Cormet Post-PMA Study: New Enrollment (PASNew)

Corin

Status

Completed

Conditions

Osteoarthritis

Avascular Necrosis

Rheumatoid Arthritis

Treatments

Device: Cormet Hip Resurfacing

Study type

Interventional

Funder types

Industry

Identifiers

NCT00722007

Cormet (P050016) New Enroll

Details and patient eligibility

About

The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.

Full description

This study tracks the performance of the Cormet Hip Resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market IDE setting as compared to the post-approval setting. Specifically this study will compare the proportion of subjects achieving a Month 24 composite clinical success (CCS) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the IDE subjects' performance on CCS as reported in the Pre-Market Application (PMA).

Enrollment

147 patients

Sex

All

Volunteers

No Healthy Volunteers

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).