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.

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

sites

University of Washington Medical Center

1959 NE Pacific St
Seattle, Washington 98195

(206) 598-3300