Abstract

Design: A Prospective, multi-center, clinical case series, evaluating the feasibility and accuracy of miniature robotic guidance for vertebral body augmentation. Participants/Methods: 34 patients (5 male, 29 female, ages 48-94) underwent one- to five-level vertebral body augmentation for treatment of osteoprotic, metastatic and trauma-induced fractures. Procedures included Kyphoplasty, Vertebroplasty, Spineoplasty and Structural Kyphoplasty, utilizing trans-pedicular or extra-pedicular paths. A miniature, bone-mounted robotic system (SpineAssist, Mazor Surgical Technologies, Caesarea, Israel) was used to guide the needle to the injection site. Results: All 55 robotically-guided needles were safely introduced into the target site (100%). One needle deviated 2mm inferiorly relative to plan without pedicle breaching and with successful cement injection. No complications related to the use of robot occurred. 63 trajectories were planned, 55 were executed (87.3 %). Non-execution was due to poor CT/Fluoro (6), user error (1) or mechanical failure (1). Conclusion:<> Robotic-assisted vertebral body augmentation is feasible and beneficial. Highly accurate placements and minimal use of fluoroscopy ensured clinical outcomes while reducing radiation exposure to the surgeon. Preoperative planning facilitated safe trajectories and optimal targeting of injection site. Particular value is seen for multi-level cases, hypoplastic pedicles, lytic lesions and biopsy of unknown lesions prior to treatment.