Total Shoulder Arthroplasty Multi-Center Registry

Recruiting

• Conditions: Shoulder Arthroplasty

• Registration Number: NCT03511586
• Lead Sponsor: Arthrex, Inc.

Brief Summary

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 Timeline

• Study Start: 2015-07-28
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-04-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-08-01
• Primary Completion: 2025-07-28
• Study Completion: 2027-11-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (12)

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States

Banner Medical Group; 🇺🇸 Phoenix, Arizona, United States

University of Arizona/Banner Health; 🇺🇸 Phoenix, Arizona, United States

Schulthess Klinik; 🇨🇭 Zürich, Switzerland

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

The Rothman Institute; 🇺🇸 New York, New York, United States

Cleveland Shoulder Institute; 🇺🇸 Beachwood, Ohio, United States

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Andrews Research & Education Foundation; 🇺🇸 Gulf Breeze, Florida, United States

Orthopädische Chirurgie München (OCM); 🇩🇪 München, Germany

The Hawkins Foundation; 🇺🇸 Greenville, South Carolina, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States