A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System

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