Comparing standard and 3D braces for treating idiopathic scoliosis in adolescents
3D Designed Boston Brace Versus Standard Boston Brace in Halting Progression in Idiopathic Scoliosis: a Randomized Controlled Trial
This study is testing whether a new 3D Boston brace works better than the standard brace for treating scoliosis in kids and teens aged 9-17.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 9 Years to 17 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Linköping and 1 other locations) |
| Trial ID | NCT04805437 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a newly developed 3D designed Boston brace compared to the standard Boston brace for treating idiopathic scoliosis in skeletally immature adolescents. Participants aged 9-17 with a Cobb angle of 25-40 degrees will be randomly assigned to receive either type of brace. The study will monitor compliance using thermal sensors and assess outcomes such as curve severity, quality of life, and surgical rates through clinical and radiological follow-ups. The goal is to improve brace comfort and increase wearing time, ultimately leading to better treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are skeletally immature adolescents aged 9-17 with idiopathic scoliosis and a Cobb angle between 25-40 degrees.
Not a fit: Patients with non-idiopathic scoliosis or those who have previously undergone spine surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved brace comfort and compliance, resulting in better management of idiopathic scoliosis in adolescents.
How similar studies have performed: Previous studies have shown that innovative brace designs can improve compliance and outcomes, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cobb 25-40 degrees * Skeletally immature, Sanders score of 6 or less and Risser 2 or less. * Menarche status maximum one year in females * Aged 9-17 years * No previous brace treatment or surgery for scoliosis * Apex of the primary curve at T7 or caudal Exclusion Criteria: * Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis) * Previous spine surgery
Where this trial is running
Linköping and 1 other locations
- Linköping university hospital — Linköping, Sweden (Not_yet_recruiting)
- Karolinska university hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Elias Diarbakerli, PT, PhD — Karolinska Institutet
- Study coordinator: Elias Diarbakerli, PT, PhD
- Email: elias.diarbakerli@sll.se
- Phone: +460851770000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.