Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Idiopathic Scoliosis

Intervention / Treatment
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* Device: 3D TLSO
* Device: Standard TLSO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D TLSO<br>A 3-dimensional Boston brace will be designed to the patient's individual type of scoliosis. In-brace radiographs will be performed after prescription. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. Patients are encouraged to use the brace for 20 hours per day and to also continue with physical activities for the entirety of the study. Compliance will be monitored with a heat sensor built in the brace that measures wearing time. | Device: 3D TLSO<br>* Brace treatment with Boston 3D 20 hours a day until skeletal maturity.<br>* Other names: Boston 3D brace;|
| Active Comparator: Standard TLSO<br>A standard Boston brace will be designed to the patient's individual type of scoliosis. In brace radiographs will be performed after prescription. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. Patients are encouraged to use the brace for 20 hours per day and to also continue with physical activities for the entirety of the study. Compliance will be monitored with a heat sensor built in the brace that measures wearing time. | Device: Standard TLSO<br>* Brace treatment with standard Boston brace 20 hours a day until skeletal maturity.<br>* Other names: Boston brace;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Curve progression | Increase in curve severity (Cobb angle) of more than 6 degrees on two consecutive radiographs after baseline | Measured at each six-month follow-up until skeletal maturity. Skeletal maturity defined as less than 1 cm body height increase in 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes | Angle of trunk rotation in forward bending, assessed with scoliometer | At each six-month follow-up and 2, 5, 10 years after skeletal maturity | 
| Patient-reported outcome measures | Scoliosis Research Society-22r questionnaire | At each six-months follow-up and 2, 5, 10 years after skeletal maturity | 
| Patient-reported outcome measures | EQ5D questionnaire | At each six-month follow-up, and 2, 5, 10 years after skeletal maturity | 
| Patient-reported outcome measures | Spinal Appearance Questionnaire (SAQ) | At each six-month follow-up, and 2, 5, 10 years after skeletal maturity | 
| Patient-reported outcome measures | International Physical Activity Questionnaire (IPAQ) | At each six-month follow-up, and 2, 5, 10 years after skeletal maturity | 
| Surgical rates | Number needing surgical intervention | At each six-months follow-up and 2, 5, 10 years after skeletal maturity | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic scoliosis, Randomized controlled trial, Brace, Orthosis