Chang Jie, Yu Lipeng, Li Qingqing, Wang Boyao, Yang Lei, Cheng Min, Wang Feng, Zhang Long, Chen Lei, Li Kun, Liang Liang, Zhou Wei, Cai Weihua, Ren Yongxin, Hu Zhiyi, Huang Zhenfei, Sui Tao, Fan Jin, Wang Junwen, Li Bo, Cao Xiaojian, Yin Guoyong
The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.
The Second Affiliated Hospital of Nanjing Medical University, Nanjing 210003, China.
J Clin Med. 2022 Nov 30;11(23):7091. doi: 10.3390/jcm11237091.
Robot-assisted orthopedic surgery has great application prospects, and the accuracy of the robot is the key to its overall performance. The aim of this study was to develop a new orthopedic surgical robot to assist in spinal surgeries and to compare its feasibility and accuracy with the existing orthopedic robot. A new type of high-precision orthopedic surgical robot (Tuoshou) was developed. A multicenter, randomized controlled trial was carried out to compare the Tuoshou with the TiRobot (TINAVI Medical Technologies Co., Ltd., Beijing) to evaluate the accuracy and safety of their navigation and positioning. A total of 112 patients were randomized, and 108 patients completed the study. The position deviation of the Kirschner wire placement in the Tuoshou group was smaller than that in the TiRobot group (p = 0.014). The Tuoshou group was better than the TiRobot group in terms of the pedicle screw insertion accuracy (p = 0.016) and entry point deviation (p < 0.001). No differences were observed in endpoint deviation (p = 0.170), axial deviation (p = 0.170), sagittal deviation (p = 0.324), and spatial deviation (p = 0.299). There was no difference in security indicators. The new orthopedic surgical robot was highly accurate and optimized for clinical practice, making it suitable for clinical application.
机器人辅助骨科手术具有广阔的应用前景，而机器人的精度是其整体性能的关键。本研究旨在开发一种新型骨科手术机器人以辅助脊柱手术，并将其可行性和准确性与现有的骨科机器人进行比较。开发了一种新型高精度骨科手术机器人（拓手）。开展了一项多中心随机对照试验，将拓手与天玑机器人（北京天智航医疗科技股份有限公司）进行比较，以评估它们导航和定位的准确性及安全性。共有112例患者被随机分组，108例患者完成了研究。拓手组克氏针置入的位置偏差小于天玑机器人组（p = 0.014）。在椎弓根螺钉置入准确性（p = 0.016）和进针点偏差方面（p < 0.001），拓手组优于天玑机器人组。在终点偏差（p = 0.170）、轴向偏差（p = 0.170）、矢状面偏差（p = 0.324）和空间偏差方面（p = 0.299）未观察到差异。安全指标方面无差异。新型骨科手术机器人具有高度准确性且针对临床实践进行了优化，使其适用于临床应用。
