Chinese Journal of Tissue Engineering Research ›› 2023, Vol. 27 ›› Issue (4): 646-654.doi: 10.12307/2022.743
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3D printing personalized osteotomy guide technology versus conventional total knee arthroplasty on the accuracy of lower limb force alignment: a meta-analysis
Chai Hao1, Yang Deyong1, Zhang Lei2, Shu Li1
- 1First Department of Joint Surgery, Sixth Affiliated Hospital of Xinjiang Medical University, Urumqi 830002, Xinjiang Uygur Autonomous Region, China; 2First Department of Surgery, Hospital Affiliated to Xinjiang Production and Construction Corps of Chinese People’s Armed Police Forces, Urumqi 830002, Xinjiang Uygur Autonomous Region, China
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Received:2021-10-22Accepted:2021-12-22Online:2023-02-08Published:2022-06-23 -
Contact:Shu Li, Master, Associate chief physician, First Department of Joint Surgery, Sixth Affiliated Hospital of Xinjiang Medical University, Urumqi 830002, Xinjiang Uygur Autonomous Region, China -
About author:Chai Hao, Attending physician, First Department of Joint Surgery, Sixth Affiliated Hospital of Xinjiang Medical University, Urumqi 830002, Xinjiang Uygur Autonomous Region, China -
Supported by:Special Scientific Research Project for Young Medical Science and Technology Talents in Health of Xinjiang Uygur Autonomous Region, No. WJWY-202024 (to SL)
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Cite this article
Chai Hao, Yang Deyong, Zhang Lei, Shu Li. 3D printing personalized osteotomy guide technology versus conventional total knee arthroplasty on the accuracy of lower limb force alignment: a meta-analysis[J]. Chinese Journal of Tissue Engineering Research, 2023, 27(4): 646-654.
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2.1 文献检索结果 初检并阅读题录后得到相应文献775篇，经过阅读题目及摘要后，初步纳入125篇文献，仔细阅读全文，排除质量较低的文献95篇，最后30篇文献符合纳入标准[12-41]，筛选流程见图2。"
纳入研究的基本情况见表1。 "
纳入的研究均为随机对照试验，使用Cochrane偏倚风险评估图及偏倚风险总结图进行文献质量评估，见图3，4。 "
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2.2 Meta分析结果 2.2.1 各组髋-膝-踝角(下肢力线)偏差值及人数(偏离理想角度±3°)差异 有11个研究比较了冠状位髋-膝-踝角(下肢力线)偏差值[13-14，17，19-20，22，24-25，27-28，33]。异质性检验结果表明，各研究间有中度异质性(I2=49%)，采用固定效应模型进行合并分析，Meta分析结果显示，2种手术方法冠状面髋-膝-踝角(下肢力线)偏差值差异有显著性意义(MD=-0.51，95%CI：-0.66至-0.36，P < 0.000 01)，截骨导板组髋-膝-踝角(下肢力线)偏差值小于传统手术组。有13个研究比较了冠状面髋-膝-踝角偏离理想角度±3°的人数[12，14-15，16，20，22-27，31，34]。异质性检验结果表明，各研究间有低度异质性(I2=17%)，采用固定效应模型进行合并分析，Meta分析结果显示，此2种手术方法髋-膝-踝角偏离理想角度±3°的人数差异无显著性意义(RR=0.79，95%CI：0.61-1.03，P=0.08)。具体结果见图5。"
2.2.2 各组冠状面股骨组件角偏差值及人数(偏离理想角度±3°)差异 有11个研究比较了冠状面股骨组件角偏差值[14，16-17，19-20，22-24，27-28，35]。异质性检验结果表明，各研究间异质性较低(I2=37%)，采用固定效应模型进行合并分析，Meta分析结果显示，2种手术方法冠状面股骨组件角偏差值差异有显著性意义(MD=-0.33，95%CI：-0.39至-0.27，P < 0.000 01)，截骨导板组冠状面股骨组件角偏差值小于传统手术组。有12项研究比较了冠状面股骨组件偏离理想角度±3°的人数[13-17，22-24，26-28，31]。异质性检验结果表明，各研究间为低度异质性(I2=37%)，采用固定效应模型进行合并分析，Meta分析结果显示，2种手术方法冠状面股骨组件角偏离理想角度±3°的人数差异有显著性意义(RR=0.52，95%CI：0.44-0.63，P < 0.000 01)，冠状面股骨组件角偏离理想角度±3°的人数少于传统手术组。见图6。"
2.2.3 各组冠状面胫骨组件角偏差值及人数(偏离理想角度±3°)差异 有12项研究比较了冠状面胫骨组件角偏差值[12-14，17-18，20-24，27-28]。异质性检验结果表明，各研究间有中度异质性(I2=40%)，采用固定效应模型进行合并分析，Meta分析结果显示，2种手术方法冠状面胫骨组件角偏差值差异有显著性意义(MD=-0.21，95%CI：-0.32至-0.10，P=0.000 2)，截骨导板组冠状面胫骨组件角偏差值小于传统手术组。共12项研究比较了冠状面胫骨组件偏离理想角度±3°的人数[12-17，22-24，26-27，31]。 异质性检验结果表明，各研究间有中度异质性(I2=46%)，采用固定效应模型进行合并分析，Meta分析结果显示，2种手术方法冠状面胫骨组件角偏离理想角度±3°的人数差异无显著性意义(RR=1.37，95%CI：0.97-1.95，P=0.08)，见图7。"
2.2.4 各组矢状面股骨组件角偏差值及人数(偏离理想角度±3°)差异 有6项研究比较了矢状面股骨组件角偏差值[13，17，22-24，27-28]。异质性检验结果表明，各研究间为中度异质性(I2=45%)，采用固定效应模型进行合并分析，Meta分析结果显示，2种手术方法矢状面股骨组件角偏差值差异有显著性意义(SMD=-0.16，95%CI：-0.26至-0.07，P=0.000 9)，截骨导板组矢状面股骨组件角偏差值小于传统手术组。有9项研究比较了矢状面股骨组件偏离理想角度±3°的人数[12-13，17，22-24，27-28，31]。异质性检验结果表明，各研究间有中度异质性(I2=48%)，采用固定效应模型进行合并分析，Meta分析结果显示，2种手术方法矢状面股骨组件角偏离理想角度±3°的人数差异无显著性意义(RR=0.84，95%CI：0.67-1.04，P=0.11)。具体结果见图8。"
2.2.5 各组矢状面胫骨组件角偏差值及人数(偏离理想角度±3°)的差异 有10项研究比较了矢状面胫骨组件角偏差值[13，17，21-24，27-28，32，35]。异质性检验结果表明，各研究间有中度异质性(I2=48%)，采用固定效应模型进行合并分析，Meta分析结果显示，2种手术方法矢状面胫骨组件角偏差值差异有显著性意义(MD=-0.17，95%CI：-0.26至-0.08，P=0.000 2)，截骨导板组矢状面胫骨组件角偏差值小于传统手术组。8项研究比较了矢状面胫骨组件偏离理想角度±3°的人数[12-13，17，22-23，27-28，31]。异质性检验结果表明，各研究间为中度异质性(I2=49%)，采用固定效应模型进行合并分析，Meta分析结果显示，2种手术方法矢状面胫骨组件角偏离理想角度±3°的人数差异无显著性意义(RR=0.89，95%CI：0.73-1.08，P=0.24)。具体结果见图9。"
2.2.6 各组KSS功能评分差异 有7项研究比较了KSS功能评分[12-13，26，29，35-36，41]。异质性检验结果表明，各研究间异质性偏高(I2=63%，P=0.01)，通过逐一剔除的方法对纳入文献进行敏感性分析，将1篇文献剔除时异质性下降最大(I2=53%，P=0.06)[26]，但结果未发生改变，提示研究结果较为稳定。仔细阅读文献，考虑可能是假体类型及是否进行术后功能锻炼造成的异质性，采用随机效应模型进行合并分析，结果显示，此2种手术方法KSS功能评分差异有显著性意义(MD=3.29，95%CI：1.35-5.23，P=0.000 9)，截骨导板组KSS功能优于传统手术。具体结果见图10。"
2.2.7 各组术后引流量差异 有3项研究比较了术后引流量[33，37-38]。异质性检验结果表明，各研究间异质性高(I2=94%， P < 0.000 01)，通过逐一剔除的方法对纳入文献进行敏感性分析， 将1篇文献剔除后异质性明显下降(I2=31%，P=0.23) [29]，但结果未发生改变，提示研究结果较为稳定，仔细阅读文献，考虑可能是手术时间和假体类型等因素所造成的异质性，采用固定效应模型进行合并分析，Meta分析结果显示，此2种手术方法术后引流量差异有显著性意义(SMD=-1.11，95%CI：-1.49至-0.74，P < 0.000 1)。截骨导板组术后引流量少于传统手术。具体结果见图11。"
2.2.8 各组术中出血量差异 有8项研究比较了术中出血量[14，17，19，29，33，35，39-40]。异质性检验结果表明，各研究间异质性高(I2=89%，P < 0.000 01)，通过逐一剔除的方法对纳入文献进行敏感性分析，将1篇文献剔除后异质性明显下降(I2=33%，P=0.18)[35]，但结果未发生改变，提示研究结果较为稳定，仔细阅读文献，考虑可能是手术熟练程度和止血带使用等因素所造成的异质性，采用固定效应模型进行合并分析，结果显示，此2种方法术中出血量差异有显著性意义(MD=-48.60，95%CI：-68.50至-28.69，P < 0.000 1)。截骨导板组术中出血少于传统手术。具体结果见图12。"
2.2.9 各组目测类比疼痛评分差异 有3项研究比较了目测类比疼痛评分[36，38，40]。异质性检验结果表明，各研究间异质性高(I2=96%)，通过逐一剔除的方法对纳入文献进行敏感性分析，将1篇文献剔除后异质性明显下降 (I2=66%，P=0.08)[38]，但结果未发生改变，提示研究结果较为稳定，仔细阅读文献，考虑可能是随访时间不同等因素所造成的异质性，故采用随机效应模型进行合并分析，Meta分析结果显示，2种手术方法术后目测类比疼痛评分差异无显著性意义(SMD=-0.52，95%CI：-1.13-0.10，P=0.10)。具体结果见图13。"
2.2.10 各组膝关节活动度差异 有4项研究比较了术后膝关节活动度[37-40]。异质性检验结果表明，各研究间异质性较高(I2=66%，P=0.03)，通过逐一剔除的方法对纳入文献进行敏感性分析，发现剔除一篇文献后异质性显著下降(I2=44%，P=0.17) [38]，但结果未发生改变，提示研究结果较为稳定，仔细阅读文献，考虑可能是假体类型不同和随访时间不同所造成的异质性，采用固定效应模型进行合并分析，结果显示，此2种方法术后膝关节活动度差异无显著性意义(MD=2.00，95%CI：-2.08-6.09，P=0.34)。具体结果见图14。"
2.3 纳入文献发表偏倚分析 以纳入研究最多的髋-膝-踝角偏离理想角度±3°的人数指标做漏斗图，可见图形双侧不十分对称，可能有发表偏倚，但偏倚较小，见图15A。再以主要结局指标之一的冠状面胫骨假体组件偏差值做漏斗图，可见图形双侧不十分对称，可能有发表偏倚，但偏倚较小，见图15B。"
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