A Safety and Efficacy Study of the Birmingham Hip Resurfacing System

This is a post-approval, prospective, non-randomized, longitudinal, unmasked, multi-center,
clinical trial designed to evaluate the longer-term safety and effectiveness of the BHR
system. The data collected will permit clinical evaluation for the device performance in
improving hip pain, function and range of motion through ten years. The study will permit
radiographic evaluation of proper component fixation and alignment maintenance through 10
years post-operative. The incidence of revision is an especially important measure in this
study. Data collected will allow analysis of the implant survivorship.

Inclusion Criteria:

- At least 21 years of age and skeletally mature

- Patients requiring primary hip resurfacing due to:

- Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis,
traumatic arthritis, avascular necrosis, or dysplasia/DDH

- Inflammatory arthritis such as rheumatoid arthritis

- Subject or his/her legal guardian is willing to consent to participate in the study by
signing and dating the approved consent form

- Subject is available for clinical follow-up through at least ten years

- Subject meets none of the exclusion criteria

Exclusion Criteria:

- Subjects with infection or sepsis

- Subjects with any vascular insufficiency, muscular atrophy, or neuromuscular disease
severe enough to compromise implant stability or postoperative recovery

- Female subjects of child-bearing age

- Subjects with bone stock inadequate to support the device

- Subjects with known moderate to severe renal insufficiency

- Subjects with known or suspected metal sensitivity (e.g. jewelry)

- Subjects who are immunosuppressed with diseases such as AIDS or persons receiving high
doses of corticosteroids

- Subjects with psychological or neurological conditions which would pre-empt their
ability or unwillingness to participate in the study

- Subjects who are severely overweight