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Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
Sponsor: Zimmer Biomet
Summary
This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse Shoulder System when used with the Comprehensive Porous Augmented Glenoid Baseplate and/or Comprehensive Mini Humeral Tray in primary and revision reverse shoulder arthroplasty.
Official title: Comprehensive Reverse Shoulder: Porous Augmented Glenoid Baseplate and Mini Humeral Tray Post-Market Clinical Follow-up Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2018-08-28
Completion Date
2030-02
Last Updated
2025-10-29
Healthy Volunteers
No
Conditions
Interventions
Comprehensive Reverse Porous Augmented Glenoid
Three glenoid baseplate options designed for various severities of glenoid erosion and deformity, the device promotes bony ingrowth while restoring natural human anatomy.
Comprehensive Mini Humeral Tray
The mini humeral tray offers additional sizing options to the Comprehensive Shoulder line. The mini tray is designed to fit smaller anatomies.
Locations (6)
Andrews Research and Education Foundation
Gulf Breeze, Florida, United States
Norton Orthopedic Specialists
Louisville, Kentucky, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
The Research Foundation for the State University of New York
Buffalo, New York, United States
Campbell Foundation
Germantown, Tennessee, United States
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia, United States