Abstract:Purpose: The purpose of this study was to obtain the range of anatomical parameters of healthy knee joints in Chinese men and to validate the statistical shape model(SSM) based on the healthy knee is validated in terms of geometric shape, which provides a basis for the design of knee SSM-based prosthesis. Methods: CT images (n>100) of healthy male knee joints were acquired to build 3D knee joint models, each model will be selected as the target sample, and the remaining models will be used as training set for Principal Component Analysis(PCA), and the obtained knee SSM will be fitted to the target sample model to predict the SSM prediction model. The same anatomical measurement points (6 on the femur, 8 on the patella, and 6 on the tibia) were marked on the sample model and SSM prediction model, respectively, and 20 anatomical parameters (17 linear and 3 angular parameters) were derived. The values of the anatomical parameters were statistically tested using independent samples t-test (parametric validation) and Mann-Whitney U-test (non-parametric validation), and the validity of the SSM in terms of geometric profile was demonstrated if the resulting p-values were all greater than 0.05. Results: The principal components vi obtained from PCA indicated different anatomical variability in the training set model, such as principal component 1 indicating volume differences in the training set model, as manifested by overall enlargement and reduction of the knee bone component, and principal components 2 and 3 indicating different proportional relationships in size and a certain change in knee flexion rotation, respectively. In this study, the ranges of anatomical parameters of the healthy right knee joint in Chinese males were derived, such as the reference ranges of LAP, TEA and ∠MA of 56.13~69.04mm, 73.96~92.12mm and 71.79~79.83°, which are helpful for the clinical diagnosis and treatment of bone defect-related diseases. The results of qualitative and quantitative comparative analysis of anatomical parameters on the healthy sample model and the SSM model showed that the mean deviation of linear parameter values was less than 6 mm and the mean deviation of angular parameter values was less than 2.5°. The results of statistical tests showed p-value>0.05 for all anatomical parameters, proving that the knee SSM prediction model is not statistically different from the true health model in terms of geometric shape. Conclusion: This study derived a reference range of anatomical parameters for the healthy knee and demonstrated that the knee SSM model is consistent with the real healthy model in terms of shape, and the results can be used as a basis for designing knee prostheses based on SSM.