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Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

RecruitingNAAges 9 Years - 17 YearsAllKarolinska Institutet
NCT04805437 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. When brace treatment for scoliosis is indicated, standard treatment consists of bracing 20 hours or more per day. Outcomes of brace treatment depend to a large extent on wearing time and since many adolescents feel uncomfortable in the brace, it is of importance to combine efficacy and comfortability of the brace.

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📋 Eligibility rules (as published)
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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What it tests

  • 3D TLSO
  • Standard TLSO
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Where

2 sites
Linköping university hospital
Linköping, Sweden
Karolinska university hospital
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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