Abstract
Introduction
Total knee arthroplasty (TKA) prostheses are semi-constrained artificial joints. A well-functioning TKA prosthesis should be designed with a good balance between stability and mobility, meaning the femorotibial constraint of the artificial joint should be appropriate for the device's function. To assess the constraint behavior of a TKA prosthesis, physical testing is typically required, and an industrial testing standard has been developed for this purpose [1]. Computer simulation has become increasingly useful in many industries, including medical device research and development where finite element analysis (FEA) has been extensively used in stress analysis and structural evaluation. This study presents an FEA-based simulation to evaluate the femorotibial constraint behavior of TKA prosthesis, and demonstrated the effectiveness of the method by validating through physical testing.
Methods
A Cruciate Retaining (CR) TKA prosthesis design (Optetrak Logic CR, Exactech, USA) was used in this study. CAD models of the implants assembled at 0° of flexion were used for the simulation. Finite element models were generated using with all materials assumed linear elastic. Boundary conditions were set up according to the ASTM F1223 standard (Figure 1). The tibial baseplate was fixed distally. A constant compressive force (710 N) was applied on the femoral component. Nonlinear Surface-Surface-Contact was defined at the femorotibial articulating surfaces. Coefficient of friction was determined from physical test. The femoral component was driven under a displacement-controlled scheme to slide along the anterior-posterior (AP) direction on the tibial insert. At each time step, constraint force occurring at the articulating surface was derived from the reaction force at the distal fixation of the tibial baseplate. A nonlinear FEA solver (NX Nastran SOL601, Siemens, USA) was used to solve the simulation. In addition, five samples of the prostheses were physically tested, and the results were compared with the simulation.
Results
The simulation successfully captured the movement of contact location and pressure along the movement of the femoral component (Figure 2). The force-displacement curve predicted by the simulation exhibited a very close hysteresis loop profile as the results of physical testing (Figure 3). Using the curve slope from 0 to 5 mm to characterize the linear constraint, the simulation predicted 45.7 N/mm anteriorly and 36.4 N/mm posteriorly, which are less than 10% different from the physical testing results (46.4 N/mm anteriorly and 39.6 N/mm posteriorly).
Discussion/Conclusion
This study demonstrated that the simulation was able to closely predict the femorotibial constraint behavior of the TKA prosthesis under ASTM F1223 testing. The simulation results resembled the physical testing results not only in the general curve profile but also in the magnitude of slope values. The increased difference at the far anterior region could be related to the fact that no material nonlinearity was currently considered, which could be improved in future studies. A validated simulation method could be very useful in TKA prosthesis design. Since no physical prototypes are required, design evaluation and optimization can be achieved in a much easier and faster manner.
