R3® Acetabular System in Patients With Degenerative Hip Disease

This clinical study can fulfill its objectives only if appropriate subjects are enrolled. All relevant medical and non-medical conditions should be taken into consideration when deciding whether a particular patient is suitable.

Inclusion Criteria:

• Patient is of legal age to consent and skeletally mature.
• Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, and dysplasia/DDH)
• Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk.
• The patient will be available for follow-up throughout the duration of the study.

Exclusion Criteria:

• Patient has active infection or sepsis (treated or untreated)
• Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
• Patient is pregnant or plans to become pregnant during the course of the study Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
• Patient has inflammatory joint disease (e.g. rheumatoid arthritis)
• Patient has known moderate to severe renal insufficiency.
• Patient has a known or suspected metal sensitivity.
• Patient is immunosuppressed or receiving high doses of corticosteroids.
• Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse.
• Patient has BMI >40.
• Patient is a prisoner