3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial.
3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial.
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3D打印支架治疗青少年特发性脊柱侧凸：前瞻性随机对照试验的研究方案
DOI：
10.1136/bmjopen-2020-038373
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发表时间：
2020-11-27
期刊：
影响因子：
2.9
通讯作者：
Liu Z
中科院分区：
文献类型：
--
作者：
Zhang Y;Liang J;Xu N;Zeng L;Du C;Du Y;Zeng Y;Yu M;Liu Z
青少年特发性脊柱侧凸（AIS）是一种三维脊柱畸形。支具治疗对符合条件的AIS患者有效，且有效性与每天平均支具佩戴时间显著相关。三维（3D）打印技术是一项最新的进步，为生物医学应用提供了独特的机会，脊柱侧凸矫正器的定制可能会提高患者的满意度和依从性。我们在此介绍了一项关于3D打印支架与胸腰骶矫形器（TLSO）治疗AIS患者的临床有效性的随机对照试验设计。方法和分析患有AIS的患者（年龄10-16岁），Risser征0-II，Cobb角20°-40°，月经前或月经后不超过1年（女性），并且没有治疗史，除非他们无法耐受治疗或拒绝参与。总共88例患者将按照1：1的比例随机分配至3D组或TLSO组。根据Zelen的试验设计，3D组的参与者将在3D打印支架和TLSO之间进行选择。主要结局指标将包括每日平均支具佩戴时间、健康相关生活质量和主弯曲的Cobb角进展。次要结局指标将包括主弯曲Cobb角的即刻支架内矫正、手术转换率和任何不良事件的发生率。本研究设计为单中心、两组、优效性和开放标签随机对照试验。参考初步研究，根据样本量计算公式计算样本量。伦理与传播本研究已获得北京大学第三医院医学科学研究伦理委员会批准（编号：2019-017-02）。试验结果将提交同行评审期刊发表，并作为会议报告。试验注册号ChiCTR 1900027379，预结果。
Introduction Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine. Brace treatment is effective for eligible patients with AIS and the effectiveness is significantly correlated with the average brace-wear time per day. Three-dimensional (3D) printing technology is a recent advancement that offers unique opportunities for biomedical applications, and customisation of scoliosis braces might lead to greater patient satisfaction and improved compliance. We present here the design of a randomised controlled trial on the clinical effectiveness of 3D-printed braces versus thoracolumbosacral orthoses (TLSO) for patients with AIS. Methods and analysis Patients with AIS (age 10–16 years) with Risser sign 0-II, Cobb angle of main curve of 20°−40°, premenarchal or no more than 1-year postmenarchal (for women), and no history of treatment are eligible, unless they are unable to tolerate the treatment or refuse participation. A total of 88 patients will be randomised into either the 3D group or TLSO group on a 1:1 basis. Participants in the 3D group will choose between a 3D-printed brace and TLSO, according to the Zelen’s design of the trial. Primary outcome measures will include the average brace-wear time per day, health-related quality of life and Cobb angle progression of the primary curve. Secondary outcome measures will include immediate in-brace correction of Cobb angle of the primary curve, rate of conversion to surgery and incidence of any adverse events. This study is designed as a single-centre, two-arm, superiority and open-label randomised controlled trial. The sample size is calculated with reference to the preliminary study and based on the sample size calculation formula. Ethics and dissemination This study was approved by the Peking University Third Hospital Medicine Science Research Ethics Committee (No: 2019-017-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations. Trial registration number ChiCTR1900027379, pre-results.
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