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Title:: Orthogonal Test Design of the Internal Fixation of Femoral Fractures System Multi-factor based on the Finite Element Analysis

作者:: 盛伟1; 纪爱敏1△; 陈长胜1; 2; 1. 河海大学机电工程学院，常州 213022；2. 常州奥斯迈医疗器械有限公司，常州 213022

Author(s):: SHENG Wei1; JI Aimin1 ; CHEN Changsheng1; 2; 1. School of Mechanical and Electrical Engineering, Hohai University, Changzhou 213022, China;2. Changzhou Orthmed Medical Instrument Co., Ltd., Changzhou 213022

Keywords:: Femoral shaft fracture; Locking plate; Stability; Orthogonal experiment; Three factors and three levels; Weight; Finite element analysis

摘要:: 评估股骨干骨折内固定系统中三个因素对内固定系统稳定性的影响，为临床治疗提供指导。采用正交试验方法设计试验方案，分别对股骨干骨折内固定系统的三因素三水平上进行生物力学有限元分析，得出各组试验的三项考察指标数值,并结合正交试验权矩阵分析方法进行数据分析。结果显示，影响内固定系统稳定性的三因素三水平有着不同权重。研究结果表明,三因素对内固定系统稳定性影响的主次顺序为螺钉直径、锁定钢板与股骨表面间距、骨折处填充物弹性模量,正交试验的最佳方案为螺钉直径为4 mm，锁定钢板与股骨表面间距为3 mm，骨折处填充物弹性模量为15 MPa。

Abstract:: To evaluate the effect that the three factors of the femoral shaft fracture internal fixation system on the stability of internal fixation system, and to provide guidance for the clinical treatment. The orthogonal test design method was used to design the experiment scheme. The finite element analysis method was used to analyze the three levers biomechanical properties of the three factors of the femoral shaft fracture internal fixation system respectively, three inspection index value for each group experiment were attained. And combined with orthogonal test matrix analysis method，the data analysis was carried on. The results showed that the each levers of the three factors had different weights. The analysis results show that the primary and secondary order of the effect that three factors had on stability of the internal fixation system are screw diameter, the distance between the plate and femur surface and the elastic modulus of the fracture filling, and the best scheme of the orthogonal test is that the screw diameter is 4 mm, the distance between locking plate and femoral surface is 3 mm and fracture fillings elastic modulus is 15 MPa.