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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
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.
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.
CHU Sainte-Justine
Montreal, Quebec, Canada
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.
Time frame: Baseline, 1 year, 2 years
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
Time frame: Baseline, 1 year, 2 years
Quality of Life (QoL) - SRS-22r
The QoL will be measured using the Scoliosis Reasearch Society (SRS)-22r.
Time frame: Baseline, 1 year, 2 years
Quality of Life (QoL) - MOBI
The QoL will be measured using the My Orthopedic Brace Inventory (MOBI) questionnaire.
Time frame: 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.
Time frame: 5 minutes after brace fitting
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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.