Osteoarthritis Shoulder Clinical Trial
Official title:
Analysis of the Performance and Safety of the Catalyst CSR Shoulder System - A Prospective Study
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 | Recruiting |
Enrollment | 90 |
Est. completion date | July 28, 2025 |
Est. primary completion date | July 28, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Northwest Center for Health Research | Portland | Oregon |
United States | Lifespan/University Orthopedics | Providence | Rhode Island |
United States | Beaumont Hospital Royal Oak | Royal Oak | Michigan |
Lead Sponsor | Collaborator |
---|---|
Catalyst OrthoScience |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient Safety | Report of adverse events/serious adverse event rates related to the procedure or device
Implant removal rate Revision rate |
perioperatively, 3, 6, 12 and 24 months | |
Primary | American Shoulder and Elbow Surgeons (ASES) Assessment Questionnaire | Change from baseline in patient reported outcome scores using the ASES | 12 Months | |
Secondary | 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 | |
Secondary | Range of Motion Assessment | Change active range of motion (ROM) from baseline (preoperative) | Baseline, 3 months, 6 months, 12 months, 24 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Patient Satisfaction Assessment | Patient Satisfaction | 6, 12 and 24 months |
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