Minimally invasive versus conventional fixation of tracer in robot-assisted pedicle screw insertion surgery: a randomized control trial.

Background: This study evaluated the minimal invasiveness, safety, and accuracy of robot-assisted pedicle screw placement procedure using a modified tracer fixation device.
Methods: Patients were randomly assigned to conventional fixation group (25 patients) and modified fixation group (27 patients).
Results: No baseline statistical difference was observed between the groups (P > 0.05). The length of unnecessary incision, amount of bleeding, and fixation duration for tracer fixation respectively were 6.08 ± 1.02 mm, 1.46 ± 0.84 ml, and 1.56 ± 0.32 min in the modified fixation group and 40.28 ± 8.52 mm, 12.02 ± 2.24 ml, and 5.08 ± 1.06 min in the conventional group. The difference between both groups was significant (P < 0.05). However, no significant difference between the two groups was observed in terms of the accuracy of pedicle screw placement (P > 0.05).
Conclusions: The modified minimally invasive procedure for tracer fixation results in minimal trauma and is simple, reliable, and highly safe. Additionally, the procedure does not compromise the accuracy of pedicle screw placement. Thus, it has great clinical applicable value.
Trial Registration: Chinese Clinical Trial Registry: Registration number, ChiCTR1800016680; Registration Date, 15/06/2018.