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

Last updated: May 19, 2025
Sponsor: NuVasive
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

NuVasive Simplify Cervical Artificial Disc

Clinical Study ID

NCT05691231
NUVA.TDR1022
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject was enrolled in the Simplify Disc IDE (NCT03123549) and/or PAS (NCT04980378)at a participating study site

  2. Patient understands the conditions of enrollment and is willing sign an informedconsent form to participate in the study

Exclusion

Exclusion Criteria:

  1. Subject had an SSI at the index level during the IDE study (NCT03123549) or the PAS (NCT04980378)

  2. Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)

Study Design

Total Participants: 158
Treatment Group(s): 1
Primary Treatment: NuVasive Simplify Cervical Artificial Disc
Phase:
Study Start date:
January 18, 2023
Estimated Completion Date:
May 10, 2029

Connect with a study center

  • Carolina Neurosurgery and Spine Associates

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Texas Back Institute

    Plano, Texas 75093
    United States

    Site Not Available

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