Abstract
BACKGROUND: Efficient registration and high-precision K-wire guidance are critical for the effective performance of spinal surgical robots. We therefore evaluate a new robotic system featuring optical tracker registration and a high-precision lateral force sensing system during K-wire placement. In this study, retrospectively collected clinical data were used to evaluate the technical efficacy and clinical utility of the system in spinal surgery. METHODS: This was a retrospective study. Between December 2022 and April 2024, a total of 127 patients were enrolled and subjected to X-ray, CT, and MRI examinations. Among these patients, 67 were enrolled in the robot-assisted group, in which K-wires were implanted using a new spinal surgical robot. The remaining 60 patients were enrolled in the freehand group, where K-wires were implanted manually. The data collected included sex, age, body mass index, number of punctures (NOP), mean time required to insert a K-wire (MTRI K-wire), average blood loss per K-wire insertion (ABL K-wire), fluoroscopy count per K-wire (FC K-wire), puncture abduction angle (PAA), and K-wire in the pedicle (K-wire IP). Distance deviations and angle deviations were used as the primary parameters to evaluate the accuracy of the new spinal surgical robot. RESULTS: Compared with free-hand K-wire insertion, robot-assisted K-wire implantation results in fewer NOP, fewer MTRI K-wires, fewer ABL K-wires, fewer intraoperative FC K-wires, and a larger PAA. Compared with the free-hand group, the robot-assisted group demonstrated significantly smaller entry point deviation (0.98 ± 0.13 vs. 5.08 ± 1.17 mm, p < 0.001) and endpoint deviation (1.38 ± 0.20 vs. 5.52 ± 0.87 mm, p < 0.001). These results demonstrate superior targeting accuracy with robotic assistance relative to conventional freehand techniques. CONCLUSIONS: Our spinal surgical robot system demonstrates clinically reliable accuracy in K-wire placement while offering significant intraoperative advantages, including a streamlined procedural workflow, a reduced operation time, and minimal tissue trauma. These results demonstrate significant potential for both clinical implementation and further technological optimization. TRIAL REGISTRATION: This trial was approved by the Ethics Committee of the Second Affiliated Hospital of Nanjing Medical University on February 21, 2023(2023XJ00401 retrospectively registered).