Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component

Inclusion Criteria

• Patient selection without bias to race or gender.
• Patient is ≥ 18 and ≤ 65 years of age.
• Female patients only, if
• Actively practicing a contraceptive method, or
• Surgically sterilized, or
• Post-menopausal
• Pre-operative Harris Hip Score ≤ 70.
• Primary surgical hip candidate, suffering from hip pain and/or disability due to degenerative joint disease (inflammatory or non-inflammatory), based on physical examination and history, which may include the following diagnosis:
• Non-inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis or osteoarthritis
• Inflammatory joint disease (IJD), e.g., rheumatoid arthritis
• Patient is willing and able to cooperate in prescribed post-operative therapy.
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
• Patient has participated in the Informed Consent process and has signed an Ethics Committee approved Informed Consent.

Exclusion Criteria

• Patient has an acute, chronic, local or systemic infection.
• Patient is skeletally immature.
• Patient is known to be pregnant.
• Patient has a severe muscular, neural or vascular disease that endangers the involved extremity.
• Patient has 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), or
• patients with local bone tumors and/or cysts of the femoral head > 1 cm
• Patient has a total or partial absence of the muscular or ligamentous apparatus.
• Patient has known moderate to severe renal insufficiency.
• Patient has a known clinical condition which may interfere with the patient's outcome, including but not limited to:
• immunocompromised conditions (AIDS),
• organ transplant,
• high doses of corticosteroids etc
• Patient is severely overweight (BMI > 40)
• Patient is scheduled for simultaneous bilateral total hip replacement.
• OPERATIVE (IPSILATERAL) HIP: Patient has a total prosthetic hip replacement device, surface arthroplasty, endoprosthesis or femoral and/or acetabular osteosynthesis.
• CONTRALATERAL HIP: Patient has had a hip replacement, surface arthroplasty or endoprosthesis, within the past 12 months, unless previously enrolled in this clinical study.
• Patient is:
• a prisoner,
• mentally incompetent,
• a known alcohol or drug abuser,
• anticipated to be non-compliant
• Patient has participated in a study of any other investigational device (drug, device or biologic) within the past 12 months. Exception: previous enrollment in the Zimmer Hip Resurfacing clinical study.
• Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.