Evaluation of a new spinal surgical robotic system of Kirschner wire placement for lumbar fusion: A multi-centre, randomised controlled clinical study

作者：Li, Junyu; Huang, Lin; Zhou, Wenyu; Wang, Zizhen; Li, Zongze; Zeng, Lin; Liu, Zhongjun; Shen, Huiyong; Cai, Zhaopeng; Gu, Hongsheng; Yang, Xinjian; Zhang, Rui; Hu, Wanheng; Yu, Miao^*; Chen, Jianting^*

来源：International Journal of Medical Robotics and Computer Assisted Surgery, 2021, 17(2): e2207.

DOI：10.1002/rcs.2207

• free&#8208
• hand technique
• posterior lumbar inter&#8208
• body fusion
• proximal facet joint violation
• randomized controlled trial
• robot&#8208
• assisted K&#8208
• wire insertion

Background To introduce a novel robotic system 'Orthbot' that has been developed and tested as a surgical assistant for auto-placement of the K-wire in lumbar fusion. @@@ Methods This is a multi-centre, randomized controlled clinical study that includes 56 patients (robot group, RG: 27, free-hand group, FG: 29). Following the pre-operative planning and intra-operative fluoroscopic images, the 'Orthbot' automatically completed registration and K-wire placement under the supervision of the surgeon. Deviation distance (DD) and deviation angle (DA) were used as the primary parameters to evaluate the accuracy of the robotic system. @@@ Results The average DD was 0.95 +/- 0.377 mm and 4.35 +/- 2.01 mm, respectively in the RG and FG (p < 0.001). The average DA of the K-wire in the coronal plane and the sagittal plane in X-Ray was respectively 6.80 +/- 7.79 degrees and 1.27 +/- 2.32 degrees in the RG (p < 0.001), and 22.22 +/- 16.85 degrees and 4.57 +/- 3.86 degrees in the FG (p < 0.001), which showed a higher accuracy rate in the robotic-assisted cases compared to the free-hand cases. @@@ Conclusions The novel robotic system could achieve accurate K-wire insertions as indicated by the radiological results.

• 单位
  北京大学; 深圳市第二人民医院; 南方医科大学