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Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2022 Sep 15;36(9):1047-1055. doi: 10.7507/1002-1892.202206026.
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.
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%).
Thirty-one specialists completed the questionnaire investigation. They all practiced in university teaching hospitals (Grade-A tertiary hospitals) from 16 provinces, 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 which 6 had more than 300 cases; in terms of research, 28 had published more than 1 related paper in the past 5 years, of which 13 had published more than 3 related papers. Twenty-six specialists attended the face-to-face meeting and reached a consensus on 9 terms, including 8 strong terms and 1 moderate term.
ACL reconstruction using the NGAL must deploy "isometric" or "near-isometric" reconstruction and should preserve the natural ACL remnants as much as possible. Bone tunnel positioning can be performed using intraoperative radiographic measurements or the lateral femoral intercondylar ridge as reference marks. Incorrect positioning of the bone tunnel is the main reason of surgical failure, and there is a lack of consensus on handling interference screws during revision. Bone tunnel enlargement exists after reconstruction but rarely causes related symptoms. Synovitis and infection are uncommon complications. The aging effect of polyethylene terephthalate fiber on the long-term clinical outcomes is unknown and deserves attention.
新一代人工韧带（NGAL）用于前交叉韧带（ACL）重建因疗效良好且功能恢复早而在中国受到欢迎，但医源性手术失败和先入为主的误解严重影响了其标准化临床应用。现制定专家共识，为骨科运动医学医生采用或考虑使用NGAL进行ACL重建提供指导和参考。
采用改良德尔菲法，专门针对国家药品监督管理局（NMPA）批准的用于ACL重建的NGAL，制定关于使用NGAL进行ACL重建的核心技术和不良事件的共识。共识专家从中国骨科医师协会（CAOS）和中国运动医学学会（CSSM）的成员中选取。起草团队基于医学证据总结共识草案条款，并组织多轮调查：两轮在线问卷调查和最后一轮面对面会议。经讨论、修订和投票，当同意率超过85%时达成对共识草案条款的共识。共识条款分为“强”（同意率：95.0%-100%）、“中”（同意率：90.0%-94.9%）和“基本”（同意率：85.0%-89.9%）。
31名专家完成问卷调查。他们均在中国16个省、自治区、直辖市的大学教学医院（三级甲等医院）执业。其中，28名是主任医师，3名是副主任医师；22名是教授，7名是副教授；骨科运动医学平均资历为25.2年（范围12-40年）；进行ACL重建手术的平均资历为13.2年（范围7-23年）；就使用NGAL进行ACL重建的数量而言，18名完成超过100例，其中6名超过300例；在研究方面，28名在过去5年发表过1篇以上相关论文，其中13名发表过3篇以上相关论文。26名专家参加了面对面会议，就9项条款达成共识，包括8项强条款和1项中条款。
使用NGAL进行ACL重建必须采用“等长”或“近等长”重建，并应尽可能保留天然ACL残端。骨隧道定位可采用术中影像学测量或股骨外侧髁间嵴作为参考标志。骨隧道定位错误是手术失败的主要原因，翻修时处理干扰螺钉缺乏共识。重建后存在骨隧道扩大，但很少引起相关症状。滑膜炎和感染是少见的并发症。聚对苯二甲酸乙二酯纤维的老化效应对长期临床结果的影响未知，值得关注。
