Trials / Active Not Recruiting
Active Not RecruitingNCT05258435
Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 131 (estimated)
- Sponsor
- NuVasive · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NuVasive Simplify Cervical Artificial Disc | Simplify Disc is a weight-bearing cervical artificial disc implant consisting of PEEK (polyetheretherketone) endplates and one semi-constrained, fully articulating, mobile Zirconia Toughened Alumina ceramic (ZTA) core. |
Timeline
- Start date
- 2022-02-09
- Primary completion
- 2028-04-01
- Completion
- 2028-04-01
- First posted
- 2022-02-28
- Last updated
- 2025-12-22
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05258435. Inclusion in this directory is not an endorsement.