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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis of the Shoulder; Post-Traumatic Arthritis; Arthropathy of Shoulder Region; Grossly Deficient Rotator Cuff; Rheumatoid Arthritis Without Humeral Metaphyseal Defects
• Intervention / Treatment: Device: Comprehensive Reverse Porous Augmented Glenoid; Device: Comprehensive Mini Humeral Tray

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • Andrews Research and Education Foundation
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Norton Orthopedic Specialists
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • New York
    • Buffalo, New York, United States, 14215
      • The Research Foundation for the State University of New York
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Campbell Foundation
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • The Rector and Visitors of the University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comp. Rev. Porous Augmented Glenoid; 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; Three glenoid baseplate options designed for various severities of glenoid erosion and deformity, the device promotes bony ingrowth while restoring natural human anatomy.
Experimental: Comp. Rev. Mini Humeral Tray; 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; The mini humeral tray offers additional sizing options to the Comprehensive Shoulder line. The mini tray is designed to fit smaller anatomies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survivorship	Based on removal or intended removal of the device and determined using the Kaplan-Meier method	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and Incidence of Adverse Events	Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.	10 years
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire.	Pain, function, and activities of daily living are measured. The American Shoulder and Elbow Surgeon (ASES) scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.	10 years
Radiographic Performance	X-rays will be evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes, component migration, scapular notching and heterotopic ossification	10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Erin Osborn, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Performance; Medical Device; Reverse Shoulder Arthroplasty; Shoulder Prosthesis; Glenoid Erosion
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: CMG2017-70E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes