School of Biological Science and Medical Engineering, Beihang University; Department of Orthopaedic Trauma, Beijing Jishuitan Hospital, Beijing 100035, China.
School of Biological Science and Medical Engineering, Beihang University, Beijing 100191, China.
Chin Med J (Engl). 2017 Nov 5;130(21):2527-2534. doi: 10.4103/0366-6999.217080.
Sacroiliac (SI) screw fixation is a demanding technique, with a high rate of screw malposition due to the complex pelvic anatomy. TiRobot™ is an orthopedic surgery robot which can be used for SI screw fixation. This study aimed to evaluate the accuracy of robot-assisted placement of SI screws compared with a freehand technique.
Thirty patients requiring posterior pelvic ring stabilization were randomized to receive freehand or robot-assisted SI screw fixation, between January 2016 and June 2016 at Beijing Jishuitan Hospital. Forty-five screws were placed at levels S1 and S2. In both methods, the primary end point screw position was assessed and classified using postoperative computed tomography. Fisher's exact probability test was used to analyze the screws' positions. Secondary end points, such as duration of trajectory planning, surgical time after reduction of the pelvis, insertion time for guide wire, number of guide wire attempts, and radiation exposure without pelvic reduction, were also assessed.
Twenty-three screws were placed in the robot-assisted group and 22 screws in the freehand group; no postoperative complications or revisions were reported. The excellent and good rate of screw placement was 100% in the robot-assisted group and 95% in the freehand group. The P value (0.009) showed the same superiority in screw distribution. The fluoroscopy time after pelvic reduction in the robot-assisted group was significantly shorter than that in the freehand group (median [Q1, Q3]: 6.0 [6.0, 9.0] s vs. median [Q1, Q3]: 36.0 [21.5, 48.0] s; χ2 = 13.590, respectively, P < 0.001); no difference in operation time after reduction of the pelvis was noted (χ2 = 1.990, P = 0.158). Time for guide wire insertion was significantly shorter for the robot-assisted group than that for the freehand group (median [Q1, Q3]: 2.0 [2.0, 2.7] min vs. median [Q1, Q3]: 19.0 [15.5, 45.0] min; χ2 = 20.952, respectively, P < 0.001). The number of guide wire attempts in the robot-assisted group was significantly less than that in the freehand group (median [Q1, Q3]: 1.0 [1.0,1.0] time vs. median [Q1, Q3]: 7.0 [1.0, 9.0] times; χ2 = 15.771, respectively, P < 0.001). The instrumented SI levels did not differ between both groups (from S1 to S2, χ2 = 4.760, P = 0.093).
Accuracy of the robot-assisted technique was superior to that of the freehand technique. Robot-assisted navigation is safe for unstable posterior pelvic ring stabilization, especially in S1, but also in S2. SI screw insertion with robot-assisted navigation is clinically feasible.
骶髂(SI)螺钉固定是一项要求很高的技术,由于骨盆解剖结构复杂,螺钉位置不当的发生率很高。TiRobot™ 是一种骨科手术机器人,可用于 SI 螺钉固定。本研究旨在评估机器人辅助 SI 螺钉固定与徒手技术相比的准确性。
2016 年 1 月至 2016 年 6 月,北京积水潭医院将 30 例需要后骨盆环稳定的患者随机分为徒手或机器人辅助 SI 螺钉固定组。S1 和 S2 水平共放置 45 枚螺钉。在两种方法中,均使用术后计算机断层扫描评估主要终点螺钉位置,并进行分类。Fisher 确切概率检验用于分析螺钉位置。还评估了轨迹规划时间、骨盆复位后的手术时间、导丝插入时间、导丝尝试次数、无骨盆复位的辐射暴露等次要终点。
机器人辅助组 23 枚螺钉,徒手组 22 枚螺钉。两组均无术后并发症或翻修。机器人辅助组螺钉放置的优良率为 100%,徒手组为 95%。P 值(0.009)显示螺钉分布的相同优势。机器人辅助组骨盆复位后的透视时间明显短于徒手组(中位数[Q1,Q3]:6.0[6.0,9.0]s 比中位数[Q1,Q3]:36.0[21.5,48.0]s;χ2=13.590,P<0.001);骨盆复位后的手术时间无差异(χ2=1.990,P=0.158)。机器人辅助组导丝插入时间明显短于徒手组(中位数[Q1,Q3]:2.0[2.0,2.7]min 比中位数[Q1,Q3]:19.0[15.5,45.0]min;χ2=20.952,P<0.001)。机器人辅助组导丝尝试次数明显少于徒手组(中位数[Q1,Q3]:1.0[1.0,1.0]次比中位数[Q1,Q3]:7.0[1.0,9.0]次;χ2=15.771,P<0.001)。两组 SI 固定的仪器化 SI 水平无差异(从 S1 到 S2,χ2=4.760,P=0.093)。
机器人辅助技术的准确性优于徒手技术。机器人辅助导航对于不稳定的后骨盆环稳定是安全的,特别是在 S1,但也在 S2。机器人辅助导航下的 SI 螺钉插入是可行的。