NCT03726554

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

Comprehensive Reverse Shoulder: Porous Augmented Glenoid Baseplate and Mini Humeral Tray Post-Market Clinical Follow-up Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Comprehensive Reverse Porous Augmented Glenoid Baseplate and Comprehensive Mini Humeral Tray belong to the Comprehensive Reverse Shoulder Arthroplasty System. They were developed to provide patients with grossly deficient rotator cuffs with another surgical option. The aim of the Comprehensive Reverse Shoulder System is to increase shoulder function while reducing pain. A maximum of 7 sites will contribute to this study. Enrollment of 7 sites on a global scale will allow for assessment of device consistency across different regions. Enrollment per site will not exceed 45 shoulders. 146 implants will be included in this study with competitive enrollment. All potential study subjects will be required to participate in the Informed Consent process.

Conditions

• Arthropathy of Shoulder Region
• Grossly Deficient Rotator Cuff
• Osteoarthritis of the Shoulder
• Rheumatoid Arthritis Without Humeral Metaphyseal Defects
• Post-Traumatic Arthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-28
• Primary completion: 2030-02-01
• Completion: 2030-02-01
• First posted: 2018-10-31
• Last updated: 2025-10-29

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study