Trials / Enrolling By Invitation
Enrolling By InvitationNCT05691231
Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 158 (estimated)
- Sponsor
- NuVasive · Industry
- Sex
- All
- Age
- 18 Years
- 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 at two levels in subjects who were enrolled in the IDE study (NCT03123549) and/or post approval study (NCT04980378).
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
- 2023-01-18
- Primary completion
- 2029-02-10
- Completion
- 2029-05-10
- First posted
- 2023-01-19
- Last updated
- 2025-12-22
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05691231. Inclusion in this directory is not an endorsement.