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NCT01390038 · ClinicalTrials.gov registry record · Phase 3
Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty
A Phase 3 study, sponsored by Stryker Trauma and Extremities.
- Completed
- Registry status
- Phase 3
- Development phase
- 157
- Enrollment target
NCT01390038: Completed Phase 3 study, sponsored by Stryker Trauma and Extremities.
NCT01390038 is a Phase 3 study that has completed, run by Stryker Trauma and Extremities. The registered enrollment target is 157 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01390038, a Phase 3 study, has completed, sponsored by Stryker Trauma and Extremities.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 157 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
Primary Outcome
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.
Interventions
- DEVICE Simpliciti™ Shoulder System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01390038 record still lists
NCT01390038 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Simpliciti™ Shoulder System is the first listed.
NCT01390038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01390038 about?
NCT01390038 is a clinical study titled "Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty". The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
What is the current status of trial NCT01390038?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 157 participants. The study started on 2011-07. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01390038?
The interventions under investigation include: Simpliciti™ Shoulder System (DEVICE).
Who is sponsoring clinical trial NCT01390038?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01390038's enrollment target sits among peer trials
157 1505th of 2000 higher than 495 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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