Clinical outcomes and radiolucent line analysis in cementless mobile-bearing total knee arthroplasty: a prospective multicentre study in Japan.

The objective of this study was to assess radiolucent lines (RLLs) and to determine their effect on clinical outcomes of the newly introduced cementless mobile-bearing total knee arthroplasty (TKA) system. This was prospective, multicentre study. Seventy-eight patients with knee osteoarthritis who underwent primary TKA were enrolled. Patient-reported outcome measures (PROMs) and radiographic assessments were evaluated at preoperative baseline and at 6 weeks, 1 year, and 2 years after surgery. KOOS, PKIP, 2011KSS, EQ-5D-3L and SKO improved from preoperative baseline to all postoperative timepoints, with no loosening of components. No RLLs were detected at 6 weeks after surgery. However, RLLs ≥ 1 mm developed in 2.8% of the patients for the femur and 9.7% for the tibia at 1 year after surgery, and values were 5.7% and 10.9%, respectively, at 2 years after surgery. RLL incidence was not correlated with PROMs. Age, sex, body mass index, range of motion knee flexion, posterior cruciate ligament treatment and ß angle did not impact the occurrence of RLLs. There were no intraoperative complications, revisions or reoperations. This TKA system improved PROMs and showed less incidence of RLLs compared to the previous reported TKA without implant-related complications.

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.

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<0.001). There were no device-related or study treatment-related adverse events in either group. Conclusions: 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.