Validation of a New Optimized Nighttime Providence Brace 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. Our team has developed an innovative conception method for brace design by optimizing for the immediate in-brace correction. The model is customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application.

Official Title
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Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis

Conditions
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Scoliosis, Idiopathic Scoliosis

Intervention / Treatment
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* Device: Immediate in-brace correction: Conventional Brace
* Device: Immediate in-brace correction: Optimized Brace
* Device: Long-term bracing: Conventional Brace
* Device: Long-term bracing: Optimized Brace


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 Pregnancy

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: Optimized Providence brace<br>The braces will be designed using optimization and finite element analysis. | Device: Immediate in-brace correction: Conventional Brace<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 (supine position) 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: Immediate in-brace correction: Optimized Brace<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 (supine position) 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: Long-term bracing: Optimized Brace<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: Conventional Providence brace<br>The braces will be designed by an orthotist using the conventional design method. | Device: Immediate in-brace correction: Conventional Brace<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 (supine position) 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: Immediate in-brace correction: Optimized Brace<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 (supine position) 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: Long-term bracing: Conventional Brace<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 out-of-brace radiographs will be taken with an low-dose biplane radiographic system (EOS) to allow 3D reconstructions. | Baseline, 1 year, 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, 1 year, 2 years | 
| Quality of Life (QoL) - SRS-22r | The QoL will be measured using the Scoliosis Reasearch Society (SRS)-22r. | Baseline, 1 year, 2 years | 
| Quality of Life (QoL) - MOBI | The QoL will be measured using the My Orthopedic Brace Inventory (MOBI) questionnaire. | 1 year, 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 the patient in a supine position. | 5 minutes after brace fitting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scoliosis, Spine deformity, Nighttime brace, Optimization