Total Shoulder Arthroplasty Multi-Center Registry

Last updated: July 27, 2023
Sponsor: Arthrex, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03511586
608
  • Ages 18-100
  • All Genders

Study Summary

The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.

  2. Patient is between the ages of 18 and 100 years.

  3. The patient has a planned primary or revision implantation of an anatomic (hemi-arthroplasty or total arthroplasty) or a reverse shoulder prosthesis system manufactured by Arthrex.

  4. Patient has a standard of care preoperative CT taken within 6 months that has been submitted for Arthrex VIP (Virtual Implant Positioning) planning.

Exclusion Criteria

  1. Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study.

Study Design

Total Participants: 2500
Study Start date:
July 28, 2015
Estimated Completion Date:
November 10, 2027

Study Description

The study is a non-randomized multi-center prospective registry and subjects will be treated according to standard of care at each center. Subjects will be approached for participation in this study after they have made the decision to undergo a primary or revision shoulder arthroplasty procedure. The treating surgeon will obtain verbal consent from the patient for a research coordinator to screen for eligibility. Patients who meet all criteria will be offered enrollment into the study. The total enrollment goal is a minimum of 500 anatomic shoulder arthroplasty and 500 reverse shoulder arthroplasty subjects enrolled in the multi-center registry.

Connect with a study center

  • Orthopädische Chirurgie München (OCM)

    München, 81369
    Germany

    Active - Recruiting

  • Schulthess Klinik

    Zürich, 8008
    Switzerland

    Active - Recruiting

  • Banner Medical Group

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • University of Arizona/Banner Health

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Scottsdale, Arizona
    United States

    Active - Recruiting

  • Denver, Colorado
    United States

    Active - Recruiting

  • University of Connecticut Health Center

    Farmington, Connecticut 06030
    United States

    Terminated

  • Andrews Research & Education Foundation

    Gulf Breeze, Florida 32561
    United States

    Active - Recruiting

  • empty

    Chicago, Illinois
    United States

    Site Not Available

  • empty

    Lexington, Kentucky
    United States

    Site Not Available

  • The University of Michigan

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

  • Grand Rapids, Michigan
    United States

    Active - Recruiting

  • Columbia, Missouri
    United States

    Site Not Available

  • The Rothman Institute

    New York, New York 10022
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Cleveland Shoulder Institute

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • empty

    Chillicothe, Ohio 45601
    United States

    Site Not Available

  • empty

    Cleveland, Ohio
    United States

    Site Not Available

  • Medford, Oregon
    United States

    Active - Recruiting

  • empty

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • The Hawkins Foundation

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • Germantown, Tennessee
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Virginia Beach, Virginia
    United States

    Active - Recruiting

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