Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

  • STATUS
    Recruiting
  • End date
    Apr 26, 2037
  • participants needed
    170
  • sponsor
    Karolinska Institutet
Updated on 26 May 2021

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.

Description

Bracing with a rigid TLSO is gold-standard treatment in terms of halting progression of idiopathic scoliosis in skeletally immature adolescents and children. The treatment is cumbersome and demanding for adolescents during a vulnerable stage in life, and may be associated with poor compliance. Furthermore, the treatment lasts in many cases for several years and has shown to have a negative psychological effect for patients. Since time in brace is of utmost importance for best possible outcome, the braces need to be tolerated by the patients. As of today, 3D designed braces have received much attention and are thought to increase comfortability and ultimately increase wearing time, leading to better outcomes.

In a multicenter randomized controlled trial, we seek to compare standard Boston brace to a newly developed 3D designed Boston brace. Skeletally immature patients with idiopathic scoliosis will be randomized to receive either standard Boston brace or Boston 3D brace. All patients will be encouraged to be physically active for 60 minutes per day. Patients, outcome assessors and clinician in charge during follow-ups will be blinded for the type of brace the patients are being treated with. Thermal sensors will be installed in all braces to monitor compliance. Outcome include change in curve severity, quality of life and surgical rates. Patients will be evaluated with clinical and radiological follow-ups every six months until skeletal maturity and thereafter at 2, 5 and 10 years. Curve progression will not lead to change of brace. A total of 85 individuals are required in each group based on the hypothesis of a 2% failure rate in the 3D-brace group and 15% in the standard brace group with 5% significance level and 80% power and consideration for dropout of up to 20%.

For individuals who are not willing to be randomized and participate in the study, standard Boston brace will be offered and these individuals will serve as an observational group with similar follow-ups and will be asked to answer same survey as the study populations will do.

Details
Condition Idiopathic Scoliosis
Treatment 3D TLSO, Standard TLSO
Clinical Study IdentifierNCT04805437
SponsorKarolinska Institutet
Last Modified on26 May 2021

Eligibility

Yes No Not Sure

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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