Total Shoulder Arthroplasty Multi-Center Registry

Shoulder Arthroplasty Clinical Trial

Official title:

Total Shoulder Arthroplasty Multi-Center Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03511586
• Other study ID #: 608
• Status: Recruiting
• Start date: July 28, 2015
• Est. completion date: November 10, 2027

Study information

• Verified date: June 2023
• Source: Arthrex, Inc.
• Contact: Kelly Ganz, BA, CCRC
• Phone: 1 (800) 933-7001
• Email: kelly.ganz[@]arthrex.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: November 10, 2027
• Est. primary completion date: July 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Arthroplasty

Locations

Country	Name	City	State
Germany	Orthopädische Chirurgie München (OCM)	München
Switzerland	Schulthess Klinik	Zürich
United States	The University of Michigan	Ann Arbor	Michigan
United States	Cleveland Shoulder Institute	Beachwood	Ohio
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	The Hawkins Foundation	Greenville	South Carolina
United States	Andrews Research & Education Foundation	Gulf Breeze	Florida
United States	The Rothman Institute	New York	New York
United States	Banner Medical Group	Phoenix	Arizona
United States	University of Arizona/Banner Health	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arthrex, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain	Measure of pain intensity. This is done with the Visual Analog Scare. (VAS)	10 years