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
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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