PDF(Pubmed)
Abstract：
UNASSIGNED: Minimally invasive lumbar fusion has recently become a widely used technique worldwide. This randomized active controlled study was conducted to demonstrate the non-inferiority of the K-wireless Minimally Invasive Spine (MIS) Percutaneous Pedicle Screw (PPS) system compared with use of the six pedicle screw systems currently used in our practices with respect to the accuracy of pedicle screw placement.Also to compare the screw-insertion time and number of fluoroscopic observations during screw insertion between the groups.
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.
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.
摘要：
■微创腰椎融合术最近已成为世界范围内广泛使用的技术。进行这项随机主动对照研究，以证明K无线微创脊柱（MIS）经皮椎弓根螺钉（PPS）系统与目前在我们的实践中使用的六个椎弓根螺钉系统相比，在准确性方面的非劣效性椎弓根螺钉放置。还比较两组之间在螺钉插入期间的螺钉插入时间和透视观察次数。
■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.
■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.
