Total Shoulder Arthroplasty Multi-Center Registry

August 19, 2026 updated by: Arthrex, Inc.
The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • München, Germany, 81369
        • Recruiting
        • Orthopädische Chirurgie München (OCM)
        • Contact:
          • Patric Raiss, Prof. Dr.
        • Principal Investigator:
          • Patric Raiss, Prof. Dr.
  • Switzerland
      • Zurich, Switzerland, 8008
        • Recruiting
        • Schulthess Klinik
        • Contact:
          • Philipp Moroder, Prof. Dr.
        • Principal Investigator:
          • Philipp Moroder, Prof. Dr.
      • Zurich, Switzerland, 8008
        • Not yet recruiting
        • Universitätsklinik Balgrist
        • Contact:
        • Principal Investigator:
          • Karl Wieser, Prof. Dr.
  • United Kingdom
      • Wigan, United Kingdom, WN1 2NN
        • Recruiting
        • Wrightington Hospital
        • Contact:
        • Principal Investigator:
          • Michael Walton
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • University of Arizona/Banner Health
        • Principal Investigator:
          • Evan Lederman, MD
        • Contact:
          • Saleh Ahmed
          • Phone Number: 1 (602) 839-2000
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Banner Medical Group
        • Contact:
        • Principal Investigator:
          • Samuel Harmsen, MD
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Orthopedic Surgery (Mayo Scottsdale)
        • Principal Investigator:
          • John Tokish, MD
    • Colorado
      • Denver, Colorado, United States, 80220
        • Recruiting
        • HCA Research Institute LLC.
        • Principal Investigator:
          • Benjamin Sears, MD
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Terminated
        • University of Connecticut Health Center
    • Florida
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Kevin Farmer, MD
      • Gulf Breeze, Florida, United States, 32561
        • Recruiting
        • Andrews Research & Education Foundation
        • Principal Investigator:
          • Christopher O'Grady, MD
        • Contact:
      • Orlando, Florida, United States
        • Recruiting
        • Advent Health Orlando
        • Principal Investigator:
          • Russell Huffman, MD
        • Contact:
          • Russell Huffman, MD
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Withdrawn
        • Northshore University Health System
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • The Trustees of Indiana University
        • Contact:
          • Charalampos (Bobby) Lyssikatos
          • Phone Number: 317-278-2565
          • Email: clyssika@iu.edu
        • Principal Investigator:
          • Mark T Dillon, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • The University of Michigan
        • Principal Investigator:
          • Bruce Miller, MD
        • Contact:
          • Chris Coordinator
          • Phone Number: 1 (734) 930-7400
      • Grand Rapids, Michigan, United States
        • Terminated
    • Missouri
      • Columbia, Missouri, United States
        • Terminated
    • New York
      • New York, New York, United States, 10022
        • Terminated
        • The Rothman Institute
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Principal Investigator:
          • Robert Creighton, MD
        • Contact:
          • Kelsey Coordinator
          • Phone Number: 1 (984) 974-5700
      • Winston-Salem, North Carolina, United States, 27157
        • Not yet recruiting
        • Wake Forest University Health Sciences
        • Principal Investigator:
          • Brian Waterman, MD
        • Contact:
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Active, not recruiting
        • Cleveland Shoulder Institute
    • Oregon
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Southern Oregon Orthopedics
        • Principal Investigator:
          • Patrick Denard, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Active, not recruiting
        • Rothman Orthopaedic Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • The Hawkins Foundation
        • Principal Investigator:
          • Stephan Pill, MD
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Campbell Foundation
        • Principal Investigator:
          • Tyler Brolin, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • Brian Werner, MD
        • Contact:
          • Elizabeth Leitch
          • Phone Number: 1 (434) 243-7778
      • Virginia Beach, Virginia, United States, 23462
        • Recruiting
        • Jordan Young Institute
        • Principal Investigator:
          • Justin Griffin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All adult patients who are seeking treatment or are undergoing a shoulder replacement procedure utilizing an Arthrex shoulder arthroplasty prostheses are being invited to participate in this research registry.

Description

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 (not required for acute humeral fractures).

Exclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: 10 years
Measure of pain intensity. This is done with the Visual Analog Scare. (VAS)
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthrex, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2015

Primary Completion (Estimated)

July 1, 2035

Study Completion (Estimated)

November 1, 2035

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (Actual)

April 30, 2018

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 608

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe