基于中国族群的个性化增材制造全膝关节置换假体设计

徐振星 , 梁国穗 , 秦江辉 , 石杜芳 , P. Augut , 黄文扬 , 周冠豪 , 黄雪莹 , 陈致远 , 赖毓霄 , 容树恒 , 秦岭 , 张颖恺

工程(英文) ›› 2021, Vol. 7 ›› Issue (3) : 386 -394.

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工程(英文) ›› 2021, Vol. 7 ›› Issue (3) : 386 -394. DOI: 10.1016/j.eng.2020.02.017
研究论文

基于中国族群的个性化增材制造全膝关节置换假体设计

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

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摘要

目前市场上大多数全膝关节置换(TKR)假体是根据高加索人的体型设计的。大量研究表明,不同种族之间的人体解剖结构不同,中国的TKR患者与现有进口假体并不匹配。本研究测量了52名中国男性和女性的膝关节计算机断层扫描(CT)图像。通过定义参数和几何尺寸,进行相关性分析。从测量结果中识别出关键参数。测量膝关节详细几何形状的坐标数据。基于与所标识的关键参数相关的解剖坐标系统,生成了可变形的三维(3D)膝关节模型。然后根据分析结果设计假体,进行表面匹配分析、切骨分析和尸体试验,并将其与商业假体产品进行比较以验证我们的设计。本研究设计的股骨组件与两种商业器械相比,具有更高的准确性[均方根比(RMS PS)为(1.08 ± 0.20) mm],而切除的骨量最低(27 412 mm3)。这项研究为基于族群的患者特定的股骨假体设计提出了一种新方法。使用一个易于获取的尺寸[即上髁宽度(ECW)]作为输入,可以根据分析的测量数据设计特定患者的股骨假体,并通过增材制造(AM)方法进行制造。同时,在原始CT扫描数据中将重建的股骨表面与原股骨表面进行比较。在所有数据中,重建的股骨表面的平均RMS PS距离为(1.10 ± 0.18)mm,这与使用多个X射线照片作为输入数据的其他统计形状建模方法相当。目前市场上对基于中国族群人体测量的膝关节假体有很大需求。本研究基于中国族群人体测量学,设计出更适合中国患者的膝关节假体,并保留了更多的骨量,这是迈向个性化膝关节假体增材制造的重要一步。

Abstract

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 defined and 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 model based on anatomical coordinates correlating with the identified key parameters was generated. A prosthesis was then designed according to the analyzed results. Surface matching analysis, bone resection analysis, and cadaveric trials were conducted and compared with commercial products to validate the proposed design. The femoral component designed by this study resulted in the highest accuracy (root mean square point-to-surface (RMS PS), (1.08 ± 0.20) mm) and lowest amount of resected bone volume (27 412 mm3) in comparison with two commercial knee prostheses. This study suggests a new approach for population-based patient-specific femoral prosthesis design. With a single, easily acquired dimension—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 surface in 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.

关键词

增材制造 / 基于族群的设计 / 全膝关节置换 / 膝关节假体 / 人体测量

Key words

Additive manufacturing / Population-based design / Total knee replacement / Knee prosthesis / Anthropometric measurement

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徐振星, 梁国穗, 秦江辉, 石杜芳, P. Augut, 黄文扬, 周冠豪, 黄雪莹, 陈致远, 赖毓霄, 容树恒, 秦岭, 张颖恺 基于中国族群的个性化增材制造全膝关节置换假体设计[J]. 工程(英文), 2021, 7(3): 386-394 DOI:10.1016/j.eng.2020.02.017

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