Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01390038 | Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty | PHASE3 | COMPLETED | 157 | — | — | Jul 1, 2011 | Dec 1, 2014 | Apr 25, 2023 | 14 | United States |
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 ...