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New flexible implant aims to straighten spines without stiff fusion

NCT ID NCT06298812

Disease control Sponsor: Globus Medical Inc 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing the REFLECT system, a flexible implant designed to correct curved spines in children with idiopathic scoliosis while allowing natural growth. About 100 children who have failed bracing will receive the device. The main goal is to keep the spine curve at 40 degrees or less and track any serious side effects.

What this could mean

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

Active substance
REFLECT Scoliosis Correction System (a flexible implant that guides spine growth)
What this could lead to
If successful, this device could offer a less rigid way to correct scoliosis in growing children, potentially avoiding more invasive surgery.
What could go wrong
This is a post-approval registry, not a randomized trial, so results may be less definitive. Risks include device breakage, screw migration, or curve progression.

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

About 100 people

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

Started

Apr 2024

Expected to finish

Mar 2032

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.

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: * Diagnosis of progressive idiopathic scoliosis * Preoperative major Cobb angle 30°-65° * Preoperative flexibility to ≤30° on side bending radiograph (left or right) * Skeletally immature at the time of surgery with Risser sign \<5 or Sanders score \<8 * Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging * Failed or intolerant to bracing * Signed informed consent and/or assent forms specific to this study Exclusion Criteria: * Prior spinal surgery at the level(s) to be treated * Documented poor bone quality, defined as a T-score of -1.5 or less * Presence of any systemic infection, local infection, or skin compromise at the surgical site * Any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions * Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent * Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study

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Conditions

The condition(s) this trial relates to.

idiopathic scoliosis

As listed by the trial registrant

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

Idiopathic scoliosis

How to take part

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

  1. The places running it

    2 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

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • New York University

    ENROLLING_BY_INVITATION

    New York, New York, 10016, United States

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