Abstract

Design: Prospective, multi-center, clinical case series. Patients and Methods: Eleven patients (6 female, 5 male), average age 48 (27-67) underwent single-level to three-level minimally-invasive pedicle screw spinal fusion. A total of 53 screws were implanted at the T11-S1 levels. Indications included degenerative disc and joint disease, spondylolisthesis, iatrogenic scoliosis and mechanical low back pain. Surgical interventions included TLIF, PLIF and ALIF with pedicle screw instrumentation. Two cases were revision surgeries. Miniature robotic guidance (SpineAssist, Mazor Surgical Technologies, Caesarea, Israel) was used for percutaneous introduction of pedicle screws in all cases. A rigid frame was attached percutaneously to the patients' spine; two fluoroscopic images (AP and Oblique) were taken and automatically registered to pre-operative CT data. The miniature robotic device was attached to the frame and guided the introduction of instrumentation to entry points and trajectories in accordance with the pre-operative plan. Results: Two screws (3.5%) were manually implanted due to unmatched fluoro-to-CT images. All 53 screw positions were evaluated by fluoroscopy and neuro-stimulation; all were determined to be safely placed within pedicle boundaries (100%); no breaches or neural compromises were detected. Two patients (8 screws) underwent post-operative CT scans, which confirmed these observations. Conclusions: Bone-mounted miniature robotic guidance technology is useful, reliable and beneficial for MIS spine surgery.