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A smarter brace for scoliosis: does 3D design stop curves from worsening?

NCT ID NCT04805437

Disease control Sponsor: Karolinska Institutet 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial compares a 3D-designed Boston brace with the standard Boston brace in 170 teens with idiopathic scoliosis, a spinal curve affecting about 3% of children. Participants wear the brace 20 hours a day until they reach skeletal maturity. Researchers measure whether the 3D brace better prevents the curve from worsening by more than 6 degrees, while also tracking comfort and quality of life.

What this could mean

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

Active substance
A 3D-designed Boston brace (custom-fitted spinal brace) worn 20 hours a day until skeletal maturity
What this could lead to
If it works, a 3D-printed brace could slow or stop spinal curve progression in teens with scoliosis, reducing the need for surgery.
What could go wrong
The trial is early and results depend on how consistently teens wear the brace. The 3D brace may not outperform the standard one, and discomfort could limit use.

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 170 people

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

Started

Apr 2021

Expected to finish

Apr 2037

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.

Ages

9 to 17 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: * Cobb 25-40 degrees * Skeletally immature, Sanders score of 6 or less and Risser 2 or less. * Menarche status maximum one year in females * Aged 9-17 years * No previous brace treatment or surgery for scoliosis * Apex of the primary curve at T7 or caudal Exclusion Criteria: * Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis) * Previous spine surgery

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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

  • Karolinska university hospital

    RECRUITING

    Stockholm, Sweden

  • Linköping university hospital

    NOT_YET_RECRUITING

    Linköping, Sweden

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