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RECRUITING
NCT04805437
NA

Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

Summary

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.

Official title: 3D Designed Boston Brace Versus Standard Boston Brace in Halting Progression in Idiopathic Scoliosis: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

9 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2021-04-30

Completion Date

2037-04

Last Updated

2025-02-21

Healthy Volunteers

No

Interventions

DEVICE

3D TLSO

Brace treatment with Boston 3D 20 hours a day until skeletal maturity.

DEVICE

Standard TLSO

Brace treatment with standard Boston brace 20 hours a day until skeletal maturity.

Locations (2)

Linköping university hospital

Linköping, Sweden

Karolinska university hospital

Stockholm, Sweden