腰骶椎轴向螺钉的设计及生物力学测试
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摘要
背景:经骶骨前入路的经皮腰骶椎前柱内固定系统即Axia LIF先后在美国及欧洲应用于临床,取得较好的临床疗效,但是在应用过程中出现了如内固定下沉、内固定控制旋转能力较差等一系列问题。目的:根据国人腰椎侧位片及CT横断面测量的解剖数据自行设计腰骶椎轴向螺钉,制成成品后在体外生物标本上进行三维运动实验和轴向抗压缩实验,对其固定节段的稳定性及轴向抗压刚度进行生物力学评价。方法:选取新鲜成人脊柱标本(L3-S5节段)6具,按正常组、峡部裂组、普通轴向螺钉固定组、自行设计轴向螺钉固定组顺序依次进行生物力学测试,分别测试各实验组在屈伸、左侧屈、左旋转运动状态下L5/S1节段的运动范围及轴向抗压缩位移。结果与结论:(1)在三维运动实验中,峡部裂组的ROM在屈伸及左旋转方向上均显著大于正常组(P<0.05),在左侧弯方向上与正常组差异无显著性意义(P>0.05);(2)普通螺钉固定组与自制螺钉固定组的ROM在屈伸、左侧弯方向上均显著小于正常组(P<0.05),在左旋转方向上与正常组差异无显著性意义(P>0.05),普通螺钉固定组与自制螺钉固定组间比较差异无显著性意义(P>0.05);(3)在1 000 N的轴向载荷压缩实验中,4组所产生的压缩位移差异有显著性意义(P<0.05),自制螺钉固定组<普通螺钉固定组<正常组<峡部裂组;(4)根据力学公式EF=P/v L,结合压缩位移结果,计算出轴向压缩刚度值,自制螺钉固定组>普通螺钉固定组>正常组>峡部裂组;(5)提示自行设计轴向螺钉可以显著提高腰骶椎在后柱失稳情况下各个运动方向的稳定性,与普通轴向螺钉相当,但在轴向抗压刚度方面明显强于普通轴向螺钉,为在防止轴向螺钉固定脊柱节段沉降和前凸损失方面提供了一种有效的解决思路。
BACKGROUND: Percutaneous lumbar sacral anterior column internal fixation system(Axia LIF) through anterior sacral approach has been applied in clinical practice in the United States and Europe and has achieved good clinical efficacy. However, there are some problems such as internal fixator subsidence, and poor in controlling rotation ability.OBJECTIVE: The axial screw of lumbosacral vertebra was designed according to the anatomic data of lumbar lateral radiographs and CT cross-sectional measurements from Chinese healthy populations, and then three-dimensional movement and axial compression tests were conducted on biospecimens in vitro, and the stability of the fixed segment and the axial compressive stiffness were evaluated by biomechanical analysis. METHODS: Six fresh adult spine specimens(L3-S5 segments) were selected, then the biomechanical tests were performed sequentially in normal, isthmic fracture, conventional axial screw fixation, and self-designed axial screw fixation groups. The L5/S1 segment in each experimental group was measured under flexion, left flexion and left rotation, and axial compressive displacement was tested. RESULTS AND CONCLUSION:(1) In the three-dimensional movement experiment, the range of motion in the isthmic fracture group was significantly larger than that in the normal group in flexion and extension and left rotation(P < 0.05). There was no significant difference between isthmic fracture and normal groups in left bend direction(P > 0.05).(2) The range of motion in the conventional and self-designed axial screw fixation groups was significantly smaller than that in the normal group in flexion and extension and left lateral direction(P < 0.05), but the range of motion in left rotation direction showed no significant difference(P > 0.05). There was no significant difference in the range of motion between conventional and self-designed axial screw fixation groups(P > 0.05).(3) In the axial load compression test of 1 000 N, the order of compression displacement was as follows: self-designed axial screw fixation group < conventional axial screw fixation group < normal group < isthmic fracture group(P < 0.05).(4) According to the mechanical formula EF=P/v L and compression displacement results, the axial compressive stiffness values were calculated, which the highest value was in the self-designed axial screw fixation group, followed by conventional axial screw fixation group, normal group, and the lowest in the isthmic fracture group(P < 0.05).(5) These results indicate that the self-designed axial screw in all directions of motion can significantly improve the stability of the lumbosacral motion under posterior column instability, which is comparable to that of the common axial screws. But it is obviously better than common axial screw in axial compressive stiffness, which provides an effective solution for the prevention of segment subsidence and loss of lordosis in the fixation of the vertebral column with axial screws.
BACKGROUND: Percutaneous lumbar sacral anterior column internal fixation system(Axia LIF) through anterior sacral approach has been applied in clinical practice in the United States and Europe and has achieved good clinical efficacy. However, there are some problems such as internal fixator subsidence, and poor in controlling rotation ability.OBJECTIVE: The axial screw of lumbosacral vertebra was designed according to the anatomic data of lumbar lateral radiographs and CT cross-sectional measurements from Chinese healthy populations, and then three-dimensional movement and axial compression tests were conducted on biospecimens in vitro, and the stability of the fixed segment and the axial compressive stiffness were evaluated by biomechanical analysis. METHODS: Six fresh adult spine specimens(L3-S5 segments) were selected, then the biomechanical tests were performed sequentially in normal, isthmic fracture, conventional axial screw fixation, and self-designed axial screw fixation groups. The L5/S1 segment in each experimental group was measured under flexion, left flexion and left rotation, and axial compressive displacement was tested. RESULTS AND CONCLUSION:(1) In the three-dimensional movement experiment, the range of motion in the isthmic fracture group was significantly larger than that in the normal group in flexion and extension and left rotation(P < 0.05). There was no significant difference between isthmic fracture and normal groups in left bend direction(P > 0.05).(2) The range of motion in the conventional and self-designed axial screw fixation groups was significantly smaller than that in the normal group in flexion and extension and left lateral direction(P < 0.05), but the range of motion in left rotation direction showed no significant difference(P > 0.05). There was no significant difference in the range of motion between conventional and self-designed axial screw fixation groups(P > 0.05).(3) In the axial load compression test of 1 000 N, the order of compression displacement was as follows: self-designed axial screw fixation group < conventional axial screw fixation group < normal group < isthmic fracture group(P < 0.05).(4) According to the mechanical formula EF=P/v L and compression displacement results, the axial compressive stiffness values were calculated, which the highest value was in the self-designed axial screw fixation group, followed by conventional axial screw fixation group, normal group, and the lowest in the isthmic fracture group(P < 0.05).(5) These results indicate that the self-designed axial screw in all directions of motion can significantly improve the stability of the lumbosacral motion under posterior column instability, which is comparable to that of the common axial screws. But it is obviously better than common axial screw in axial compressive stiffness, which provides an effective solution for the prevention of segment subsidence and loss of lordosis in the fixation of the vertebral column with axial screws.
引文
[1]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.
[2]Ledet EH,Carl AL,Cragg A.Novel lumbosacral axial fixation techniques.Expert Rev Med Devices.2006;3(3):327-334.
[3]Marotta N,Cosar M,Pimenta L,et al.A novel minimally invasive presacral approach and instrumentation technique for anterior L5-S1 intervertebral discectomy and fusion:technical description and case presentations.Neurosurg Focus.2006;20(1):E9.
[4]王善坤,宋西正.经骶前间隙入路轴向腰椎间融合术的研究进展[J].中国矫形外科杂志,2014,22(7):625-628.
[5]颜琳力,宋西正.腰骶轴向融合与尾骨周围解剖研究进展[J].中南医学科学杂志,2016,44(4):364-367.
[6]宋西正,王文军,易明,等.L5/S1轴向固定经皮椎弓根单向锁定研究[J].中华实验外科杂志,2016,33(4):1063-1066.
[7]陈海丹,符策岗,曾艳,等.腰椎椎间融合各术式之间的比较[J].中国老年学杂志,2016,36(16):4097-4100.
[8]宋西正,王文军,易明,等.L5S1椎体结构的CT测量及经皮椎弓根单向锁定的可行性研究[J].中华骨科杂志,2015,35(10):1068-1074.
[9]李阳.L5--S1轴向融合术(AxiaL IF)的相关解剖学测量及有限元分析[D].南方医科大学,2014.
[10]Ledet EH,Tymeson MP,Salerno S,et al.Biomechanical evaluation of a novel lumbosacral axial fixation device.J Biomech Eng.2005;127(6):929-933.
[11]Akesen B,Wu C,Mehbod AA,et al.Biomechanical evaluation of paracoccygeal transsacral fixation.J Spinal Disord Tech.2008;21(1):39-44.
[12]刘继成,王文军.组合微创技术在腰椎疾病中的应用[J].骨科,2013,4(3):165-168.
[13]邓旭东.微创椎弓根螺钉内固定联合骶前间隙轴向融合治疗L5椎体滑脱症的临床观察[J].创伤外科杂志,2016,18(8):461-465.
[14]欧阳智华,阙伊辰,宋西正,等.轴向融合联合经皮螺钉治疗轻中度腰5椎体滑脱症的临床观察[J].中南医学科学杂志,2017,45(3):226-229,233.
[15]易红蕾,夏虹,韦葛堇,等.经皮骶前轴向腰骶椎间融合术(Axia LIF)在成人脊柱侧凸长节段脊柱融合术中的应用研究进展[J].颈腰痛杂志,2015,36(6):502-504.
[16]李庆龙,倪文飞,吴爱悯,等.L_5/S_1轴向联合斜向螺钉内固定术的生物力学研究[J].脊柱外科杂志,2015,13(6):377-381.
[17]李庆龙.L5/S1轴向联合斜向螺钉内固定行椎间融合的生物力学研究[D].温州医科大学,2015.
[18]易新.腰骶椎带锁轴向融合固定器有限元分析[D].南华大学,2014.
[19]易明.L4-S1轴向固定单向锁定影像学研究[D].南华大学,2015.
[20]Hofstetter CP,Shin B,Tsiouris AJ,et al.Radiographic and clinical outcome after 1-and 2-level transsacral axial interbody fusion.J Neurosurg Spine.2013;19(4):454-463.
[21]曾德辉,王文军,张卫,等.国人直肠后间隙入路轴向行腰骶椎融合的影像学与解剖学测量[J].中国脊柱脊髓杂志,2011,21(5):390-394.
[22]马向阳.腰骶椎带锁轴向融合固定的影像学研究[D].南华大学,2013.
[23]王善坤.腰骶椎带锁轴向融合内固定的生物力学测试[D].南华大学,2014.
[24]刘发平.腰5骶1前路内固定系统的研制[D].第三军医大学,2008.
[25]朱如森,冯世庆,刘岩.脊柱内固定椎弓根螺钉置入后生物力学的稳定性[J].中国组织工程研究,2013,17(17):3156-3163.
[26]潘鹤海,王丽冰,于滨生,等.L5/S1和骶髂关节对腰-髂固定稳定性影响的生物力学分析[J].中国脊柱脊髓杂志,2013,23(9):837-841.
[27]刘上楼,徐军,倪卓民,等.经胸腰段伤椎单节段椎弓根螺钉固定后的生物力学特性[J].中国组织工程研究,2013,17(39):6908-6913.
[28]闫石,苏峰,张志敏,等.经伤椎置钉对椎弓根皮质劈裂合并椎体骨折的生物力学稳定性的影响[J].中国医学科学院学报,2014,36(4):415-419.
[29]车武,姜允琦,马易群,等.单节段椎弓根螺钉固定联合上方棘突间Coflex置入的生物力学评价[J].中国脊柱脊髓杂志,2015,25(1):62-66.
[30]Yuan Q,Han X,Han X,et al.Krag versus Caudad trajectory technique for pedicle screw insertion in osteoporotic vertebrae:biomechanical comparison and analysis.Spine.2014;15;39:B27-35.
[31]Wadhwa RK,Thakur JD,Khan IS,et al.Adjustment of suboptimally placed lumbar pedicle screws decreases pullout strength and alters biomechanics of the construct:A pilot cadaveric study.World Neurosurg.2014;2(14).1878-1880.
[32]Law M,Tencer AF,Anderson PA.Caudo-epbalad loading of pedicle screws:mechanisms of losing and methods of augmentation.Spine.1993;17(18):2438-2443.
[33]Gaines RW Jr.The use of pediele-screw internal fixation for the operative treatment of spinal disorders.Bone Joint Surg Am 2000;82-A(10):1458-1476.
[34]臧法智,陈华江,王建喜,等.钽涂层椎弓根螺钉的研制与初步动物实验研究[J].颈腰痛杂志,2016,37(2):85-88.
[35]路荣建,刘洪臣.多孔钽作为骨植入材料的研究进展[J].中华老年口腔医学杂志,2013,11(3):173-176.
[36]李斌,华永新,杨光,等.多孔钽金属的生物学特性:近期临床应用安全但远期反应待证实[J].中国组织工程研究,2014,18(43):7028-7032.
[37]张宇,张永兴,赵庆华,等.多孔钽金属在临床骨关节修复中的应用[J].国际骨科学杂志,2015,36(1):36-39.
[38]蔡洪桢,贺慧霞.钽金属在临床应用中的研究进展[J].口腔颌面修复学杂志,2017,18(1):46-50.
[2]Ledet EH,Carl AL,Cragg A.Novel lumbosacral axial fixation techniques.Expert Rev Med Devices.2006;3(3):327-334.
[3]Marotta N,Cosar M,Pimenta L,et al.A novel minimally invasive presacral approach and instrumentation technique for anterior L5-S1 intervertebral discectomy and fusion:technical description and case presentations.Neurosurg Focus.2006;20(1):E9.
[4]王善坤,宋西正.经骶前间隙入路轴向腰椎间融合术的研究进展[J].中国矫形外科杂志,2014,22(7):625-628.
[5]颜琳力,宋西正.腰骶轴向融合与尾骨周围解剖研究进展[J].中南医学科学杂志,2016,44(4):364-367.
[6]宋西正,王文军,易明,等.L5/S1轴向固定经皮椎弓根单向锁定研究[J].中华实验外科杂志,2016,33(4):1063-1066.
[7]陈海丹,符策岗,曾艳,等.腰椎椎间融合各术式之间的比较[J].中国老年学杂志,2016,36(16):4097-4100.
[8]宋西正,王文军,易明,等.L5S1椎体结构的CT测量及经皮椎弓根单向锁定的可行性研究[J].中华骨科杂志,2015,35(10):1068-1074.
[9]李阳.L5--S1轴向融合术(AxiaL IF)的相关解剖学测量及有限元分析[D].南方医科大学,2014.
[10]Ledet EH,Tymeson MP,Salerno S,et al.Biomechanical evaluation of a novel lumbosacral axial fixation device.J Biomech Eng.2005;127(6):929-933.
[11]Akesen B,Wu C,Mehbod AA,et al.Biomechanical evaluation of paracoccygeal transsacral fixation.J Spinal Disord Tech.2008;21(1):39-44.
[12]刘继成,王文军.组合微创技术在腰椎疾病中的应用[J].骨科,2013,4(3):165-168.
[13]邓旭东.微创椎弓根螺钉内固定联合骶前间隙轴向融合治疗L5椎体滑脱症的临床观察[J].创伤外科杂志,2016,18(8):461-465.
[14]欧阳智华,阙伊辰,宋西正,等.轴向融合联合经皮螺钉治疗轻中度腰5椎体滑脱症的临床观察[J].中南医学科学杂志,2017,45(3):226-229,233.
[15]易红蕾,夏虹,韦葛堇,等.经皮骶前轴向腰骶椎间融合术(Axia LIF)在成人脊柱侧凸长节段脊柱融合术中的应用研究进展[J].颈腰痛杂志,2015,36(6):502-504.
[16]李庆龙,倪文飞,吴爱悯,等.L_5/S_1轴向联合斜向螺钉内固定术的生物力学研究[J].脊柱外科杂志,2015,13(6):377-381.
[17]李庆龙.L5/S1轴向联合斜向螺钉内固定行椎间融合的生物力学研究[D].温州医科大学,2015.
[18]易新.腰骶椎带锁轴向融合固定器有限元分析[D].南华大学,2014.
[19]易明.L4-S1轴向固定单向锁定影像学研究[D].南华大学,2015.
[20]Hofstetter CP,Shin B,Tsiouris AJ,et al.Radiographic and clinical outcome after 1-and 2-level transsacral axial interbody fusion.J Neurosurg Spine.2013;19(4):454-463.
[21]曾德辉,王文军,张卫,等.国人直肠后间隙入路轴向行腰骶椎融合的影像学与解剖学测量[J].中国脊柱脊髓杂志,2011,21(5):390-394.
[22]马向阳.腰骶椎带锁轴向融合固定的影像学研究[D].南华大学,2013.
[23]王善坤.腰骶椎带锁轴向融合内固定的生物力学测试[D].南华大学,2014.
[24]刘发平.腰5骶1前路内固定系统的研制[D].第三军医大学,2008.
[25]朱如森,冯世庆,刘岩.脊柱内固定椎弓根螺钉置入后生物力学的稳定性[J].中国组织工程研究,2013,17(17):3156-3163.
[26]潘鹤海,王丽冰,于滨生,等.L5/S1和骶髂关节对腰-髂固定稳定性影响的生物力学分析[J].中国脊柱脊髓杂志,2013,23(9):837-841.
[27]刘上楼,徐军,倪卓民,等.经胸腰段伤椎单节段椎弓根螺钉固定后的生物力学特性[J].中国组织工程研究,2013,17(39):6908-6913.
[28]闫石,苏峰,张志敏,等.经伤椎置钉对椎弓根皮质劈裂合并椎体骨折的生物力学稳定性的影响[J].中国医学科学院学报,2014,36(4):415-419.
[29]车武,姜允琦,马易群,等.单节段椎弓根螺钉固定联合上方棘突间Coflex置入的生物力学评价[J].中国脊柱脊髓杂志,2015,25(1):62-66.
[30]Yuan Q,Han X,Han X,et al.Krag versus Caudad trajectory technique for pedicle screw insertion in osteoporotic vertebrae:biomechanical comparison and analysis.Spine.2014;15;39:B27-35.
[31]Wadhwa RK,Thakur JD,Khan IS,et al.Adjustment of suboptimally placed lumbar pedicle screws decreases pullout strength and alters biomechanics of the construct:A pilot cadaveric study.World Neurosurg.2014;2(14).1878-1880.
[32]Law M,Tencer AF,Anderson PA.Caudo-epbalad loading of pedicle screws:mechanisms of losing and methods of augmentation.Spine.1993;17(18):2438-2443.
[33]Gaines RW Jr.The use of pediele-screw internal fixation for the operative treatment of spinal disorders.Bone Joint Surg Am 2000;82-A(10):1458-1476.
[34]臧法智,陈华江,王建喜,等.钽涂层椎弓根螺钉的研制与初步动物实验研究[J].颈腰痛杂志,2016,37(2):85-88.
[35]路荣建,刘洪臣.多孔钽作为骨植入材料的研究进展[J].中华老年口腔医学杂志,2013,11(3):173-176.
[36]李斌,华永新,杨光,等.多孔钽金属的生物学特性:近期临床应用安全但远期反应待证实[J].中国组织工程研究,2014,18(43):7028-7032.
[37]张宇,张永兴,赵庆华,等.多孔钽金属在临床骨关节修复中的应用[J].国际骨科学杂志,2015,36(1):36-39.
[38]蔡洪桢,贺慧霞.钽金属在临床应用中的研究进展[J].口腔颌面修复学杂志,2017,18(1):46-50.