3D打印个性化截骨导板辅助全膝关节置换疗效的Meta分析

Meta analysis of the efficacy of 3D printing patient-specific instrumentation assisted total knee arthroplasty

目的对比3D打印个性化截骨导板辅助全膝关节置换与传统方法行全膝关节置换的临床疗效。方法计算机检索PubMed、Embase、Cochrane Library、中国知网、万方、维普等数据库中有关对比3D打印个性化截骨导板与传统方法行全膝关节置换临床疗效的随机对照研究;检索时间为建库至2022年2月;由2名研究人员根据纳入、排除标准独立筛选文献并提取数据,使用Jadad评分进行文献质量评价、Revman 5.3软件进行效应量合并与数据分析;结局指标为:下肢力线(hip-knee-ankle angle,HKA)离群值、冠状面股骨假体角(frontal femoral component,FFC)离群值、冠状面胫骨假体角(frontal tibial component,FTC)离群值、矢状面股骨假体角(lateral femoral component,LFC)离群值、矢状面胫骨假体角(lateral tibial component,LTC)离群值、股骨假体旋转对位(Femoral rotation)离群值、KSS评分、OKS评分、WOMAC评分、手术时间、出血量、并发症发生率。结果最终纳入27项研究共2251例,其中PSI组1128例,CI组1123例;Meta分析结果显示:(1)两组下肢力线离群值,差异无统计学意义(OR=0.96,95%CI[0.75,1.24],P=0.78);(2)两组FFC离群值,差异无统计学意义(OR=0.87,95%CI[0.62,1.24],P=0.45)、FTC离群值,差异无统计学意义(OR=1.41,95%CI[0.95,2.09],P=0.09)、LFC离群值,差异无统计学意义(OR=1.13,95%CI[0.76,1.68],P=0.55)、LTC离群值,差异无统计学意义(OR=1.24,95%CI[0.84,1.82],P=0,27)、Femoral retation离群值,差异无统计学意义(OR=0.87,95%CI[0.5,1.5],P=0.61);(3)KSS评分,差异无统计学意义(OR=0.86,95%CI[-0.89,2.62],P=0.33);OKS评分,差异无统计学意义(OR=1.06,95%CI[-0.37,2.50],P=0.15);WOMAC评分,差异无统计学意义(OR=-1.03,95%CI[-3.09,1.03],P=0.33);PSI组手术时间短于CI组(OR=-6.17,95%CI[-10.41,1.94],P=0.004);(4)PSI组出血量少于CI组(OR=-96.94,95%CI[-154.35,39.54],P=0.0009);(5)两组并发症发生率,差异无统计学意义(OR=0.01,95%CI[-0.01,0.04],P=0.33)。结论3D打印个性化截骨导板辅助全膝关节置换与传统方法相比可缩短手术时间、减少出血量,但在恢复下肢力线、改善关节功能方面与传统方法无显著差异;在并发症发生率与安全性方面与传统方法基本一致。由于文章纳入研究数量有限,仅能代表部分真实情况,结论尚需要更多大样本、长随访时间的随机对照试验进一步验证。

Objective To compare the clinical effect of total knee arthroplasty assisted by 3D printing personalized osteotomy guide plate and traditional method.Methods A randomized controlled study on the clinical efficacy of 3D printing personalized osteotomy guide plate and traditional method in total knee arthroplasty was searched in PubMed,Embase,Cochrane Library,China knowledge Network,Wanfang,VIP and other databases until February 2022.The two researchers independently screened the literature and extracted the data according to the inclusion and exclusion criteria.The literature quality was evaluated by Jadad score,and the effect was combined and analyzed by Revman 5.3 software.The outcome indexes included lower limb force line(HKA)outliers,coronal femoral prosthesis angle(FFC)outliers,coronal tibial prosthesis angle(FTC)outliers,sagittal femoral prosthesis angle(LFC)outliers,sagittal tibial prosthesis angle(LTC)outliers,femoral prosthesis rotation(femoral rotation)outliers,KSS score,OKS score,WOMAC score,operation time,bleeding volume and incidence of complications.Results A total of 2251 patients were included in 27 studies,including 1128 in PSI group and 1123 in CI group.Meta analysis showed that there were no significant differences in lower limb force line outliers between the two groups(OR=0.96,95%CI[0.75,1.24],0.78);there were no significant differences in FFC outliers(OR=0.87,95%CI,0.62,0.45),FTC outliers(OR=1.41,95%CI,0.95,0.09),LFC outliers(OR=1.135,95%CI,0.76,0.55)and LTC outliers(OR=1.24)between the two groups;there were no significant differences in outliers of 95%CI(0.84,0.27)and femoral rotation(OR=0.87,95%CI[0.5,1.5],0.61);there were no significant differences in KSS score(OR=0.86,95%CI[-0.89,2.62],0.33),OKS score(OR=1.06,95%CI[-0.37,2.50],0.15)and WOMAC score(OR=-1.03,0.33).The operation time in PSI group was shorter than that in CI group(OR=-6.17,1.94,0.004).The amount of bleeding in PSI group was less than that in CI group(OR=-96.94,95%CI,0.0009).There were no significant differences in the incidence of complications between the two groups(OR=0.01,95%CI[-0.01,0.04],0.33).Conclusions Compared with the traditional method,3D printing personalized osteotomy guide plate assisted total knee arthroplasty can shorten the operation time and reduce the amount of bleeding,but there are no significant differences in restoring the line of force of the lower extremities and improving the joint function between the two groups.The incidence and safety of complications are basically the same as those of the traditional method.Due to the limited studies included in the article,the conclusion needs to be further verified by more large-sample and long follow-up randomized controlled trials.