Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

December 16, 2025 updated by: NuVasive

Extended Follow-up of Investigational Device Exemption (IDE) Subjects Treated With 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Orthopaedic Education and Research Institute of Southern California
      • San Diego, California, United States, 92121
        • USCD
      • Santa Monica, California, United States, 90403
        • The Spine Institute for Spine Restoration
    • Colorado
      • Thornton, Colorado, United States, 80229
        • Spine Education and Research Foundation
    • Florida
      • Sarasota, Florida, United States, 34232
        • Kennedy-White orthopedic Center
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Health System
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Indiana Spine Group
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Orthopaedic Institute of Western Kentucky
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Spine Institute of Louisiana
    • New Jersey
      • Egg Harbor, New Jersey, United States, 08234
        • Rothman Institute
    • New York
      • Lockport, New York, United States, 14094
        • Buffalo Spine Surgery
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolina Neurosurgery and Spine Associates
    • Texas
      • Addison, Texas, United States, 75001
        • Texas Spine Consultants
      • Plano, Texas, United States, 75093
        • Texas Back Institute
    • Virginia
      • Reston, Virginia, United States, 20191
        • Virginia Spine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

The population will include subjects that were previously enrolled in the Simplify Disc IDE study and meet the inclusion/exclusion criteria for this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Simplify Disc
Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154
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: Historical ACDF Control
Historical ACDF Data from similar protocol used as control.
Other: ACDF
Historical ACDF control data

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
IDE study 24 months + PAS 36 months = 60 months total

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
IDE study 24 months + PAS 36 months = 60 months total
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).
IDE study 24 months + PAS 36 months = 60 months total
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.
IDE study 24 months + PAS 36 months = 60 months total
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.
IDE study 24 months + PAS 36 months = 60 months total
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.
IDE study 24 months + PAS 36 months = 60 months total
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)
IDE study 24 months + PAS 36 months = 60 months total
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".
IDE study 24 months + PAS 36 months = 60 months total
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.
IDE study 24 months + PAS 36 months = 60 months total
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.
IDE study 24 months + PAS 36 months = 60 months total

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NuVasive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P200022 PAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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