Comprehensive Reverse Shoulder Data Collection

Zimmer Biomet

Status: Invitation-only

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

Treatments: Device: Biomet Comprehensive Reverse Shoulder

Study type: Observational

Funder types: Industry

Identifiers

NCT03404778

ORTHO.CR.EX007

Details and patient eligibility

About

This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.

Full description

The Biomet Comprehensive Reverse Shoulder was developed to provide an additional surgical option for patients anatomically and structurally suited to receive a reverse shoulder arthroplasty. The aim of the Biomet Comprehensive Reverse Shoulder is to increase shoulder function while reducing pain.

This is a multi-center study. Having several clinical sites will allow for multiple investigators to contribute to the results of the study. 175 implants will be included into the study. All potential study subjects will be required to participate in the Informed Consent Process.

Enrollment: 175 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biomet® Comprehensive™ Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
• The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
• The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Exclusion criteria

• Absolute contraindications include infection, sepsis, and osteomyelitis.
• Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
• Osteoporosis.
• Metabolic disorders which may impair bone formation.
• Osteomalacia.
• Distant foci of infections which may spread to the implant site.
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Trial design

175 participants in 1 patient group

Biomet Comprehensive Reverse Shoulder

Description:

Subjects in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Shoulder System.

Treatment:

Device: Biomet Comprehensive Reverse Shoulder