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10-Year study tracks artificial disc safety in neck patients

NCT ID NCT05258435

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 131 people who already received the Simplify Disc for cervical disc disease. Researchers will check the disc's safety and how well it works over 10 years. The goal is to see if patients have lasting pain relief and fewer complications.

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

About 131 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Apr 2028

An estimate. End dates often move.

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 includes subjects treated with the NuVasive Simplify Disc in IDE study (NCT02667067) and followed in the PAS (NCT04630626).

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: 1. Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site 2. Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study Exclusion Criteria: 1. Subject had an SSI at the index level during the post approval study (NCT04630626) 2. Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)

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Conditions

The condition(s) this trial relates to.

cervical disk degenerative disorder intervertebral disk degenerative disorder lumbar disk degenerative disorder

As listed by the trial registrant

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

Cervical disc disease Degenerative disc disease

Contacts and locations

Locations

  • Carolina Neurosurgery and Spine Associates

    Charlotte, North Carolina, 28204, United States

  • Hoag Orthopedics

    Orange, California, 92686, United States

  • Indiana Spine Group

    Carmel, Indiana, 46032, United States

  • Kennedy-White Orthopaedic Center

    Sarasota, Florida, 34232, United States

  • NorthShore University Health System

    Evanston, Illinois, 60201, United States

  • Spine Education and Research

    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

More trials for these conditions

Other studies related to the condition(s) this trial covers.