Accuracy and safety of percutaneous pedicle screw placement using the K-wireless minimally invasive spine percutaneous pedicle screw system in Japan: A randomized active controlled study

Autor: Kazuo Ohmori, Sei Terayama, Koichiro Ono, Miyuki Sakamoto, Yukie Horikoshi
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: North American Spine Society Journal, Vol 10, Iss , Pp 100121- (2022)
Druh dokumentu: article
ISSN: 2666-5484
DOI: 10.1016/j.xnsj.2022.100121
Popis: Background: 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. Methods: 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. Results: 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
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