UNASSIGNED: A total of 80 patients with degenerative spinal diseases or vertebral fractures were assigned, including 41 patients in the K-wireless MIS PPS system group (K-wireless group) and 39 in the control group (K-wire group).The accuracy of the screw insertion, screw-insertion time, number of fluoroscopic observations during screw insertion, and the incidence of adverse events were compared between the K-wireless group and the K-wire group. The accuracy rate was calculated as the number of screws with no breach divided by the total number of screws.
UNASSIGNED: The accuracy rates of screw insertion were 85.7% and 75.0% in the K-wireless and K-wire groups, respectively, with an intergroup difference of 10.7% (95% confidence interval: 2.3-19.1%). The K-wireless group demonstrated non-inferiority compared with the K-wire group. The mean screw-insertion time was significantly shorter in the K-wireless group (2.62 and 2.97 min in the K-wireless and K-wire groups, respectively; P=0.005). There were also significantly fewer fluoroscopies in the K-wireless group (10.7 and 17.4 in the K-wireless and K-wire groups, respectively; P<0.001). There were no device-related or study treatment-related adverse events in either group.
UNASSIGNED: The accuracy of pedicle screw insertion using the K-wireless MIS PPS system was not inferior to that of existing products. In terms of safety, no product-related or treatment-related adverse events were identified in this study and no new safety concerns were noted.
■共80例脊柱退行性疾病或椎体骨折患者,其中K无线MISPPS系统组(K无线组)41例,对照组(K线组)39例。螺钉插入的准确性,螺钉插入时间,螺钉插入期间的透视观察次数,比较了K-wireless组和K-wire组的不良事件发生率.准确率计算为无缺口的螺钉数除以螺钉总数。
■在K-wireless和K-wire组中,螺钉插入的准确率分别为85.7%和75.0%,分别,组间差异为10.7%(95%置信区间:2.3-19.1%)。与K线组相比,K无线组表现出非劣效性。K无线组的平均螺钉插入时间明显较短(K无线组和K线组的平均螺钉插入时间分别为2.62和2.97分钟,分别为;P=0.005)。在K-无线组中也有明显较少的荧光镜检查(在K-无线组和K-wire组中有10.7和17.4,分别;P<0.001)。两组均无装置相关或研究治疗相关的不良事件。
■使用K-无线MISPPS系统插入椎弓根螺钉的精度不逊于现有产品。在安全方面,本研究未发现产品相关或治疗相关的不良事件,也未发现新的安全性问题.