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Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
Sponsor: NuVasive
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).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
158
Start Date
2023-01-18
Completion Date
2029-05-10
Last Updated
2025-12-22
Healthy Volunteers
No
Interventions
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.
Locations (2)
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States
Texas Back Institute
Plano, Texas, United States