Interest of intra-operative 3D imaging in spine surgery: a prospective randomized study.

Abstract

We report a single-center, prospective, randomized study for pedicle screw insertion in opened and percutaneous spine surgeries, using a computer-assisted surgery (CAS) technique with three-dimensional (3D) intra-operative images intensifier (without planification on pre-operative CT scan) vs conventional surgical procedure. We included 143 patients: Group C (conventional, 72 patients) and Group N (3D Fluoronavigation, 71 patients). We measured the pedicle screw running time, and surgeon's radiation exposure. All pedicle runs were assessed according to Heary by two independent radiologists on a post-operative CT scan. 3D Fluoronavigation appeared less accuratein percutaneous procedures (24% of misplaced pedicle screws vs 5% in Group C) (p=0.007), but more accurate in opened surgeries (5% of misplaced pedicle screws vs 17% in Group C) (p=0.025). For one vertebra, the average surgical running time reached 8min in Group C vs 21min in Group N for percutaneous surgeries (p=3.42×10(-9)), 7.33min in Group C vs 16.33min in Group N (p=2.88×10(-7)) for opened surgeries. The 3D navigation device delivered less radiation in percutaneous procedures [0.6 vs 1.62mSv in Group C (p=2.45×10(-9))]. For opened surgeries, it was twice higher in Group N with 0.21 vs 0.1mSv in Group C (p=0.022). The rate of misplaced pedicle screws with conventional techniques was nearly the same as most papers and a little bit higher with CAS. Surgical running time and radiation exposure were consistent with many studies. Our work hypothesis is partially confirmed, depending on the type of surgery (opened or closed procedure).