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Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels

NCT05691231 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 158

Last updated 2025-12-22

No results posted yet for this study

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

  • Cervical Disc Disease
  • Degenerative Disc Disease

Interventions

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.

Sponsors & Collaborators

  • NuVasive

    lead INDUSTRY

Principal Investigators

  • Kyle Malone · NuVasive

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2029-02-10
Completion
2029-05-10
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 NCT05691231 on ClinicalTrials.gov