Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

Completed · Not applicable

Conditions studied: Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus, Rheumatoid Arthritis Shoulder

In brief

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.

Key facts

Study ID

NCT04968405

Run by

Catalyst OrthoScience

People needed

87

Starts

2022-07-22

Expected to finish

2026-02-01

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Beaumont Hospital Royal Oak — Royal Oak, Michigan, United States
• Kaiser Permanente Northwest Center for Health Research — Portland, Oregon, United States
• Lifespan/University Orthopedics — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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