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The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be collected and analyzed to monitor pain, function, and survivorship and to confirm the performance of the Trabecular Metal Reverse Shoulder System.
Performance will be evaluated by monitoring the frequency and incidence of adverse events as well as by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Trabecular metal Reverse Shoulder System.
Pain and functional performance will be measured using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE), survivorship will be based on removal or intended removal of the device, health status will be determined by evaluation of the Short Form Survey12 (SF-12) as well as Adverse Events (AEs) and radiographic parameters analysis of x-rays.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trabecular Metal Reverse Shoulder System | Patients requiring primary or revision reverse total shoulder arthroplasty who receive the Trabecular Metal Reverse Shoulder System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabecular Metal Reverse Shoulder System | Device | Trabecular Metal Reverse Shoulder System used in primary or revision total shoulder arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship | Based on removal or intended removal of the device and determined using the Kaplan-Meier method. | 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Functional Performance | Measurements will be based on the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE) | 10 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Each investigator will screen from his/her patients who suffer from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, ununited humeral head fracture, irreduciable 3-and 4-part proximal humeral fractures, avascular necrosis, gross rotator cuff dificiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision) who meet the inclusion/exclusion criteria stated in the protocol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Norton Orthopaedic & Sports Medicine |
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|
| Louisville |
| Kentucky |
| 40241 |
| United States |
| The Rothman Institute | Egg Harbor | New Jersey | 08234 | United States |
| The Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Royal Blackburn Hospital | Blackburn | Lancashire | BB2 3HH | United Kingdom |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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