NCT03404778

Comprehensive Reverse Shoulder Data Collection

Comprehensive Reverse Shoulder Clinical Outcomes Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 175 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.

Detailed description

The Biomet Comprehensive Reverse Shoulder was developed to provide an additional surgical option for patients anatomically and structurally suited to receive a reverse shoulder arthroplasty. The aim of the Biomet Comprehensive Reverse Shoulder is to increase shoulder function while reducing pain. This is a multi-center study. Having several clinical sites will allow for multiple investigators to contribute to the results of the study. 175 implants will be included into the study. 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 Arthitis

Interventions

Type	Name	Description
DEVICE	Biomet Comprehensive Reverse Shoulder	Designed to eliminate the potential for scapular notching, this reverse shoulder system combines a a true locking mechanism that minimized wear and oxidative breakdown with a modular central screw for secure fixation.

Timeline

• Start date: 2010-03-07
• Primary completion: 2026-12-01
• Completion: 2036-12-01
• First posted: 2018-01-19
• Last updated: 2025-10-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study