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Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc

NCT04980378 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 291

Last updated 2026-01-08

Study results available
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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 two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206

Conditions

  • Cervical Degenerative Disc Disorder

Interventions

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.

Sponsors & Collaborators

  • NuVasive

    lead INDUSTRY

Principal Investigators

  • Kyle Malone · Globus Medical

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2024-01-24
Completion
2024-01-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04980378 on ClinicalTrials.gov