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Artificial disc shows promise in 5-Year neck pain study

NCT ID NCT04980378

Disease control Sponsor: NuVasive Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 291 patients for 5 years after receiving the Simplify Disc, an artificial disc for the neck. The goal was to see if the disc remains safe and effective over time. Researchers measured pain, nerve function, and whether any further surgeries were needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Simplify Disc (artificial cervical disc)
What this could lead to
If successful, this could confirm that the Simplify Disc is a safe and effective long-term option for treating cervical disc disease, potentially reducing pain and improving function.
What could go wrong
This is a post-approval study confirming earlier results, not a new breakthrough. Risks include implant failure, need for additional surgery, or no long-term benefit for some patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

291 people

The number who actually took part.

Started

Aug 2021

Finished

Jan 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include subjects who were enrolled in the IDE study G150206. This will include up to 170 subjects eligible for study enrollment from sixteen (16) sites in the two level Simplify Disc IDE study who consent to long-term follow-up. Additionally, up to 17 training subjects from the two level Simplify Disc IDE study from seventeen (17) sites will be enrolled.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- All subjects enrolled in the two level 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

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Conditions

The condition(s) this trial relates to.

cervical disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical degenerative disc disorder

Contacts and locations

Locations

  • Buffalo Spine Surgery

    Lockport, New York, 14094, United States

  • Carolina Neurosurgery and Spine Associates

    Charlotte, North Carolina, 28204, United States

  • Connecticut Orthopaedic Specialists

    Hamden, Connecticut, 06518, United States

  • Indiana Spine Group

    Carmel, Indiana, 46032, United States

  • Kennedy-White Orthopedic Center

    Sarasota, Florida, 34232, United States

  • NorthShore University Health System

    Evanston, Illinois, 60201, United States

  • Oregon Neurosurgery

    Springfield, Oregon, 97477, United States

  • Orthopaedic Education and Research Institute of Southern California

    Orange, California, 92868, United States

  • Orthopaedic Institute of Western Kentucky

    Paducah, Kentucky, 42003, United States

  • Parkview Research Center

    Fort Wayne, Indiana, 46845, United States

  • Spine Education and Research Foundation

    Thornton, Colorado, 80229, United States

  • Spine Institute of Louisiana

    Shreveport, Louisiana, 71101, United States

  • Texas Back Institute

    Plano, Texas, 75093, United States

  • Texas Spine Consultants

    Addison, Texas, 75001, United States

  • The Disc Replacement Center

    West Jordan, Utah, 84088, United States

  • The Spine Institute for Spine Restoration

    Santa Monica, California, 90403, United States

  • Virginia Spine Institute

    Reston, Virginia, 20191, United States

  • William Beaumont Hospital Research Institute

    Royal Oak, Michigan, 48073, United States

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