Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis

Stopped early · Not applicable

Conditions studied: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Post-traumatic Arthritis

In brief

This study is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension® MCP.

Key facts

Study ID

NCT02408471

Run by

Smith & Nephew, Inc.

People needed

97

Starts

2002-06-01

Expected to finish

2015-01-01

Last updated by the study team

2023-10-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southwest Shoulder Elbow and Hand Center, P.C. — Tucson, Arizona, United States
• Bloomington Bone and Joint Clinic — Bloomington, Indiana, United States
• Reconstructive Hand Surgeons of Indiana — Carmel, Indiana, United States
• The Indiana Hand Center — Indianapolis, Indiana, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• The Center for Ortho/ Neuro Care & Research — Bend, Oregon, United States
• ROC Houston, PA — Houston, Texas, United States
• Fondren Orthopedic Group, L.L.P. — Houston, Texas, United States
• The Hand Center of San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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