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Artificial disc holds up over 5 years in neck pain study

NCT ID NCT04630626

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 145 people who received the Simplify Cervical Artificial Disc to treat neck problems caused by worn-out discs. Researchers checked if the disc was still working safely after 5 years, looking for pain improvement, device failures, or need for more surgery. The goal was to confirm the disc's long-term benefits and risks.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

145 people

The number who actually took part.

Started

Jan 2021

Finished

Apr 2023

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.

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 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

  • 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

  • Orthopaedic Education and Research Institute of Southern California

    Orange, California, 92868, United States

  • Orthopaedic Institute of Western Kentucky

    Paducah, Kentucky, 42003, United States

  • Rothman Institute

    Egg Harbor, New Jersey, 08234, 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 Spine Institute for Spine Restoration

    Santa Monica, California, 90403, United States

  • USCD

    San Diego, California, 92121, United States

  • Virginia Spine Institute

    Reston, Virginia, 20191, United States

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