3D打印儿童脑瘫下肢矫形器临床使用专家共识
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1.南京医科大学附属儿童医院;2.复旦大学附属儿科医院;3.南京市第一医院;4.东南大学附属中大医院;5.徐州医科大学;6.上海交通大学;7.奥托博克(中国)工业有限公司;8.浙江省人民医院;9.上海交通大学医学院附属第九人民医院;10.上海市儿童医院;11.佛山市第五人民医院

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江苏省重点研发计划(社会发展)项目(BE2019608)-江苏智慧康复体系建设与跨区域应用示范研究、国家重点研发计划重点专项(2020YFB1711505)-面向智能设计/仿真协同平台的3D打印医疗器械标准研究与临床应用、上海市科委项目(19441917500)- 3D打印定制式骨关节康复矫形辅具、上海市科委项目(19441908700)-远程下肢康复训练评估反馈系


Expert consensus on clinical use of 3D printed lower limb orthoses for children with cerebral palsy
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1.Children’s Hospital of Nanjing Medical University;2.Children’s Hospital of Fudan University;3.NANJING FIRST HOSPITAL;4.ZHONGDA HOSPITAL SOUTHEAST UNIVERSITY;5.XUZHOU MEDICAL UNIVERSITY;6.SHANGHAI JIAO TONG UNIVERSITY;7.Ottobock China Industries Corporation;8.ZHEJIANG PROVINCIAL PEOPLE’S HOSPITAL;9.Shanghai Ninth People’s Hospital, Shanghai JiaoTong University School of Medicine;10.Children’s Hospital of Shanghai;11.Foshan No.5 People’s Hospital

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    摘要:

    脑性瘫痪是导致儿童肢体残障的最主要疾病。大量研究证明,下肢矫形器的佩戴对提高脑瘫患儿运动功能和改善异常姿势方面起到了非常重要的作用。个性化定制矫形器具有舒适度高、依从性强、治疗效果佳等特点,而3D打印则是实现个性化定制的环保工艺。本文就3D打印儿童脑瘫下肢矫形器临床使用规范,提出了3D打印儿童脑瘫下肢矫形器的定义、分类及适用症,设计、制备及应用基本流程,临床质量控制的相关技术规范与全生命周期监管等提出要求。

    Abstract:

    Cerebral Palsy is the most important disease causing physical disability in children. A large number of studies have proved that the wearing of lower limb orthosis plays a very important role in improving the motor function and abnormal posture of children with cerebral palsy. Personalized customized orthopedic appliances have the characteristics of high comfort, strong compliance and good treatment effect, while 3D printing is an environmental protection process to achieve personalized customization. In this paper, the clinical use specifications of 3D printed children""s cerebral palsy lower limb orthoses put forward the definition, classification and applicability of 3D printed children""s cerebral palsy lower limb orthoses, the basic process of design, preparation and application, and the relevant technical specifications and life cycle supervision of clinical quality control.

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  • 收稿日期:2022-06-09
  • 最后修改日期:2022-06-09
  • 录用日期:2022-08-23
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