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

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis of the Shoulder; Grossly Deficient Rotator Cuff; Rheumatoid Arthritis Without Humeral Metaphyseal Defects; Arthropathy of Shoulder Region; Post-Traumatic Arthritis
• Interventions: Device: Comprehensive Reverse Porous Augmented Glenoid; Device: Comprehensive Mini Humeral Tray

• Registration Number: NCT03726554
• Lead Sponsor: Zimmer Biomet

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.

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 Timeline

• Study Start: 2018-08-28
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-10-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2030-02
• Study Completion: 2030-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Comp. Rev. Porous Augmented Glenoid	Comprehensive Reverse 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.
Comp. Rev. Mini Humeral Tray	Comprehensive 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

Primary Outcome Measures

Name	Time	Method
Implant Survivorship	10 years	Based on removal or intended removal of the device and determined using the Kaplan-Meier method

Secondary Outcome Measures

Name	Time	Method
Radiographic Performance	10 years	X-rays will be evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes, component migration, scapular notching and heterotopic ossification
Frequency and Incidence of Adverse Events	10 years	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.
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire.	10 years	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.

Trial Locations

Locations (6)

Andrews Research and Education Foundation; 🇺🇸 Gulf Breeze, Florida, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

The Research Foundation for the State University of New York; 🇺🇸 Buffalo, New York, United States

Campbell Foundation; 🇺🇸 Germantown, Tennessee, United States

The Rector and Visitors of the University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Norton Orthopedic Specialists; 🇺🇸 Louisville, Kentucky, United States