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ACTIVE NOT RECRUITING
NCT03726554
NA

Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty

Sponsor: Zimmer Biomet

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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