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Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
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 in subjects who were enrolled in the post approval study (NCT04630626).
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
131
Start Date
2022-02-09
Completion Date
2028-04
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 (10)
Hoag Orthopedics
Orange, California, United States
The Spine Institute for Spine Restoration
Santa Monica, California, United States
Spine Education and Research
Thornton, Colorado, United States
Kennedy-White Orthopaedic Center
Sarasota, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
Indiana Spine Group
Carmel, Indiana, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States
Texas Spine Consultants
Addison, Texas, United States
Texas Back Institute
Plano, Texas, United States