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NOT YET RECRUITING
NCT07812324
NA

A Trial to Assess the Safety and Effectiveness of an Anatomic Total Shoulder System

Sponsor: Medacta USA

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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