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New spine device aims to stop Post-Surgery failure

NCT ID NCT04888104

Disease control Sponsor: International Spine Study Group Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a new device called the VersaTie system, used during spine fusion surgery to help prevent a complication called proximal junctional failure. The trial will enroll 225 adults with spinal deformities like scoliosis or kyphosis who need surgery on five or more vertebrae. Researchers will compare outcomes to see if the device reduces the need for repeat surgeries.

What this could mean

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

Active substance
VersaTie posterior fixation system (a device used during spine surgery)
What this could lead to
If it works, this could reduce the risk of spine problems above the fusion area, helping patients avoid additional surgeries.
What could go wrong
This is a relatively early study with 225 participants, so results may not apply to everyone. The device is new, and long-term benefits or risks are not yet known.

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 225 people

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

Started

Jul 2021

Expected to finish

Dec 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Multicenter, prospective, observational, study evaluating the safety and performance of the VersaTie System by comparing adult patients receiving minimum 5 level posterior spinal fusion with pedicle screw fixation supplemented at the proximal aspect of the construct with the VersaTie System

Ages

18 years and older

Sex

Anyone

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. \>18 years of age at the time of treatment 2. EOS full body or standing 36" AP \& Lateral images of entire spine 3. Posterior spine fusion with pedicle screw fixation construct of 5 or more levels 4. Pedicle screw fixation to be supplemented proximally with NuVasive VersaTie system 5. Upper instrumented vertebra (UIV) terminating at a newly instrumented level 6. Lowest instrumented vertebra (LIV) sacrum/pelvis 7. Surgery scheduled to take place in the next 6 months Exclusion Criteria: 1. Active spine tumor or infection 2. Deformity due to acute trauma 3. Prisoners 4. Women who are pregnant 5. Patient is unwilling or unable to complete questionnaires

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Conditions

The condition(s) this trial relates to.

Kyphosis scoliosis vertebral column disorder

As listed by the trial registrant

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

Adult spinal deformity Kyphosis Scoliosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Barrow Neurological Institute

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • Duke University Health System

    NOT_YET_RECRUITING

    Durham, North Carolina, 27708, United States

  • Louisiana Spine Institute

    RECRUITING

    Shreveport, Louisiana, 71101, United States

  • New York University, Department of Orthopedic Surgery

    RECRUITING

    New York, New York, 10003, United States

  • Presbyterian/St. Luke's Medical Center

    RECRUITING

    Denver, Colorado, 80218, United States

  • Shiley Center for Orthopaedic Research and Education at Scripps Clinic

    RECRUITING

    La Jolla, California, 92037, United States

  • University at Buffalo, Department of Neurosurgery

    RECRUITING

    Buffalo, New York, 14260-1660, United States

  • University of California - San Francisco

    WITHDRAWN

    San Francisco, California, 94143, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

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