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Spine-Tethering device aims to straighten scoliosis without fusion

NCT ID NCT06521814

Disease control Sponsor: Medical University of South Carolina 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 was designed to test a device called the Globus Reflect Tether for children and teens with scoliosis who are still growing. The device is surgically attached to the spine to hold the curve in place, allowing the other side to grow and gradually straighten the spine. The trial was withdrawn before any participants were enrolled, so no data was collected.

What this could mean

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

Active substance
Globus Reflect scoliosis correction system (a surgical tether device)
What this could lead to
If successful, this device could offer a way to correct scoliosis in growing children without permanently fusing the spine, allowing more natural growth.
What could go wrong
This trial was withdrawn before enrolling any participants, so no results are available. The device is still experimental and may not work as hoped or could cause 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.

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.

Started

Nov 2025

Finished

Nov 2025

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.

Ages

10 to 18 years

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: * Skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 35 to 60 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. * Patients should have failed bracing and/or be intolerant to brace wear. Exclusion Criteria: * Pregnancy (current) * Prior spinal or chest surgery * MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord) * Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis * Associated syndrome, including Marfan Disease or Neurofibromatosis * Sanders stage greater than 4 * Thoracic curve less than 35 or greater than 60 * Lumbar curve greater than or equal to 35 * Unable or unwilling to firmly commit to returning for required follow-up visits * Investigator judgement that the subject/family may not be a candidate for the intervention

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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.

Scoliosis idiopathic

More trials for these conditions

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