NCT04968405Completed
Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty
Analysis of the Performance and Safety of the Catalyst CSR Shoulder System - A Prospective Study
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 87 (actual)
- First submitted
- 11 Mar 2020
- Start date
- 22 Jul 2022
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Catalyst OrthoScience
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04968405
What you commit to
- Study type: Interventional
- Participants enrolled: 87
- From 22 Jul 2022 to the primary completion date, 1 Feb 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has a history of open surgery to index shoulder prior to treatment with the Catalyst CSR system? (history of previous arthroscopic surgery allowed)
Other illness
- 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
- Neuromuscular disorders that do not allow control of the joint
- Vascular insufficiency
- Alcohol, drug, substance abuse or other conditions that would affect or impair the patient from complying with post-operative instructions
- Any disease that could adversely affect the function or expected longevity of the implants (e.g., metabolic disorders)
Age
- Subject's age, weight or activity level cause the surgeon to expect early failure of the system
Other
- 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
- Inadequate or malformed bone that precludes adequate support of fixation of the prosthesis
- Osteoporosis
- Chronic instability, chronic dislocation or deficient soft tissues and other support structures (e.g., brachial plexus or deltoid muscles)
- The patient is unwilling to comply or unable to comply with the post-operative care instructions
- Patients with known sensitivity to Co-Cr-Mo alloys typically used prosthetic devices
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaiser Permanente Northwest Center for Health Research Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Lifespan/University Orthopedics Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Beaumont Hospital, Royal Oak Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.