Ascension® MCP Post-Approval Study

Last updated: January 6, 2014
Sponsor: Ascension Orthopedics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Musculoskeletal Diseases

Lupus

Systemic Lupus Erythematosus

Treatment

N/A

Clinical Study ID

NCT01398735
CP-MCP-002
  • Ages 18-85
  • Both

Study Summary

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

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

Total Participants: 100
Study Start date:
February 01, 2002
Estimated Completion Date:
May 31, 2015

Connect with a study center

  • Southwest Shoulder, Elbow and Hand Center

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Bloomington Bone and Joint Clinic

    Bloomington, Indiana 47403
    United States

    Active - Recruiting

  • Reconstructive Hand Surgeons of Indiana

    Carmel, Indiana 46032
    United States

    Completed

  • Indiana Hand Center

    Indianapolis, Indiana 46260
    United States

    Completed

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Completed

  • The Center

    Bend, Oregon 97701
    United States

    Active - Recruiting

  • Fondren Orthopedic Group

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Park Plaza Hospital and Medical Center

    Houston, Texas 77004
    United States

    Site Not Available

  • Hand Center of San Antonio

    San Antonio, Texas 78240
    United States

    Site Not Available

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