三维数字技术辅助测量汉族人群股骨形态学参数及在国产髓内钉设计中的临床应用

Our previous random controlled study has demonstrated that there were several implants-related intra-operative and post-operative complications when using PFNA-Ⅱand InterTan for internal fixation of intertrochanteric fracture. The underlying reason may be the mismatch between these implants and the Asian femur, as the implants were designed according to the anatomy of Caucasian. This phenomenon also exists in those PFNA-Ⅱthat specially designed for Asian. Up to now, the database of femoral anatomy of Chinese people is not well established. Most domestic proximal femoral intramedullary nail is produced by imitation of imported implants, which doesn’t fit Chinese people and leads to complications. Additionally, our further study found that Chinese population has narrower proximal femoral medullary cavity, shorter proximal femur and smaller femoral bending angles than Caucasians, which may lead to stress concentration around the distal tip of the nail. Therefore, the objective of this study is to measure the anatomical parameter of femur of Chinese population with 3-D method and large sample size to establish the database. These anatomical parameters includes lateral bending angle of the proximal femur, the diameter and morphological character of the femoral medullary cavity in different levels, and the position and radians of anterior bow of femoral shaft, bending angle of the supracondylar fracture of femur and so on. Furthermore, we will specially design several kinds of femoral intramedullary nails for Chinese population. Finally, in order to achieve the requirements for clinical use and minimize complications, we will evaluate the biomechanical properties of femoral intramedullary nails with Finite Element Analysis (FEA).

前期的随机对照研究发现以PFNA-Ⅱ与InterTan治疗股骨转子间骨折时均存在内固定相关并发症，其原因可能为进口髓内钉以高加索人解剖特点设计，与亚洲人解剖学匹配性较差，即使是亚洲型PFNA-Ⅱ亦存在以上问题。而国产髓内钉缺乏汉族人群股骨解剖学数据库，多模仿进口器械所设计。进一步研究发现汉族人群有股骨近端髓腔较窄、近端较短、外偏角较小等特点，且股骨干前弓较高加索人大，存在应力集中问题。在此，本课题拟通过选取大样本量汉族人群股骨CT资料，通过三维重建的方法1）研究股骨近端外偏角、髓腔解剖形态特点及各平面直径、股骨干前弓弧度及位置、股骨髁上折弯角及位置、髁上髓腔狭窄处位置及直径等参数，对汉族人群股骨髓腔形态进行全面分类、分型，为丰富国人股骨解剖学数据提供参考；2）并进一步设计出适合汉族人群的各种型号的股骨近端髓内钉；3）以有限元分析评估其力学特性，达到降低临床并发症发生率的目的。

前期研究发现PFNA等进口髓内钉应用于亚洲人群时存在较多并发症，源于进口髓内钉以高加索人解剖特点设计，与亚洲人解剖学匹配性较差。本课题拟通过选取大样本量汉族人群股骨CT资料，通过三维重建的方法1）研究股骨近端外偏角、髓腔解剖形态特点及各平面直径、股骨干前弓弧度及位置、股骨髁上折弯角及位置、髁上髓腔狭窄处位置及直径等参数，对汉族人群股骨髓腔形态进行全面分类、分型，为丰富国人股骨解剖学数据提供参考；2）并进一步设计出适合汉族人群的各种型号的股骨近端髓内钉；3）以有限元分析评估其力学特性，达到降低临床并发症发生率的目的。4）同时通过三维数字化技术探索了髋臼前柱、后柱螺钉的安全通道；5）通过生物力学实验对股骨颈骨折内侧钢板的生物力学特点进行探讨。.通过研究结果得出结论为：1,总共纳入 466 例患者（其中男性353 例，女性113 例），得出结论中国汉族人群样本股骨近端形态学参数测量中，颈干角可能随着年龄增加而减小；女性的股骨前倾角、髋臼前倾角可能大于男性，股骨头直径、股骨颈直径可能小于男性；左侧可能有更大的股骨偏心距。中国汉族成年人的股骨近端形态学参数跟白种人之间具有明显差异；2,根据中国人已经设计出新型髓内钉，并申报专利；4, 前柱可容纳单枚螺钉的平均最大直径为11.20 4±1.73(7.80-14.60mm)，可容纳两枚螺钉的平均最大直径为8.71 4±0.91(6．60-10.60mm)。5，股骨颈骨折合并内侧骨质缺损时，三枚平行空心钉复合股骨颈内侧钢板在正立位轴向负重、水平侧向抗压及骨颈轴旋转上，生物力学性能均优于其他内固定方式。.本课题得出了较大样本量的国人股骨近端及髋臼解剖学数据，同时设计出一种股骨近端髓内钉，并且通过三维导航技术论证了髋臼前柱螺钉的植入直径及方向，提出一种新型的内固定理念，对于围髋部治疗方式的改变进行了佐证。