Short-term safety and effectiveness of a second-generation motion-guided total knee system

BACKGROUND: Modern knee prostheses are designed to more closely replicate normal knee kinematics. The JOURNEY II Bi-Cruciate Stabilized Total Knee System (Smith & Nephew Inc., Memphis, TN) is a second-generation motion-guided knee system that demonstrates axial rotation patterns during flexion, which resemble those of the normal knee. The aim of this study was to assess the short-term safety and effectiveness of this system in standard clinical practice. METHODS: A total of 186 subjects (209 primary total knee arthroplasties [TKAs]) were enrolled at 12 U.S. sites. Subjects were operated on between December 2011 and October 2013 and followed for 24 months. Radiographic, clinical, and patient-reported outcome data were collected at 6-, 12-, and 24-month postoperatively. RESULTS: At 24-month follow-up, the average objective Knee Society Score was 96.20 (standard deviation [SD] = 6.63), the average satisfaction score was 35.22 (SD = 6.63), the average expectation score was 10.91 (SD = 3.16), and the average functional activities score was 81.49 (SD = 14.65). On a 0-10 scale, pain level for walking was 0.79 (SD = 1.51) and 1.50 (SD = 1.97) for climbing stairs or inclines. The cumulative incidence of reoperation at 2-year follow-up was 1.48% (95% confidence interval [CI] 0.48%-4.52%). Ten TKAs in 7 patients were treated with closed manipulations for stiffness. Iliotibial band syndrome was reported in 2 TKAs. Two deep infections occurred, 1 requiring reoperation. No dislocations occurred in the study cohort. CONCLUSIONS: In short-term follow-up, the JOURNEY II Bi-Cruciate Stabilized Guided Motion Total Knee System appears to be a safe and effective device for TKA.