Post PMA-Approval Study: New Enrollment Post PMA-Approval Study Post-approval Study Group (New Enrollment)
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis, Orthopedic |
Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | Any |
Updated: | 1/7/2017 |
Start Date: | April 2008 |
End Date: | December 2011 |
Cormet Resurfacing Hip System Post PMA-Approval Study Post-approval Study Group (New Enrollment)
The primary objective of this study is to evaluate the performance of the Cormet Hip
Resurfacing implant system in the post-approval environment.
Resurfacing implant system in the post-approval environment.
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).
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).
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).
We found this trial at
6
sites
Click here to add this to my saved trials
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials