Cormet Post-PMA Study: New Enrollment (PASNew)

This is an interventional treatment trial for Osteoarthritis focused on measuring hip resurfacing, osteoarthritis, avascular necrosis, rheumatoid arthritis Read More

Inclusion Criteria:

• Male or female patient who meets eligibility criteria consistent with product labeling
• skeletally mature
• mentally capable of completing follow-up forms
• Will be available for follow-up out to 2 years and annually thereafter until the last patient reaches the two-year evaluation
• Has been deemed a candidate for hip replacement by diagnosis of the investigator
• consented to participate in the clinical study

Exclusion Criteria:

• Patient with active or suspected infection in or around the hip joint;
• Patient with bone stock inadequate to support the device
• Patient with severe osteopenia
• Patient with a family history of severe osteoporosis or severe osteopenia;
• Patient with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT Grade)
• Patient with multiple cysts of the femoral head (>1cm)
• In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.
• Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery;
• Female of child-bearing age due to unknown effects on the fetus of metal ion release.
• Patient with known moderate or severe renal insufficiency;
• Patient who is immunosuppressed with diseases such as AIDS or person receiving high doses of corticosteroids;
• Patient who is severely overweight;
• Patient with known or suspected metal sensitivity (e.g., jewelry).