Shoulder ArthroplastyNCT03511586
Total Shoulder Arthroplasty Multi-Center Registry
An observational study of Shoulder Arthroplasty, run by Arthrex, Inc. at 27 sites in 4 countries.
Trial summary
The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Shoulder Arthroplasty
- How many people
- 2,500 participants
- Where
- 27 sitesin 4 countries
- Study dates
- 28 Jul 2015to Nov 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 (not required for acute humeral fractures).
Who cannot join
- 1. Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study.
Trial locations and contacts
27 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 4 countries
United States23 sites, 16 recruiting
- Recruiting
The University of Michigan
Ann Arbor, Michigan, 48105
Chris Coordinator, 1 (734) 930-7400
Bruce Miller, MD
- Active, not recruiting
Cleveland Shoulder Institute
Beachwood, Ohio, 44122
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Kelsey Coordinator, 1 (984) 974-5700
Robert Creighton, MD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Elizabeth Leitch, 1 (434) 243-7778
Brian Werner, MD
- Terminated
Study site
Columbia, Missouri
- Recruiting
HCA Research Institute LLC.
Denver, Colorado, 80220
Benjamin Sears, MD
- Withdrawn
NorthShore University Health System
Evanston, Illinois, 60201
- Terminated
University of Connecticut Health Center
Farmington, Connecticut, 06030
- Recruiting
University of Florida
Gainesville, Florida, 32607
Kevin Farmer, MD
- Recruiting
Campbell Foundation
Germantown, Tennessee, 38138
Tyler Brolin, MD
- Terminated
Study site
Grand Rapids, Michigan
- Recruiting
The Hawkins Foundation
Greenville, South Carolina, 29615
Stephan Pill, MD
- Recruiting
Andrews Research & Education Foundation
Gulf Breeze, Florida, 32561
Madison Coordinator, (850)916-8590, madison.burklow@andrewsref.org
Christopher O'Grady, MD
- Recruiting
The Trustees of Indiana University
Indianapolis, Indiana, 46202
Charalampos (Bobby) Lyssikatos, 317-278-2565, clyssika@iu.edu
Mark T Dillon, MD
- Recruiting
Southern Oregon Orthopedics
Medford, Oregon, 97504
Patrick Denard, MD
- Terminated
The Rothman Institute
New York, New York, 10022
- Recruiting
Advent Health Orlando
Orlando, Florida
Russell Huffman, MD
Russell Huffman, MD
- Active, not recruiting
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania
- Recruiting
University of Arizona/Banner Health
Phoenix, Arizona, 85006
Saleh Ahmed, 1 (602) 839-2000
Evan Lederman, MD
- Recruiting
Banner Medical Group
Phoenix, Arizona, 85016
Demaris Research Coordinator, 1(833) 252-5535, demaris.yturralde@bannerhealth.com
Samuel Harmsen, MD
- Recruiting
Orthopedic Surgery (Mayo Scottsdale)
Phoenix, Arizona, 85054
John Tokish, MD
- Recruiting
Jordan Young Institute
Virginia Beach, Virginia, 23462
Justin Griffin, MD
- Not yet recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Katherine Leonard, 888-716-9253, Katherine.leonard@advocatehealth.org
Brian Waterman, MD
Switzerland2 sites, 2 recruiting
- Recruiting
Schulthess Klinik
Zurich, 8008
Philipp Moroder, Prof. Dr.
Philipp Moroder, Prof. Dr.
- Not yet recruiting
Universitätsklinik Balgrist
Zurich, 8008
Livia Rätzo, +41 44 386 55 20, ctu@balgrist.ch
Karl Wieser, Prof. Dr.
Germany1 site, 1 recruiting
- Recruiting
Orthopädische Chirurgie München (OCM)
München, 81369
Patric Raiss, Prof. Dr.
Patric Raiss, Prof. Dr.
United Kingdom1 site, 1 recruiting
- Recruiting
Wrightington Hospital
Wigan, WN1 2NN
Michael Walton, +44 01257 256564, Michael.Walton@wwl.nhs.uk
Michael Walton
About this study
The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.
Read the 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.
- Conditions
- Shoulder Arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Measure of pain intensity. This is done with the Visual Analog Scare. (VAS)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start28 Jul 2015
- Primary completionJul 2035 (estimated)
- Study completionNov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511586
- Sponsor's protocol ID
- 608
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2018
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Shoulder Arthroplasty Multi-Center Registry
- ClinicalTrials.gov ID
- NCT03511586
- Acronym / sponsor ID
- 608
- Conditions
- Shoulder Arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2015 (actual)
- Primary completion
- Jul 2035 (estimated)
- Study completion
- Nov 2035 (estimated)
- First posted
- 30 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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 (not required for acute humeral fractures).
Key exclusion criteria (1 listed)
- 1. Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Pain
Time frame: 10 years
Measure of pain intensity. This is done with the Visual Analog Scare. (VAS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
27 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthroplasty, run by Arthrex, Inc. at 27 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Switzerland, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Ganz, BA, CCRC (1 (800) 933-7001 ext. 71119, kelly.ganz@arthrex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.