Total Shoulder Arthroplasty Multi-Center Registry

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: 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.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Kelly Ganz, BA, CCRC; Phone Number: 71119 1 (800) 933-7001; Email: kelly.ganz@arthrex.com
• Study Contact Backup: Name: Alicia Ruiz, MS, CCRP, CCRA; Phone Number: 71970 1 (800) 933-7001; Email: alicia.ruiz@arthrex.com

Study Locations

• Germany
  • München, Germany, 81369
    • Recruiting
    • Orthopädische Chirurgie München (OCM)
    • Contact: Patric Raiss, Prof. Dr.
    • Principal Investigator: Patric Raiss, Prof. Dr.
• Switzerland
  • Zürich, Switzerland, 8008
    • Recruiting
    • Schulthess Klinik
    • Contact: Philipp Moroder, Prof. Dr.
    • Principal Investigator: Philipp Moroder, Prof. Dr.
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • University of Arizona/Banner Health
      • Contact: Saleh Ahmed; Phone Number: 602-839-2000
      • Principal Investigator: Evan Lederman, MD
    • Phoenix, Arizona, United States, 85016
      • Active, not recruiting
      • Banner Medical Group
    • Scottsdale, Arizona, United States
      • Recruiting
  • Colorado
    • Denver, Colorado, United States
      • Recruiting
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Terminated
      • University of Connecticut Health Center
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • Recruiting
      • Andrews Research & Education Foundation
      • Principal Investigator: Christopher O'Grady, MD
      • Contact: Josh Cook; Phone Number: 850-916-8590; Email: joshua.cook@andrewsref.org
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Recruiting
      • The University of Michigan
      • Contact: Ryan Mills; Phone Number: 734-930-7400
      • Principal Investigator: Bruce Miller, MD
    • Grand Rapids, Michigan, United States
      • Recruiting
  • Missouri
    • Columbia, Missouri, United States
      • Active, not recruiting
  • New York
    • New York, New York, United States, 10022
      • Active, not recruiting
      • The Rothman Institute
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina
      • Contact: Bradley Lauck; Phone Number: 984-974-5700
      • Principal Investigator: Robert Creighton, MD
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Active, not recruiting
      • Cleveland Shoulder Institute
  • Oregon
    • Medford, Oregon, United States
      • Recruiting
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • The Hawkins Foundation
      • Principal Investigator: Michael Kissenberth, MD
      • Contact: Allison Nall; Phone Number: 888-666-2904
      • Contact: Sam Piergiovanni
  • Tennessee
    • Germantown, Tennessee, United States
      • Recruiting
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: Elizabeth Leitch; Phone Number: 434-243-7778
      • Principal Investigator: Brian Werner, MD
    • Virginia Beach, Virginia, United States
      • Recruiting

Participation Criteria

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.

Exclusion Criteria

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arthrex, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2015
• Primary Completion (Estimated): July 28, 2025
• Study Completion (Estimated): November 10, 2027

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 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: June 1, 2023

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