腰骶椎带锁轴向融合内固定的生物力学测试
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摘要
背景:21世纪以来国内外学者对L_5-S_1单纯轴向融合内固定进行了大量基础及临床研究,证实其技术微创,利于植骨的成功融合,并能够满足人体生理需求,但其抗旋转固定不够。因此需要一种既能微创操作、又能达到稳定固定的新内固定器械。目的:通过对团队前期研制的腰骶椎带锁轴向融合内固定螺钉进行生物力学评价,为进一步加以改进及应用于临床提供实验数据。方法:选取5具新鲜成人脊柱标本,截取腰骶椎运动节段(L_3-S_5),分为以下5组顺次进行生物力学测试:(1)正常组:结构完整;(2)峡部裂组:双侧峡部裂;(3)锁定组:带锁轴向固定螺钉固定+双侧峡部裂;(4)螺钉组:轴向固定螺钉固定+双侧峡部裂;(5)复合固定组:轴向固定螺钉固定+双侧峡部裂+双侧椎弓根螺钉固定。分别测试各个标本在屈伸、左右侧弯、左右旋转各个不同运动状态下L_5/S_1节段的活动度及轴向抗压刚度;其中在屈伸状态下,另外测试各组标本在施加300 N轴向跟随力时的运动范围。实验方法得到医院伦理委员会批准。结果与结论:(1)峡部裂组在屈伸及旋转方向上的活动度均显著大于正常组(P <0.05),在侧弯方向上与正常组差异无显著性意义(P> 0.05);(2)在屈伸及侧弯方向上,3种内固定方式的活动度均显著小于正常组(P <0.05),其中在屈伸方向上复合固定组及锁定组的活动度均显著小于螺钉组(P <0.05),轴向螺钉+椎弓根钉组(复合固定组)与锁定组差异无显著性意义(P> 0.05);(3)在侧弯方向上锁定组的活动度与其他2种内固定方式差异无显著性意义(P> 0.05),复合固定组的活动度显著小于螺钉组(P <0.05);(4)在旋转方向上,轴向锁定组与轴向螺钉+椎弓根钉组(复合固定组)的活动度均显著小于正常组(P <0.05),轴向螺钉组与正常组差异无显著性意义(P> 0.05),复合固定组活动度显著小于锁定组(P <0.05);锁定组中左旋与右旋的活动度比较差异无显著性意义(P> 0.05);(5)在轴向抗压刚度方面,3种内固定方式均显著大于正常组(P <0.05),3种内固定方式间差异均无显著性意义(P> 0.05);(6)提示腰骶椎带锁轴向融合内固定系统可以显著提高腰骶椎后柱失稳情况下各个运动方向的稳定性,为腰骶椎后柱结构失稳情况下单纯行轴向融合内固定抗旋转稳定性差的问题提供了有效的解决办法。
BACKGROUND: In the 21~(st) century, domestic and foreign scholars have carried out a lot of basic and clinical researches on L_5-S_1 simple axial fusion internal fixation, which prove that its technology is minimally invasive, is conducive to the successful fusion of bone grafting and can meet the physiological needs of human body, but its anti-rotation fixation is poor. Therefore, a new internal fixation device that is both minimally invasive and stable is needed. OBJECTIVE: To evaluate the biomechanical stability of the locking axial lumbosacral interbody fusion, so as to provide experimental data for future clinical usage. METHODS: Five fresh human lumbar spines(L_3-S_5) were tested by applying pure moments. Each specimen was tested for the following order: normal control group; bilateral spondylolysis; locking AxiaLIF and bilateral spondylolysis; AxiaLIF and bilateral spon dylolysis; AxiaLIF, bilateral pedicle screws and bilateral spondylolysis. The L_5/S_1 range of motion was obtained by applying pure moments in flexion, extension, lateral bending, axial rotation and axial compression loaded with 300 N force. The study was approved by the ethics committee of the hospital. RESULTS AND CONCLUSION:(1) Spondylolysis significantly increased the range of motion in flexion-extension and axial rotation compared with the normal control group(P < 0.05). The two groups showed no significant difference in the lateral bending(P > 0.05).(2) Three kinds of fixation ways significantly reduced the range of motion in flexion-extension and lateral bending compared with the normal control group(P < 0.05). In flexion-extension, the combined fixation and locking AxiaLIF groups significantly reduced the range of motion compared with t he screw group(P < 0.05), and there was no significant difference between combined fixation and locking AxiaLIF groups(P > 0.05).(3) In lateral bending, the range of motion in the locking AxiaLIF ROM group had no significant difference compared with the other fixation groups(P > 0.05), but the combined group significantly reduced the range of motion compared with the screw group(P < 0.05).(4) Locking AxiaLIF and combined groups significantly reduced the range of motion in axial rotation compared with the normal control group(P < 0.05), and there was no significant difference between screw and normal control groups(P > 0.05). Screw group significantly increased the range of motion in axial rotation compared with the combined group(P < 0.05). In the locking group, there was no significant difference between left axial rotation and right axial rotation(P > 0.05).(5) Three fixation groups significantly increased the axial compressive stiffness compared with the normal control group(P < 0.05), but there was no significant difference among three fixation groups(P > 0.05).(6) These results indicate that the locking axial lumbosacral interbody fusion can significantly enhance the stability of lumbosacral vertebral instability in al l loading modes. It provides an effective solution for the question that the AxaiLIF has a poor stability in axial rotation.
BACKGROUND: In the 21~(st) century, domestic and foreign scholars have carried out a lot of basic and clinical researches on L_5-S_1 simple axial fusion internal fixation, which prove that its technology is minimally invasive, is conducive to the successful fusion of bone grafting and can meet the physiological needs of human body, but its anti-rotation fixation is poor. Therefore, a new internal fixation device that is both minimally invasive and stable is needed. OBJECTIVE: To evaluate the biomechanical stability of the locking axial lumbosacral interbody fusion, so as to provide experimental data for future clinical usage. METHODS: Five fresh human lumbar spines(L_3-S_5) were tested by applying pure moments. Each specimen was tested for the following order: normal control group; bilateral spondylolysis; locking AxiaLIF and bilateral spondylolysis; AxiaLIF and bilateral spon dylolysis; AxiaLIF, bilateral pedicle screws and bilateral spondylolysis. The L_5/S_1 range of motion was obtained by applying pure moments in flexion, extension, lateral bending, axial rotation and axial compression loaded with 300 N force. The study was approved by the ethics committee of the hospital. RESULTS AND CONCLUSION:(1) Spondylolysis significantly increased the range of motion in flexion-extension and axial rotation compared with the normal control group(P < 0.05). The two groups showed no significant difference in the lateral bending(P > 0.05).(2) Three kinds of fixation ways significantly reduced the range of motion in flexion-extension and lateral bending compared with the normal control group(P < 0.05). In flexion-extension, the combined fixation and locking AxiaLIF groups significantly reduced the range of motion compared with t he screw group(P < 0.05), and there was no significant difference between combined fixation and locking AxiaLIF groups(P > 0.05).(3) In lateral bending, the range of motion in the locking AxiaLIF ROM group had no significant difference compared with the other fixation groups(P > 0.05), but the combined group significantly reduced the range of motion compared with the screw group(P < 0.05).(4) Locking AxiaLIF and combined groups significantly reduced the range of motion in axial rotation compared with the normal control group(P < 0.05), and there was no significant difference between screw and normal control groups(P > 0.05). Screw group significantly increased the range of motion in axial rotation compared with the combined group(P < 0.05). In the locking group, there was no significant difference between left axial rotation and right axial rotation(P > 0.05).(5) Three fixation groups significantly increased the axial compressive stiffness compared with the normal control group(P < 0.05), but there was no significant difference among three fixation groups(P > 0.05).(6) These results indicate that the locking axial lumbosacral interbody fusion can significantly enhance the stability of lumbosacral vertebral instability in al l loading modes. It provides an effective solution for the question that the AxaiLIF has a poor stability in axial rotation.
引文
[1]梁昌详,昌耘冰,顾宏林,等.动态内固定Coflex系统治疗腰椎退变性疾病:椎间孔高度恢复与疗效[J].中国组织工程研究,2014,18(13):2065-2070.
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[4]Foley KT,Holly LT,Schwender JD.Minimally invasive lumbar fusion.Spine.2003;28(15S):S26-S35.
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[7]舒小林,宋西正.AxiaLIF在腰骶椎融合治疗中的应用[J].中国组织工程研究,2018,22(3):456-463.
[8]Ahn J,Tabaraee E,Singh K.Minimally invasive transforaminal lumbar interbody fusion.J Spinal Disord Tech.2015;28(6):222-225.
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[11]田伟.脊柱与关节退行性疾病流行病学现状与诊疗发展[J].骨科临床与研究杂志,2016,1(1):1-3.
[12]Watanabe K.Treatment for patients with Charcot-Marie-Tooth disease:orthopaedic aspects.Brain Nerve.2016;68(1):51-57.
[13]Tsantrizos A,Ito K,Aebi M,et al.Internal strains in healthy and degenerated lumbar intervertebral discs.Spine.2005;30(19):2129-2137.
[14]丁自海,杜心如.脊柱外科临床解剖学[M].济南:山东科学技术出版社,2008:25.
[15]Mihara H,Onari K,Cheng BC,et al.The biomechanical effects of spondylolysis and its treatment.Spine(Phila Pa 1976).2003;28(3):235-238.
[16]Justin KS,Bakhsheshian J,Fakurnejad S,et al.Evidence based medicine of traumatic thoracolumbar burst fract ures:Asystematic review of operative management across 20 years.Global Spine J.2015;5(1):73-82.
[17]Crisco JJ.The biomechanicsal stability of the human lumbar spine:experimental and theoretical investigations].USA:Yale university,1989.
[18]Stanley SK,Ghanayem AJ,Voronov LI,et al.Flexion-extension response of the thoracolumbar spine under compressive follower preload.Spine(Phila Pa 1976).2004;29(22):E510-514.
[19]谢勇,晏怡果.离体脊柱生物力学测试的加载方法研究进展[J].医用生物力学,2018,33(2):174-180.
[20]Bell KM,Hartman RA,Gilbertson LG,et al.In vitro spine testing using a robot-based testing system:comparison of displacement control and“hybrid control”.J Biomech.2013;46(10):1663-1669.
[21]Goel VK,Wilder DG,Pope MH,et al.Biomechanical testing of the spine.Load-controlled versus displacementcontrolled analysis.Spine(Phila Pa 1976).1995;20(21):2354-2357.
[22]McAfeePC,Farey ID,Sutterlin TC.Theeffects of spinal implant rigidity on vertebral bonedensity:Acanine model.Spine.1991;16:190-197.
[23]Tai CL,Hsieh PH,Chen WP,et al.Biomechanical comparison of lumbar spine instability between laminectomy and bilateral laminotomy for spinal stenosis syndrome.An experimental study in porcine model.BMC Musculoskelet Disord.2008;9(1):1-9.
[24]易新,宋西正.腰骶椎带锁轴向融合内固定器的有限元分析[J].中国组织工程研究,2018,22(31):4982-4986.
[2]Hallett A,Huntley JS,Gibson JN.Foraminal stenosis and single-evel degenerative disc disease:a randomized controlled trial comparing decomoression with decomprssion and instrumented fusion.Spine.2007;32:1375-1380.
[3]Kepler CK,Anthony LY,Gruskay JA,et al.Comparison of open and minimally invasive techniques for posterior lumbar instrumentation and fusion after open anterior lumbar interbody fusion.Spine J.2013;13(5):489-497.
[4]Foley KT,Holly LT,Schwender JD.Minimally invasive lumbar fusion.Spine.2003;28(15S):S26-S35.
[5]Zdeblick TA,Nachemson A,Obrien JP.Lumbar disc disease with discogenic pain.What surgical treatment is Most effective?Spine.1996;21(15):1835-1838.
[6]Goldstein CL,Phillips FM,Rampersaud YR.Comparative effectiveness and economic evaluations of open versus minimally invasive posterior or transforaminal lumbar interbody fusion.Spine.2016;41(1):S74-S89.
[7]舒小林,宋西正.AxiaLIF在腰骶椎融合治疗中的应用[J].中国组织工程研究,2018,22(3):456-463.
[8]Ahn J,Tabaraee E,Singh K.Minimally invasive transforaminal lumbar interbody fusion.J Spinal Disord Tech.2015;28(6):222-225.
[9]Cragg A,Carl A,Casteneda F,et al.New percutaneous access method for minimally invasive anterior lumbosacral surgery.J Spinal Disord Tech.2004;17(1):21-28.
[10]马向阳.腰骶椎带锁轴向融合固定的影像学研究[D].衡阳:南华大学,2013.
[11]田伟.脊柱与关节退行性疾病流行病学现状与诊疗发展[J].骨科临床与研究杂志,2016,1(1):1-3.
[12]Watanabe K.Treatment for patients with Charcot-Marie-Tooth disease:orthopaedic aspects.Brain Nerve.2016;68(1):51-57.
[13]Tsantrizos A,Ito K,Aebi M,et al.Internal strains in healthy and degenerated lumbar intervertebral discs.Spine.2005;30(19):2129-2137.
[14]丁自海,杜心如.脊柱外科临床解剖学[M].济南:山东科学技术出版社,2008:25.
[15]Mihara H,Onari K,Cheng BC,et al.The biomechanical effects of spondylolysis and its treatment.Spine(Phila Pa 1976).2003;28(3):235-238.
[16]Justin KS,Bakhsheshian J,Fakurnejad S,et al.Evidence based medicine of traumatic thoracolumbar burst fract ures:Asystematic review of operative management across 20 years.Global Spine J.2015;5(1):73-82.
[17]Crisco JJ.The biomechanicsal stability of the human lumbar spine:experimental and theoretical investigations].USA:Yale university,1989.
[18]Stanley SK,Ghanayem AJ,Voronov LI,et al.Flexion-extension response of the thoracolumbar spine under compressive follower preload.Spine(Phila Pa 1976).2004;29(22):E510-514.
[19]谢勇,晏怡果.离体脊柱生物力学测试的加载方法研究进展[J].医用生物力学,2018,33(2):174-180.
[20]Bell KM,Hartman RA,Gilbertson LG,et al.In vitro spine testing using a robot-based testing system:comparison of displacement control and“hybrid control”.J Biomech.2013;46(10):1663-1669.
[21]Goel VK,Wilder DG,Pope MH,et al.Biomechanical testing of the spine.Load-controlled versus displacementcontrolled analysis.Spine(Phila Pa 1976).1995;20(21):2354-2357.
[22]McAfeePC,Farey ID,Sutterlin TC.Theeffects of spinal implant rigidity on vertebral bonedensity:Acanine model.Spine.1991;16:190-197.
[23]Tai CL,Hsieh PH,Chen WP,et al.Biomechanical comparison of lumbar spine instability between laminectomy and bilateral laminotomy for spinal stenosis syndrome.An experimental study in porcine model.BMC Musculoskelet Disord.2008;9(1):1-9.
[24]易新,宋西正.腰骶椎带锁轴向融合内固定器的有限元分析[J].中国组织工程研究,2018,22(31):4982-4986.