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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03726554
Other study ID # CMG2017-70E
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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