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Introduction: Spinal bracing remains the gold standard for conservative management of adolescent idiopathic scoliosis (AIS). However, poor adherence often limits treatment efficacy. The development of a brace that enhances compliance while maintaining sufficient corrective force is crucial. This study aimed to develop and evaluate the effectiveness of a novel semi-rigid brace for AIS based on wearing time and correction rate.
Materials and Methods: The investigators enrolled patients who met the following Scoliosis Research Society (SRS) criteria for brace treatment: (1) confirmed AIS diagnosis, (2) Risser sign ≤ 2, (3) Cobb angle between 25° and 40°, (4) age ≥ 10 years, and (5) single-curve pattern. Wearing time was objectively measured over 180 days using embedded temperature sensors. Correction rates were assessed at initiation and after 180 days or more.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal bracing | Device | The semi-rigid spinal brace was developed to enhance patient compliance while maintaining effective curve correction. Patients were instructed to wear the brace for 18-20 h daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Wearing time | 180 days from registration |
| Measure | Description | Time Frame |
|---|---|---|
| Initial correction rate | Immediately after registration | |
| Correction rate after 180 days or more | 180 days or more from registration | |
| Treatment success rate |
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Inclusion Criteria:
Exclusion Criteria:
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Conducted at seven medical institutions in Japan.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aizu Medical Center at Fukushima Medical University | Aizu-Wakamatsu | Fukushima | 969-3492 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16166897 | Background | Richards BS, Bernstein RM, D'Amato CR, Thompson GH. Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2068-75; discussion 2076-7. doi: 10.1097/01.brs.0000178819.90239.d0. | |
| 24047455 | Background |
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The investigators will not be sharing individual participant data (IPD) due to privacy concerns.
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| 2 years or more from registration |
| Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19. |
| 41700840 | Derived | Hirata K, Shirado O, Suzuki N, Iida T, Inoue M, Inage K, Katayanagi J, Matsumoto K, Nikaido T, Abe M, Endo T. Development and short-term evaluation of a novel semi-rigid brace for adolescent idiopathic scoliosis: Results from a multicenter prospective observational study of the first 60 patients. Prosthet Orthot Int. 2026 Feb 17. doi: 10.1097/PXR.0000000000000519. Online ahead of print. |