Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-01 @ 11:52 AM
Study NCT ID:
NCT00916968
Status:
COMPLETED
Last Update Posted:
2009-07-02
First Post:
2009-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Function and Fit of Standard and Gender-Specific CR High-Flex Total Knee Prostheses
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-01', 'studyFirstSubmitDate': '2009-06-09', 'studyFirstSubmitQcDate': '2009-06-09', 'lastUpdatePostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Society Knee Score', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Implant or bone overhang', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gender specific', 'cruciate retaining', 'total knee arthroplasty', 'Bilateral Osteoarthritis of the knee joint'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.', 'detailedDescription': 'The design features of the gender-specific knee prostheses have been claimed to improve fit and function of total knee arthroplasty in women. The purpose of this prospective, randomized study was to compare functional outcome, radiographic results, range of motion, patients satisfaction, and fit of the femoral component in patients receiving either a standard posterior cruciate-retaining high-flexion (CR-flex) and gender-specific CR-flex total knee prostheses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.\n\nExclusion Criteria:\n\n* Inflammatory arthritis\n* Osteoarthritis effecting hip joint\n* Traumatic arthritis\n* Neurologic disorders affecting motor function of lower extremity\n* foot and ankle disorders limiting ambulation of the patient'}, 'identificationModule': {'nctId': 'NCT00916968', 'acronym': 'CR', 'briefTitle': 'Comparison of Function and Fit of Standard and Gender-Specific CR High-Flex Total Knee Prostheses', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'Comparison of Function and Fit of Standard Posterior Cruciate-Retaining High-Flexion and Gender-Specific Posterior Cruciate-Retaining High-Flexion Total Knee Prostheses A Prospective, Randomized Study', 'orgStudyIdInfo': {'id': '2009-6-9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard CR-Flex', 'interventionNames': ['Device: Standard CR-Flex total knee']}, {'type': 'EXPERIMENTAL', 'label': 'Gender specific CR-Flex', 'interventionNames': ['Device: Gender specific CR-Flex']}], 'interventions': [{'name': 'Standard CR-Flex total knee', 'type': 'DEVICE', 'otherNames': ['Zimmer, Nexgen CR-flex'], 'description': 'total knee implant used for joint replacement surgery of the knee', 'armGroupLabels': ['Standard CR-Flex']}, {'name': 'Gender specific CR-Flex', 'type': 'DEVICE', 'otherNames': ['Gender Specific Nexgen CR-Flex implant'], 'description': 'TKA by Gender specific Nexgen CR-Flex', 'armGroupLabels': ['Gender specific CR-Flex']}]}, '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.', 'oldOrganization': 'Ewha Womans University Mokdong Hospital Joint Replacement Center'}}}}