A New Pilot Hole Preparation System for Percutaneous Pedicle Screw Placement: A Randomized Controlled Study.

Study design: A randomized controlled study.

Objective: To introduce a new pilot hole preparation system for percutaneous pedicle screw placement and investigate its efficiency and safety in comparison with the conventional method.

Summary of background data: Placing screws accurately, rapidly, and safely with less radiation exposure is critical for minimally invasive lumbar interbody fusion (LIF). Optimizing pilot hole preparation instruments has important clinical implications.

Materials and methods: A total of 60 patients (180 screws) were included in this study. All patients were randomized into two groups (new system vs. conventional method) and performed single-level minimally invasive percutaneous fixation, interbody fusion, and unilateral decompression. Basic information, time of pilot hole preparation, time of screw placement, and fluoroscopy time were recorded. Screw placement accuracy was graded based on the Gertzbein-Robbins scale, and the angle between the screw axis and the pedicle axis was collected in postoperative CT.

Results: There was no statistical difference in basic information between the 2 groups. The mean time of single pilot hole preparation was 4.08±1.01 minutes in the new system group and 5.34±1.30 minutes in the conventional method group ( P <0.001). The time of single screw placement was significantly shorter in the new system group (0.82±0.20 vs. 1.72±0.33 min), and the fluoroscopy time was also less in the new system group (13.70±3.42 vs. 19.95±5.50 s) ( P <0.001). Screw placement accuracy assessment showed that there were 85 (94.45%) A-grade screws in the new system group while 76 (84.44%) A-grade screws in the conventional method group ( P =0.027).

Conclusions: The new pilot hole preparation system has shown significant reductions in the time of pilot hole preparation, time of screw placement, and radiation exposure, and has good clinical application value.