NCT03511586

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
116mo left

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
3 countries

24 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jul 2015Nov 2035

Study Start

First participant enrolled

July 28, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
17.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2035

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2035

Last Updated

August 11, 2025

Status Verified

June 1, 2025

Enrollment Period

19.9 years

First QC Date

April 12, 2018

Last Update Submit

August 6, 2025

Conditions

Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Change in Pain

    Measure of pain intensity. This is done with the Visual Analog Scare. (VAS)

    10 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • Patient is between the ages of 18 and 100 years.
  • 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.
  • Patient has a standard of care preoperative CT taken within 6 months that has been submitted for Arthrex VIP (Virtual Implant Positioning) planning.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

University of Arizona/Banner Health

Phoenix, Arizona, 85006, United States

RECRUITING

Banner Medical Group

Phoenix, Arizona, 85016, United States

RECRUITING

Unknown Facility

Scottsdale, Arizona, United States

RECRUITING

Unknown Facility

Denver, Colorado, United States

RECRUITING

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

TERMINATED

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

RECRUITING

Advent Health Orlando

Orlando, Florida, United States

RECRUITING

NorthShore University Health System

Evanston, Illinois, 60201, United States

WITHDRAWN

The Trustees of Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

The University of Michigan

Ann Arbor, Michigan, 48105, United States

RECRUITING

Unknown Facility

Grand Rapids, Michigan, United States

TERMINATED

Unknown Facility

Columbia, Missouri, United States

TERMINATED

The Rothman Institute

New York, New York, 10022, United States

TERMINATED

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

NOT YET RECRUITING

Cleveland Shoulder Institute

Beachwood, Ohio, 44122, United States

ACTIVE NOT RECRUITING

Unknown Facility

Medford, Oregon, United States

RECRUITING

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

ACTIVE NOT RECRUITING

The Hawkins Foundation

Greenville, South Carolina, 29615, United States

RECRUITING

Unknown Facility

Germantown, Tennessee, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Unknown Facility

Virginia Beach, Virginia, United States

RECRUITING

Orthopädische Chirurgie München (OCM)

München, 81369, Germany

RECRUITING

Schulthess Klinik

Zurich, 8008, Switzerland

RECRUITING

Central Study Contacts

Kelly Ganz, BA, CCRC

CONTACT

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

Alicia Ruiz, MS, CCRP, CCRA

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2018

First Posted

April 30, 2018

Study Start

July 28, 2015

Primary Completion (Estimated)

July 1, 2035

Study Completion (Estimated)

November 1, 2035

Last Updated

August 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)US(22)DE(1)