Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation

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. Our team has developed an innovative conception method for brace design by simulating the growth modulation using numerical models. Those models are customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and validate its clinical application.

Official Title
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Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation

Conditions
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Adolescent Idiopathic Scoliosis, Scoliosis

Intervention / Treatment
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* Device: Test brace versus control brace: Immediate correction
* Device: Test brace versus control brace: Long-term correction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 a 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: 16 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
Interventional Model Description: The study will be separated into two stages. Each patient will initially try a control brace and a test brace in a crossover study model to evaluate the immediate correction. Each patient will then use one brace from either the control arm or test arm to evaluate the long-term correction of the brace.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group: Braces designed with growth modulation simulation<br>The braces will be designed using a growth modulation method. | Device: Test brace versus control brace: Immediate correction<br>* The trunk surface will be scanned to reconstruct a numerical model of the patient's trunk, this reconstruction will help to produce the optimized brace. The patient skeletal will also be reconstructed from a bilateral radiograph using an EOS imaging system. Each patient will try both the control and the test brace. Radiographic and patient-reported data will be gathered and analyzed to observe changes between the immediate correction of the braces. The SRS-22r will be collected. The study protocol requires no additional visits beyond the standard of care. There will be one additional radiograph compared to the standard of care.<br>Device: Test brace versus control brace: Long-term correction<br>* After comparing the immediate correction of the braces, each patient will be using either the test or the control brace for a period of two years. There will be follow-up visits, between 6 months and 1 year depending on the patient growth. The brace will be renewed using the same procedure to adapt to the patient's growth. The study protocol requires no additional visits beyond the standard of care. There will be no additional radiograph compared to the standard of care. Compliance monitors are installed in each brace.<br>|
| Active Comparator: Control group: Conventional method<br>The braces will be designed by an orthotist without growth modulation simulation. | Device: Test brace versus control brace: Immediate correction<br>* The trunk surface will be scanned to reconstruct a numerical model of the patient's trunk, this reconstruction will help to produce the optimized brace. The patient skeletal will also be reconstructed from a bilateral radiograph using an EOS imaging system. Each patient will try both the control and the test brace. Radiographic and patient-reported data will be gathered and analyzed to observe changes between the immediate correction of the braces. The SRS-22r will be collected. The study protocol requires no additional visits beyond the standard of care. There will be one additional radiograph compared to the standard of care.<br>Device: Test brace versus control brace: Long-term correction<br>* After comparing the immediate correction of the braces, each patient will be using either the test or the control brace for a period of two years. There will be follow-up visits, between 6 months and 1 year depending on the patient growth. The brace will be renewed using the same procedure to adapt to the patient's growth. The study protocol requires no additional visits beyond the standard of care. There will be no additional radiograph compared to the standard of care. Compliance monitors are installed in each brace.<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 - 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure rate | Treatment failure is defined as having a Cobb angle progress by more than 5 degrees compared to the baseline measurement or exceeding a value of 45 degrees | Baseline, 2 years | 
| Quality of Life (QoL) | The QoL will be measured using the SRS-22r and MOBI questionnaire. | Baseline, 2 years | 
| Immediate in-brace Cobb angle | Radiographics will be gathered and analyzed to observe changes between the control and test braces. All radiographs will be taken with an low-dose biplane radiographic system (EOS). | 5 minutes after brace fitting | 

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