Warsaw, IN, USA'], 'description': 'Mobile Bearing Total knee Arthroplasty', 'armGroupLabels': ['Mobile Bearing']}, {'name': 'total knee arthroplasty', 'type': 'DEVICE', 'otherNames': ['Nexgen® Legacy® Knee LPS-Flex, Zimmer, Warsaw, IN, USA'], 'description': 'Fixed Total Knee Arthroplasty', 'armGroupLabels': ['Fixed Bearing']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sahnghoon Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Myung Chul Lee, M.D., Ph.D.', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}