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

NCT03726554 | Active Not Recruiting FDA Device

• 1 other identifier: CMG2017-70E
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Reverse Shoulder Arthroplasty; Medical Device; Performance; Safety; Shoulder Prosthesis; Glenoid Erosion

Outcome Measures

Primary Outcomes (1)

• Implant Survivorship

  Based on removal or intended removal of the device and determined using the Kaplan-Meier method

  10 years

Secondary Outcomes (3)

• Frequency and Incidence of Adverse Events

  10 years

• Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire.

  10 years

• Radiographic Performance

  10 years

Study Arms (2)

Comp. Rev. Porous Augmented Glenoid

EXPERIMENTAL

Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Porous Augmented Glenoid.

Device: Comprehensive Reverse Porous Augmented Glenoid

Comp. Rev. Mini Humeral Tray

EXPERIMENTAL

Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Mini Humeral Tray

Device: Comprehensive Mini Humeral Tray

Interventions

Comprehensive Reverse Porous Augmented Glenoid DEVICE

Three glenoid baseplate options designed for various severities of glenoid erosion and deformity, the device promotes bony ingrowth while restoring natural human anatomy.

Comp. Rev. Porous Augmented Glenoid

Comprehensive Mini Humeral Tray DEVICE

The mini humeral tray offers additional sizing options to the Comprehensive Shoulder line. The mini tray is designed to fit smaller anatomies.

Comp. Rev. Mini Humeral Tray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

Andrews Research and Education Foundation

Gulf Breeze, Florida, 32561, United States

Location

Norton Orthopedic Specialists

Louisville, Kentucky, 40241, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

The Research Foundation for the State University of New York

Buffalo, New York, 14215, United States

Location

Campbell Foundation

Germantown, Tennessee, 38138, United States

Location

The Rector and Visitors of the University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 31, 2018
• Study Start: August 28, 2018
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)