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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | Intervention with a 510k cleared shoulder arthroplasty device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catalyst CSR Total Shoulder System | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Safety | Report of adverse events/serious adverse event rates related to the procedure or device
| perioperatively, 3, 6, 12 and 24 months |
Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| J. Michael Wiater, MD | Beaumont Hospital Royal Oak | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital Royal Oak | Royal Oak | Michigan | 48073 | United States | ||
| Kaiser Permanente Northwest Center for Health Research |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Catalyst CSR Shoulder System
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|
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 |
| Portland |
| Oregon |
| 97227 |
| United States |
| Lifespan/University Orthopedics | Providence | Rhode Island | 02914 | United States |
| D001847 |
| Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |