Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

Not Applicable

Recruiting

• Conditions: Osteoarthritis Shoulder; Avascular Necrosis of the Head of Humerus; Rheumatoid Arthritis Shoulder

• Registration Number: NCT04968405
• Lead Sponsor: Catalyst OrthoScience

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-3-11
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - 18 years of age or older<br><br> - Patient must be skeletally mature with degenerative disease of the glenohumeral<br> joint where hemi or total shoulder arthroplasty<br><br> - Meets the Catalyst CSR Shoulder System Indications for Use according to approved<br> labeling<br><br>Exclusion Criteria<br><br> - Has a history of open surgery to index shoulder prior to treatment with the Catalyst<br> CSR system? (history of previous arthroscopic surgery allowed)<br><br> - Has a full thickness rotator cuff tear diagnosed by MFI or marked posterior glenoid<br> wear<br><br> - Patient is unwilling or unable to comply with the post-operative care instructions,<br> attend follow visits per the study schedule and complete the study assessments<br> (i.e., Pros)<br><br> - The patient is a non-English speaker<br><br> - In the opinion of the investigator, is it not in the patient's best interest to<br> participate in this study<br><br> - Local or systemic infection, or osteomyelitis of the proximal humerus or scapula; if<br> a systemic infection or a secondary remote infection is suspected or confirmed,<br> joint replacement surgery should be delayed until infection is resolved<br><br> - Inadequate or malformed bone that precludes adequate support of fixation of the<br> prosthesis<br><br> - Osteoporosis<br><br> - Neuromuscular disorders that do not allow control of the joint<br><br> - Chronic instability, chronic dislocation or deficient soft tissues and other support<br> structures (e.g., brachial plexus or deltoid muscles)<br><br> - Vascular insufficiency<br><br> - Subject's age, weight or activity level cause the surgeon to expect early failure of<br> the system<br><br> - The patient is unwilling to comply or unable to comply with the post-operative care<br> instructions<br><br> - Alcohol, drug, substance abuse or other conditions that would affect or impair the<br> patient from complying with post-operative instructions<br><br> - Patients with known sensitivity to Co-Cr-Mo alloys typically used prosthetic devices<br><br> - Any disease that could adversely affect the function or expected longevity of the<br> implants (e.g., metabolic disorders)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire

Secondary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire;PROMIS Physical and Mental Function (PROMIS GLOBAL-10) Questionnaire;Single Assessment Numeric Evaluation (SANE);Visual Analog Score (VAS) Scale;Patient Satisfaction Assessment;Radiographic Assessment;Range of Motion Assessment