Effect of robotic-assisted percutaneous pedicle screw internal fixation for thoracolumbar fractures: a randomized, controlled clinical trial

Robotic-assisted techniques have been applied to orthopaedic diseases, improving the accuracy of internal fixation placement and the outcome of surgery. However, the clinical effect of robotic-assisted percutaneous pedicle screw internal fixation in treating thoracolumbar fractures has not been fully validated. A total of 49 patients who were diagnosed with thoracolumbar fractures and underwent percutaneous pedicle screw internal fixation were recruited and randomly allocated to a freehand fluoroscopy-guided surgery group (FF, n = 24) or a robotic-assisted navigation and automated pedicle screw internal fixation placement group (RA, n = 25). The outcome assessments included screw placement accuracy measured by the Gertzbein–Robbins system (GRS), operative time, intraoperative blood loss, frequency of intraoperative fluoroscopy, length of stay, medical treatment cost, Oswestry Disability Index (ODI) score, visual analog scale (VAS) score and incidence of complications. A total of 154 pedicle screws were implanted in the RA group, and a total of 146 pedicle screws were implanted in the FF group. No statistically significant differences in the accuracy rates of screw placement (GRS grade A + B, 96.1% vs. 96.5%, p = 0.828), operative time (146.9 ± 24.8 min vs. 151.1 ± 34.3 min, p = 0.784), intraoperative blood loss (46.7 ± 24.0 ml vs. 38.3 ± 18.3 ml, p = 0.689), length of stay (6.4 ± 3.2 days vs. 7.0 ± 2.9 days, p = 0.810), medical treatment cost (31,054 ± 2751 yuan vs. 30,053 ± 3265 yuan, p = 0.937), VAS score (Day 7 after operation: 2.6 ± 0.9 vs. 2.9 ± 1.7, p = 0.876; Six months after operation: 0.48 ± 0.82 vs. 0.41 ± 0.65, p = 0.275), or ODI score improvement (Day 7 after operation: 43.8 ± 21.4 vs. 47.0 ± 20.5, p = 0.801; Six months after operation: 10.1 ± 6.08 vs. 9.41 ± 5.91, p = 0.895) were detected between the RA group and the FF group. However, the RA group had a significantly lower frequency of intraoperative fluoroscopy (5.2 ± 1.0 vs. 37.0 ± 4.8, p < 0.001) than did the FF group. No screw-related complications occurred in either group immediately after the surgery or at the six-month follow-up visit. Robotic-assisted percutaneous pedicle screw internal fixation can be used as a safe and effective treatment for thoracolumbar fractures, especially for reducing intraoperative radiation exposure.