Clinical trial NCT03726554: Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
Official title: Comprehensive Reverse Shoulder: Porous Augmented Glenoid Baseplate and Mini Humeral Tray Post-Market Clinical Follow-up Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthropathy of Shoulder Region
Grossly Deficient Rotator Cuff
Osteoarthritis of the Shoulder
Rheumatoid Arthritis Without Humeral Metaphyseal Defects
Post-Traumatic Arthritis
Keywords: Reverse Shoulder Arthroplasty
Medical Device
Performance
Safety
Shoulder Prosthesis
Glenoid Erosion
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-10-31
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Implant Survivorship
timeFrame: 10 years
Secondary outcomes:
measure: Frequency and Incidence of Adverse Events
timeFrame: 10 years
measure: Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire.
timeFrame: 10 years
measure: Radiographic Performance
timeFrame: 10 years
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Andrews Research and Education Foundation
state: Florida
city: Louisville
country: United States
facility: Norton Orthopedic Specialists
state: Kentucky
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Buffalo
country: United States
facility: The Research Foundation for the State University of New York
state: New York
city: Germantown
country: United States
facility: Campbell Foundation
state: Tennessee
city: Charlottesville
country: United States
facility: The Rector and Visitors of the University of Virginia
state: Virginia
Study officials:
affiliation: Zimmer Biomet
name: Erin Osborn
role: STUDY_DIRECTOR
References: