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

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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.


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
Indianapolis, Indiana 46260
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Indianapolis, IN
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Bend, OR
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Bloomington, Indiana 47403
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Bloomington, IN
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Carmel, IN
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Houston, Texas 77004
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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San Antonio, Texas 78240
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San Antonio, TX
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Tucson, AZ
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