An interventional study of Optimized brace versus conventional Boston brace in Scoliosis and Adolescent Idiopathic Scoliosis (AIS), sponsored by St. Justine's Hospital. Completed at 1 site in Canada. Open to participants aged 10 Years to 14 Years. Per ClinicalTrials.gov, last updated 2021-11-24.
Sponsored by St. Justine's Hospital · Not applicable, Interventional, and Treatment
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
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's planned enrollment of 90 is above the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →St. Justine's Hospital is the lead sponsor of 155 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Test group: Patient will receive optimized brace (3D computer assisted design of the brace)
Other: Optimized brace versus conventional Boston brace
Control goup: Patient will receive the Boston Thoracolumbosacral orthosis (TLSO) (conventional design method)
Other: Optimized brace versus conventional Boston brace
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.
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.
Time frame: Baseline, 6 months, 1 year
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.
Time frame: 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.
Time frame: Baseline, 6 months, 1 year
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St. Justine's Hospital