Trials / Completed
CompletedNCT04980378
Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 291 (actual)
- Sponsor
- NuVasive · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study is intended to demonstrate the 5-year long-term safety and efficacy of the Simplify® Cervical Artificial Disc ("Simplify Disc") in subjects enrolled in the non-randomized two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Simplify Disc | The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core. |
Timeline
- Start date
- 2021-08-01
- Primary completion
- 2024-01-24
- Completion
- 2024-01-24
- First posted
- 2021-07-28
- Last updated
- 2026-01-08
- Results posted
- 2025-03-26
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04980378. Inclusion in this directory is not an endorsement.