Pierre Auloge1, Roberto Luigi Cazzato2, Nitin Ramamurthy3, Pierre de Marini2, Chloé Rousseau4, Julien Garnon2, Yan Philippe Charles5, Jean-Paul Steib5, Afshin Gangi2. 1. Interventional Radiology, Imagerie Interventionnelle, Nouvel Hôpital Civil, University Hospital of Strasbourg, 1, Place de l'Hôpital, B.P. 426, 67091, Strasbourg Cedex, France. pierreauloge@gmail.com. 2. Interventional Radiology, Imagerie Interventionnelle, Nouvel Hôpital Civil, University Hospital of Strasbourg, 1, Place de l'Hôpital, B.P. 426, 67091, Strasbourg Cedex, France. 3. Department of Radiology, Norfolk and Norwich University Hospital, Colney Lane, Norwich, NR4 7UY, UK. 4. Clinical Investigation Center INSERM 1414, University Hospital of Rennes and University of Rennes, Rennes, France. 5. Service de Chirurgie du Rachis, Hôpitaux Universitaires de Strasbourg, Fédération de Médecine Translationnelle (FMTS), Université de Strasbourg, 1, Place de l'Hôpital, B.P. 426, 67091, Strasbourg Cedex, France.
Abstract
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 vertebroplastyacross 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.
RCT Entities:
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.
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