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

Abstract

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. 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. The average DD was 0.95±0.377mm and 4.35±2.01mm, 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° and 1.27±2.32° in the RG (p<0.001), and 22.22±16.85° and 4.57±3.86° in the FG (p<0.001), which showed a higher accuracy rate in the robotic-assisted cases compared to the free-hand cases. The novel robotic system could achieve accurate K-wire insertions as indicated by the radiological results.