Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Department of Reconstructive Orthopaedics, Karolinska University Hospital, Stockholm, Sweden.
PLoS One. 2021 Aug 9;16(8):e0255264. doi: 10.1371/journal.pone.0255264. eCollection 2021.
Idiopathic scoliosis is the most common spinal deformity in children. Treatment strategies aim to halt progression of the curve. Patients are treated mainly with thoracolumbosacral orthosis (TLSO) if indicated. This form of brace treatment has been shown to be cumbersome and tough on growing individuals. However, computer aided design and manufactured (CAD/CAM) braces might increase comfortability and ultimately outcome if compliance is improved. In a multicenter, randomized controlled trial, we aim to compare CAD/CAM designed Boston 3D-brace to standard Boston brace.
Subjects: 170 previously untreated and skeletally immature children diagnosed with idiopathic scoliosis, aged 9-17 years of age (curve magnitude Cobb 25-40 degrees) will be included. Interventions: Both groups will receive a physical activity prescription according to the World Health Organization recommendations. Randomization will be performed 1:1 to a 3D CAD/CAM designed Boston 3D-brace or a standard Boston brace, both with prescribed daily wear time of 20 hours. Outcome: The subjects will participate in the study until curve progression or until skeletal maturity. The primary outcome variable is failure of treatment, defined as progression of the Cobb angle more than 6 degrees compared to the baseline x-ray. The progression is confirmed if seen on two consecutive standing spinal x-rays. Radiographs will be taken at each six-month follow-up. Secondary outcome measures include patient and clinical reported outcomes, including number of individuals requiring surgical intervention.
This study will show if efficacy in brace treatment can be improved with new brace designs.
The protocol has been registered on ClinicalTrials.gov, identifier: NCT04805437.
特发性脊柱侧凸是儿童中最常见的脊柱畸形。治疗策略旨在阻止曲线进展。如果有指征，患者主要接受胸腰骶支具（TLSO）治疗。这种支具治疗形式被证明对生长中的个体来说既麻烦又苛刻。然而，如果提高依从性，计算机辅助设计和制造（CAD/CAM）支具可能会提高舒适度并最终改善结果。在一项多中心、随机对照试验中，我们旨在比较 CAD/CAM 设计的波士顿 3D 支具与标准波士顿支具。
研究对象：170 名未经治疗且骨骼未成熟的特发性脊柱侧凸患儿，年龄 9-17 岁（Cobb 角 25-40 度），将被纳入研究。干预措施：两组均将根据世界卫生组织的建议接受体育活动处方。将以 1:1 的比例随机分配至 3D CAD/CAM 设计的波士顿 3D 支具或标准波士顿支具，两者均规定每天佩戴 20 小时。结果：受试者将参加研究，直至曲线进展或骨骼成熟。主要结局变量是治疗失败，定义为与基线 X 射线相比 Cobb 角增加超过 6 度。如果在连续两次站立脊柱 X 光片上看到进展，则确认进展。每六个月进行一次 X 光随访。次要结局指标包括患者和临床报告的结果，包括需要手术干预的个体数量。
本研究将表明新的支具设计是否可以提高支具治疗的效果。
该方案已在 ClinicalTrials.gov 上注册，标识符为 NCT04805437。
