Evaluation of the Catalyst CSR Shoulder System for shoulder surgery

Analysis of the Performance and Safety of the Catalyst CSR Shoulder System - A Prospective Study

This study is testing a new shoulder system to see if it helps people with shoulder joint problems feel better after surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Catalyst OrthoScience (industry)
• Locations: 3 sites (Royal Oak, Michigan and 2 other locations)
• Trial ID: NCT04968405 on ClinicalTrials.gov

What this trial studies

This study evaluates the performance and safety of the Catalyst CSR Shoulder System in patients with degenerative diseases of the glenohumeral joint requiring hemi or total shoulder arthroplasty. It is a prospective multi-center study conducted across various locations in the United States. Participants will undergo the procedure and be monitored with clinical and radiographic assessments at multiple time points, including pre-operative and at 3, 6, 12, and 24 months post-surgery. The study aims to gather comprehensive data to determine the effectiveness of this shoulder system.

Who should consider this trial

Good fit: Ideal candidates are skeletally mature adults aged 18 and older with degenerative diseases of the glenohumeral joint requiring shoulder arthroplasty.

Not a fit: Patients with a history of previous open shoulder surgery, significant rotator cuff tears, or those unable to comply with post-operative care may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from shoulder degenerative diseases.

How similar studies have performed: Other studies have shown promise in similar approaches to shoulder arthroplasty, suggesting potential for success with this new system.

Eligibility 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)

Where this trial is running

Royal Oak, Michigan and 2 other locations

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

Study contacts

• Principal investigator: J. Michael Wiater, MD — Beaumont Hospital Royal Oak
• Study coordinator: Robin Waite, RN

Conditions: Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus, Rheumatoid Arthritis Shoulder, Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Correction of functional deformity