Methods

An open-label prospective clinical study was conducted to compare 3D modeling with manual TKA (non-randomized) at 4 U.S. centers between July 2016 and August 2018. Men and women aged > 18 with body mass index < 40kg/m² scheduled for unilateral primary TKA were recruited for the study. 144 3DTKA and 86 manual TKA (230 patients) were included in the analysis of accuracy outcomes. Seven high-volume, arthroplasty fellowship-trained surgeons performed the surgeries. The surgeon targeted a neutral (0°) mechanical axis for all except 9 patients (4%) for whom the target was within 0°±3°. Computed tomography (CT) scans obtained approximately 6 weeks post-operatively were analyzed using anatomical landmarks to determine femoral and tibial component varus/valgus position, femoral component internal/external rotation, and tibial component posterior slope. Absolute deviation from surgical plan was defined as the absolute value of the difference between the CT measurement and the surgeon's operative plan. Smaller absolute deviation from plan indicated greater accuracy. Mean component positions for manual and 3DTKA groups were compared using two-sample t tests for unequal variances. Differences of absolute deviations from plan were compared using stratified Wilcoxon tests, which controlled for study center and accounted for skewed distributions of the absolute values. Alpha was 0.05 two-sided. At the time of this report, CT measurements of femoral component rotation position referenced from the posterior condylar axis were not yet completed; therefore, the current analysis of femoral component rotation accuracy to plan reflects one center that exclusively used manual instruments referencing the transepicondylar axis (TEA).