RECRUITING Not applicable ClinicalTrials.gov

Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

Sponsor: Karolinska Institutet • ClinicalTrials.gov ID: NCT04805437

Registry updated: 2026-08-27

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Description

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.

Interventions

3D TLSO (Device)
Brace treatment with Boston 3D 20 hours a day until skeletal maturity.
Standard TLSO (Device)
Brace treatment with standard Boston brace 20 hours a day until skeletal maturity.

Eligibility criteria

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

Conditions

Idiopathic Scoliosis

Locations

Linköping university hospital — Linköping, Sweden
Karolinska university hospital — Stockholm, Sweden

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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