A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System



Status:Active, not recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:9/9/2018
Start Date:March 2006
End Date:June 2019

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

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.

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.

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
We found this trial at
6
sites
Bedford, Texas 76021
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Bedford, TX
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927 Cordova Station Avenue
Cordova, Tennessee 38018
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Cordova, TN
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New Albany, Ohio 43054
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New Albany, OH
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Plano, TX
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Richmond, Virginia 23294
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Richmond, VA
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929 West Higgins Road
Schaumburg, Illinois 60195
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Schaumburg, IL
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