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Business decision was made to remove the CE mark from this product, thus prompting the closing of this study.
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The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty.
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi 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 Humeral Stem.
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 Humeral Stem.
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 SF-12 as well as AEs and radiographic parameters by analysis of x-rays.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trabecular Metal Humeral Stem | Patients requiring primary, total or hemi shoulder arthroplasty who receive the Trabecular Metal Humeral Stem. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabecular Metal Humeral Stem | Device | Trabecular Metal Humeral Stem used in primary, total or hemi 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, Irreducible 3- and 4-part proximal humeral fractures, Avascular necrosis who meet the inclusion/exclusion criteria stated in the protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Orthopaedic Specialists | Louisville | Kentucky | 40241 | United States | ||
| William Beaumont Hospital |
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| Royal Oak |
| Michigan |
| 48073 |
| United States |
| The Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| 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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