双平面骨科机器人系统辅助骶髂关节螺钉置入的实验研究

目的本研究应用双平面骨科机器人系统进行尸体骨骨盆骶髂关节螺钉置入的实验研究,评估该系统的安全性和有效性。方法双平面骨科机器人系统是由北京航空航天大学和北京积水潭医院联合开发的一种基于术中X线图像的手术导航系统。在该系统辅助下对4具尸体骨骨盆进行骶髂关节螺钉置入,共12枚空心钉,均置入S1。作为对比,由同一位医生操作,应用传统方法在C型臂透视控制下对模型骨盆进行骶髂关节螺钉置入,同样为12枚空心钉。记录从采集图像到置入空心钉导针所需透视的次数、透视累计时间及操作时间,并进行统计学分析。置入骶髂关节螺钉后,通过目测、透视和锯开骶骨直接测量的方法检查螺钉的位置。结果在机器人导航辅助下,置入一枚导针的平均透视次数是2.5次,平均透视累计时间为1.5s,平均操作时间为253s;12枚骶髂关节螺钉均在安全区内。在透视控制下徒手操作,置入每枚导针的平均透视次数是20.3次,平均透视累计时间为13.7s,平均操作时间为246s;12枚骶髂关节螺钉中,两枚螺钉误置。应用双平面骨科机器人系统辅助操作的透视次数和透视累计时间少于徒手操作,二者差异有显著性意义(P<0.05)。而操作时间二者差异无显著性意义(P>0.05)。结论双平面骨科机器人系统为骶髂关节螺钉置入提供精准的空间定位和稳定的路径导航,而这一切都在短短的数分钟之内完成,具备极好的安全性和高效性,并使患者和医生受到的X线照射量显著减少。目前的应用结果鼓舞我们进一步的临床实验应用。

The bi-planar navigation robot system: application for insertion of sacroiliac screws

Objective To assess effects and security of the insertion of sacroiliac screws by the bi-planar navigation robot system. Methods In a simulated surgical setup, 12 AO cannulated screws were placed into the S1 vertebral bodies of 4 human pelvic bone under the guidance of the bi-planar navigation robot system which was developed jointly by Beijing Aeronautics and Space University and our hospital. To compare this new technique with the conventional technique, another 12 cannulated screws were placed into 4 Synbone pelvic models under fluoroscopic control. The fluoroscopic times, the radiation exposure time and operation time between image acquisition and guide-wire insertion were recorded. Results With the guidance of the bi-planar navigation robot system, the average fluoroscopic times were 2.5, the average radiation exposure time was 1.5 seconds, and the average operation time was 253 seconds. All the screws were in the safe area. Under the fluoroscopic control, the average fluoroscopic times were 20.3, the average radiation exposure time was 13.7 seconds, and the average operation time was 246 seconds. Two screws (16.7%) were misplaced. The fluoroscopic times and the radiation exposure time were reduced significantly when the bi-planar navigation robot system was used (P< 0.05), but no significantly difference was found in operation time (P >0.05). Conclusions The bi-planar navigation robot system can provide precise navigation for insertion of sacroiliac screws within several minutes, and reduce the radiation exposure to the patient and the staff significantly. The results of this prospectively controlled experimental study are encouraging for further clinical trials.