Cormet Post-PMA Study: New Enrollment
Completed · Not applicable
Conditions studied: Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
In brief
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
Key facts
- Study ID
- NCT00722007
- Run by
- Corin
- People needed
- 147
- Starts
- 2008-04-24
- Expected to finish
- 2014-05-12
- Last updated by the study team
- 2019-07-02
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- George Washington University — Washington D.C., District of Columbia, United States
- Florida Orthopaedic Institute — Tampa, Florida, United States
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States
- Lattimore Orthopaedics P.C. — Rochester, New York, United States
- Willamette Orthopedic Group LLC — Salem, Oregon, United States
- Memorial Bone and Joint Clinic — Houston, Texas, United States
Full record on ClinicalTrials.gov
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