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New study checks safety of Spine-Correcting device in kids

NCT ID NCT07589023

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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks back at medical records of 100 children and teens who had surgery for idiopathic scoliosis (a curved spine) using the REFLECT system. Researchers want to see how often the device's cords break and if more surgeries are needed. The goal is to understand how well the system works and its safety.

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 100 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

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 consists of skeletally immature pediatric and adolescent patients with progressive idiopathic scoliosis who were treated surgically with the REFLECT™ Scoliosis Correction System as part of routine clinical care. Eligible patients had a major spinal curve between 30° and 65°, required surgical correction after failing or being unable to tolerate bracing, and had adequate bone quality to support screw fixation. This is a multicenter, international retrospective cohort including approximately 100 patients treated at participating institutions in Germany, Turkey, and the United States. The cohort includes patients treated with either 4.0 mm or 5.0 mm REFLECT cords, using single or dual cords per curve, with at least 12 months of postoperative clinical and radiographic follow-up available for review.

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: Subjects must meet all of the following criteria to be included in the study: 1. Requires surgical treatment to obtain and maintain correction of idiopathic scoliosis 2. Skeletally immature 3. Major Cobb angle of 30° and 65° 4. Bone structure adequate to safely accommodate screw fixation 5. Failed bracing treatment and/or intolerant to brace wear 6. Treated with the REFLECT™ Scoliosis Correction System, using single or dual REFLECT cord(s) per curve 7. Availability of medical and radiographic records evaluating the product under study preoperatively through a minimum of 12 months postoperative Exclusion Criteria: Patients were excluded from the study if they met any of the following conditions: 1. Presence of any systemic infection, local infection, or skin compromise at the surgical site 2. Prior spinal surgery at the level(s) to be treated 3. Known poor bone quality, defined as a T-score of -1.5 or less 4. Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, or patient unwillingness or inability to cooperate with postoperative care instructions

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Conditions

The condition(s) this trial relates to.

idiopathic scoliosis 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

    3 sites in 3 countries. 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

  • Acibadem Maslak Hospital

    Istanbul, I, 34457, Turkey (Türkiye)

  • Eifel Clinic St. Brigida GmbH & Co. KG

    Simmerath, Simmerath, 52152, Germany

  • NYU Langone Orthopedic Center

    New York, New York, 11554, United States

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