NCT03511586Recruiting

Total Shoulder Arthroplasty Multi-Center Registry

Arthrex, Inc.

Start Date

7/28/2015

Completion Date

11/1/2035

Summary

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

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 100 years

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.

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Conditions

Shoulder Arthroplasty

Locations

University of Arizona/Banner Health

Phoenix, Arizona 85006

United States

Banner Medical Group

Phoenix, Arizona 85016

United States

Scottsdale, Arizona

United States

Denver, Colorado

United States

University of Connecticut Health Center

Farmington, Connecticut 06030

United States

Andrews Research & Education Foundation

Gulf Breeze, Florida 32561

United States

Advent Health Orlando

Orlando, Florida

United States

NorthShore University Health System

Evanston, Illinois 60201

United States

The Trustees of Indiana University

Indianapolis, Indiana 46202

United States

The University of Michigan

Ann Arbor, Michigan 48105

United States

Grand Rapids, Michigan

United States

Columbia, Missouri

United States

The Rothman Institute

New York, New York 10022

United States

University of North Carolina

Chapel Hill, North Carolina 27599

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States

Cleveland Shoulder Institute

Beachwood, Ohio 44122

United States

Medford, Oregon

United States

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania

United States

The Hawkins Foundation

Greenville, South Carolina 29615

United States

Germantown, Tennessee

United States

University of Virginia

Charlottesville, Virginia 22903

United States

Virginia Beach, Virginia

United States

Orthopädische Chirurgie München (OCM)

München, 81369

Germany

Schulthess Klinik

Zurich, 8008

Switzerland