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 |
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.
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
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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