机器人辅助经皮椎体后凸成形术在胸腰椎压缩性骨折治疗中的应用

目的 探讨骨科机器人辅助经皮椎体后凸成形术在胸腰椎压缩性骨折治疗中的应用价值。方法 前瞻性随机对照研究。选取2021年4—7月新疆医科大学第一附属医院骨科胸腰椎压缩性骨折患者30例,其中男15例、女15例,年龄60~75岁。单节段骨折26例,双节段骨折4例;骨折椎体节段：T₁₀ 2例,T₁₁ 2例,T₁₂ 10例,L₁ 8例,L₂ 5例,L₃ 7例。30例患者按数字表法随机分为对照组和机器人组,每组15例。对照组行传统经皮椎体穿刺成形术,机器人组行机器人辅助下经皮椎体后凸成形术。观察项目：（1）比较2组患者伤椎穿刺点导针定位时间、术中透射次数、出血量、骨水泥渗漏情况,以及术前、术后伤椎前缘相对高度（伤椎前缘高度/上下邻椎前缘高度平均值）;（2）机器人组中,测量比较术前规划穿刺通道与术中实际穿刺通道的矢状截面角、横截面角、进针点距椎体中线距离,评估机器人导针定位的精准度。结果 2组患者性别构成、年龄、身高、体质量、伤椎分布情况、术前伤椎前缘相对高度等基线资料比较,差异均无统计学意义（P值均>0.05）。机器人组单个导针平均定位时间、术中透射次数分别为（283.5±118.7）s、（12.4±5.7）次,均少于对照组的（469.2±113.9）s、（16.5±4.7）次,差异均有统计学意义（t=-5.68、-2.78,P值均<0.05）。机器人组术中出血量、术后伤椎前缘相对高度分别为（8.8±4.6）mL、0.9±0.1,对照组分别为（10.3±5.3）mL、0.9±0.5,差异均无统计学意义（P值均>0.05）。2组患者术后伤椎前缘相对高度均高于术前,差异均有统计学意义（t=3.81、3.59,P=0.002、0.003）。机器人组术中发生骨水泥渗漏2例,对照组发生骨水泥渗漏4例,差异无统计学意义（P=0.387）。机器人组中,术前规划穿刺通道矢状截面角、横截面角、进针点距椎体中线距离分别为16.7°±3.4°、10.0°±6.6°、（33.3±6.2）mm,术中实际进针隧道矢状截面角、横截面角、进针点距椎体中线距离分别为16.6°±3.8°、8.5°±6.2°、（33.3±6.2）mm,两组间差异均无统计学意义（t=0.08、0.82、-0.01,P值均>0.05）。结论 与传统经皮穿刺椎体后凸成形术相比,机器人辅助下经皮椎体穿刺成形术治疗胸腰椎压缩性骨折,恢复伤椎椎体高度效果相同,还具有导针定位精准、定位时间短、术中透视次数少的优势。临床试验注册 在中国临床试验注册中心注册,注册号：ChiCTR200004033。

Clinical application of robot-assisted percutaneous kyphoplasty in the treatment of thoracolumbar compression fractures

Objective To investigate the clinical application value of orthopedic robot-assisted percutaneous kyphoplasty in the treatment of thoracolumbar compression fractures. Methods A prospective randomized controlled trial was conducted between April 2021 and July 2021 among 30 patients, including 15 males and 15 females aged 60-75 years old, with thoracolumbar compression fracture at the First Affiliated Hospital of Xinjiang Medical University. There were 26 cases of single segment fracture and 4 cases of double segment fracture. The compression fracture sites were T₁₀ in 2 cases, T₁₁ in 2 cases, T₁₂ in 10 cases, L₁ in 8 cases, L₂ in 5 cases, and L₃ in 7 cases. The patients were randomly divided into conventional and study groups with 15 cases in each group. The conventional group underwent traditional percutaneous kyphoplasty, and the study group underwent robot-assisted percutaneous kyphoplasty. The positioning time, the number of fluoroscopy, blood loss, leakage of bone cement, and ralative height of anterior edge of injured vertebra before and after operation (anterior height of the injured vertebra/average height of upper and lower adjacent anterior vertebrae) between the two groups were recorded and compared. The differences in the transverse section angle, sagittal section angle, and distance from the midline of the vertebral body were compared between the preoperative planned needle insertion tunnel and actual needle insertion tunnel in the study group to evaluate the accuracy of the orthopedic robot system. Results The two groups showed no significant difference in gender, age, height, weight, distribution of injured vertebrae, and preoperative relative height of injured vertebrae (all P values >0.05). The average positioning time and the number of intraoperative fluoroscopy of the study group were (283.5±118.7) s and (12.4±5.7) times, respectively. Those of the conventional group were (469.2±113.9) s and (16.5±4.7) times. Compared with the conventional group, the study group had less positioning time and radiation (t=-5.68, -2.78; all P values <0.05). The blood loss and postoperative relative height of the injured vertebrae in the study group were (8.8±4.6) mL and 0.9±0.1, respectively, and those of the conventional group were (10.3±5.3) mL and 0.9±0.5. The blood loss and postoperative height ratio of the injured vertebrae between the two groups showed no significant difference (all P values >0.05). The postoperative relative height of the two groups were higher than those before operation, and the differences were statistically significant (t=3.81, 3.59; P=0.002, 0.003). Two cases of intraoperative bone cement leakage occurred in the study group, whereas four cases were recorded in the conventional group. No significant difference was observed between the two groups in terms of the occurrence of bone cement leakage (P=0.387). The transverse section angle, sagittal section angle, and distance from the midline of the vertebral body in the preoperatively planned insertion tunnel in the study group were 16.7°±3.4°, 10.0°±6.6°, and (33.3±6.2) mm, respectively. The transverse section angle, sagittal section angle, and distance from the midline of the vertebral body in the actual needle insertion tunnel of the study group were 16.6°±3.8°, 8.5°±6.2°, and (33.3±6.2) mm, respectively. No significant difference was observed between the preoperative planned insertion tunnel and actual insertion tunnel in the study group (t=0.08, 0.82, -0.01; all P values >0.05). Conclusion Compared with the traditional percutaneous kyphoplasty, robot-assisted percutaneous kyphoplasty has the same effect of restoring the height of the injured vertebrae. In addition, robot-assisted percutaneous kyphoplasty has the advantages of good accuracy, short positioning time, and less radiation times. Trial Registration This study was registrated at Chinese Trial Registry with the registration number of ChiCTR200004033.