Han Xiaoguang, Tian Wei, Liu Yajun, Liu Bo, He Da, Sun Yuqing, Han Xiao, Fan Mingxing, Zhao Jingwei, Xu Yunfeng, Zhang Qi
1Department of Spine Surgery, Beijing Jishuitan Hospital; and.
2Beijing Key Laboratory of Robotic Orthopaedics, Beijing, People's Republic of China.
J Neurosurg Spine. 2019 Feb 8;30(5):615-622. doi: 10.3171/2018.10.SPINE18487. Print 2019 May 1.
The object of this study was to compare the safety and accuracy of pedicle screw placement using the TiRobot system versus conventional fluoroscopy in thoracolumbar spinal surgery.
Patients with degenerative or traumatic thoracolumbar spinal disorders requiring spinal instrumentation were randomly assigned to either the TiRobot-assisted group (RG) or the freehand fluoroscopy-assisted group (FG) at a 1:1 ratio. The primary outcome measure was the accuracy of screw placement according to the Gertzbein-Robbins scale; grades A and B (pedicle breach < 2 mm) were considered clinically acceptable. In the RG, discrepancies between the planned and actual screw placements were measured by merging postoperative CT images with the trajectory planning images. Secondary outcome parameters included proximal facet joint violation, duration of surgery, intraoperative blood loss, conversion to freehand approach in the RG, postoperative hospital stay, and radiation exposure.
A total of 1116 pedicle screws were implanted in 234 patients (119 in the FG, and 115 in the RG). In the RG, 95.3% of the screws were perfectly positioned (grade A); the remaining screws were graded B (3.4%), C (0.9%), and D (0.4%). In the FG, 86.1% screws were perfectly positioned (grade A); the remaining screws were graded B (7.4%), C (4.6%), D (1.4%), and E (0.5%). The proportion of clinically acceptable screws was significantly greater in the RG than in the FG (p < 0.01). In the RG, the mean deviation was 1.5 ± 0.8 mm for each screw. The most common direction of screw deviation was lateral in the RG and medial in the FG. Two misplaced screws in the FG required revision surgery, whereas no revision was required in the RG. None of the screws in the RG violated the proximal facet joint, whereas 12 screws (2.1%) in the FG violated the proximal facet joint (p < 0.01). The RG had significantly less blood loss (186.0 ± 255.3 ml) than the FG (217.0 ± 174.3 ml; p < 0.05). There were no significant differences between the two groups in terms of surgical time and postoperative hospital stay. The mean cumulative radiation time was 81.5 ± 38.6 seconds in the RG and 71.5 ± 44.2 seconds in the FG (p = 0.07). Surgeon radiation exposure was significantly less in the RG (21.7 ± 11.5 μSv) than in the FG (70.5 ± 42.0 μSv; p < 0.01).
TiRobot-guided pedicle screw placement is safe and useful in thoracolumbar spinal surgery.Clinical trial registration no.: NCT02890043 (clinicaltrials.gov).
本研究旨在比较在胸腰椎脊柱手术中，使用TiRobot系统与传统透视引导下椎弓根螺钉置入的安全性和准确性。
将需要脊柱内固定的退行性或创伤性胸腰椎脊柱疾病患者按1:1比例随机分为TiRobot辅助组（RG）和徒手透视辅助组（FG）。主要观察指标是根据Gertzbein-Robbins标准评估的螺钉置入准确性；A和B级（椎弓根穿破<2mm）被认为在临床上是可接受的。在RG组中，通过将术后CT图像与轨迹规划图像合并来测量计划和实际螺钉置入之间的差异。次要观察指标包括近端小关节侵犯、手术时间、术中失血、RG组中转徒手操作、术后住院时间和辐射暴露。
234例患者共植入1116枚椎弓根螺钉（FG组119枚，RG组115枚）。在RG组中，95.3%的螺钉位置理想（A级）；其余螺钉分级为B级（3.4%）、C级（0.9%）和D级（0.4%）。在FG组中，86.1%的螺钉位置理想（A级）；其余螺钉分级为B级（7.4%）、C级（4.6%）、D级（1.4%）和E级（0.5%）。RG组中临床可接受螺钉的比例显著高于FG组（p<0.01）。在RG组中，每枚螺钉的平均偏差为1.5±0.8mm。螺钉偏差最常见的方向在RG组为外侧，在FG组为内侧。FG组中有2枚误置螺钉需要翻修手术，而RG组无需翻修。RG组中无一螺钉侵犯近端小关节，而FG组中有12枚螺钉（2.1%）侵犯近端小关节（p<0.01）。RG组的失血量（186.0±255.3ml）明显少于FG组（217.0±174.3ml；p<0.05）。两组在手术时间和术后住院时间方面无显著差异。RG组的平均累计辐射时间为81.5±38.6秒，FG组为71.5±44.2秒（p=0.07）。RG组外科医生的辐射暴露明显低于FG组（21.7±11.5μSv对70.5±42.0μSv；p<0.01）。
TiRobot引导下的椎弓根螺钉置入在胸腰椎脊柱手术中是安全且有用的。临床试验注册号：NCT02890043（clinicaltrials.gov）。
