A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Biomet Orthopedics, LLC
- Enrollment
- 388
- Locations
- 6
- Primary Endpoint
- Survivorship
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
Study Objective To 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. Study Design The study is designed as a prospective, multi-center, non-randomized post approval study. There are two phases to this study: 1. A complications study where patients will be followed for at least 2 years to record all complications that may occur, and 2. 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. Phase 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. Phase 2 (3-9 year) only gathers survival data through patient directed mailing and/or phone call.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with one of the following diagnoses in the medial compartment of the knee: Osteoarthritis, Avascular Necrosis
Exclusion Criteria
- •Patients with Rheumatoid arthritis or other forms of inflammatory joint disease
- •Patients with infection, sepsis, and osteomyelitis
- •Patients with Osteoporosis, Paget's Disease, Charcot's disease, Osteomalacia, and Severe Osteoporosis
Outcomes
Primary Outcomes
Survivorship
Time Frame: Annually for 9 years post-op
Assessment of frequency of Revisions
Secondary Outcomes
- Complications(2 Years)