Durom(R) Hip Resurfacing System Multicenter Trial

Inclusion Criteria:

• Patient selection without bias to race or gender
• Patient is greater than or equal to 18 and less than or equal to 65 years of age.

• Female patients only:

  • actively practicing a contraceptive method, or
  • surgically sterilized, or
  • post-menopausal
• Pre-operative Harris Hip Score less than or equal to 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, including 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 and IRB approved Informed Consent.

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.