Safety and Effectiveness Study of Ascension's PyroCarbon Radial Head Compared to Ascension's Metal Radial Head



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 85
Updated:7/11/2015
Start Date:January 2009
End Date:July 2015
Contact:Candi Langmaid, MPH
Email:candi.langmaid@integralife.com
Phone:512-852-3935

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Safety and Effectiveness Study of Ascension's PyroCarbon Radial Head Compared to Ascension's Metal Radial Head to Treat Arthritis, Fractures of the Radial Head, Relief of Symptoms After Radial Head Resection, or Revision of a Failed Radial Head Implant.

The purpose of this study is to determine if the Ascension PyroCarbon Radial Head is safe
and effective in the treatment of arthritis, fractures, symptoms from radial head
resections, and failed radial head implants.


Inclusion Criteria: Patients must need a radial head replacement for:

- Degenerative, post-traumatic or rheumatoid arthritis

- Primary replacement after fracture of the radial head

- Relief of symptoms after radial head resection

- Revision of failed radial head arthroplasty

- Skeletally mature individuals ages 18 - 85

Exclusion Criteria:

- Inadequate bone stock or soft tissue coverage

- Previous open fracture or infection in the joint

- Individuals under age of 18 or over 85 years of age

- Physical interference with or by other prostheses during implantation or use

- Procedures requiring modification of the prosthesis

- Skin, bone, circulatory and/or neurological deficiency at the implantation site

- Prisoners

- Patients on chronic corticosteroid or non-steroidal anti-inflammatory therapy
We found this trial at
15
sites
Rockford, Illinois 61107
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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Asheville, North Carolina 28801
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Asheville, NC
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Fort Collins, Colorado 80525
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Fort Collins, CO
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Fort Wayne, Indiana 46845
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Fort Wayne, IN
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Houston, Texas 77030
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Houston, TX
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Kansas City, KS
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Kettering, Ohio 45429
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Kettering, OH
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10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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La Jolla, CA
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Lexington, Kentucky 40509
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Lexington, KY
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Seattle, WA
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South Bend, Indiana 46617
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South Bend, IN
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Van Buren, Arkansas 72957
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Van Buren, AR
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