Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-28 @ 1:27 PM
Study NCT ID:
NCT02020057
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2013-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2013-12-13', 'studyFirstSubmitQcDate': '2013-12-18', 'lastUpdatePostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'knee society knee score', 'timeFrame': '3 months, 1 year, and yearly thereafter the operation, until 15 years after the operation', 'description': 'clinical evaluation of knee function by knee score. This knee score will be compared, between preoperative and the latest score, and between the latest scores of study and control group.'}], 'secondaryOutcomes': [{'measure': 'range of motion', 'timeFrame': 'preoperative, 3 months, 1 year, and yearly thereafter the operation until 15 years', 'description': 'this value will be compared between preoperative and the latest value, and between the latest value of study and control groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'To our knowledge, there has been no information on in vivo clinical results of posterior cruciate-substituting arthroplasties using highly cross-linked polyethylene. We evaluated whether the clinical and radiographic results, incidence of post fracture of the tibial polyethylene insert, failure of the locking mechanism of the tibial polyethylene insert, and the incidence of osteolysis would be similar between posterior cruciate-substituting total knee prostheses using conventional and highly cross-linked polyethylene.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties\n\nExclusion Criteria:\n\n* inflammatory arthritis\n* osteoarthritis of the hip causing pain or restricted mobility\n* a foot or ankle disorder which limited walking\n* dementia or a neurological disorder including a past history of stroke which affected mobility'}, 'identificationModule': {'nctId': 'NCT02020057', 'briefTitle': 'Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'Comparison of Highly Cross-Linked and Conventional Polyethylene in Posterior Cruciate-Substituting Total Knee Arthroplasty in the Same Patients', 'orgStudyIdInfo': {'id': 'PSXL'}, 'secondaryIdInfos': [{'id': '2006-32', 'type': 'OTHER', 'domain': 'Institutional Review Board, Dongdaemun Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': 'knee receiving Total knee arthroplasty with conventional polyethylene inserts', 'interventionNames': ['Procedure: Total knee arthroplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Prolong', 'description': 'knee receiving total knee arthroplasty with highly cross linked polyethylene insert', 'interventionNames': ['Procedure: Total knee arthroplasty']}], 'interventions': [{'name': 'Total knee arthroplasty', 'type': 'PROCEDURE', 'description': 'Total knee arthroplasty with standard incision and approach, and cement fixation. Zimmer Nexgen posterior stabilized total knee implants are used.', 'armGroupLabels': ['Conventional', 'Prolong']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Young-Hoo Kim, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ewha Womans University Mokdong Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young Hoo Kim', 'investigatorAffiliation': 'Ewha Womans University'}}}}