A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System

Study Overview
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Brief Summary
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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
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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: A complications study where patients will be followed for at least 2 years to record all complications that may occur, and 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.

Official Title
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A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System

Conditions
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Osteoarthritis, Avascular Necrosis

Intervention / Treatment
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* Device: Oxford® Meniscal Unicompartmental Knee System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oxford® Meniscal Unicompartmental Knee<br>Patients with PKA using the Oxford® Meniscal Unicompartmental Knee System | Device: Oxford® Meniscal Unicompartmental Knee System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship | Assessment of frequency of Revisions | Annually for 9 years post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Patients will be followed for at least 2 years to record all complications that may occur | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unicompartmental Knee, Partial Knee, Knee arthroplasty