Recruiting

Observational Study

Sponsor:

Arthrex, Inc.

Code:

NCT03511586

Conditions

Shoulder Arthroplasty

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Shoulder Arthroplasty

Study ID

NCT03511586

Start date

Jul 28, 2015

Status verified date

Aug, 2026

Completion date

Nov, 2035

Anticipated

Primary completion date

Jul, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in Pain [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Kelly Ganz, BA, CCRC

1 (800) 933-7001kelly.ganz@arthrex.com

Alicia Ruiz, MS, CCRP, CCRA

1 (800) 933-7001alicia.ruiz@arthrex.com

Locations

University of Arizona/Banner Health

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Saleh Ahmed

1 (602) 839-2000

Principal Investigator:

Evan Lederman, MD

Banner Medical Group

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Demaris Research Coordinator

1(833) 252-5535demaris.yturralde@bannerhealth.com

Principal Investigator:

Samuel Harmsen, MD

Orthopedic Surgery (Mayo Scottsdale)

Recruiting

Phoenix, Arizona, United States, 85054

Principal Investigator:

John Tokish, MD

HCA Research Institute LLC.

Recruiting

Denver, Colorado, United States, 80220

Principal Investigator:

Benjamin Sears, MD

University of Florida

Recruiting

Gainesville, Florida, United States, 32607

Principal Investigator:

Kevin Farmer, MD

Andrews Research & Education Foundation

Recruiting

Gulf Breeze, Florida, United States, 32561

Contacts

Madison Coordinator

(850)916-8590madison.burklow@andrewsref.org

Principal Investigator:

Christopher O'Grady, MD

Advent Health Orlando

Recruiting

Orlando, Florida, United States

Principal Investigator:

Russell Huffman, MD

The Trustees of Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Charalampos (Bobby) Lyssikatos

317-278-2565clyssika@iu.edu

Principal Investigator:

Mark T Dillon, MD

The University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Chris Coordinator

1 (734) 930-7400

Principal Investigator:

Bruce Miller, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Kelsey Coordinator

1 (984) 974-5700

Principal Investigator:

Robert Creighton, MD

Southern Oregon Orthopedics

Recruiting

Medford, Oregon, United States, 97504

Principal Investigator:

Patrick Denard, MD

The Hawkins Foundation

Recruiting

Greenville, South Carolina, United States, 29615

Principal Investigator:

Stephan Pill, MD

Campbell Foundation

Recruiting

Germantown, Tennessee, United States, 38138

Principal Investigator:

Tyler Brolin, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Elizabeth Leitch

1 (434) 243-7778

Principal Investigator:

Brian Werner, MD

Jordan Young Institute

Recruiting

Virginia Beach, Virginia, United States, 23462

Principal Investigator:

Justin Griffin, MD

More Information

Sponsor

Arthrex, Inc.

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Arthrex, Inc. on 2026-08-20.