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

Last updated: January 6, 2014
Sponsor: Ascension Orthopedics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Rheumatoid Arthritis

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT00825409
CP-RH-002
  • Ages 18-85
  • Both

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 203
Study Start date:
January 01, 2009
Estimated Completion Date:
July 31, 2015

Connect with a study center

  • Summit Medical Center

    Van Buren, Arkansas 72957
    United States

    Site Not Available

  • Scripps Clinic

    La Jolla, California 92037
    United States

    Terminated

  • Orthopedic Center of the Rockies

    Fort Collins, Colorado 80525
    United States

    Active - Recruiting

  • University of Florida

    Gainesville, Florida 32611
    United States

    Active - Recruiting

  • Rockford Orthopedics Associates

    Rockford, Illinois 61107
    United States

    Active - Recruiting

  • Parkview Health

    Fort Wayne, Indiana 46845
    United States

    Site Not Available

  • Saint Joseph Regional Medical Center

    South Bend, Indiana 46617
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Saint Joseph East Hospital

    Lexington, Kentucky 40509
    United States

    Terminated

  • Mission Health System

    Asheville, North Carolina 28801
    United States

    Active - Recruiting

  • Kettering Health Network

    Kettering, Ohio 45429
    United States

    Suspended

  • Rothman Institute Orthopedics

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Orthopedic Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle, Washington 98105
    United States

    Terminated

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