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

Zimmer Biomet

Status: Active, not recruiting

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

Treatments: Device: Comprehensive Mini Humeral Tray; Device: Comprehensive Reverse Porous Augmented Glenoid

Study type: Interventional

Funder types: Industry

Identifiers

NCT03726554

CMG2017-70E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Comp. Rev. Porous Augmented Glenoid

Experimental group

Description:

Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Porous Augmented Glenoid.

Treatment:

Device: Comprehensive Reverse Porous Augmented Glenoid

Comp. Rev. Mini Humeral Tray

Experimental group

Description:

Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Mini Humeral Tray

Treatment:

Device: Comprehensive Mini Humeral Tray