Purpose: To assess technical feasibility, accuracy, safety and patient radiation exposure of a novel navigational tool integrating augmented reality (AR) and artificial intelligence (AI), during percutaneous vertebroplasty of patients with vertebral compression fractures (VCFs).
Material and methods: This prospective parallel randomised open trial compared the trans-pedicular access phase of percutaneous vertebroplasty across two groups of 10 patients, electronically randomised, with symptomatic single-level VCFs. Trocar insertion was performed using AR/AI-guidance with motion compensation in Group A, and standard fluoroscopy in Group B. The primary endpoint was technical feasibility in Group A. Secondary outcomes included the comparison of Groups A and B in terms of accuracy of trocar placement (distance between planned/actual trajectory on sagittal/coronal fluoroscopic images); complications; time for trocar deployment; and radiation dose/fluoroscopy time.
Results: Technical feasibility in Group A was 100%. Accuracy in Group A was 1.68 ± 0.25 mm (skin entry point), and 1.02 ± 0.26 mm (trocar tip) in the sagittal plane, and 1.88 ± 0.28 mm (skin entry point) and 0.86 ± 0.17 mm (trocar tip) in the coronal plane, without any significant difference compared to Group B (p > 0.05). No complications were observed in the entire population. Time for trocar deployment was significantly longer in Group A (642 ± 210 s) than in Group B (336 ± 60 s; p = 0.001). Dose-area product and fluoroscopy time were significantly lower in Group A (182.6 ± 106.7 mGy cm2 and 5.2 ± 2.6 s) than in Group B (367.8 ± 184.7 mGy cm2 and 10.4 ± 4.1 s; p = 0.025 and 0.005), respectively.
Conclusion: AR/AI-guided percutaneous vertebroplasty appears feasible, accurate and safe, and facilitates lower patient radiation exposure compared to standard fluoroscopic guidance. These slides can be retrieved under Electronic Supplementary Material.
Keywords: Artificial intelligence; Augmented reality; Prospective study; Randomised clinical trial; Spine surgery; Vertebroplasty.