一种新型腰椎间融合器的研制及生物力学评价

Development and biomechanical evaluation of a model of lumbar interbody fusion device

目的介绍一种新型腰椎间融合器(cage)的设计理念和结构,对其进行生物力学评价。方法采用纳米羟基磷灰石和多聚氨基酸/硫酸钙共聚物材料研制的部分可吸收椎间融合器(PBIFC),在新鲜小牛L3/L4脊柱功能节段标本上测试自体植骨融合组、PBIFC组、纳米羟基磷灰石/聚酰胺66(n-HA/PA66)融合器组在前屈、后伸、侧屈、旋转状态下的活动角度值(ROM)和最大抗压载荷和拔出力。结果各运动状态,髂骨组ROM值比其余两组大,差异有统计学意义(P<0.05);PBIFC组ROM值较nHA/PA66组大,但差异无统计意义(P>0.05)。PBIFC组拔出力较髂骨组大,差异有统计学意义(P<0.05);PBIFC组较传统融合器组平均拔出力值小,但差异无统计意义(P>0.05)。髂骨组的抗压载荷显著低于两椎间融合器组,差异有统计学意义(P<0.05);PBIFC组抗压缩载荷较n-HA/PA66组稍低,但差异无统计意义(P>0.05)。结论 PBIFC具有良好的植入运动稳定性、抗拔出和抗压缩性能,能满足临床植入的生物力学要求。

objective To introduce the design concept and structure of a new type of lumbar intervertebral fusion cage ,and to e-valuate its biomechanical properties .Method A partially bioasorbable interbody fusion cage（PBIFC） made of nano hydroxyapatite and poly amino acid /calcium sulfate copolymer materials was developed .Range of motion（ROM ） ,compressive load ,and pull-out test on flexion ,extension ,lateral bending ,and torsion moment on fresh calf L3/L4 specimens of functional spinal union were carried out of iliac bone group ,PBIFC group ,and nano hydroxyapatite/polyamide 66（nHA/PA66） group .Result Of each movement ,the ROM value of iliac bone group are higher than the other two groups ,the difference was statistically significant （P〈0 .05） ,and the ROM value of nHA/PA66 group are higher than PBIFC group ,but no statistical difference（P〉0 .05） .The pull-out strength of PB-IFC group are higher than iliac bone group ,and the difference was statistically significant （P〈0 .05）;The pull-out strength of PB-IFC group is lower than the traditional group ,but no statistical difference（P〉0 .05） .The compressive load of iliac bone group was lower than that of two cage group ,the difference was statistically significant （P〈0 .05） .The compressive load of PBIFC group is slightly lower than the traditional group ,but no statistical difference（P〉0 .05） .Conclusion With good implant stability ,pull-out resistance ,and compression resistance performance ,PBIFC can meet the biomechanics requirements of clinical implant .