Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-04 @ 8:55 AM
Study NCT ID:
NCT03385759
Status:
UNKNOWN
Last Update Posted:
2022-11-14
First Post:
2017-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Unicompartmental Versus 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'}]}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2017-12-21', 'studyFirstSubmitQcDate': '2017-12-27', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Society Score', 'timeFrame': '1 year', 'description': 'Functional outcome questionnaire ranging from 0-100, with 100 being best'}, {'measure': 'Knee Society Score', 'timeFrame': '2 years', 'description': 'Functional knee outcome questionnaire ranging from 0-100, with 100 being best'}], 'secondaryOutcomes': [{'measure': 'Revision', 'timeFrame': '2 years', 'description': 'complication requiring revision surgery'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['unicompartmental knee', 'total knee arthroplasty', 'osteoarthritis'], 'conditions': ['Osteo Arthritis Knee']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, randomized trial to compare patient outcomes of unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) for the treatment of medial compartment osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medial compartment osteoarthritis of the knee\n* knee flexion greater than greater than 90 degrees\n* flexion contracture of less than 10 degrees\n* varus deformity \\< 20 degrees\n* grade IV degeneration of the medial compartment\n\nExclusion Criteria:\n\n* lateral compartment degenerative changes\n* previous lateral meniscectomy\n* anterior cruciate ligament deficiency\n* body mass index \\> 40\n* inflammatory arthritis\n* history of septic arthritis\n* hemoglobin A1c \\> 8.0\n* chronic liver disease\n* stage 3A or greater chronic renal disease\n* active IV drug abuse\n* patients requiring thromboembolic prophylaxis'}, 'identificationModule': {'nctId': 'NCT03385759', 'briefTitle': 'Trial of Unicompartmental Versus Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Anderson Orthopaedic Research Institute'}, 'officialTitle': 'A Prospective Randomized Trial of Unicompartmental Versus Total Knee Arthroplasty for the Treatment of Medial Compartment Osteoarthritis', 'orgStudyIdInfo': {'id': '17-2931'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'UKA', 'description': 'Medial unicompartmental knee arthroplasty', 'interventionNames': ['Procedure: Unicompartmental knee arthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TKA', 'description': 'Total knee arthroplasty', 'interventionNames': ['Procedure: Total knee arthroplasty']}], 'interventions': [{'name': 'Unicompartmental knee arthroplasty', 'type': 'PROCEDURE', 'description': 'Implant to replace the medial compartment of a patient with knee osteoarthritis', 'armGroupLabels': ['UKA']}, {'name': 'Total knee arthroplasty', 'type': 'PROCEDURE', 'description': 'Implant to replace the knee joint of a patient with knee osteoarthritis', 'armGroupLabels': ['TKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '22306', 'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'Anderson Orthopaedic Research Institute', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}], 'overallOfficials': [{'name': 'Kevin Fricka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anderson Orthopaedic Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anderson Orthopaedic Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rush University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sr. Project Director', 'investigatorFullName': 'Nancy Parks', 'investigatorAffiliation': 'Anderson Orthopaedic Research Institute'}}}}