国人解剖型后踝锁定钢板的设计、研发及生物力学分析  

Design and R&D of anatomic posterior malleolus locking plate for chinese people and its biomechanical analysis

作　　者：李勇奇 廖燚 夏江[1] 李兵[1,3] 周海超 赵有光[1] 杨云峰[1,3] Li Yongqi;Liao Yi;Xia Jiang;Li Bing;Zhou Haichao;Zhao Youguang;Yang Yunfeng(Department of Orthopaedics,Shanghai Tongji Hospital,Shanghai 200065,China;Department of Orthopaedics,Karamay Hospital of People's Hospital of Xinjiang Uygur Autonomous Region(Karamay Central Hospital),Karamay 834000,China;Ruijin Hospital,Shanghai JiaoTong University School of Medicine)

机构地区：[1]上海市同济医院骨科,上海200065 [2]新疆维吾尔自治区人民医院克拉玛依医院(克拉玛依市中心医院)骨科,克拉玛依834000 [3]上海交通大学医学院附属瑞金医院骨科

出　　处：《中华骨科杂志》2024年第10期692-699,共8页Chinese Journal of Orthopaedics

基　　金：上海市科委项目(21ZR1458500,22S31900300)。

摘　　要：目的设计、研发国人解剖型后踝锁定钢板,测量并分析其生物力学特性。方法收集上海市同济医院2022年6月至2023年5月招募的100名健康志愿者的胫腓骨+踝关节CT数据。对胫腓骨及踝关节三维重建,测量国人后踝影像解剖学参数,设计生产国人解剖型后踝锁定钢板。通过制作胫骨人工骨模型,对钢板进行验证和生物力学测试。生物力学测试方法为分别在康定胫骨远端后侧钢板、六孔型后踝解剖锁定钢板、五孔型后踝解剖锁定钢板固定下:测量轴向施加载荷500、1000和1500 N的垂直位移;测量位移为2 mm时的失效载荷及内固定完全失效时的最大失效载荷。结果影像解剖学测量示后踝宽度为26.6(19.4,35.0)mm,并分别以第一四分位数、中位数和第三四分位数对应小、中、大三种型号后踝基础钢板;置钉安全区高度为5.5(5.3,5.7)mm;后翻角度为153.0°(148.5°,157.5°);后翻高度为20.0(19.7,20.9)mm。利用胫腓骨+踝关节螺旋CT及计算机辅助技术设计、生产后踝解剖锁定钢板,与胫骨后踝匹配良好,解剖贴服。生物力学测试:相较康定胫骨远端后侧钢板轴向载荷500、1000和1500 N时垂直位移的(0.60±0.02)、(2.22±0.03)、(2.81±0.04)mm,六孔型和五孔型后踝解剖锁定钢板分别减少为(0.45±0.04)、(1.10±0.03)、(1.50±0.03)mm和(0.52±0.04)、(1.15±0.03)、(1.67±0.03)mm,差异有统计学意义(F=88.287,P<0.001;F=10061.890,P<0.001;F=9774.019,P<0.001);三种固定方式下,后踝骨折位移为2 mm时的失效载荷分别为0.80(0.73,0.80)、2.00(1.93,2.00)、1.70(1.70,1.70)kN,差异有统计学意义(H=54.245,P<0.001);三种固定方式下,内固定完全失效的最大失效载荷分别为1.90(1.90,1.98)、4.30(4.30,4.30)、3.70(3.63,3.70)kN,差异有统计学意义(H=53.863,P<0.01)。结论国人解剖型后踝锁定钢板与后踝匹配良好,力学强度高、稳定性好。Objective A novel anatomic posterior malleolus locking plate for Chinese people was designed,researched,developed,and tested biomechanically.Methods An anatomic parameter database of posterior malleolus of Chinese people was established by collecting CT images of ankle joints from 100 healthy volunteers in Shanghai Tongji hospital from June 2022 to May 2023.Combined with relevant computer-aided technologies,a novel anatomic posterior malleolus locking plate for Chinese people was designed and produced.In addition,model verification and biomechanical test were carried out on vertical displacements under different fixation modes and different axial loads(500,1000,and 1500 N).Failure loads at a displacement of 2 mm and maximum failure loads at the complete failure of internal fixation were also tested and recorded.Results Based on the imaging anatomic measurement,the width quartile of posterior malleolus was 19.4,26.6,35.0 mm.The 3D reconstruction models of ankle joint CT corresponded to small,medium,and large basic posterior malleolus plates.Height of the screw safety zone was 5.5(5.3,5.7)mm.The tip-back angle was 153.0°(148.5°,157.5°)and tip-back height was 20.0(19.7,20.9)mm.The novel anatomic posterior malleolus locking plate based on tibiofibular and ankle joint CT scan and relevant computer-aided technologies fit well with posterior malleolus of tibia,showing anatomic fitting.Based on the associate biomechanical test,the novel plate fixation had smaller vertical displacements of posterior malleolus fragment under axial loads of 500,1000,and 1500 N compared with the control plate,but greater failure loads when the vertical displacement of the posterior malleolus fragment was 2 mm and greater maximum failure loads at complete failure of the internal fixation.At an axial load of 500 N,the vertical displacements of the posterior malleolus fragment after posterior malleolus fixation with a control plate,a 6-hole anatomical locking plate,and a 5-hole anatomical locking plate were 0.60±0.02,0.45±0.04,and 0.52±0.

关 键 词：踝骨折 模型 解剖学 内固定器 计算机辅助设计 生物力学现象 

分 类 号：R687.3[医药卫生—骨科学]