Designing and in vitro testing of a novel patient-specific total knee prosthesis using the probabilistic approach.

In order to prevent failure as well as ensure comfort, patient-specific modelling for prostheses has been gaining interest. However, deterministic analyses have been widely used in the design process without considering any variation/uncertainties related to the design parameters of such prostheses. Therefore, this study aims to compare the performance of patient-specific anatomic Total Knee Arthroplasty (TKA) with off-the-shelf TKA. In the patient-specific model, the femoral condyle curves were considered in the femoral component's inner and outer surface design. The tibial component was designed to completely cover the tibia cutting surface. In vitro experiments were conducted to compare these two models in terms of loosening of the components. A probabilistic approach based on the finite element method was also used to compute the probability of failure of both models. According to the deterministic analysis results, 103.10 and 21.67 MPa von Mises stress values were obtained for the femoral component and cement in the anatomical model, while these values were 175.86 and 25.76 MPa, respectively, for the conventional model. In order to predict loosening damage due to local osteolysis or stress shield, it was determined that the deformation values in the examined cement structures were 15% lower in the anatomical model. According to probabilistic analysis results, it was observed that the probability of encountering an extreme value for the anatomical model is far less than that of the conventional model. This indicates that the anatomical model is safer than the conventional model, considering the failure scenarios in this study.