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

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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.


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
Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Bend, Oregon 97701
712
mi
from 91732
Bend, OR
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Bloomington, Indiana 47403
1771
mi
from 91732
Bloomington, IN
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1795
mi
from 91732
Carmel, IN
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1357
mi
from 91732
Houston, TX
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Indianapolis, Indiana 46260
1792
mi
from 91732
Indianapolis, IN
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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...
1524
mi
from 91732
Rochester, MN
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San Antonio, Texas 78240
1188
mi
from 91732
San Antonio, TX
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426
mi
from 91732
Tucson, AZ
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