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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Ascension Orthopedics, Inc.
Sponsor:
Information provided by (Responsible Party):
Ascension Orthopedics, Inc.
ClinicalTrials.gov Identifier:
NCT00825409
First received: January 16, 2009
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Degenerative Arthritis
Post-Traumatic Arthritis
Rheumatoid Arthritis
Device: Carbon Modular Radial Head
Device: Metal Radial Head

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Ascension Orthopedics, Inc.:

Primary Outcome Measures:
  • The proportion of patient successes with the Carbon Modular Radial Head at the 2-year evaluation is no lower than the proportion of patient successes with the Metal Radial Head (delta less than or equal to .06) [ Time Frame: 2-year evaluation ] [ Designated as safety issue: No ]

Estimated Enrollment: 203
Study Start Date: January 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Carbon Modular Radial Head
Device: Carbon Modular Radial Head
Surgery with radial head replacement.
Other Name: Ascension CMRH
Active Comparator: 2
Metal Radial Head
Device: Metal Radial Head
Surgery with radial head replacement.
Other Name: Ascension MRH

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825409

Contacts
Contact: Candi Langmaid, MPH 512-852-3935 candi.langmaid@integralife.com

Locations
United States, Arkansas
Summit Medical Center Withdrawn
Van Buren, Arkansas, United States, 72957
United States, California
Scripps Clinic Terminated
La Jolla, California, United States, 92037
United States, Colorado
Orthopedic Center of the Rockies Recruiting
Fort Collins, Colorado, United States, 80525
Contact: Nik Allain    970-493-4084      
Principal Investigator: Satoru Chamberlain, M.D.         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Aimee Struck    352-273-7419      
Principal Investigator: Thomas W. Wright, M.D.         
Sub-Investigator: Paul C. Dell, M.D.         
Sub-Investigator: Kevin W. Farmer, M.D.         
Sub-Investigator: Larry Keith Chidgey, M.D.         
Sub-Investigator: Deenesh Sahajpal, M.D.         
United States, Illinois
Rockford Orthopedics Associates Recruiting
Rockford, Illinois, United States, 61107
Contact: Shelly Kopinski    815-381-7457      
Principal Investigator: Kenneth Korcek, M.D.         
Sub-Investigator: Brain Bear, M.D.         
Sub-Investigator: Edric Schwartz, M.D.         
United States, Indiana
Parkview Health Active, not recruiting
Fort Wayne, Indiana, United States, 46845
Saint Joseph Regional Medical Center Recruiting
South Bend, Indiana, United States, 46617
Contact: Korie Whitfield    574-247-9441      
Principal Investigator: Adelbert Mencias, M.D.         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Sharon Bradshaw    913-945-6289      
Principal Investigator: Bruce Toby, M.D.         
Sub-Investigator: John Sojka, M.D.         
Sub-Investigator: Archie Heddings, M.D.         
Sub-Investigator: Michael Tilley, M.D.         
United States, Kentucky
Saint Joseph East Hospital Terminated
Lexington, Kentucky, United States, 40509
United States, North Carolina
Mission Health System Recruiting
Asheville, North Carolina, United States, 28801
Principal Investigator: Gordon Groh, MD         
United States, Ohio
Kettering Health Network Suspended
Kettering, Ohio, United States, 45429
United States, Pennsylvania
Rothman Institute Orthopedics Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Bethany Worobey, MS    267-339-3615    Bethany.Worobey@rothmaninstitute.com   
Principal Investigator: Charles L Getz, MD         
Sub-Investigator: Matthew L Ramsey, MD         
Sub-Investigator: Joesph A Abboud, MD         
Sub-Investigator: Pedro K Beredjiklian, MD         
Sub-Investigator: Asif M Ilyas, MD         
United States, Texas
Texas Orthopedic Hospital Recruiting
Houston, Texas, United States, 77030
Principal Investigator: James H. Bennett, MD         
Sub-Investigator: Thomas L. Mehlhoff, MD         
Baylor College of Medicine Withdrawn
Houston, Texas, United States, 77030
United States, Washington
University of Washington Medical Center Terminated
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Ascension Orthopedics, Inc.
  More Information

No publications provided

Responsible Party: Ascension Orthopedics, Inc.
ClinicalTrials.gov Identifier: NCT00825409     History of Changes
Other Study ID Numbers: CP-RH-002
Study First Received: January 16, 2009
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ascension Orthopedics, Inc.:
radial head arthroplasty
pyrocarbon
Primary replacement after fracture of the radial head
Relief of symptoms after radial head resection
Revision of failed radial head arthroplasty

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014