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A Trial to Assess the Safety and Effectiveness of an Anatomic Total Shoulder System
Sponsor: Medacta USA
Summary
This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis meets the performance of currently marketed device in terms of a composite success endpoint (functional score, radiologic appearance, revisions, adverse events) at 24 months of follow up.
Official title: Randomized, Controlled, Multi-center, Prospective Trial to Assess the Efficacy and Safety of an Anatomic Total Shoulder System.
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
286
Start Date
2026-09
Completion Date
2029-12
Last Updated
2026-09-16
Healthy Volunteers
No
Interventions
Mirror Anatomic Total Shoulder Prosthesis
Total shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function. To reduce polyethylene wear, a new Shoulder System, mirroring the materials at the humeral/glenoid interface.
Medacta Anatomic Shoulder
Total shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function.
Locations (12)
OrthoArizona
Gilbert, Arizona, United States
West Boca Medical Center
Boca Raton, Florida, United States
Andrews Research & Education Foundation
Gulf Breeze, Florida, United States
Foundation for Orthopedic Research and Education
Tampa, Florida, United States
Central Indiana Orthopedics
Fishers, Indiana, United States
Johns Hopkins - Washington
Columbia, Maryland, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, United States
Cornell Med NY
New York, New York, United States
Southern Oregon Orthopedics
Medford, Oregon, United States
Penn Medicine
Philadelphia, Pennsylvania, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Intermountain Health
St. George, Utah, United States