Population-Based and Personalized Design of Total Knee Replacement Prosthesis for Additive Manufacturing Based on Chinese Anthropometric Data

摘要

At present,most total knee replacement(TKR)prostheses on the market are designed according to the sizes of Caucasians.However,extensive studies have indicated that human anatomies differ among different ethnicities.A number of reports have indicated that Chinese TKR patients do not match with available prostheses.In this study,computed tomography(CT)images of 52 knees of Chinese men and women were used for anthropometric measurements.Index and geometric measurements were definedand used for correlation analysis.Key parameters from the measurement results were identified.Detailed geometries of knees were measured as coordinates.A deformable three-dimensional(3D)knee modelbased on anatomical coordinates correlating with the identified key parameters was generated.A pros-thesis was then designed according to the analyzed results.Surface matching analysis,bone resectionanalysis,and cadaveric trials were conducted and compared with commercial products to validate theproposed design.The femoral component designed by this study resulted in the highest accuracy(rootmean square point-to-surface(RMS PS),(1.08±0.20)mm)and lowest amount of resected bone volume(27412mm^(3))in comparison with two commercial knee prostheses.This study suggests a new approachfor population-based patient-specific femoral prosthesis design With a single,easilty acquired dimen-sion-namely,epicondyle width(ECW)-as input,a patient-specific femoral prosthesis can be designed according to the analyzed measured data and manufactured by additive manufacturing(AM)methods.Meanwhile,the reconstructed femoral condylar surface was compared with the femoral condylar surfacein the original CT scanning data The average RMS PS distance of the reconstructed femoral condylar surface among all data was(1.10±0.18)mm,which is comparable to other statistical shape modeling methods using multiple radiographs as input data.There is a need to develop an anthropometric-based knee prosthesis for the Chinese population.Based on the anthropometry of the Chinese population,our new design fits Chinese patients better and reserves more bone volume compared with current commercial prostheses,which is an essential step toward AM for personalized knee prostheses.