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Cervical Degenerative Disc DisorderNCT04630626

Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

A study testing Simplify Disc and ACDF in people with Cervical Degenerative Disc Disorder, run by NuVasive at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Simplify Disc IDE study. This study was conducted under IDE G140154. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cervical Degenerative Disc Disorder
What is being tested?
Simplify Disc and ACDF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
15 sitesUnited States
Study dates
1 Jan 2021to 23 Apr 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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  • Subjects who were withdrawn or withdrew consent to participate in the IDE study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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Texas Spine Consultants

    Addison, Texas, 75001

  • Indiana Spine Group

    Carmel, Indiana, 46032

  • Carolina Neurosurgery and Spine Associates

    Charlotte, North Carolina, 28204

  • Rothman Institute

    Egg Harbor, New Jersey, 08234

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • Buffalo Spine Surgery

    Lockport, New York, 14094

  • Orthopaedic Education and Research Institute of Southern California

    Orange, California, 92868

  • Orthopaedic Institute of Western Kentucky

    Paducah, Kentucky, 42003

  • Texas Back Institute

    Plano, Texas, 75093

  • Virginia Spine Institute

    Reston, Virginia, 20191

  • USCD

    San Diego, California, 92121

  • The Spine Institute for Spine Restoration

    Santa Monica, California, 90403

  • Kennedy-White orthopedic Center

    Sarasota, Florida, 34232

  • Spine institute of Louisiana

    Shreveport, Louisiana, 71101

  • Spine Education and Research Foundation

    Thornton, Colorado, 80229

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Simplify Disc, ACDF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simplify DiscDevice

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

  • ACDFOther

    Historical ACDF control data

Study groups in NCT04630626
Study groupRoleWhat they receive
Simplify DiscExperimentalExtended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154
Receives: Device: Simplify Disc
Historical ACDF ControlOtherHistorical ACDF Data from similar protocol used as control.
Receives: Other: ACDF

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: IDE study 24 months + PAS 36 months = 60 months total

Secondary outcomes (9)

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

    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.

    Measured: IDE study 24 months + PAS 36 months = 60 months total

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

    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).

    Measured: IDE study 24 months + PAS 36 months = 60 months total

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

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

    Measured: IDE study 24 months + PAS 36 months = 60 months total

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

    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.

    Measured: IDE study 24 months + PAS 36 months = 60 months total

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

    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.

    Measured: IDE study 24 months + PAS 36 months = 60 months total

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

    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)

    Measured: IDE study 24 months + PAS 36 months = 60 months total

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

    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".

    Measured: IDE study 24 months + PAS 36 months = 60 months total

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

    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.

    Measured: IDE study 24 months + PAS 36 months = 60 months total

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

    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.

    Measured: IDE study 24 months + PAS 36 months = 60 months total

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2020
  2. Study start1 Jan 2021
  3. Primary completion23 Apr 2023
  4. Study completion23 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04630626
Sponsor's protocol ID
P200022 PAS
Status last verified
Dec 2025
First submitted
9 Nov 2020
Last updated
8 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Simplify Disc and ACDF in people with Cervical Degenerative Disc Disorder, run by NuVasive at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04630626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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