颈椎自张式记忆合金椎间融合器的研制及基础研究
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摘要
一、目的 设计制作颈椎自张式记忆合金椎间融合器，通过生物力学实验评估自张式记忆合金椎间融合器的生物力学性能。在活体山羊颈椎上从维持颈椎高度、颈椎曲度能力及椎间融合组织学方面比较三面皮质骨、钛网及颈椎自张式记忆合金椎间融合器的术后效果。通过以上实验研究颈椎自张式记忆合金椎间融合器的临床应用价值。
二、方法 生物力学实验采用6具成年男性颈椎标本，随机分为3组：完整颈椎组(空白对照组)；钛网组；颈椎自张式记忆合金椎间融合器组。钛网组和颈椎自张式记忆合金椎间融合器组标本均附加颈前路AO钢板。先采集完整颈椎的生物力学数据，再行C4椎体次全切除术，每个样本依次分别植入钛网和颈椎自张式记忆合金椎间融合器，分别测定各项生物力学指标，计算出各组平均刚度、位移、ROM、扭转刚度及应力保护率，比较其术后即刻稳定性和应力遮挡效应。
动物实验使用成年公山羊颈椎模型，18只山羊随机分为三组：自体三面皮质髂骨组；钛网组；颈椎自张式记忆合金椎间融合器组。各组山羊分别行C4椎体次全切除术并植入以上骨移植物，各组均附加颈前路AO钢板。钛网组及颈椎自张式记忆合金椎间融合器组内植物内置入切除的C4椎体碎骨，术后即刻摄取山羊颈椎正侧位X线片。术后饲养动物12周，12周后处死动物，摄取山羊颈椎正侧位X线平片及CT扫描片，测量比较各实验组颈椎高度及颈椎曲度并评价各实验组影像学融合状态。取山羊颈椎手术节段标本，甲醛固定、丙酮脱水，树脂包埋、切片，甲苯胺蓝染色，显微镜下观察椎间融合状态，进行组织学评估。
三、结果 颈椎自张式记忆合金椎间融合器组的应变、位移小于空白对照组，刚度高于空白对照组，扭转刚度低于空白对照组。颈椎自张式记忆合金椎间融合器组的应变、位移小于钛网组，刚度高于钛网组，扭转刚度明显高于钛网组。颈椎自张式记忆合金椎间融合器组的前屈位、侧屈位ROM小于空白对照组，后伸位、旋转位ROM小于空白对照组。颈椎自张式记忆合金椎间融合器的应力保护率为48.76±4.61％；钛网组的应力保护率为59.50±2.86％，两者应力保护率存在显著统计学差异。
Objective We designed and manufactured Ni-Ti shape memory expansion mesh cage . The purpose of this study is to evaluate the biomechanical effect of Ni-Ti shape memory expansion mesh cage, and to compare the characteristics of interbody fusion achieved using SME-MC with those of an autologous tricortical iliac crest graft and TMC in a goat cervical spine model.
Methods In the biomechanical study, 6 human cadower cervical spines (C2-7) were tested in flexion, extension, axial rotation, and lateral bending using a nonconstrained testing apparatus. 6 human cervical spine specimens were divided into three groups: control group (intact specimen, IS), cervical Titanium mesh cage group (TMC), Ni-Ti shape memory expansion mesh cage (SME-MC). TMC and SME-MC were implanted after C4 corpectomy was performed. The TMC and SME-MC were supplemented with AO cervical anterior plate. The load-strain, load-displacement, strength and stiffness, ROM in neutral, flexion, extension, lateral bending and torsion were tested respectively. The axial stress of three groups was tested respectively.
18 goats underwent C4 corpectomy and intervertebral fusion in which the following were used: autologous tricortical iliac crest bone graft (6 goats) ; TMC filled with autologous iliac crest graft (6 goats) ; SME-MC filled with autologous iliac bone (6 goats). All goats cervical spine were supplemented with cervical anterior plate after the grafts were implanted.
二、方法 生物力学实验采用6具成年男性颈椎标本，随机分为3组：完整颈椎组(空白对照组)；钛网组；颈椎自张式记忆合金椎间融合器组。钛网组和颈椎自张式记忆合金椎间融合器组标本均附加颈前路AO钢板。先采集完整颈椎的生物力学数据，再行C4椎体次全切除术，每个样本依次分别植入钛网和颈椎自张式记忆合金椎间融合器，分别测定各项生物力学指标，计算出各组平均刚度、位移、ROM、扭转刚度及应力保护率，比较其术后即刻稳定性和应力遮挡效应。
动物实验使用成年公山羊颈椎模型，18只山羊随机分为三组：自体三面皮质髂骨组；钛网组；颈椎自张式记忆合金椎间融合器组。各组山羊分别行C4椎体次全切除术并植入以上骨移植物，各组均附加颈前路AO钢板。钛网组及颈椎自张式记忆合金椎间融合器组内植物内置入切除的C4椎体碎骨，术后即刻摄取山羊颈椎正侧位X线片。术后饲养动物12周，12周后处死动物，摄取山羊颈椎正侧位X线平片及CT扫描片，测量比较各实验组颈椎高度及颈椎曲度并评价各实验组影像学融合状态。取山羊颈椎手术节段标本，甲醛固定、丙酮脱水，树脂包埋、切片，甲苯胺蓝染色，显微镜下观察椎间融合状态，进行组织学评估。
三、结果 颈椎自张式记忆合金椎间融合器组的应变、位移小于空白对照组，刚度高于空白对照组，扭转刚度低于空白对照组。颈椎自张式记忆合金椎间融合器组的应变、位移小于钛网组，刚度高于钛网组，扭转刚度明显高于钛网组。颈椎自张式记忆合金椎间融合器组的前屈位、侧屈位ROM小于空白对照组，后伸位、旋转位ROM小于空白对照组。颈椎自张式记忆合金椎间融合器的应力保护率为48.76±4.61％；钛网组的应力保护率为59.50±2.86％，两者应力保护率存在显著统计学差异。
Objective We designed and manufactured Ni-Ti shape memory expansion mesh cage . The purpose of this study is to evaluate the biomechanical effect of Ni-Ti shape memory expansion mesh cage, and to compare the characteristics of interbody fusion achieved using SME-MC with those of an autologous tricortical iliac crest graft and TMC in a goat cervical spine model.
Methods In the biomechanical study, 6 human cadower cervical spines (C2-7) were tested in flexion, extension, axial rotation, and lateral bending using a nonconstrained testing apparatus. 6 human cervical spine specimens were divided into three groups: control group (intact specimen, IS), cervical Titanium mesh cage group (TMC), Ni-Ti shape memory expansion mesh cage (SME-MC). TMC and SME-MC were implanted after C4 corpectomy was performed. The TMC and SME-MC were supplemented with AO cervical anterior plate. The load-strain, load-displacement, strength and stiffness, ROM in neutral, flexion, extension, lateral bending and torsion were tested respectively. The axial stress of three groups was tested respectively.
18 goats underwent C4 corpectomy and intervertebral fusion in which the following were used: autologous tricortical iliac crest bone graft (6 goats) ; TMC filled with autologous iliac crest graft (6 goats) ; SME-MC filled with autologous iliac bone (6 goats). All goats cervical spine were supplemented with cervical anterior plate after the grafts were implanted.
引文
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18. Majd M, Vadhva M, Holt RT. Anterior cervical reconstruction using titanium cages with anterior plating. Spine, 1999,24:1604-1610.
19. Kanayama M, Hashimoto T, Shigenobu K, Ishida T, Yamane S. Pitfall of anterior cervical fusion using titanium mesh and local autograft. J Spinal Disord Tech, 2003 Dec; 16(6):513-8
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1. Dececrin J, Aguado E, Guyen JM, et al. Influence of local environment on incorporation of ceramic for lumbar fusion. Spine, 1997;22:1683-1689
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5. Gore DR. The arthrodesis rate in multilevel anterior cervical fusions using autogenous fibula. Spine, 2001 Jun 1; 26(11):1259-63
6. Younger EM, Chapman MW. Morbidity of bone graft donor sites. J Orthop Trauma, 1989,3:192-195
7. Bishop RC, Moore KA, Hadley MN. Anterior cervical interbody fusion using antigenic and allogenic bone graft subatrate. A prospective comparative analysis. J Neurosurg, 1996,85:206-210.
8. Watters WC, Levinthal R. Anterior cervical discectomy with and without fusion. Spine, 1994,19:2343-2347.
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10. An HS, Simpson JM, Glover JM, Stephany J. Comparison between allograft plus demineralized bone matrix versus autograft in anterior cervical fusion. Spine, 1995,20:2211-2216.
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14. Zdeblick TA, Ducke TB. The use of freeze-dried allograft bone for anterior cervical fusions. Spine, 1991,16:726-729.
15. MacDonald RL, Fehlings MG, Tator CH, et al. Multilevel anterior cervical corpectomy and fibular allograft fusion for cervical myelopathy. J Neurosurg, 1997,86:990-997.
16. Martin GJ, Haid RW, MacMillan M, Rodts GE, Berkman R: Anterior cervical discectomy with freeze-dried fibula allograft. Spine, 1999,24:852-859.
17. Bendo JA, Spivak JM, Neuwirth MG, Chung P. Use of the anterior interbody fresh-frozen femoral head allograft in circumferential lumbar fusions. J Spinal Disord, 2000 Apr; 13(2): 144-9
18. Majd M, Vadhva M, Holt RT. Anterior cervical reconstruction using titanium cages with anterior plating. Spine, 1999,24:1604-1610.
19. Kanayama M, Hashimoto T, Shigenobu K, Ishida T, Yamane S. Pitfall of anterior cervical fusion using titanium mesh and local autograft. J Spinal Disord Tech, 2003 Dec; 16(6):513-8
20. Thalgott JS, Xiongsheng C, Giuffre JM. Single stage anterior cervical reconstruction with titanium mesh cages, local bone graft, and anterior plating. Spine J, 2003 Jul-Aug; 3(4):294-300
21. Robert JH. Threaded cages for degenerative cervical disease. Clin Orthop Relat Res, 2002 Jan; (94):39-46
22. Rieger A, Holz C, Marx T, Sanchin L, Menzel M. Vertebral autograft used as bone transplant for anterior cervical corpectomy: technical note. Neurosurgery, 2003 Feb;52(2):449-53;discussion 453-4
23. Zdeblick TA, Cooke ME, Kunz DN, et al. Anterior cervical discectomy and fusion using a porous hydroxyapatite bone graft substitute. Spine, 1994;19:348-357
24. Papavero L, Zwonitzer R, Burkard I, Klose K, Herrmann HD. A composite bone graft substitute for anterior cervical fusion: assessment of osseointegration by quantitative computed tomography. Spine, 2002 May 15; 27(10): 1037-43
25. Thalgott JS, Fritts K, Giuffre JM, et al. Anterior interbody fusionof the cervical spine with coralline hydroxyapatite. Spine, 1999; 24: 1295-1299
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