Comparing standard and 3D braces for treating idiopathic scoliosis in adolescents

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 clinical trial aims to evaluate the effectiveness of a newly developed 3D designed Boston brace compared to the standard Boston brace for treating idiopathic scoliosis in skeletally immature adolescents. Participants aged 9-17 with a Cobb angle of 25-40 degrees will be randomly assigned to receive either type of brace. The study will monitor compliance using thermal sensors and assess outcomes such as curve severity, quality of life, and surgical rates through clinical and radiological follow-ups. The goal is to improve brace comfort and increase wearing time, ultimately leading to better treatment outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Karolinska university hospital
  Stockholm, Sweden Recruiting
• Linköping university hospital
  Linköping, Sweden Not yet recruiting

Study contacts

• Principal investigator: Elias Diarbakerli, PT, PhD — Karolinska Institutet
• Study coordinator: Elias Diarbakerli, PT, PhD
• Email: elias.diarbakerli@sll.se
• Phone: +460851770000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Enhanced Recovery After Surgery for Adolescent Idiopathic Scoliosis Surgery

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  Recruiting at 11 sites Hospices Civils de Lyon · Amiens and 10 other locations · NCT06908213

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.