Development of a flexible 3D-printed scoliosis brace

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to improve the comfort and adherence of scoliosis treatment by developing a 3D-printed brace with varying flexibility. Participants aged 8-18 with idiopathic scoliosis will receive a custom brace that mirrors their current one in shape but is made using 3D printing technology. The process involves scanning the patient's body, modifying the design, and fabricating the brace without additional imaging. Patient feedback will be collected to assess the comfort and effectiveness of the new brace design.

Why it matters

Who can join: the full rules

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

Where it's running

• Align Clinic
  The Woodlands, Texas, United States Recruiting
• University of Texas Health Science Center at Houston
  Houston, Texas, United States Completed

Study contacts

• Study coordinator: Megan EG Castille, MS
• Email: megan.glahn@bcm.edu
• Phone: 713-798-3098

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.