Arthropathy of Shoulder RegionGrossly Deficient Rotator CuffOsteoarthritis of the ShoulderRheumatoid Arthritis Without Humeral Metaphyseal DefectsPost-Traumatic Arthritis
Investigational drug(s) / intervention(s)
Comprehensive Reverse Porous Augmented GlenoidComprehensive Mini Humeral Tray
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Implant Survivorship — 10 years Based on removal or intended removal of the device and determined using the Kaplan-Meier method
Trial sites (6)
Facility
City
Region
Status
Andrews Research and Education Foundation
Gulf Breeze
Florida
Norton Orthopedic Specialists
Louisville
Kentucky
William Beaumont Hospital
Royal Oak
Michigan
The Research Foundation for the State University of New York
Buffalo
New York
Campbell Foundation
Germantown
Tennessee
The Rector and Visitors of the University of Virginia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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