Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-24 @ 7:55 AM
Study NCT ID:
NCT00578994
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2007-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2007-12-19', 'studyFirstSubmitQcDate': '2007-12-19', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survivorship', 'timeFrame': 'Annually for 9 years post-op', 'description': 'Assessment of frequency of Revisions'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '2 Years', 'description': 'Patients will be followed for at least 2 years to record all complications that may occur'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Unicompartmental Knee', 'Partial Knee', 'Knee arthroplasty'], 'conditions': ['Osteoarthritis', 'Avascular Necrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect information on complications and survivorship of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.', 'detailedDescription': 'Study Objective\n\nTo provide a prospective 2-year post-operative evaluation of complications and 9-year long-term survivorship analysis of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.\n\nStudy Design\n\nThe study is designed as a prospective, multi-center, non-randomized post approval study. There are two phases to this study:\n\n1. A complications study where patients will be followed for at least 2 years to record all complications that may occur, and\n2. A survival study that will record at yearly intervals out to 9 years whether or not the device is still in place or if it has been removed for any reason.\n\nPhase 1 requires clinical follow-up (0-2 year) and patients will be evaluated at pre-defined intervals up to 2 years post-operative. Information gathered in phase 1 includes all adverse events and survival data.\n\nPhase 2 (3-9 year) only gathers survival data through patient directed mailing and/or phone call.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A Multi-center study conducted in the United States of patients who meet the FDA approved indications for use. The Oxford Meniscal Unicompartmental Knee System is intended for use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and is intended to be implanted with bone cement.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with one of the following diagnoses in the medial compartment of the knee: Osteoarthritis, Avascular Necrosis\n\nExclusion Criteria:\n\n* Patients with Rheumatoid arthritis or other forms of inflammatory joint disease\n* Patients with infection, sepsis, and osteomyelitis\n* Patients with Osteoporosis, Paget's Disease, Charcot's disease, Osteomalacia, and Severe Osteoporosis"}, 'identificationModule': {'nctId': 'NCT00578994', 'briefTitle': 'A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System', 'orgStudyIdInfo': {'id': 'ORTHO.CR.K016'}, 'secondaryIdInfos': [{'id': 'P010014', 'type': 'OTHER', 'domain': 'FDA PMA'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oxford® Meniscal Unicompartmental Knee', 'description': 'Patients with PKA using the Oxford® Meniscal Unicompartmental Knee System', 'interventionNames': ['Device: Oxford® Meniscal Unicompartmental Knee System']}], 'interventions': [{'name': 'Oxford® Meniscal Unicompartmental Knee System', 'type': 'DEVICE', 'description': 'Oxford® Meniscal Unicompartmental Knee System is a medial, unicompartmental knee prosthesis containing three components: a femoral component, a tibial component, and a tibial meniscal bearing.', 'armGroupLabels': ['Oxford® Meniscal Unicompartmental Knee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60195', 'city': 'Schaumburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Barrington Orthopedic Specialissts', 'geoPoint': {'lat': 42.03336, 'lon': -88.08341}}, {'zip': '43054', 'city': 'New Albany', 'state': 'Ohio', 'country': 'United States', 'facility': 'Joint Implant Surgeons', 'geoPoint': {'lat': 40.08117, 'lon': -82.80879}}, {'zip': '38018', 'city': 'Cordova', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Mid-South Orthopedic Associates', 'geoPoint': {'lat': 35.15565, 'lon': -89.7762}}, {'zip': '76021', 'city': 'Bedford', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Orthopedic Specialist', 'geoPoint': {'lat': 32.84402, 'lon': -97.14307}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Center for Joint Replacement', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Advanced Orthopaedic Centers', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Kacy Arnold', 'role': 'STUDY_DIRECTOR', 'affiliation': 'kacy.arnold@zimmerbiomet.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomet Orthopedics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}