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中华关节外科杂志(电子版)

中华关节外科杂志(电子版) ›› 2023, Vol. 17 ›› Issue (01) : 35 -43. doi: 10.3877/cma.j.issn.1674-134X.2023.01.005

荟萃分析

单髁置换术中应用3D打印导板对手术效果的影响
马鹏程1, 张思平2, 柴浩1, 姜侃1,†()   
  1. 1. 830000　乌鲁木齐，新疆医科大学第六附属医院关节外科
    2. 830000　乌鲁木齐，新疆医科大学第四附属医院
  • 收稿日期:2022-02-02 出版日期:2023-02-01
  • 通信作者: 姜侃

Effect of 3D printed patient-specific instrumentation on unicompartmental knee arthroplasty

Pengcheng Ma1, Siping Zhang2, Hao Chai1, Kan Jiang1,†()   

  1. 1. The Department of Joint Surgery of Sixth Affiliated Hospital of Xinjiang Medical University, Urumqi 830000, China
    2. The Fourth Affiliated Hospital of Xinjiang Medical University, Urumqi 830000, China
  • Received:2022-02-02 Published:2023-02-01
  • Corresponding author: Kan Jiang
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引用本文：

马鹏程, 张思平, 柴浩, 姜侃. 单髁置换术中应用3D打印导板对手术效果的影响[J]. 中华关节外科杂志(电子版), 2023, 17(01): 35-43.

Pengcheng Ma, Siping Zhang, Hao Chai, Kan Jiang. Effect of 3D printed patient-specific instrumentation on unicompartmental knee arthroplasty[J]. Chinese Journal of Joint Surgery(Electronic Edition), 2023, 17(01): 35-43.

目的

本研究旨在探讨在单髁置换术(UKA)中使用3D打印导板(PSI)对手术效果有何种影响。

方法

文献的纳入标准包括队列研究和随机对照试验(RCTs)、研究对象为初次行UKA的患者、干预措施同时包含PSI辅助UKA和传统UKA等。排除标准包括未包含所需结局指标的研究、随访脱落率过高的研究等。依此标准检索Web of Science、考克兰图书馆(The Cochrane Library)、荷兰医学文摘数据库(Embase)、PubMed、中国知网、万方、维普7个数据库，使用纽卡斯尔－渥太华量表(NOS)评价队列研究的质量，使用改良Jadad量表评价RCTs的质量，使用Revman 5.3软件进行Meta分析。

结果

共纳入9篇文献，包括5篇队列研究和4篇RCTs，均为高质量文献。Meta分析的结果显示，与传统器械相比，PSI可以减少胫骨假体冠状面[平均差(MD)＝－1.09，95%置信区间(CI)(－1.50，－0.67)，P<0.001]和矢状面[MD＝－0.73，95%CI(－1.43，－0.02)，P＝0.04]的位置偏差，但可能会增加股骨假体冠状面的位置偏差[MD＝0.89，95%CI(0.17，1.60)，P＝0.01]，差异均有统计学意义。在髋膝踝角[MD＝－0.13，95%CI(－0.72，0.46)，P＝0.66]、手术时间[MD＝2.07，95%CI(－0.14，4.29)，P＝0.07]、美国特种外科医院(HSS)评分[MD＝－0.70，95%CI(－1.71，0.31)，P＝0.17]以及假体位置异常数量[MD＝0.64，95%CI(0.38，1.08)，P＝0.10]方面，PSI辅助UKA没有产生比传统UKA更好的效果，差异均无统计学意义。

结论

PSI辅助UKA对假体定位有一定帮助，但总体的手术效果与传统UKA无明显差别。

关键词: 骨关节炎，膝, 关节成形术，置换，膝, 打印，三维, 外科器械, 预后, Meta分析
Objective

To investigate the effect of 3D printed patient-specific instrumentation (PSI) on unicompartmental knee arthroplasty (UKA).

Methods

Inclusion criteria for literature study included: cohort studies and randomised controlled trials (RCTs), patients receiving UKA for the first time, surgical procedures involving both PSI-assisted UKA and conventional UKA. Exclusion criteria: studies that did not include the required outcome indicators, and studies with high dropout rates at follow-up, etc.. Seven databases including Web of Science, The Cochrane Library, Excerpta Medica Database (Embase), PubMed, China National Knowledge Infrastructure (CNKI), China Online Journals (Wanfang) and China Science and Technology Journal Database (VIP) were retrieved based on above criteria. Newcastle-Ottawa scale (NOS) was applied to evaluate the quality of cohort studies. The improved Jadad scale was adopted to evaluate the quality of RCTs, and meta-analysis was performed using Revman 5.3.

Results

A total of nine works of literature were collected, including five cohort studies and four RCTs, all of which were of high quality. Results of the meta-analysis showed that PSI could reduce the coronal [mean difference (MD)=-1.09, 95% confidence interval (CI) (-1.50, -0.67), P <0.001]and sagittal [MD=-0.73, 95%CI(-1.43, -0.02), P=0.04]deviation of the tibial prosthesis compared with conventional instrumentation, but might increase the position deviation of the coronal plane of the femoral prosthesis [MD=0.89, 95%CI (0.17, 1.60), P=0.01]. The differences were statistically significant. In terms of hip-knee-ankle angle [MD=-0.13, 95%CI (-0.72, 0.46), P=0.66], operation time [MD=2.07, 95%CI (-0.14, 4.29), P=0.07], Hospital for Special Surgery (HSS) score [MD=-0.70, 95%CI (-1.71, 0.31), P=0.17] and the number of outliers in prosthesis positions [MD=0.64, 95%CI (0.38, 1.08), P=0.10], PSI-assisted UKA did not deliver better results than conventional UKA, and the differences were not statistically significant.

Conclusion

Prosthesis localization can benefit from the PSI-assisted UKA, but the overall surgical effect may not show remarkable difference from that of conventional UKA.

Key words: Osteoarthritis, Arthroplasty, replacement, knee, Printing, three-dimensional, Surgical instruments, Prognosis, Meta-analysis
图1 文献纳入流程
Figure 1 Process diagran for included articles
表1 纳入文献的基本特征
Table 1 The basic characteristics of included articles
作者Author 发表年Publication year 国别Country 实验类型Type of experiment 组别Group 样本量Sample size 平均年龄(岁)Mean age(years) 性别(男/女)Gender(male/female) 平均BMI(kg/m2)Mean BMI 随访时间Follow-up period 结局指标Outcome 质量评价Quality
Alvand[13] 2017 英国 RCTs PSI 23 66.9 10/13 29.8 12个月 ①②③⑤ 6分
CI 22 68.2 13/9 31.8 12个月
Leenders [17] 2021 荷兰 RCTs PSI 56 65 21/35 29 24个月 ①②③⑤⑥ 6分
CI 59 64 30/29 29 24个月
Ollivier[18] 2015 法国 RCTs PSI 30 63 13/17 27 12个月 ①②③④ 6分
CI 30 62 13/17 28 12个月
Kerens[19] 2014 荷兰 队列研究 PSI 30 63 13/17 29 6周 ①③⑤⑥ 7分
CI 30 61 13/17 29 6周
Kalache[20] 2020 法国 队列研究 PSI 25 65.1 19/6 27.3 2个月 ④⑤⑥ 8分
CI 22 70.5 7/15 26.4 2个月
Sanz-Ruiz [21] 2018 美国 队列研究 PSI 25 63.5 8/17 28.8 24个月 ①③④⑥ 8分
CI 25 64.8 7/18 29.5 24个月
郭东辉[22] 2021 中国 RCTs PSI 40 58.5 21/19 — 3个月 ④⑥⑦ 5分
CI 40 61.5 17/23 — 3个月
蔡康[23] 2019 中国 队列研究 PSI 21 61.3 13/8 — 6个月 ②⑥⑦ 7分
CI 21 60.8 11/10 — 6个月
樊宗庆[24] 2018 中国 队列研究 PSI 12 60.9 1/11 — 6个月 ②⑥⑦ 7分
CI 13 61.4 1/12 — 6个月
图2 股骨假体冠状面的位置偏差森林图
Figure 2 Forest plot of the position deviation of the femoral prosthesis in the coronal plane
图3 胫骨假体冠状面的位置偏差森林图
Figure 3 Forest plot of the position deviation of the tibial prosthesis in the coronal plane
图4 胫骨假体矢状面的位置偏差森林图
Figure 4 Forest plot of the position deviation of the tibial prosthesis in the sagittal plane
图5 髋膝踝角森林图
Figure 5 Forest plot of the hip-knee-ankle angle
图6 假体位置异常数量森林图
Figure 6 Forest plot of the number of outliers in prosthesis position
图7 手术时间森林图
Figure 7 Forest plot of the operation time
图8 HSS(美国特种外科医院)评分森林图
Figure 8 Forest plot of the HSS score
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