Status:
COMPLETED
Cormet Post-PMA Study: New Enrollment
Lead Sponsor:
Corin
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
Phase:
NA
Brief Summary
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 24 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2014
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00722007
Start Date
April 24 2008
End Date
May 12 2014
Last Update
July 2 2019
Active Locations (6)
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1
George Washington University
Washington D.C., District of Columbia, United States, 20006
2
Florida Orthopaedic Institute
Tampa, Florida, United States, 33637
3
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
4
Lattimore Orthopaedics P.C.
Rochester, New York, United States, 14620