摘要
脊柱椎间融合术是脊柱外科的常规手术。植骨作为该手术的关键步骤之一,目的是达到重建椎体间稳定性。现阶段临床上使用的植骨材料均存在较为明显的缺点,而通过增材制造技术制备的可降解植骨材料有望解决现有问题。但由于其大部分尚处于临床前试验阶段,研究者对于其制备和临床试验流程在国内外均缺乏统一认识和标准。因此,本共识专家组经过多轮讨论,从脊柱椎间融合可降解植骨材料的"增材制造流程"和"临床试验流程"两方面出发形成本共识,为其在脊柱外科的临床试验阶段提供建议和指导。
Spinal interbody fusion is a routine operation in spine surgery.Bone grafting is one of the key steps in this operation to achieve intervertebral stability.There are obvious shortcomings in bone grafting materials used in clinic,and degradable bone grafting materials prepared by additive manufacturing technology are expected to solve the existing problems.But most of them are still in pre-clinical trials,and there is a lack of unified understanding and standards for their preparation and clinical trial process.After many discussions,we formulated this consensus based on the additive manufacturing process and the clinical trial process of degradable bone grafting materials for spinal interbody fusion,and provided recommendations and guidance for clinical trials in spine surgery.
作者
中国医学装备协会医用增材制造专业委员会
李春旭
田静静
雷鹏飞
翟吉良
朱皓
李梦
石志良
景明
李嘉浩
赵宇
肖骏
张培训
方忠
戴红莲
周钢
胡懿郃
孙晓丹
邱贵兴
Medical Additive Manufacturing Professional Committee of China Medical Equipment Association;LI Chunxu;TIAN Jingjing;LEI Pengfei;ZHAI Jiliang;ZHU Hao;LI Meng;SHI Zhiliang;JING Ming;LI Jiahao;ZHAO Yu;XIAO Jun;ZHANG Peixun;FANG Zhong;DAI Honglian;ZHOU Gang;HU Yihe;SUN Xiaodan;QIU Guixing(不详;Department of Orthopaedics,Peking Union Medical College Hospital,CAMS&PUMC,Beijing 100730;Academic Medical Centers,Peking Union Medical College Hospital,CAMS&PUMC,Beijing 100730;Department of Orthopaedics,Xiangya Hospital,Central South University,Changsha 410008;Department of Orthopaedics,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030;State Key Laboratory of Advanced Technology for Composite Materials,Wuhan University of Technology,Wuhan 430070;School of Mechanical and Electrical Engineering,Wuhan University of Technology,Wuhan 430070;Tianjin Center for Quality Supervision and Inspection of Medical Devices,Tianjin 300384;Department of Traumatic Orthopaedics,Peking University People's Hospital,Beijing 100044;State Key Laboratory of Material Forming and Mould Technology,Huazhong University of Science and Technology,Wuhan 430074;State Key Laboratory of Advanced Ceramics and Fine Processing,School of Materials,Tsinghua University,Beijing 100084,China)
出处
《中华骨与关节外科杂志》
2021年第7期584-591,共8页
Chinese Journal of Bone and Joint Surgery
基金
国家重点研发计划(2018YFB1105504)
自主科研计划清华大学-北京协和医院2019年度合作课题(20191080871)
关键词
椎间融合术
植骨材料
可降解
增材制造
临床试验
Interbody Fusion
Bone Grafting Materials
Degradable
Additive Manufacturing
Clinical Trial
作者简介
共同第一作者:李春旭;共同第一作者:田静静;共同第一作者:雷鹏飞;共同第一作者:翟吉良;共同第一作者:朱皓;共同第一作者:李梦;共同第一作者:石志良;共同第一作者:景明;共同第一作者:李嘉浩;通信作者:赵宇,E-mail:zhaoyupumch@163.com;通信作者:肖骏,E-mail:jun_xiao@hust.edu.cn;通信作者:张培训,E-mail:zhangpeixun@126.com;通信作者:方忠,E-mail:Zhongfangtjh@yahoo.com;通信作者:戴红莲,E-mail:daihonglian@whut.edu.cn;通信作者:周钢,E-mail:gangzhou@hust.edu.cn;通信作者:胡懿郃,E-mail:csuhuyihe@163.com;通信作者:孙晓丹,E-mail:sunxiaodan@tsinghua.edu.cn;通信作者:邱贵兴,E-mail:qguixing@126.com
