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Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

NCT04805437 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-02-21

No results posted yet for this study

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.

Conditions

  • Idiopathic Scoliosis

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.

Sponsors & Collaborators

Principal Investigators

  • Elias Diarbakerli, PT, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2027-09-30
Completion
2037-04-30

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04805437 on ClinicalTrials.gov