评价独立机械臂机器人与徒手置钉准确性在腰椎手术中应用的对比研究
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1.北京大学第三医院;2.中日友好医院

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Spine Surgery Robotic System with Independent Arm: Report on Accuracy of Spinal Instrumented Fusions Compared to Freehand Technique
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1.Peking University Third Hospital;2.china-japan friendship hospital

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    摘要:

    【目的】本文介绍一款以独立机械臂动力系统安装克氏针的新型脊柱外科机器人(XGK-6508A智能骨科微创系统;鑫君特科技有限公司,中国深圳)在腰椎手术当中的应用,并比较该机器人与传统徒手置钉的准确性。【方法】22位病人被随机纳入实验组(机器人辅助置钉组)和对照组(徒手置钉组)。机器人根据术前的CT规划以及术中的X线图像,在术者的监督下,自动完成注册以及克氏针的置入。本试验通过术前规划、术中透视和术后影像学资料,对以下参数进行测量对比,包括螺钉偏差距离、在矢状位和冠状位偏差角度。同时,本研究利用Gertzbein-Robbins分级法对螺钉的准确性进行评估,且对两组近端关节侵扰情况进行了记录。【结果】偏差角度方面,克氏针冠状位中,机器人组的X线偏差角度为:6.04±6.07°,徒手组的X线偏差角度为:20.01±16.16°(P<0.001)。克氏针矢状位中,机器人组的X线偏差角度为:1.53±2.84°,徒手组的X线偏差角度为:4.28±4.14°(P<0.001)。在椎弓根螺钉置入方面,轴位中机器人组的CT偏差角度为:5.57±5.35°,徒手组的CT偏差角度为:6.76±4.87°(P=0.109)。矢状位中,机器人组的CT偏差角度为:0.79±1.57°,徒手组的CT偏差角度为:3.77±3.17°(P<0.001)。【结论】该新型脊柱外科机器人比传统椎弓根徒手置钉操作:具有更高准确性;与现行同类机器人技术相比具有机械臂自动置钉的优势,且对术前规划具有可靠执行力。由此,临床应用前景较佳。

    Abstract:

    [Objective]To introduce a novel robot system with independent arm (XGK-6508A; Xin Junte Surgical Technologies, Shenzhen, China) that has been developed and tested as a surgical assistant for auto-placement of K-wire and to compare the accuracy of this robotic system with a conventional open approach free-hand instrumentation in lumbar fusions. [Methods]22 Patients were randomized assigned to robot‐assisted, posterior lumbar interbody fusion Group (RG) or a conventional, freehand, open‐approach, posterior lumbar interbody fusion Arm (FG) .According to preoperative planning and intraoperative fluoroscopic images, the robotic system automatically completed registration and K-wire placement under the supervision of the surgeon. Results were measured based on the postoperative imaging: Deviation Distance(DD), Deviation Angle(DA). We also evaluate the accuracy of the pedicle screws using Gertzbein-Robbins classification, proximal joint violation were recorded. [Results]The average DA of K-wire from preoperative surgeon’s plan was 6.04±6.07°in the RG, 20.01±16.16°in the FG in coronal panel in X-Ray(P<0.001),1.53±2.84°in the RG, 4.28±4.14°in the FG in sagittal panel in X-Ray(P<0.001).As for the Screws, the average deviation angel in axial panel(RG:5.57±5.35°,FG:6.76±4.87°;P=0.109)and in sagittal panel (RG:0.79±1.57°,FG:3.77±3.17°;P<0.001)show higher accuracy of the robotic system compared to free-hand approach. [Conclusion]The novel robotic system offers a number of benefits: significant accuracy, fully-automatic, outstanding ability to follow a preoperative plan over the conventional techniques. Further studies with larger patient populations are warranted.

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  • 收稿日期:2019-03-05
  • 最后修改日期:2020-01-21
  • 录用日期:2020-03-09
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