Durom(R) Hip Resurfacing System Multicenter Trial

Exclusion Criteria

• •Patient with an acute, chronic, local or systemic infection.
• •Patient who is skeletally immature.
• •Patient with a severe muscular, neural or vascular disease that endangers the involved extremity.
• •Patient with an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible, including but not limited to:
• •* patient with severe osteopenia
• •* patients with a family history of severe osteoporosis or osteopenia
• •* patients with osteonecrosis or avascular necrosis (AVN) with \> 50% involvement of the femoral head (regardless of FICAT grade)
• •* patients with multiple cysts of the femoral head \> 1cm
• •Patient with total or partial absence of the muscular of ligamentous apparatus.
• •Patient has known moderate to severe renal insufficiency.
• •Patient with a known clinical condition which may interfere with patient outcome, including but not limited to:
• •* immuno-compromised conditions (AIDS),
• •* organ transplant recipient,
• •* high doses of corticosteroids etc
• •Patient who is severely overweight (BMI \>40)
• •Operative (ipsilateral) Hip: Patient has a total prosthetic hip replacement device, surface arthroplasty or endoprosthesis.
• •Contralateral Hip: Patient has had hip replacement, surface arthroplasty or endoprosthesis, within the past 12 months, unless already enrolled in this investigational study.
• •Patient who is:
• •* a prisoner
• •* mentally incompetent
• •* a known alcohol or drug abuser
• •* anticipated to be non-compliant
• •Patient who has participated in a study of any other investigational device (drug, device or biologic) within the past 12 months. Exception: previous enrollment in the Durom Hip Resurfacing System clinical study.
• •Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.