Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-27 @ 1:23 PM
Study NCT ID:
NCT00699257
Status:
TERMINATED
Last Update Posted:
2017-06-21
First Post:
2008-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Investigation of the Oxford® Partial Knee System
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2008-06-13', 'studyFirstSubmitQcDate': '2008-06-13', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Society Score', 'timeFrame': '6 weeks, 3 months, 1 year, 3 years, 5 years'}, {'measure': 'Oxford-12 Self Assessment Form', 'timeFrame': '6 weeks, 3 months, 1 year, 3 years, 5 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of revisions and removals', 'timeFrame': 'Any time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Partial Knee Arthroplasty', 'Partial Knee Replacement', 'Arthritis of Medial Compartment of the Knee', 'Oxford Knee'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective data collection is to document the performance and clinical outcomes of the Oxford® Partial Knee System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that have already made the decision to undergo knee surgery and will receive the Oxford® Partial Knee System.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* For use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. The implant is intended to be implanted with bone cement.\n\nExclusion Criteria:\n\n* Infection\n* Use in the lateral compartment of the knee\n* Rheumatoid arthritis or other forms of inflammatory joint disease\n* Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture\n* Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device\n* Disease or damage to the lateral compartment of the knee\n* Uncooperative patient or patient with neurologic disorders who is incapable of following directions\n* Osteoporosis\n* Metabolic disorders which may impair bone formation\n* Osteomalacia\n* Distant foci of infections which may spread to the implant site\n* Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram\n* Vascular insufficiency, muscular atrophy, neuromuscular disease\n* Incomplete or deficient soft tissue surrounding the knee\n* Charcot's disease\n* A fixed varus deformity (not passively correctable) of greater than 15 degrees\n* A flexion deformity greater than 15 degrees"}, 'identificationModule': {'nctId': 'NCT00699257', 'briefTitle': 'A Clinical Investigation of the Oxford® Partial Knee System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Prospective, Non-controlled, Clinical Investigation of the Oxford® Partial Knee System', 'orgStudyIdInfo': {'id': 'Biomet 12380-63'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oxford® Partial Knee System'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kenneth J Beres, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Research, Biomet Orthopedics, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomet Orthopedics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}