Patient-Specific Instrumentation Accuracy Evaluated with 3D Virtual Models.

There have been remarkable advances in knee replacement surgery over the last few decades. One of the concerns continues to be the accuracy in achieving the desired alignment. Patient-specific instrumentation (PSI) was developed to increase component placement accuracy, but the available evidence is not conclusive. Our study aimed to determine a PSI system's three-dimensional accuracy on 3D virtual models obtained by post-operative computed tomography. We compared the angular placement values of 35 total knee arthroplasties (TKAs) operated within a year obtained with the planned ones, and we analyzed the possible relationships between alignment and patient-reported outcomes. The mean (SD) discrepancies measured by two experienced engineers to the planned values observed were 1.64° (1.3°) for the hip-knee-ankle angle, 1.45° (1.06°) for the supplementary angle of the femoral lateral distal angle, 1.44° (0.97°) for the proximal medial tibial angle, 2.28° (1.78°) for tibial slope, 0.64° (1.09°) for femoral sagittal flexion, and 1.42° (1.06°) for femoral rotation. Neither variables related to post-operative alignment nor the proportion of change between pre-and post-operative alignment influenced the patient-reported outcomes. The evaluated PSI system's three-dimensional alignment analysis showed a statistically significant difference between the angular values planned and those obtained. However, we did not find a relevant effect size, and this slight discrepancy did not impact the clinical outcome.