Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

Catalyst OrthoScience

Status

Enrolling

Conditions

Rheumatoid Arthritis Shoulder

Avascular Necrosis of the Head of Humerus

Osteoarthritis Shoulder

Treatments

Device: Catalyst CSR Total Shoulder System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04968405

1226-9272-01

Details and patient eligibility

About

Evaluation of the performance and safety of the Catalyst CSR Shoulder System with clinical and radiographic results at multiple time points through 24 months postoperatively This study will be a prospective multi-center study conducted in the United States.

Full description

The purpose of this study is to assess the performance and safety of the Catalyst CSR Shoulder System in skeletally mature patients with degenerative disease of the glenohumeral joint where hemi or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. Patients who sign informed consent and meet the inclusion/exclusion criteria will have the Catalyst CSR Shoulder system implanted at participating sites. Data will be collected at baseline (pre-operative), perioperatively, and postoperatively at 3 months, 6 months, 12 months and 24 months. This study is expected to take 36 months to complete.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

18 years of age or older
Patient must be skeletally mature with degenerative disease of the glenohumeral joint where hemi or total shoulder arthroplasty
Meets the Catalyst CSR Shoulder System Indications for Use according to approved labeling

Exclusion Criteria

Has a history of open surgery to index shoulder prior to treatment with the Catalyst CSR system? (history of previous arthroscopic surgery allowed)
Has a full thickness rotator cuff tear diagnosed by MFI or marked posterior glenoid wear
Patient is unwilling or unable to comply with the post-operative care instructions, attend follow visits per the study schedule and complete the study assessments (i.e., Pros)
The patient is a non-English speaker
In the opinion of the investigator, is it not in the patient's best interest to participate in this study
Local or systemic infection, or osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, joint replacement surgery should be delayed until infection is resolved
Inadequate or malformed bone that precludes adequate support of fixation of the prosthesis
Osteoporosis
Neuromuscular disorders that do not allow control of the joint
Chronic instability, chronic dislocation or deficient soft tissues and other support structures (e.g., brachial plexus or deltoid muscles)
Vascular insufficiency
Subject's age, weight or activity level cause the surgeon to expect early failure of the system
The patient is unwilling to comply or unable to comply with the post-operative care instructions
Alcohol, drug, substance abuse or other conditions that would affect or impair the patient from complying with post-operative instructions
Patients with known sensitivity to Co-Cr-Mo alloys typically used prosthetic devices
Any disease that could adversely affect the function or expected longevity of the implants (e.g., metabolic disorders)