NCT04630626

Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

Extended Follow-up of Investigational Device Exemption (IDE) Subjects Treated With the Simplify Cervical Artificial Disc

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (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 Simplify Disc IDE study. This study was conducted under IDE G140154.

Detailed description

This post approval study (PAS) is a continuation of the IDE pivotal study (G140154) as required under P200022. These data include long-term follow-up of subjects enrolled and treated under the IDE study from February 2016 to 2018 out to 60 months post-op. The control group is comprised of a historical ACDF population. Subjects were enrolled (signed consent) into the PAS on a rolling basis at either the 36 month, 48 month or 60 month visit based on their treatment date (under IDE G140154) and the date of PAS protocol approval. Data presented are compared to baseline data collected as part of the IDE study. Therefore, the start date and end dates of the PAS are not inclusive of the full 60 months of reported data.

Conditions

• Cervical Degenerative Disc Disorder

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.
OTHER	ACDF	Historical ACDF control data

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-04-23
• Completion: 2023-04-23
• First posted: 2020-11-16
• Last updated: 2026-01-08
• Results posted: 2024-05-30

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study