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Completed

NCT Number: NCT04630626

Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

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.

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Key information

Conditions

Cervical Degenerative Disc Disorder

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Education and Research Institute of Southern California, Orange, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All subjects enrolled in the Simplify Disc IDE study are considered for this long-term follow-up study.

Exclusion criteria

  • Subjects who were not implanted with the Simplify Disc during the IDE study
  • Subjects who had a secondary surgical intervention at the index level during the IDE study
  • Subjects who were withdrawn or withdrew consent to participate in the IDE study
  • Subjects who do not consent to participate in long-term follow-up post-approval study

Treatment and study plan

Simplify Disc

Device

The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.

ACDF

Other

Historical ACDF control data

Primary outcomes

  1. Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS)

    Time frame: IDE study 24 months + PAS 36 months = 60 months total

    Individual success for Simplify Disc and the historical control Anterior Cervical Discectomy and Fusion (ACDF) is defined as follows:

    • Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline in the Simplify Disc IDE study, and
    • No device failures by Month 60, and
    • No subsequent surgical procedure at the index level (including revision, removal, reoperation, or supplemental fixation) by Month 60.

Secondary outcomes

  1. Number of Participants With Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Neurological Status), Parent IDE Study + Post Approval Study (PAS)

    Time frame: IDE study 24 months + PAS 36 months = 60 months total

    Endpoint includes the number of participates in each group that had improvement in one or more radicular symptoms or myelopathy based on their Neurological Status (motor exam, sensory exam, gait exam, and reflexes) at 60 months when compared to baseline data from the prior IDE study.

  2. Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Visual Analog Scale), Parent IDE Study + Post Approval Study (PAS)

    Time frame: IDE study 24 months + PAS 36 months = 60 months total

    Endpoint was examined using the Visual Analog Scale (VAS) for neck and arm pain which is a straight horizontal line of fixed length (100 millimeters) oriented from zero or no pain (best) to 100mm or the worst pain ever (worst).

  3. Participants Average Disc Height, Parent IDE Study + Post Approval Study (PAS)

    Time frame: IDE study 24 months + PAS 36 months = 60 months total

    Disc height is calculated as a simple average of the anterior and posterior disc heights of the treated index level.

  4. Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Superior Level, Parent IDE Study + Post Approval Study (PAS)

    Time frame: IDE study 24 months + PAS 36 months = 60 months total

    Adjacent level disc deterioration looks at the quality of the disc space above (superior) and below (inferior) the treated index level on available radiographic images and each is graded as None, Mild, Moderate, Severe.

  5. Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Inferior Level, Parent IDE Study + Post Approval Study (PAS)

    Time frame: IDE study 24 months + PAS 36 months = 60 months total

    Adjacent level disc deterioration looks at the quality of the disc space above (superior) and below (inferior) the treated index level on available radiographic images and each is graded as None, Mild, Moderate, Severe.

  6. Percentage of Participants With No Displacement or Migration of the Device, Parent IDE Study + Post Approval Study (PAS)

    Time frame: IDE study 24 months + PAS 36 months = 60 months total

    Displacement or Migration of the device will be compared device placement at 60 months to immediate post-op data collected under the IDE study (changes of >3 mm will be considered significant)

  7. Percentage of Participants Reporting Overall Treatment Satisfaction of "Very Satisfied" or "Satisfied", Parent IDE Study + Post Approval Study (PAS)

    Time frame: IDE study 24 months + PAS 36 months = 60 months total

    Overall Treatment satisfaction was examined at 60 months. This was collected via a questionnaire completed by the subject. Response options to "How does the subject rate satisfaction with the treatment received?" included "Very Satisfied", "Satisfied", "Somewhat Satisfied", "Somewhat Dissatisfied", and "Very Dissatisfied". Response options to "If you could go back in time, would you choose to have the same treatment that you received for your neck condition?" included "Definitely Yes", "Probably Yes", "Maybe", "Probably Not" and "Definitely Not".

  8. Participants With Maintenance or Improvement on 12-Item Short Form Survey (SF-12), Parent IDE Study + Post Approval Study (PAS)

    Time frame: IDE study 24 months + PAS 36 months = 60 months total

    12-Item Short Form Survey (SF-12) is a questionnaire completed by the subject. Outcomes will be comparted at 60 months post treatment to baseline data collected from the IDE study.

  9. Percentage of Participants With No Dysphagia Handicap Index (DHI), Parent IDE Study + Post Approval Study (PAS)

    Time frame: IDE study 24 months + PAS 36 months = 60 months total

    Dysphagia Handicap Index (DHI) is a questionnaire completed by the subject. Outcomes at 60 months post-op were compared to baseline data collected under the IDE study.

Sponsors and collaborators

Lead sponsor

NuVasive

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2020
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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