Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Device: Catalyst CSR Total Shoulder System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Catalyst CSR Shoulder System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Intervention with a 510k cleared shoulder arthroplasty device | Device: Catalyst CSR Total Shoulder System<br>* The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire | Change from baseline in patient reported outcome scores using the ASES | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Assessment | Lack of radiographic evidence of osteolysis, stress shielding or lucent line formation through a minimum of 12-months post operation. | 3 months, 6 months, 12 months, 24 months | 
| Range of Motion Assessment | Change active range of motion (ROM) from baseline (preoperative) | Baseline, 3 months, 6 months, 12 months, 24 months | 
| American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire | Change from baseline in patient reported outcome scores using the ASES | Baseline 3 months, 6 months, 12 months, 24 months | 
| PROMIS Physical and Mental Function (PROMIS GLOBAL-10) Questionnaire | Change from baseline in patient reported outcome scores using the PROMIS | Baseline 3 months, 6 months, 12 months, 24 months | 
| Single Assessment Numeric Evaluation (SANE) | Change from baseline in patient reported outcome scores using the SANE | Baseline 3 months, 6 months, 12 months, 24 months | 
| Visual Analog Score (VAS) Scale | Change from baseline in patient reported outcome scores using the VAS | Baseline 3 months, 6 months, 12 months, 24 months | 
| Patient Satisfaction Assessment | Patient Satisfaction | 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Correction of functional deformity