膝关节置换3D打印个性化手术工具临床应用专家共识(2023年版)

doi:10.3877/cma.j.issn.1674-134X.2023.04.001

全膝关节置换术(TKA)是治疗终末期膝骨关节疾病的有效手段，术中截骨的精准度是影响TKA术后疗效的重要因素。3D打印个性化手术工具，可以在计算机辅助下进行PSI术前三维设计和个性化定制，术中代替传统工具进行个性化的截骨导向辅助，减少手术步骤，降低了由于手术经验、测量误差等原因导致的截骨失准和术后力线不良，提高了TKA术后的下肢力线优良率，有利于患者术后功能改善和满意度提高。因此，PSI靠其精准、便捷、个性化等特点，现已广泛用于常规人工膝关节置换领域。然而，目前缺少PSI在人工膝关节置换领域临床应用的指引性规范。本共识以现有文献证据为基础，对PSI在人工膝关节置换的临床应用进行评价，通过共识性推荐意见对PSI在当前主题领域的使用做出指导性意见。

关键词: 膝, 关节成形术，置换, 打印，三维, 外科器械

Total knee arthroplasty (TKA) is an effective method for treating end-stage knee osteoarthritis, and the accuracy of osteotomy is an important factor affecting the postoperative efficacy of TKA. 3D printed patient-specific instrumentation (PSI) is designed and customized by computer technology preoperatively. During surgery, traditional tools are replaced with PSI to preform osteotomy procedure, resulting in higher accuracy of alignment, which may can improve postoperative function and satisfaction. Therefore, PSI has been widely used in total knee arthroplasty due to its precise, convenient, and personalized characteristics. However, there is currently a lack of guiding standards for the clinical application of PSI for TKA. On the basis of evidence-based medicine, the proposed consensus will provide the indications, preoperative design, intraoperative principles and perioperative managements of PSI for TKA.

Key words: Knee, Arthroplasty, replacement, Printing, three-dimensional, Surgical instruments

表1 PSI辅助TKA专家共识确定的临床问题

临床问题(PSI辅助TKA的临床应用及疗效)
1.合并关节外畸形的膝关节置换手术使用PSI辅助是否更有价值？
2.PSI辅助TKA的术后力线是否优于传统工具？
3.使用PSI是否有助于减少围手术期失血量？
4.PSI的使用是否会增加/减少特定手术并发症？
5.PSI辅助TKA的学习曲线？
6.PSI辅助TKA，是否会提高患者的术后满意度？
7.PSI辅助TKA的术后力线与导航相比是否有优势？
8.PSI的使用是否具有卫生经济学优势？
9.初次膝关节置换手术是否需要常规使用PSI辅助？

表1 PSI辅助TKA专家共识确定的临床问题

临床问题(PSI辅助TKA的临床应用及疗效)
1.合并关节外畸形的膝关节置换手术使用PSI辅助是否更有价值？
2.PSI辅助TKA的术后力线是否优于传统工具？
3.使用PSI是否有助于减少围手术期失血量？
4.PSI的使用是否会增加/减少特定手术并发症？
5.PSI辅助TKA的学习曲线？
6.PSI辅助TKA，是否会提高患者的术后满意度？
7.PSI辅助TKA的术后力线与导航相比是否有优势？
8.PSI的使用是否具有卫生经济学优势？
9.初次膝关节置换手术是否需要常规使用PSI辅助？

表2 英国牛津大学循证医学中心证据分级和推荐标准

推荐意见	证据级别	描述
A	1a	基于随机对照试验的系统评价(有同质性)
	1b	单个随机对照试验
	1c	"全或无"证据(有治疗以前，所有患者都死亡；有治疗之后，有患者能存活，或者再有治疗之前，一些患者死亡；有治疗之后，无患者死亡)
B	2a	基于队列研究的系统评价(有同质性)
	2b	单个队列研究(包括低质量RCT；如<80%随访)
	3a	基于病例对照研究的系统评价(有同质性)
	3b	单个病例对照研究
C	4	病例报道(低质量队列研究)
D	5	专家意见或评论

表2 英国牛津大学循证医学中心证据分级和推荐标准

推荐意见	证据级别	描述
A	1a	基于随机对照试验的系统评价(有同质性)
	1b	单个随机对照试验
	1c	"全或无"证据(有治疗以前，所有患者都死亡；有治疗之后，有患者能存活，或者再有治疗之前，一些患者死亡；有治疗之后，无患者死亡)
B	2a	基于队列研究的系统评价(有同质性)
	2b	单个队列研究(包括低质量RCT；如<80%随访)
	3a	基于病例对照研究的系统评价(有同质性)
	3b	单个病例对照研究
C	4	病例报道(低质量队列研究)
D	5	专家意见或评论

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Expert consensus on clinical application of 3D printed patient-specific instrumentation for total knee arthroplasty(2023)

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Expert consensus on clinical application of 3D printed patient-specific instrumentation for total knee arthroplasty(2023)