Design and analysis of polycentric prosthetic knee with enhanced kinematics and stability

This paper describes a continuation of earlier work using the finite element method to conduct an engineering failure analysis of an existing polycentric prosthetic knee. The primary purpose of this work is to enhance the quality of the existing knee which has been reported with multiple cases of failure during its clinical practice in India. A modified design of the polycentric knee has been proposed based on the findings of failure analysis. Simulation-based comparative analysis of polycentric knees has been performed as per the ISO 10328:2016 standard in terms of stress distribution, total contour deformation, safety factor, and fatigue life. The upper extension lever is subjected to static and cyclic loads of 4130 and 1230 N, whereas the lower plate has a translational constraint. The modified polycentric knee prosthesis outperforms static and fatigue strength tests. The standard of the existing knee prosthesis has significantly improved as a result of design variations and integration of high-strength and lightweight aluminium 7075-T6 alloy. The modified polycentric knee prosthesis has a predicted maximum deformation of less than 0.7 mm and a minimum safety factor between 1.7 and 2 compared to 2.66 mm and 1.0 for the existing knee prosthesis. Based on the fatigue simulation results, it is predicted that the modified polycentric knee will have a lifespan of at least ten years indicating a safe design. It has improved alignment stability and kinematics, with a significant weight reduction of 33 g, and a high cost-benefit ratio to reach the maximum amputee population in low-income countries like India.