Idiopathic Scoliosis, Scoliosis
Conditions
Keywords
Scoliosis, Spine deformity, Nighttime brace, Optimization
Brief summary
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.
Interventions
DEVICEImmediate in-brace correction: Conventional Brace
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.
DEVICEImmediate in-brace correction: Optimized Brace
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.
DEVICELong-term bracing: Conventional 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.
DEVICELong-term bracing: Optimized 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.
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cobb angle | Baseline, 1 year, 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure rate | Baseline, 1 year, 2 years | 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 |
| Quality of Life (QoL) - SRS-22r | Baseline, 1 year, 2 years | The QoL will be measured using the Scoliosis Reasearch Society (SRS)-22r. |
| Quality of Life (QoL) - MOBI | 1 year, 2 years | The QoL will be measured using the My Orthopedic Brace Inventory (MOBI) questionnaire. |
| Immediate in-brace Cobb angle | 5 minutes after brace fitting | 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. |
Countries
Canada
Outcome results
None listed