采用新一代人工韧带重建前十字韧带的关键技术和不良事件——基于改良Delphi法制订的中国专家共识(二)  

Core techniques and adverse events in anterior cruciate ligament reconstruction using a new generation of artificial ligaments:the consensus of Chinese specialists based on a modified Delphi method(Part 2)

作　　者：新一代人工韧带重建前十字韧带中国专家共识制订小组 陈世益[2,3,4,5,6] 陈天午 Chinese Specialist Consensus Group on New Generation Artificial Ligaments Used for Anterior Cruciate Ligament Reconstruction;CHEN Shiyi

机构地区：[1]不详 [2]复旦大学运动医学研究所 [3]复旦大学附属华山医院运动医学科 [4]中华医学会运动医疗分会 [5]中国医师协会骨科医师分会运动医学专业委员会 [6]亚太膝关节-关节镜-骨科运动医学会 [7]复旦大学附属华山医院

出　　处：《中国修复重建外科杂志》2022年第9期1047-1055,共9页Chinese Journal of Reparative and Reconstructive Surgery

摘　　要：目的新一代人工韧带(a new generation of artificial ligaments,NGAL)重建前十字韧带(anterior cruciate ligament,ACL)凭借良好的临床疗效和早期功能恢复优势在中国获得一定范围应用,但医源性因素导致的手术失败和先入为主的错误观念严重影响其规范化临床应用。现通过制订专家共识,为骨科运动医学专科医生在采用或考虑采用NGAL重建ACL时提供指导和参考。方法采用改良Delphi法制订NGAL重建ACL的关键技术和不良事件的中国专家共识,仅涉及国家药品监督管理局(NMPA)批准用于ACL重建的NGAL。共识专家遴选自中国医师协会骨科医师分会和中华医学会运动医疗分会成员。共识起草小组在医学证据基础上归纳共识条款草案并组织轮回调查:两轮在线问卷调查和一轮面对面会议。条款草案经讨论、修改和投票,赞成率达85%视为达成共识。共识条款分“高度”(赞成率95.0%~100%)、“普遍”(赞成率90.0%~94.9%)、“基本”(赞成率85.0%~89.9%)三级。结果来自全国16个省、自治区、直辖市大学教学医院(三级甲等医院)的31名专家完成问卷调查,其中主任医师28名、副主任医师3名;正教授22名、副教授7名;从事骨科运动医学12~40年,平均25.2年;开展ACL重建术7~23年,平均13.2年;完成NGAL重建ACL手术量,18名专家达100例以上,其中6名超过300例;科研工作方面,28名专家近5年内发表1篇以上相关论文,其中13名发表论文3篇以上。26名专家出席面对面会议,就9项条款草案达成共识,包括8项高度共识条款和1项普遍共识条款。结论采用NGAL重建ACL必须采用“等长”或“类等长”重建,并尽可能保留天然ACL残端。骨隧道定位可采用术中X线测量定位,也可参照股骨外侧髁间嵴骨性标志。骨隧道定位错误是手术失败主要原因,翻修时对挤压螺钉的处理缺乏共识。重建术后存在骨隧道扩大现象,但很少引起相应症状。滑膜炎和感染�Objective Anterior cruciate ligament(ACL)reconstruction using a new generation of artificial ligaments(NGAL)gained popularity in China owing to its good effectiveness and early functional recovery,but iatrogenic surgical failures and preconceived misconceptions have seriously affected its standardized clinical application.A specialist consensus is now developed to provide guidance and reference for orthopaedic sports medicine doctors when adopting or considering the NGAL for ACL reconstruction.Methods The consensus on the core techniques and adverse events in ACL reconstruction using the NGAL was developed by a modified Delphi method,referring exclusively to the NGAL for ACL reconstruction approved by the National Medical Products Administration(NMPA).Consensus specialists were selected from the members of the Chinese Association of Orthopaedic Surgeons(CAOS)and the Chinese Society of Sports Medicine(CSSM).The drafting team summarized the draft consensus terms based on medical evidence and organized rounds of investigation:two rounds of online questionnaire investigation and the final round of face-to-face meeting.After discussion,revision,and voting,a consensus on the draft consensus term was reached when the agreement rate exceeded 85%.The consensus terms were categorized as“strong”(agreement rate:95.0%-100%),“moderate”(agreement rate:90.0%-94.9%),and“basic”(agreement rate:85.0%-89.9%).Results Thirty-one specialists completed the questionnaire investigation.They all practiced in university teaching hospitals(Grade-A tertiary hospitals)from 16provinces,autonomous regions,and municipalities in China.Among them,28 were chief physicians and 3 were associate chief physicians;22 were professors and 7 were associate professors;the average seniority in orthopedic sports medicine was 25.2 years(range,12-40 years);the average seniority in performing ACL reconstruction procedures was 13.2 years(range,7-23 years);in terms of the number of ACL reconstruction using the NGAL,18 completed more than 100 cases,of whi

关 键 词：人工韧带 前十字韧带重建 中国专家 共识 关键技术 不良事件 

分 类 号：R687.4[医药卫生—骨科学]