The purposes of this study were to quantify the increase in tibial force imbalance (i.e. magnitude of difference between medial and lateral tibial forces)and changes in laxities caused by 2° and 4° of varus-valgus (V-V) malalignment of the femoral component in kinematically aligned total knee arthroplasty (TKA) and use the results to detemine sensitivities to errors in making the distal femoral resections. Because V-V malalignment would introduce the greatest changes in the alignment of the articular surfaces at 0° flexion, the hypotheses were that the greatest increases in tibial force imbalance would occur at 0° flexion, that primarily V-V laxity would significantly change at this flexion angle, and that the tibial force imbalance would increaseand laxities would change in proportion to the degree of V-V malalignment. Kinematically aligned TKA was performed on ten human cadaveric knee specimens using disposable manual instruments without soft tissue release. One 3D-printed reference femoral component, with unmodified geometry, was aligned to restore the native distal and posterior femoral joint lines. Four 3D-printed femoral components, with modified geometry, introduced V-V malalignments of 2° and 4° from the reference component. Medial and lateral tibial forces were measured during passive knee flexion-extension between 0° to 120° using a custom tibial force sensor. Eight laxities were measured from 0° to 120° flexion using a six degree-of-freedom load application system. With the tibial component kinematically aligned, the increase in the tibial force imbalance from that of the reference component at 0° of flexion was sensitive to the degree of V-V malalignment of the femoral component. Sensitivities were 54N/deg (medial tibial force increasing > lateral tibial force) (p < 0.0024) and 44N/deg (lateral tibial force increasing > medial tibial force) (p < 0.0077) for varus and valgus malalignments, respectively. Varus-valgus malalignment did not significantly change varus, internal-external rotation, anterior-posterior, and compression-distraction laxities from 0° to 120° flexion. At only 30° of flexion, 4° of varus malalignment increased valgus laxity 1° (p = 0.0014). At 0° flexion, V-V malalignment of the femoral component caused the tibial force imbalance to increase significantly, whereas the laxities were relatively unaffected. Because tibial force imbalance has the potential to adversely affect patient-reported outcomes andsatisfaction, surgeons should strive to limit errors in resecting the distal femoral condyles to within ± 0.5mm which in turn limits the average increase in tibial force imbalance to 68N. Because laxities were generally unaffected, instability resulting from large increases in laxity is not a clinical concern within the ± 4° range tested. Therapeutic, Level II.
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