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Simpliciti Shoulder System · 1 trial · 2 indications
A subject is a Patient Success at 24-months if: 1. There is NO continuous radiolucent line around the prosthesis; and 2. The adjusted Constant Score is \> 85 (successful outcome); and 3. They did not have revision surgery; and 4. They did not have a system-related serious adverse event.
| Arm | Type | Description |
|---|---|---|
| Simpliciti™ Shoulder System | EXPERIMENTAL | The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder. |
| Name | Type | Description |
|---|---|---|
| Simpliciti™ Shoulder System | DEVICE | Total shoulder arthroplasty system |
Inclusion Criteria: * Adult subject 22 years or older * Clinical indication for total shoulder replacement due to primary diagnosis of arthritis. Primary arthritis for this study includes osteoarthritis, and/or traumatic arthritis. * Scapula and proximal humerus must have reached skeletal maturity ...
The Simpliciti Shoulder System is used for primary generalized (osteo)arthritis of the shoulder, as well as post-traumatic arthrosis of the upper arm joints. It is a device designed for total shoulder arthroplasty, specifically replacing the humeral head. The system is intended for patients aged 22 years and older.
The Simpliciti Shoulder System is developed by Stryker Corporation, a medical technology company. Stryker is publicly traded on the New York Stock Exchange under the ticker symbol SYK. The company is responsible for the design, manufacturing, and clinical development of this shoulder replacement system.
The Simpliciti Shoulder System is in Phase 3 clinical development. It has completed one Phase 3 clinical trial, which was an Investigational Device Exemption (IDE) study. The device is investigational and not yet approved for commercial use, as it is still undergoing clinical evaluation to establish its safety and effectiveness.
The Simpliciti Shoulder System has been studied in one clinical trial, identified as NCT01390038. This trial, titled 'Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty,' was a Phase 3 study that has been completed. The trial enrolled 157 participants in the United States and included healthy volunteers.
The Simpliciti Shoulder System works by replacing the humeral head, the ball portion of the shoulder joint, during total shoulder arthroplasty. This procedure is designed to treat conditions such as primary generalized osteoarthritis and post-traumatic arthrosis. The system aims to restore shoulder function and alleviate pain associated with these degenerative joint conditions.