可降解个性化接骨板的增材制造及临床试验流程  

Expert Consensus on Additive Manufacturing and Clinical Trial Processes of Degradable Personalized Bone Plate

作　　者：中国装备协会医用增材制造专家委员会 齐大虎 李慈 朱皓 董献振 苏瑾 景明[6] 张焙智 胡斌 石志良[8] 田静静 戴红莲[4] 周钢[5] 方忠[2] 罗政强 胡懿郃[10] 张培训[3] 赵宇[9] 肖骏 Medical Additive Manufacturing Expert Committee of China Equipment Association;QI Da-hu;LI Ci;ZHU Hao;DONG XIAN-zhen;SU Jin;JING Ming;ZHANG Bei-zhi;HU Bin;SHI Zhi-liang;TIAN Jing-jing;DAI Hong-lian;ZHOU Gang;FANG Zhong;LUO Zheng-qiang;HU Yi-he;ZHANG Pei-xun;ZHAO Yu;XIAO Jun(不详;Department of Orthopaedics,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Department of Orthopaedics,Peking University People's Hospital,Beijing 100044,China;State Key Laboratory of Advanced Technology for Composite Materials,Wuhan University of Technology,Wuhan 430070,China;State Key Laboratory of Material Forming and Mould Technology,Huazhong University of Science and Technology,Wuhan 430074,China;Tianjin Center for Quality Supervision and Inspection of Medical Devices,Tianjin 300384,China;Hubei Joye 3D High-tech Company Limited,Xianning 437000,China;School of Mechanical and Electrical Engineering,Wuhan University of Technology,Wuhan 430070,China;Department of Orthopaedics,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China;Department of Orthopaedics,Xiangya Hospital,Central South University,Changsha 410008,China)

机构地区：[1]不详 [2]华中科技大学同济医学院附属同济医院骨科,武汉430030 [3]北京大学人民医院创伤骨科,北京100044 [4]武汉理工大学材料复合新技术国家重点实验室,武汉430070 [5]华中科技大学材料成形与模具技术国家重点实验室,武汉430074 [6]天津市医疗器械质量监督检验中心,天津300384 [7]湖北嘉一三维高科股份有限公司,湖北咸宁437000 [8]武汉理工大学机电工程学院,武汉430070 [9]中国医学科学院北京协和医学院北京协和医院骨科,北京100730 [10]中南大学湘雅医院骨科,长沙410008

出　　处：《骨科》2021年第4期293-299,共7页ORTHOPAEDICS

基　　金：国家重点研发计划(2018YFB1105500)。

摘　　要：骨折复位内固定术是骨科的常规手术,内固定作为该手术的关键步骤之一,目的是维持骨折断端的复位。现阶段临床上使用的接骨板和螺钉系统大多数采用金属材料通过传统工艺制备而成,因其缺乏个性化外形且不具备降解性能,常常难以匹配特殊形态的骨折部位且需要二次手术取出。可降解材料结合增材制造技术有望解决以上问题,其可赋予接骨板个性化外形和降解性能,达到更好的治疗效果。但目前可降解个性化接骨板的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,以有机/无机复合材料接骨板为例,从可降解个性化接骨板的“增材制造流程”和“临床试验流程”两方面出发形成本共识,为国内外各中心可降解个性化接骨板的制备和临床试验提供参考。Fracture reduction and internal fixation is a routine orthopedic operation.Internal fixation is one of the key steps in this operation to maintain the reduction of the fracture ends.At present,most of the bone plates and screw systems used clinically are made of metal materials through traditional processes.Due to their lack of personalized shape and degradation performance,they are often difficult to match the fracture site with special shape and need to be removed by a second operation.The combination of biodegradable materials and additive manufacturing technology is expected to solve this problem by giving the plate a personalized shape and degradable properties,and lead to better therapeutic outcomes.However,there is a lack of unified understanding and standards about the preparation and clinical trial process of biodegradable personalized bone plate at home and abroad.Therefore,after several rounds of discussions,taking organic/inorganic composite materials bone plate as an example,this consensus was formed from two aspects:“additive manufacturing process”and“clinical trial process”of degradable personalized bone plate,in order to provide reference for the preparation and clinical trial of biodegradable personalized bone plate in various centers at home and abroad.

关 键 词：骨折内固定术 接骨板 可降解 个性化 增材制造 临床试验 

分 类 号：R68[医药卫生—骨科学]