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

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 A This is a multi-center, RCT randomized controlled clinical study contain that includes 56 patients (Robot Group, RG: 27, Free-hand Group, FG: 29). Following the preoperative planning and intraoperative 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 important the primary parameters to evaluate the accuracy of the robotic system. RESULTS The average DD was 0.95±0.377 mm (RG) and 4.35±2.01 mm (FG), 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° (RG) and 1.27±2.32° (RG) in the RG (P<0.001), and 22.22±16.85°(FG) and 4.57±3.86° (FG) in the FG (P<0.001), which showed a higher accuracy of rate in the robotic-assisted cases compared to the free-hand cases. CONCLUSIONS The novel robotic system could achieve accurate radiological results in K-wires insertions as indicated by the radiological results. This article is protected by copyright. All rights reserved.