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New 3D-Printed brace aims to make scoliosis treatment less painful for teens

NCT ID NCT06785207

Symptom relief Sponsor: Baylor College of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study tests a new 3D-printed scoliosis brace that has flexible sections to improve comfort. Five teens aged 8-18 who already wear a standard brace will try the new brace and compare how it feels during everyday tasks like sitting and putting on shoes. The goal is to see if a more comfortable brace helps teens wear it more consistently.

What this could mean

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

Active substance
3D-printed scoliosis brace with variable flexibility
What this could lead to
If it works, this could lead to a more comfortable scoliosis brace that helps teens wear it longer and better manage their spine curvature.
What could go wrong
This is a very small early trial with only 5 participants, so results may not apply to everyone. The brace is still a prototype and may not be more comfortable than current braces.

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 5 people

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

Started

Apr 2025

Expected to finish

Oct 2026

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

8 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: 1. Have a diagnosis of juvenile idiopathic scoliosis or adolescent idiopathic scoliosis 2. Have a Cobb angle between 20-40 degrees 3. Are between ages 8-18 4. Present as Risser 2+ on x-ray 5. Currently wear a traditionally fabricated scoliosis brace 6. Have good brace adherence in current brace (self-reported to be 75% of prescribed time) 7. Be an established patient of Align Clinic and Dr. Timothy Borden 8. Speak English (survey and semi-structured interview will only be available in English) 9. Assent and receive parental consent Exclusion Criteria: 1. Have a diagnosis other than juvenile idiopathic scoliosis or adolescent idiopathic scoliosis 2. Have a Cobb angle outside the range of 20-40 degrees 3. Present as Risser 0 or 1 4. Do not currently wear a traditionally fabricated scoliosis brace 5. Have poor adherence in their current brace 6. Do not speak English 7. Are not willing participate in the study

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Conditions

The condition(s) this trial relates to.

adolescent idiopathic scoliosis juvenile idiopathic scoliosis

As listed by the trial registrant

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

Scoliosis idiopathic adolescent treatment

How to take part

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

  1. The places running it

    1 site. 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

  • Align Clinic

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • University of Texas Health Science Center at Houston

    COMPLETED

    Houston, Texas, 77030, United States

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