A novel guide wire used in percutaneous pedicle screw insertion : evaluation of its efficacy and safety / 介入放射学杂志

ABSTRACT

Objective To compare the biomechanical characteristics of a novel guide wire with that of the conventional guide wire by using cadaver specimen test,and to evaluate the safety and effectiveness of this new guide wire through clinical experiment.Methods By using cadaver specimen test,the average push-out force on the guide wire and the extra-force required to penetrate the anterior wall of the vertebral bodies,from L1 to L5,were determined,and the results were compared between the novel guide wire and the conventional guide wire.Results The definition of push-out force was a force that caused the tip of the guide wire to bend or disperse within the vertebral body and then the further moving of the wire to the front of the vertebral body was impeded.The average push-out forces for the novel guide wire and the conventional guide wire were (15.5±1.9) and (5.7±0.8) newton respectively (P＜0.001).The mean force required to penetrate the anterior wall of the vertebral body for the novel guide wire and the conventional guide wire were (69.1±4.2) and (37.1±4.8) newton respectively (P＜0.000 5).A total of 222 novel guide wires were used in clinical trial,and no penetration of vertebral anterior wall by the guide wire occurred.Conclusion The average push-out force within the vertebral body and the mean force required to penetrate the anterior wall of the vertebral body for the novel guide wire are about 2 times and 3 times greater than those for the conventional guide wire respectively.The use of this novel guide wire can effectively prevent the wire from moving forward in the vertebral body as well as from penetrating the vertebral anterior wall.Therefore,the use of this novel guide wire can reliably improve the safety for patients with osteoporosis receiving percutaneous pedicle screw insertion procedure.