Rheumatoid Arthritis Clinical Trial
— CMRHOfficial title:
Safety and Effectiveness Study of Ascension PyroCarbon Radial Head Compared to Ascension Metal Radial Head
NCT number | NCT02405234 |
Other study ID # | CP-RH-002 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2009 |
Est. completion date | January 2017 |
Verified date | August 2017 |
Source | Smith & Nephew, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 78 |
Est. completion date | January 2017 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Hand Center of Southwestern Ohio | Dayton | Ohio |
United States | University of Florida Orthopedic and Rehabilitation | Gainesville | Florida |
United States | Texas Orthopedic Hospital | Houston | Texas |
United States | The Rothman Institute | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Smith & Nephew, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of patient successes with the Carbon Modular Radial Head vs patient successes with the Metal Radial Head as assessed by implant survival | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
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