Meta-analysis of clinical outcomes of computer-navigated versus conventional opening wedge high tibial osteotomy

doi:10.3969/j.issn.2095-4344.0549

Abstract

Abstract:

BACKGROUND: Traditional high tibia osteotomy relies on preoperative planning and intraoperative fluoroscopy to adjust the angle of correction, but it is affected by position, perspective and measurement error, so it is instability. Some studies have reported that computer navigated high tibia osteotomy can improve the accuracy of the correction angle. As the number of cases in previous studies is small and controversial, it is necessary to systematically analyze and evaluate the clinical and imaging results of computer navigated high tibia osteotomy and traditional surgery.

OBJECTIVE: To systematically evaluate the clinical and imaging results of computer navigated versus conventional opening wedge high tibial osteotomy.

METHODS: Databases of PubMed, EMbase, Cochrane Library, Web of Science, CNKI, CBM, WanFang, and VIP were retrieved for the clinical studies about computer navigated versus conventional opening wedge high tibial osteotomy before April 2018. The quality of the studies was evaluated by two researchers, and heterogeneity test and meta-analysis were conducted on RevMan 5.3 software.

RESULTS AND CONCLUSION: (1) Thirteen clinical studies involving 1 030 patients with genu varum were enrolled, 471 patients underwent computer navigated high tibial osteotomy (navigation group), and 559 patients underwent opening wedge high tibial osteotomy (traditional group). (2) Results of meta-analysis showed that compared with the traditional group, patients in the navigation group had better weight bearing line ratio, closest to Fujisawa point (MD=2.14, 95%CI (0.23, 4.05)), less increase in tibial posterior slope (MD=-1.27, 95%CI (-1.95, -0.60)), more exact mechanical axis (MD=0.81, 95%CI (0.37, 1.25)), lower in outliers of alignment (OR=0.39, 95%CI (0.27, 0.59)) and longer operation time (MD=14.90, 95%CI (9.93, 19.88)). There were no significant differences in Lysholm score (MD=1.30, 95%CI (-0.31, 2.90)), range of motion of knee (MD=3.19, 95%CI (-1.60, 7.98)), delayed union rate at tibia osteotomy (OR=1.58, 95%CI (0.44, 5.65)), and infection rate (OR=1.75, 95%CI (0.37, 8.30)) between two groups. (3) These results indicate that compared with conventional opening wedge high tibial osteotomy, computer-navigated high tibial osteotomy obtains more accurate radiographic results, and longer operation time, but no difference is found in Lysholm score, delayed union rate or infection rate. Due to the limitations of this study, the conclusion still needs to be investigated by large samples and long-term randomized controlled studies to confirm the long-term efficacy and imaging findings.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Genu Varum, Tibia, Surgery, Computer-Assisted, Osteotomy, Meta-Analysis

CLC Number:

R318

Shi Jun-heng, Zhong De-gui, Hong Wei-wu, Huang Yong-quan. Meta-analysis of clinical outcomes of computer-navigated versus conventional opening wedge high tibial osteotomy[J]. Chinese Journal of Tissue Engineering Research, 2018, 22(31): 5077-5084.

Figures/Tables 4

2.3 结局指标Meta分析 2.3.1 术后下肢负重线比率纳入研究中有6篇文献采用术后下肢负重线比率为结局指标[13，15，18-20，22]，其中导航组患者210例、传统组患者239例。经异质性检验， χ2=9.24，P=0.10≥ 0.1，I2=46%，提示纳入的6个研究间具有同质性，故选用固定效应模型进行合并[MD=2.14，95%CI(0.23，4.05)]，合并效应量检验Z=2.19，P=0.03 < 0.05，提示相较于传统内侧开放HTO，计算机导航辅助下行内侧开放HTO术后下肢负重线比率更大，更接近Fujisawa[23]认为标准下肢负重线比率点的62%，差异有显著性意义，见图2。 2.3.2 术后胫骨后倾角增加程度纳入研究中有8篇文献采用术后胫骨后倾角增加程度作为结局指标[13-14，16-18，20-22]，其中导航组患者321例、传统组339例患者。经异质性检验，χ2=11.21，P=0.13 > 0.1，I2=38%，提示纳入的8个研究间具有同质性，选用固定效应模型进行合并[MD=-1.27，95%CI(-1.95，-0.60)]，合并效应量检验Z=3.72，P= 0.000 2 ≤ 0.05，提示相较于传统内侧开放HTO，计算机导航辅助下行内侧开放HTO术后胫骨后倾角增加程度更小，其差异有显著性意义。见图3。 2.3.3 术后机械胫股角纳入研究中有6篇文献采用术后机械胫股角作为结局指标[9，12-14，16，18]，其中导航组患者201例、传统组159例患者。经异质性检验，χ2=5.65，P=0.34 > 0.1，I2=11%，提示纳入的6个研究间具有同质性，选用固定效应模型进行合并[MD=0.81，95%CI(0.37，1.25)]，合并效应量检验Z=3.59，P=0.000 3 < 0.05，提示相较于传统内侧开放HTO，计算机导航辅助下行内侧开放HTO术后机械胫股角更大，更接近于理想机械胫股角[24]，差异有显著性意义。见图4。 2.3.4 术后胫股角异常比率纳入研究中有9篇文献采用术后胫股角异常比率作为结局指标[6，9，12，14-15，18-20，22]，其中导航组患者306例、传统组319例患者。经异质性检验，χ2=11.81，P=0.16 > 0.1，I2=32%，提示纳入的9个研究间具有同质性，选用固定效应模型进行合并[OR=0.39，95%CI(0.27，0.59)]，合并效应量检验Z=4.61，P < 0.000 01，提示相较于传统内侧开放HTO，计算机导航辅助下行内侧开放HTO术后出现胫股角异常的患者更少、比率更低，差异有显著性意义。见图5。"

2.3.5 手术时间纳入研究中有2篇文献采用收拾时间作为结局指标[14，20]，其中导航组患者102例、传统组99例患者。经异质性检验，χ2=3.53，P=0.17 > 0.1，I2=43%，提示纳入的2个研究间具有同质性，选用固定效应模型进行合并[MD=14.90，95%CI(9.93，19.88)]，合并效应量检验Z=5.87，P < 0.0000 1，提示相较于传统内侧开放HTO，计算机导航辅助下行内侧开放HTO术手术时间更长，差异有显著性意义。见图6。 2.3.6 术后Lysholm评分纳入研究中有4篇文献采用术后膝关节Lysholm评分作为结局指标[13-14，16，20]，其中导航组患者127例、传统组122例患者。经异质性检验， χ2=4.19，P=0.24 > 0.1，I2=28%，提示纳入的4个研究间具有同质性，选用固定效应模型进行合并[MD=1.30，95%CI(-0.31，2.90)]，合并效应量检验Z=1.59，P=0.11 > 0.05，提示计算机导航辅助下与传统内侧开放HTO术后膝关节Lysholm评分的差异无显著性意义。见图7。 2.3.7 术后膝关节活动度纳入研究中有2篇文献采用术后膝关节活动度作为结局指标[14，20]，其中导航组患者62例、传统组59例患者。经异质性检验，χ2=0.85，P=0.36 > 0.1，I2=0%，提示纳入的2个研究间具有同质性，选用固定效应模型进行合并[MD=3.19，95%CI(-1.60，7.98)]，合并效应量检验Z=1.31，P=0.19 > 0.05，提示计算机导航辅助下与传统内侧开放HTO术后膝关节活动度的差异无显著性意义。见图8。 2.3.8 胫骨截骨处延迟愈合比率纳入研究中有3篇文献采用术后胫骨截骨处延迟愈合比率作为结局指标[13，19-20]，其中导航组111例、传统组148例患者，计算机导航组5例出现胫骨截骨处延迟，传统组5例出现胫骨截骨处延迟。经异质性检验，χ2=0.52，P=0.47 > 0.1，I2=0%，提示纳入的3个研究间具有同质性，选用固定效应模型进行合并[OR=1.58，95%CI(0.44，5.65)]，合并效应量检验Z=0.70，P=0.48 > 0.05，提示计算机导航辅助下与传统内侧开放HTO术后胫骨截骨处延迟愈合比率的差异无显著性意义。见图9。 2.3.9 手术部位感染比率纳入研究中有2篇文献采用术后手术部位感染比率作为结局指标[19-20]，其中导航组患者64例、传统组105例患者，导航组3例出现术后手术部位感染，传统组4例出现术后手术部位感染。由于1项研究报道导航组和传统组均未出现手术部位感染[20]，异质性检验无法运用，合并效应量[OR=1.75，95%CI(0.37，8.30)]，合并效应量检验Z=0.70，P=0.48，提示计算机导航辅助下与传统内侧开放HTO后手术部位感染比率的差异无显著性意义。见图10。"

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