Phase
Condition
Rheumatoid Arthritis
Bone Diseases
Joint Injuries
Treatment
N/AClinical Study ID
Ages 18-85 Both
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
• Indications consistent with the FDA approved Indications For Use: Index, long, ring, orsmall finger metacarpophalangeal (MCP) joints that exhibit symptoms of pain, limitedmotion, or inadequate bony alignment (i.e., subluxation/dislocation) secondary toarticular destruction or degenerative disease related to rheumatoid arthritis, systemiclupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissuereconstruction 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
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.
Study Design
Connect with a study center
Southwest Shoulder, Elbow and Hand Center
Tucson, Arizona 85712
United StatesSite Not Available
Bloomington Bone and Joint Clinic
Bloomington, Indiana 47403
United StatesActive - Recruiting
Reconstructive Hand Surgeons of Indiana
Carmel, Indiana 46032
United StatesCompleted
Indiana Hand Center
Indianapolis, Indiana 46260
United StatesCompleted
Mayo Clinic
Rochester, Minnesota 55905
United StatesCompleted
The Center
Bend, Oregon 97701
United StatesActive - Recruiting
Fondren Orthopedic Group
Houston, Texas 77030
United StatesActive - Recruiting
Park Plaza Hospital and Medical Center
Houston, Texas 77004
United StatesSite Not Available
Hand Center of San Antonio
San Antonio, Texas 78240
United StatesSite Not Available
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