Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-02-11 @ 6:45 AM
Study NCT ID:
NCT01312532
Status:
COMPLETED
Last Update Posted:
2011-03-10
First Post:
2011-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-06', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-09', 'studyFirstSubmitDate': '2011-03-09', 'studyFirstSubmitQcDate': '2011-03-09', 'lastUpdatePostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Society Scoring', 'timeFrame': 'five years after surgery', 'description': 'was used for evaluating the function of the knee and high scores indicated better knee function'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'five years after surgery', 'description': 'Pain was evaluated with a Visual Analogue Scale (VAS) with scores ranging from zero to 10ten (0 for no pain and 10 for intolerable pain).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Total knee arthroplasty', 'Fixed-bearing', 'Mobile-bearing'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://mui.ac.ir', 'label': 'Isfahan university of medical sciences'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine which prosthesis is better in total knee arthroplasty', 'detailedDescription': 'Theoretical advantages of mobile-bearing devices led surgeons to use these prostheses instead of fixed-bearing devices as traditional implants. This study was designed to compare Fixed-bearing versus Mobile-bearing Prosthesis in Total Knee Arthroplasty through a five-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with expected primary total knee arthroplasty\n\nExclusion Criteria:\n\n* Mediolateral instability\n* Infective arthritis\n* Severe deformity\n* Revision'}, 'identificationModule': {'nctId': 'NCT01312532', 'briefTitle': 'Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Study of Prosthesis in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'ASD-1213-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'fixed-bearing', 'description': 'fixed-bearing device is a kind of prosthesis', 'interventionNames': ['Device: fixed-bearing (P.F.C.® Sigma)']}, {'type': 'OTHER', 'label': 'mobile-bearing', 'description': 'mobile-bearing device is a kind of prosthesis', 'interventionNames': ['Device: mobile-bearing (P.F.C.® Sigma)']}], 'interventions': [{'name': 'fixed-bearing (P.F.C.® Sigma)', 'type': 'DEVICE', 'description': 'P.F.C.® Sigma, DePuy, Johnson \\& Johnson, Leeds, UK', 'armGroupLabels': ['fixed-bearing']}, {'name': 'mobile-bearing (P.F.C.® Sigma)', 'type': 'DEVICE', 'description': 'P.F.C.® Sigma, DePuy, Johnson \\& Johnson, Leeds, UK', 'armGroupLabels': ['mobile-bearing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'state': 'Isfahan', 'country': 'Iran', 'facility': 'Al-zahra university hospital', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'overallOfficials': [{'name': 'mohammad dehghani, A.Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Isfahan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Alireza Yousefy, Associate Professor of Medical Education', 'oldOrganization': 'Isfahan University of Medical Sciences'}}}}