Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT01075620
Status:
COMPLETED
Last Update Posted:
2010-02-25
First Post:
2010-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Nonposterior- and Posterior-Stabilized Mobile-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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-24', 'studyFirstSubmitDate': '2010-02-16', 'studyFirstSubmitQcDate': '2010-02-24', 'lastUpdatePostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Society knee score', 'timeFrame': 'at 3 months, 1 year, than annually'}], 'secondaryOutcomes': [{'measure': 'Range of motion', 'timeFrame': 'at 3 months, 1 year, than annually'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rotating platform', 'posterior stabilized', 'non-posterior stabilized'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if there are any clinical or radiographic differences in non-posterior stabilized rotating mobile bearing design versus a posterior stabilized rotating mobile bearing designs.', 'detailedDescription': 'Out comes measures were to determine\n\n1. whether the knee and function scores and the radiographic results of the knees with a PFC Sigma RP knee prosthesis would be better than those with an LCS RP prosthesis.\n2. whether the patients with a PFC RP knee prosthesis would have a better range of knee motion than those with an LCS RP prosthesis.\n3. whether patient satisfaction and preference would be better in the patients having a PFC Sigma RP knee prosthesis than those of patients having an LCS RP knee prosthesis\n4. whether complication rate would be less in the knees with a PFC sigma RP knee prosthesis than in the knees with an LCS RP prosthesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease\n\nExclusion Criteria:\n\n* Inflammatory disease\n* patient with other Lower extremity disease which may affect functional outcome\n* Neurologic disease effecting patients lower extremity\n* Revision surgery\n* Patient not medically cleared for bilateral surgery'}, 'identificationModule': {'nctId': 'NCT01075620', 'briefTitle': 'Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty A Prospective, Randomized Study', 'orgStudyIdInfo': {'id': '2010-2-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PFC sigma RP', 'description': 'Posterior stabilized rotating platform knee (press Fit Condylar Sigma rotating-platform, Depuy, Warsaw, Indiana)', 'interventionNames': ['Device: PFC-Sigma RP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LCS RP', 'description': 'non posterior stabilized Low Contact Stress Rotating-Platform; Depuy, Warsaw, Indiana', 'interventionNames': ['Device: LPS RP']}], 'interventions': [{'name': 'PFC-Sigma RP', 'type': 'DEVICE', 'otherNames': ['PFC sigma RP'], 'description': 'Posterior stabilizing rotating platform total knee components', 'armGroupLabels': ['PFC sigma RP']}, {'name': 'LPS RP', 'type': 'DEVICE', 'otherNames': ['LCS RP'], 'description': 'non-posterior stabilized rotating platform design', 'armGroupLabels': ['LCS RP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yoowang Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ewha Womans University Mokdong Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Young-Hoo, Kim M.D. Professor', 'oldOrganization': 'Ewha Womans University Mokdong Hospital Joint Replacement Center'}}}}