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

Post-Traumatic Arthritis Clinical Trial

Official title:

Comprehensive Reverse Shoulder: Porous Augmented Glenoid Baseplate and Mini Humeral Tray Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03726554
• Other study ID #: CMG2017-70E
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: February 2030

Study information

• Verified date: November 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: February 2030
• Est. primary completion date: February 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Survivorship	Based on removal or intended removal of the device and determined using the Kaplan-Meier method	10 years
Secondary	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
Secondary	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
Secondary	Radiographic Performance	X-rays will be evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes, component migration, scapular notching and heterotopic ossification	10 years