RecruitingNot ApplicableNCT04805437

Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

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


Sponsor

Karolinska Institutet

Enrollment

170 participants

Start Date

Apr 30, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 9 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called 3D TLSO and a medical device called Standard TLSO for people with idiopathic scoliosis. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 9 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE3D TLSO

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

DEVICEStandard 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

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NCT04805437


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