Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis

Study Overview
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Brief Summary
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Adolescent Idiopathic scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. The design is made relatively corsets empirically, hence the relative efficiency of this treatment. Our team has developed innovative methods for design, optimization and computer aided manufacturing-based numerical simulation models customized to each patient, and a system of evaluation and adjustment of corsets. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and demonstrate its clinical application

Conditions
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Scoliosis, Adolescent Idiopathic Scoliosis (AIS)

Intervention / Treatment
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* Other: Optimized brace versus conventional Boston brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10 years or older AIS diagnosis Risser 0-2 Primary curve angles 20 degrees - 40 degrees If female, either premenarchal or less than 18 months postmenarchal. Exclusion Criteria: Patients with a pre-existing cardiovascular condition Patients with symptom of a neurological disorder Patients with any other disorder of the musculoskeletal system affecting the lower limbs,

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optimized brace<br>Test group: Patient will receive optimized brace (3D computer assisted design of the brace) | Other: Optimized brace versus conventional Boston brace<br>* Surface topography using Inspeck cameras allows production of a 3D reconstruction of the patient's trunk, this reconstruction will help to produce the optimized brace. Radiographic and patient-reported data will be gathered and analyzed to observe changes between time points. All radiographs will be taken with an EOS imaging system to allow 3D reconstructions. The SRS-22r will be collected at all clinical visits. Study questions will be aligned as much as possible with other prospective scoliosis protocols so as to minimize patient and surgeon response burden. The study protocol requires no additional visits or radiographs beyond standard of care. Ibuttons are installed in each brace and used to measure the compliance of the patient.<br>|
| Active Comparator: Standard brace<br>Control goup: Patient will receive the Boston Thoracolumbosacral orthosis (TLSO) (conventional design method) | Other: Optimized brace versus conventional Boston brace<br>* Surface topography using Inspeck cameras allows production of a 3D reconstruction of the patient's trunk, this reconstruction will help to produce the optimized brace. Radiographic and patient-reported data will be gathered and analyzed to observe changes between time points. All radiographs will be taken with an EOS imaging system to allow 3D reconstructions. The SRS-22r will be collected at all clinical visits. Study questions will be aligned as much as possible with other prospective scoliosis protocols so as to minimize patient and surgeon response burden. The study protocol requires no additional visits or radiographs beyond standard of care. Ibuttons are installed in each brace and used to measure the compliance of the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cobb angle | Radiographics will be gathered and analyzed to observe changes between time points. All radiographs will be taken with an low-dose biplane radiographic system (EOS) to allow 3D reconstructions. | Baseline, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Scoliosis Research Society questionnaire (SRS-22r) scores | The SRS-22r questionnaire is available from SRS.org. It is a self-reported tools assessing self-image, function, pain, mental health with 5 questions each and satisfaction with care with 2 questions. A total score is also available based on all 22 questions. | Baseline, 6 months, 1 year | 
| Change in surface topography | Four optical scanners are used to capture full trunk images. Subjects are positioned in a standard frame, and reference points marked. Parameters quantifying the external back surface deformity are assessed. | Baseline, 6 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D, Scoliosis, Spine deformity, Brace