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Clinical Trials in the USA / NCT03726554
Active, not recruiting Not applicable

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

NCT03726554 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Not applicable
Started
2018-08-28
Last updated
2026-07-09

Condition(s) studied

Arthropathy of Shoulder RegionGrossly Deficient Rotator CuffOsteoarthritis of the ShoulderRheumatoid Arthritis Without Humeral Metaphyseal DefectsPost-Traumatic Arthritis

Investigational drug(s) / intervention(s)

Comprehensive Reverse Porous Augmented GlenoidComprehensive Mini Humeral Tray

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient must be 18 years of age or older. * Patient must be anatomically and structurally suited to receive the implants and possess a functional deltoid. * Patient must have a grossly deficient rotator cuff with severe arthropathy and/or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. * Patient must be able and willing to complete the protocol required follow-up. * Patient must be able and willing to sign the Institutional Review Board/Ethics Committee approved informed consent. Exclusion Criteria: * Patient is a prisoner. * Patient is a current alcohol or drug abuser. * Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. * Patient presents with osteoporosis. * Patient has a metabolic disorder that may impair bone formation. * Patient has osteomalacia. * Patient has distant foci of infections which may spread to the implant site. * Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Primary outcome measure(s)

  • Implant Survivorship — 10 years
    Based on removal or intended removal of the device and determined using the Kaplan-Meier method

Trial sites (6)

FacilityCityRegionStatus
Andrews Research and Education Foundation Gulf Breeze Florida
Norton Orthopedic Specialists Louisville Kentucky
William Beaumont Hospital Royal Oak Michigan
The Research Foundation for the State University of New York Buffalo New York
Campbell Foundation Germantown Tennessee
The Rector and Visitors of the University of Virginia Charlottesville Virginia

More Zimmer Biomet trials in the USA

Zimmer Biomet Shoulder Arthroplasty PMCF Recruiting
Database Retrieval for the Comprehensive Shoulder Active, not recruiting
Comprehensive Reverse Shoulder Data Collection Enrolling by invitation
Cemented vs Cementless Persona Keel RCT Active, not recruiting
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System Active, not recruiting

Other trials for the same condition

Database Retrieval for the Comprehensive Shoulder Active, not recruiting
Comprehensive Reverse Shoulder Data Collection Enrolling by invitation
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System Active, not recruiting
Pyrocarbon Clinical Follow-up Study Active, not recruiting
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03726554 on ClinicalTrials.gov ↗ ← All trials in the USA