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

NCT03726554 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2025-10-29

No results posted yet for this 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.

Conditions

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

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.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Hillary Overholser · Zimmer Biomet

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2030-02-28
Completion
2030-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03726554 on ClinicalTrials.gov