OBJECTIVEThe object of this study was to compare the safety and accuracy of pedicle screw placement using the TiRobot system versus conventional fluoroscopy in thoracolumbar spinal surgery.METHODSPatients with degenerative or traumatic thoracolumbar spinal disorders requiring spinal instrumentation were randomly assigned to either the TiRobot-assisted group (RG) or the freehand fluoroscopy-assisted group (FG) at a 1:1 ratio. The primary outcome measure was the accuracy of screw placement according to the Gertzbein-Robbins scale; grades A and B (pedicle breach < 2 mm) were considered clinically acceptable. In the RG, discrepancies between the planned and actual screw placements were measured by merging postoperative CT images with the trajectory planning images. Secondary outcome parameters included proximal facet joint violation, duration of surgery, intraoperative blood loss, conversion to freehand approach in the RG, postoperative hospital stay, and radiation exposure.RESULTSA total of 1116 pedicle screws were implanted in 234 patients (119 in the FG, and 115 in the RG). In the RG, 95.3% of the screws were perfectly positioned (grade A); the remaining screws were graded B (3.4%), C (0.9%), and D (0.4%). In the FG, 86.1% screws were perfectly positioned (grade A); the remaining screws were graded B (7.4%), C (4.6%), D (1.4%), and E (0.5%). The proportion of clinically acceptable screws was significantly greater in the RG than in the FG (p < 0.01). In the RG, the mean deviation was 1.5 ± 0.8 mm for each screw. The most common direction of screw deviation was lateral in the RG and medial in the FG. Two misplaced screws in the FG required revision surgery, whereas no revision was required in the RG. None of the screws in the RG violated the proximal facet joint, whereas 12 screws (2.1%) in the FG violated the proximal facet joint (p < 0.01). The RG had significantly less blood loss (186.0 ± 255.3 ml) than the FG (217.0 ± 174.3 ml; p < 0.05). There were no significant differences between the two groups in terms of surgical time and postoperative hospital stay. The mean cumulative radiation time was 81.5 ± 38.6 seconds in the RG and 71.5 ± 44.2 seconds in the FG (p = 0.07). Surgeon radiation exposure was significantly less in the RG (21.7 ± 11.5 μSv) than in the FG (70.5 ± 42.0 μSv; p < 0.01).CONCLUSIONSTiRobot-guided pedicle screw placement is safe and useful in thoracolumbar spinal surgery.Clinical trial registration no.: NCT02890043 (clinicaltrials.gov)

The purpose of this study was to determine the efficacy and feasibility of 5th generation wireless systems (5G) telerobotic spinal surgery in our first 12 cases. Methods: A total of 12 patients (5 males, 7 females; age, 23-71 years) with spinal disorders (4 thoracolumbar fractures, 6 lumbar spondylolisthesis, 2 lumbar stenosis) were treated with 5G telerobotic spinal surgery. Sixty-two pedicle screws were implanted. Results: All patients had substantial relief from their symptoms. Screw placements were classified using Gertzbein-Robbins criteria. There were 59 grade A, 3 grade B. Mean operation time was 142.5 ± 46.7 minutes. Mean guiding wire insertion time was 41.3 ± 9.8 minutes. The deviation between the planned and actual positions was 0.76 ± 0.49 mm. No intraoperative adverse event was found. Conclusion: 5G remote robot-assisted spinal surgery is accurate and reliable. We conclude that 5G telerobotic spinal surgery is both efficacious and feasible for the management of spinal diseases with safety.

Study Design. Prospective, randomized, controlled trial. Objective. To compare robot-assisted and conventional implantation techniques by evaluating the accuracy and safety of implanting screws in cervical vertebrae. Summary of Background Data. Cervical spinal surgery is difficult and dangerous as screw misplacement might lead not only to decreased stability but also neurological, vascular, and visceral injuries. A new robot-assisted surgical procedure has been introduced to improve the accuracy of implant screw positioning. Methods. We randomly assigned 135 patients with newly diagnosed cervical spinal disease and who required screw fixation using either robot-assisted or conventional fluoroscopy-assisted cervical spinal surgery. The primary outcomes were the discrepancies between the planned trajectories and the actual screw positions. Results. Altogether, 127 patients underwent the assigned intervention (61 robot-assisted and 66 conventional fluoroscopy-assisted). The baseline characteristics including the screw types, were similar in the two groups. Altogether, 390 screws were planed and placed in the cervical vertebrae, and 94.9% were acceptable. The robot-assisted group had a better screw placement accuracy than the conventional fluoroscopy-assisted group with associated P values <0.001 (0.83 [0.44, 1.29] vs. 1.79 [1.41, 2.50] mm). The Gertzbein and Robbins scales also showed a significant difference between the two groups (P < 0.001). Furthermore, the robot-assisted group experienced significantly less blood loss during surgery than the conventional fluoroscopy-assisted group (200 [50, 375] vs. 350 [100, 500] mL; P = 0.002) and shorter length of stay after surgery (P = 0.021). These two groups did not differ significantly regarding the duration of the operation (P = 0.525). Neurological injury occurred in one case in the conventional fluoroscopy-assisted group. Conclusion. The accuracy and clinical outcomes of cervical spinal surgery using the robot-assisted technique tended to be superior to those with the conventional fluoroscopy-assisted technique in this prospective, randomized, controlled trial. Level of Evidence: 2

The pedicle screw placement procedure is the most commonly used technique for spinal fixation and can provide reliable three‐column stabilization. Accurate screw placement is necessary in clinical practice. To avoid screw malposition, which may decrease the stiffness of the screw‐rod construct or increase the likelihood of neural and vascular injuries, the surgeons must fully understand the regional anatomy. Deformities, such as scoliosis, kyphosis or congenital anomalies, may complicate the application of the pedicle screw placement technique and increase the chance of screw encroachments. Incidences of pedicle screw malposition vary in different districts and hospitals and with surgeons and techniques. Today, the minimally invasive spinal surgery is well developed. However, the narrow corridors and limited views for surgeons increase the difficulty of pedicle screw placement and the possibility of screw encroachment. Evidenced by previous studies, robotic surgery can provide accurate screw placement, especially in settings of spinal deformities, anatomical anomalies, and minimally invasive procedures. Based on the consensus of consultant specialists, the literature review and our local experiences, this guideline introduces the robotic system and describes the workflow of robot‐assisted procedures and the precautions to take during procedures. This guideline aims to outline a standardized method for robotic surgery for thoracolumbar pedicle screw placement.

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