可调角度自锁式胫骨下段解剖型钢板的研制与生物力学测定  

Design and biomechanical study of polyaxial self-locking anatomical plate of distal tibia

作　　者：梁伟国[1] 叶伟雄[1] 周子强[1] 陈志光[1] 李爱国[1] 

机构地区：[1]暨南大学附属广州红十字会医院骨科,510220

出　　处：《中华创伤杂志》2011年第11期999-1002,共4页Chinese Journal of Trauma

基　　金：广州市医药卫生基金重点资助项目（2008-ZDi-15）,志谢 衷心感谢常州创生医疗器械厂蔡勇工程师和南方医科大学生物力学实验室赵卫东研究员的大力帮助!

摘　　要：目的研制可调角度自锁式胫骨下段解剖型钢板，并测试其生物力学性能，为临床应用提供科学依据。方法根据国人胫骨下段的解剖特征，自行研制可调角度自锁式胫骨下段解剖型钢板。选用6对（左、右侧）新鲜尸体胫骨标本制作骨折内固定模型，随机分A组（普通胫骨下段解剖型锁定钢板固定）和B组（可调角度自锁式胫骨解剖型钢板固定），每组6例。测试在858 Mini Bionix试验机上进行。对两组内固定模型分别进行轴向压缩、四点弯曲和扭转力学试验，比较两种内固定的刚度。结果钢板外形与胫骨下段匹配，自锁螺钉术中可调角度最大可达30°，安装方便。内固定模型测定：（1）压缩刚度：A组（557．53±20．72）N／mm，B组（562．80±28．26）N／mm；（2）四点弯曲刚度：A组（268．02±36．77）N／mm，B组（265．76±27．21）N／mm；（3）扭转刚度：A组（0．28±0．01）Nm／deg，B组（0．29±0．02）Nm／deg。A、B两组三项测试指标差异均无统计学意义（P〉0．05）。结论可调角度自锁式胫骨下段解剖型钢板与国人胫骨下段形态匹配，自锁螺钉术中可调角度最大可达30°，安装方便。其生物力学性能与临床现用的胫骨下段固定角度锁定钢板相当，达到临床要求。Objective To evaluate biomechanical properties of self-designed polyaxial self-locking anatomical plate so as to offer scientific evidence for clinical application. Methods According to anatomic characteristics of distal tibiae of domestic people, a polyaxial self-locking anatomical plate for distal tibia was designed. Six paired （ left, right） fresh cadaver tibial specimens were used to make fracture fixation models and were divided into groups A and B, six specimens per group. Common anatomical locking plates were assembled in group A and polyaxial self-locking anatomical plates were assembled in group B. The biomechanical tests were performed by using 858 Mini Bionix testing machine. Non-destructive tests were performed in both groups, including axial loading, 4-point bending and torsional loading and the stiffness of the two fixation instruments was compared. SPSS 13.0 software was used for statistical analysis. Results Polyaxial self-locking anatomical plate was fit for the morphology of distal tibiae. The self-designed polyaxial plate could increase angular regulation amplitude for the locking screw up to 30°. Compression stiffness was （557.53 ± 20.72） N/mm in group A and （562.80 ± 28.26） N/mm in group B. Four-point bending stiffness was （268.02 ± 36.77 ） N/mm in group A and （265.76 ± 27.21 ） N/mm in group B. Torsional stiffness was （0.28 ±0.01 ） Nm/deg in group A and （0.29 ± 0.02） Nm/ deg in group B. The three tests in two groups showed no statistical significance （ P 〉 0.05 ）. Conclusions The self-designed polyaxial self-locking anatomical plate of distal tibia is fit for the tibial morphology of domestic people. Its biomechanical properties are equivalent to those of common anatomical locking plate, which can meet the needs for clinical application.

关 键 词：胫骨骨折 骨折固定术 内 生物力学 内置物设计 

分 类 号：R687.3[医药卫生—骨科学]