一种新型经皮椎弓根置钉导丝的安全性和有效性

摘要

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.%目的 尸体标本实验中比较新型导丝和传统导丝的生物力学特征,并通过临床实验分析新型导丝的安全性和有效性.方法 通过尸体标本比较新型导丝和传统导丝从腰1椎体至腰5椎体的平均推力和需要穿透椎体前壁的力量.结果 对新型导丝的推力导致导丝尖端螺旋部分在椎体内弯曲或散开,从而阻止导丝向椎体前方移动,新型导丝和传统导丝平均的推力分别为(15.5±1.9)和(5.7±0.8)牛顿(P＜0.001),新型导丝和传统导丝穿破椎体前壁的平均推力分别为(69.1±4.2)和(37.1±4.8)牛顿,(P＜0.000 5),在使用的222根新型导丝的临床实践中无导丝穿破椎体前壁的现象.结论 新型导丝在椎体内的平均推力和需要穿透椎体前壁的力量为传统导丝的2～3倍,新型导丝可有效阻止导丝在椎体内向前方移动并防止导丝穿透椎体前壁,新型导丝可有效提高合并骨质疏松患者接受经皮置钉手术的安全性.