Three-Dimensional Quantitative Assessment of Pedicle Screw Accuracy in Clinical Utilization of a New Robotic System in Spine Surgery: A Multicenter Study.

OBJECTIVE: The objective of this study was to evaluate the accuracy of pedicle screw placement in patients undergoing percutaneous pedicle screw fixation with robotic guidance, using a newly developed 3-dimensional quantitative measurement system. The study also aimed to assess the clinical feasibility of the robotic system in the field of spinal surgery. METHODS: A total of 113 patients underwent pedicle screw insertion using the CUVIS-spine pedicle screw guide system (CUREXO Inc.). Intraoperative O-arm images were obtained, and screw insertion pathways were planned accordingly. Image registration was performed using paired-point registration and iterative closest point methods. The accuracy of the robotic-guided pedicle screw insertion was assessed using 3-dimensional offset calculation and the Gertzbein-Robbins system (GRS). RESULTS: A total of 448 screws were inserted in the 113 patients. The image registration success rate was 95.16%. The average error of entry offset was 2.86 mm, target offset was 2.48 mm, depth offset was 1.99 mm, and angular offset was 3.07°. According to the GRS grading system, 88.39% of the screws were classified as grade A, 9.60% as grade B, 1.56% as grade C, 0.22% as grade D, and 0.22% as grade E. Clinically acceptable screws (GRS grade A or B) accounted for 97.54% of the total, with no reported neurologic complications. CONCLUSION: Our study demonstrated that pedicle screw insertion using the novel robot-assisted navigation method is both accurate and safe. Further prospective studies are necessary to explore the potential benefits of this robot-assisted technique in comparison to conventional approaches.

Novel C-arm-based planning robotic spinal surgery in a cadaver model using quantitative accuracy assessment methodology.

BACKGROUND: This preclinical study emulating the clinical environment quantitatively analysed the accuracy of pedicle screw insertion using a navigated robotic system. METHODS: Pedicle screws were placed from T7 to L5 in the whole-body form of a cadaver. After the insertion of multiple artificial markers into each vertebra, errors between the planned insertion path and the inserted screw were quantified using the Gertzbein-Robbins system (GRS) and offset calculation. RESULTS: A total of 22 screws were placed. Almost all (95.45% [21/22]) were classified as GRS A or B, while one (4.55%) was GRS C. The mean and standard deviations of entry, tip, and angular offset were 1.78 ± 0.94 mm, 2.30 ± 1.01 mm, and 2.64 ± 1.05°, respectively. CONCLUSIONS: This study demonstrated that pedicle screw insertion using a navigated robotic system had high accuracy and safety. A future clinical study is necessary to validate our findings.

Novel C-arm based planning spine surgery robot proved in a porcine model and quantitative accuracy assessment methodology.

BACKGROUND: We assessed pedicle screw accuracy utilizing a novel navigation-based spine surgery robotic system by comparing planned pathways with placed pathways in a porcine model. METHODS: We placed three mini screws per vertebra for accuracy evaluation and used a reference frame for registration in four pigs (46 screws in 23 vertebrae). We planned screw paths and performed screw insertion under robot guidance. Using C-arm and CT images, we evaluated accuracy by comparing the 3D distance of the placed screw head/tip from the planned screw head/tip and 3D angular offset. RESULTS: Mean registration deviation between the preoperative 3D space (C-arm) and postoperative CT scans was 0.475 ± 0.119 mm. The average offset from preoperative plan to final placement was 4.8 ± 2.0 mm from the head (tail), 5.3 ± 2.3 mm from the tip and 3.9 ± 2.4 degrees of angulation. CONCLUSIONS: Our spine surgery robot showed good accuracy in executing an intended planned trajectory and screw path. This faster and more accurate robotic system will be applied in future studies, first in cadavers and subsequently in the clinical field.