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

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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.

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).

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
2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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13020 N Telecom Pkwy
Tampa, Florida 33637
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Houston, Texas 77043
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Rochester, New York 14620
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Salem, Oregon 97301
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Washington DC, District of Columbia 20052
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