Ascension® MCP Post-Approval Study
Status: | Completed |
---|---|
Conditions: | Arthritis, Lupus, Osteoarthritis (OA), Rheumatoid Arthritis |
Therapuetic Areas: | Immunology / Infectious Diseases, Rheumatology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 7/11/2015 |
Start Date: | February 2002 |
End Date: | May 2015 |
Contact: | Candi Langmaid, MPH |
Email: | candi.langmaid@integralife.com |
Phone: | 512-852-3935 |
Ascension® MCP Finger Implant Post-Approval Study
This study is a non-randomized, consecutive enrollment, one-year post-approval study of
patients who are treated with the Ascension MCP.
patients who are treated with the Ascension MCP.
Inclusion Criteria:
• Indications consistent with the FDA approved Indications For Use: Index, long, ring, or
small finger metacarpophalangeal (MCP) joints that exhibit symptoms of pain, limited
motion, or inadequate bony alignment (i.e., subluxation/dislocation) secondary to
articular destruction or degenerative disease related to rheumatoid arthritis, systemic
lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue
reconstruction can provide adequate stabilization;
- Willing to participate in the study;
- Signed an Informed Consent Form
- The means and ability to return for all required study visits; and
- Are not transient.
Exclusion Criteria:
Patients who have any of the following contraindications will be excluded from the study:
- Inadequate bone stock at the implantation site;
- Active infection in the MCP joint;
- Nonfunctioning and irreparable MCP musculotendinous system;
- Physical interference with or by other prostheses during implantation or use;
- Procedures requiring modification of the prosthesis; or
- Skin, bone, circulatory and/or neurological deficiency at the implantation site.
We found this trial at
9
sites
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials