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

N/AActive Not RecruitingNCT03726554

Zimmer Biomet99 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arthropathy of Shoulder Region Grossly Deficient Rotator Cuff

Interventions

Comprehensive Reverse Porous Augmented GlenoidDEVICE

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 TrayDEVICE

The mini humeral tray offers additional sizing options to the Comprehensive Shoulder line. The mini tray is designed to fit smaller anatomies.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Andrews Research and Education Foundation

Gulf Breeze, Florida, United States

Norton Orthopedic Specialists

Louisville, Kentucky, 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

Outcomes

Primary Outcomes

Implant Survivorship

Based on removal or intended removal of the device and determined using the Kaplan-Meier method

Time frame: 10 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 10 years

Radiographic Performance

X-rays will be evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes, component migration, scapular notching and heterotopic ossification

Time frame: 10 years