Using Design for Six Sigma to develop an Innovative Porous Tibial Implant and Assessing the Proposed Design using Finite Element

Despite the continued efforts in total knee arthroplasty (TKA) field, several risks and complications are still associated with such surgeries. Undoubtedly, implant design and surgical procedure modifications can be significantly attributed to advances in engineering and manufacturing technology. Motivated by such contributions, this research focuses on introducing an innovative design of tibial implant that has been developed via employing the Design for Six Sigma (DFSS) approach. Particularly, this paper adopts the six sigma DMADV (Define-Measure-Analyze-Design-Verify) methodology to highlight the complications after TKA and their causes. Analysis has revealed that the implant design has a significant correlation with several complications. Accordingly, a new tibial implant design characterized by a hollow stem with a porous hexagonal structure has been proposed. A 3D model has been developed for two different stem design alternatives. The proposed designs have been analyzed and validated using the Finite Element Method (FEM). Comparisons with solid stem models and some other models in previously published work demonstrated the superior performance of the new design in terms of stresses and load-bearing capabilities. Besides, it is expected that the employed hollow and porous structure can significantly enhance the integrity of the implant with the bone in the long term.