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、1 000和1 500 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、1 000和1 500 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=10 061.890,P＜0.001;F=9 774.019,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.
Abstract
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 un-der different fixation modes and different axial loads(500,1 000,and 1 500 N).Failure loads at a displacement of 2 mm and maxi-mum failure loads at the complete failure of internal fixation were also tested and recorded.Results Based on the imaging ana-tomic 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 poste-rior malleolus of tibia,showing anatomic fitting.Based on the associate biomechanical test,the novel plate fixation had smaller ver-tical displacements of posterior malleolus fragment under axial loads of 500,1 000,and 1 500 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±0.04 mm,respectively with significant difference(F=88.287,P＜0.001);at an axial load of 1 000 N,the vertical displacements were 2.22±0.03,1.10±0.03,and 1.15±0.03 mm for the three fixation modes,respective-ly,and the difference was statistically significant(F=10 061.890,P＜0.001);At an axial load of 1 500 N,the vertical displacements were 2.81±0.04,1.50±0.03 and 1.67±0.03 mm for the three fixation modes,respectively with significant difference(F=9 774.019,P＜0.001).When the vertical displacement of the posterior malleolus fragment was 2 mm,the failure loads for the three fixation modes were 0.80(0.73,0.80)、2.00(1.93,2.00)and 1.70(1.70,1.70)kN,respectively with significant differences(H=54.245,P＜0.001).The maximum failure loads at complete failure of the internal fixation for the three fixation modes were 1.90(1.90,1.98)、4.30(4.30,4.30)and 3.70(3.63,3.70)kN,respectively with significant differences(H=53.863,P＜0.001).Conclusions The novel anatomic posterior malleolus locking plate for Chinese people was well matched to the posterior malleolus with high mechanical strength and good stability,showing a promising future for clinical application.
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