Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
Status: | Terminated |
---|---|
Conditions: | Arthritis, Lupus, Osteoarthritis (OA), Rheumatoid Arthritis |
Therapuetic Areas: | Immunology / Infectious Diseases, Rheumatology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 8/9/2017 |
Start Date: | February 2002 |
End Date: | January 2017 |
Post-Approval Study Protocol; Ascension® MCP Finger Implant; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
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
- 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
- Skin, bone, circulatory and/or neurological deficiency at the implantation site
We found this trial at
9
sites
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