Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-17 @ 10:27 PM
Study NCT ID:
NCT03668756
Status:
COMPLETED
Last Update Posted:
2018-09-13
First Post:
2018-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-12', 'studyFirstSubmitDate': '2018-09-11', 'studyFirstSubmitQcDate': '2018-09-12', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Knee Society (IKS)', 'timeFrame': 'up to 8-year follow-up', 'description': 'To assess the functional outcome of TKA by self-explanatory questionnaire'}], 'secondaryOutcomes': [{'measure': 'Radiographic evaluation', 'timeFrame': 'Baseline and 3 months after operation', 'description': 'Standard anteroposterior, lateral radiographs of the knee and standing long-leg radiographs of the lower extremity were obtained pre- and postoperatively. The lower extremities were fully extended so that the tibial tuberosities were facing forward and the lateral malleoli were 15 cm apart to ensure that the tibia was vertical and facing forward with minimal rotation. The X-ray beam (20-25 mA/s; 80-85 kV) was centered at the knee joint level at a distance of 120-140 cm.Radiographic data included the mechanical axis angle and the four component alignments described by Ewald: the femoral valgus (FV) angle; tibial valgus angle (TV); femoral flexion (FF) angle; and tibial flexion angle (TF)'}, {'measure': 'Hospital for Special Surgery (HSS) Questionnaire', 'timeFrame': 'Baseline, 8-year follow-up', 'description': 'To assess the functional outcome of TKA by self-explanatory questionnaire'}, {'measure': 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC)', 'timeFrame': 'Baseline, 8-year follow-up', 'description': 'To assess the functional outcome of TKA by self-explanatory questionnaire'}, {'measure': 'Short Form-36 (SF-36) Health Survey', 'timeFrame': 'Baseline, 8-year follow-up', 'description': 'To assess the functional outcome of TKA by self-explanatory questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthropathy of Knee Joint']}, 'descriptionModule': {'briefSummary': 'To compare the functional outcomes of Computer-Assisted Navigation (CAS) and Conventional Instrumentation TKA at the 8-year follow-up.', 'detailedDescription': 'The data of the present study was collected from the review of the medical chart of the patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive Computer-Assisted Navigation (CAS) TKA in one limb and conventional TKA. Then, comparing the functional outcomes of CAS and Conventional Instrumentation was performed by statistical software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03668756', 'briefTitle': 'Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty: The Functional Outcome of Mid-Term Follow-up Study', 'orgStudyIdInfo': {'id': 'CORPG6G0251'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Computer-Assisted Navigation TKA', 'description': 'the patients who were received CAS TKA in one limb', 'interventionNames': ['Procedure: Computer-Assisted Navigation TKA']}, {'label': 'Conventional TKA', 'description': 'the patients who were received conventional TKA in one limb'}], 'interventions': [{'name': 'Computer-Assisted Navigation TKA', 'type': 'PROCEDURE', 'description': 'TKAs were performed using the image-free CAS navigation system VectorVision', 'armGroupLabels': ['Computer-Assisted Navigation TKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '613', 'city': 'Pizi', 'country': 'Taiwan', 'facility': 'Sports Medicine Center, Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.95389, 'lon': 120.42361}}], 'overallOfficials': [{'name': 'Robert Wen-Wei HSU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}