自体骨腰椎椎间融合的生物力学及临床研究
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摘要
第一部分自体骨腰椎椎间融合器的制备及其生物力学研究
研究目的
本研究通过进行体外动物模型生物力学实验,模拟使用自行研发的器械(自体骨椎间融合成形器),制备自体骨腰椎椎间融合器,比较自体骨腰椎椎间融合器内固定与PEEK(聚醚醚酮)椎间融合器内固定的生物力学即刻稳定性,为临床上自体骨腰椎椎间融合器内固定术的应用及相关器械改良提供理论依据和实验指导。
材料与方法
1.选取12具健康成年猪的腰段均一脊柱标本(L1-L4),排除骨病后随机分为两组:自体骨腰椎椎间融合器结合椎弓根螺钉内固定组(实验组),PEEK椎间融合器结合椎弓根螺钉内固定组(对照组),每组6只。
2.利用树脂包埋法及腰椎后路附件逐级破坏、椎间盘切除术制作腰椎不稳模型。实验组标本采用自体骨腰椎椎间融合器椎弓根螺钉内固定,对照组标本采用PEEK椎间融合器椎弓根螺钉内固定。使用脊柱三维运动测试模拟机对两组标本在正常、不稳、融合3个状态下进行前屈、后伸、左右侧屈、左右旋转等各个活动的生物力学测试。记录不同载荷下不稳节段的运动范围(Range ofmotion,ROM),并用SPSS16.0软件对数据进行比较分析。
3.待两组标本三维运动逐一测量完毕后,再依次将标本置于MTS858材料试验机上进行拔出实验。记录每个样本的最大拔出力,并用SPSS16.0软件对数据进行比较分析。
结果
1.在正常及不稳状态下,实验组与对照组两组间比较各稳定度指标无统计学差异(P>0.05);两组内不稳状态各稳定度指标明显差于正常状态(P<0.05);融合后两组间L2-3节段椎间各稳定度指标无统计学差异(P>0.05)。
2.在进行融合器最大拔出力测试中,实验组(自体骨椎间融合器)的最大拔出阻力为111.83±9.11N,对照组(PEEK椎间融合器)的最大拔出阻力为118.173±8.17N,两组最大拔出力比较无统计学差异(P>0.05);
结论
本研究所制备的自体骨腰椎椎间融合器,植入椎间后,结合椎弓根内固定,具有较好的生物力学即刻稳定性,为临床应用提供了力学基础。
第二部分后路自体颗粒骨打压植骨椎间融合内固定术治疗下腰椎退变性不稳
目的
探讨后路自体颗粒骨打压植骨椎间融合内固定术治疗下腰椎退变性不稳的可行性及临床疗效。
方法
2007年1月至2010年1月收治下腰椎退变性不稳并神经根管狭窄患者60例。随机分为实验组和对照组各30例30节段。其中实验组行后路自体颗粒骨打压植骨椎间融合内固定术,对照组行椎间融合器植骨融合内固定术。两组患者术前一般资料比较差异无统计学意义(P >0.05)。比较两组患者手术资料、影像学结果及临床疗效。
结果
两组手术时间、术中出血量、下地时间差异无统计学意义(P >0.05);两组JOA及ODI评分均较术前改善(P<0.05),两组间差异无统计学意义(P >0.05);采用Macnab标准评价临床结果实验组优良率为90.0%,对照组为93.3%,两组间差异无统计学意义(P >0.05);两组术后一个月与术前相比椎间隙高度、椎间孔高度得到恢复(P<0.05),末次随访椎间隙高度、椎间孔高度均有丢失,但两组差异无统计学意义(P >0.05)。末次随访时实验组融合率为90%,对照组为93.3%,两组间差异无统计学意义(P >0.05);
结论
后路自体颗粒骨打压植骨腰椎椎体间融合术结合椎弓根螺钉系统固定可达到彻底减压、神经根松解、腰椎稳定性的重建、满意植骨合率的目的,具有并发症少的优点,是治疗下腰椎退变性不稳的安全、有效方法之一,值得推广应用。
PartⅠPreparation and Biomechanical Research of Autogeneous Bone Lumbar Interbody Fusion Cage
Objective
The research made animal model building with pig spine. To produce autogeneous bone lumbar interbody fusion cage made by special instrument. To analyze and compare the biomechanical initial stability properties of the lumbar interbody fusion cage with vertebral pedicle screw fixation, PEEK cage with vertebral pedicle screw fixation, so as to provide theoretical basis and experiment guidance in clinical use of autogeneous bone lumbar interbody fusion cage with vertebral pedicle screw fixation in PLIF.
Methods
1. 12 fresh adult pigs separated the lumbarvertebrae involved 4 vertebrae segments (L1-L4) were obtained. To take the posteroanterior and lateral radiograph, removing muscles tissue carefully with the ligament and disc reserved. Randomly divided these specimens into 2 groups: autogeneous bone lumbar interbody fusion cage with vertebral pedicle screw fixation (experimental group), PEEK cage with vertebral pedicle screw fixation (control group).
2.Resin embedding method and graded facetectomy and discectomy were made to model the types of Spinal Instability. Experimental group used autogeneous bone lumbar interbody fusion cage with vertebral pedicle screw fixation; control group used PEEK cage with vertebral pedicle screw fixation. The 3-dimensional motion of specimens were tested in intacted state, instability state and fusion state, which the flexion, extension, bilateral bending and axial rotation loading were applied to the specimens and the range of motion(ROM) were determined by the 3-dimensional laser scanner. Analyzed the data with SPSS 16.0 software.
3. After the 3-dimensional motional stability test finished, the specimens were measured on the MTS testing system.The pullout test was performed on MTS testing system. Recorded the largest pullout force and analyzed data with SPSS 16.0 software.
Results
1. There was no significant difference in all stability index between two groups in intact state (P>0.05). Compare with intact state,there was significant difference in all stability index in instable state in both groups(P<0.05). After PLIF,there was no significant difference in all stability index between two group(P>0.05).
2. In the largest pullout force test of lumbar interbody fusion cage, the mean force of the experimental group was 111.83±9.11N,weaker than 118.173±8.17N that of control group(P>0.05).
Conclusion
The produced autogeneous bone lumbar interbody fusion cage with vertebral pedicle screw fixation can provide the good biomechanical initial stability properties.
PartⅡApplication of Posterior Lumbar Interbody Fusion(PLIF) with Autogenous Morselized Bone Graft Impaction in Degenerated Lumbar Instability
Objective:
To investigate the clinical feasibility and outcomes of patients for degenerated lumbar instability with foraminal stenosis treated by PLIF with autogenous morselized bone graft impaction.
Methods
Between January 2007 and January 2010,60 consecutive patients seeking PLIF treatment for degenerated lumbar instability with foraminal stenosis in our department were included in this study. All patients were randomized to autogenous morselized bone graft impaction fusion group (n=30) and to PEEK cage fusion group (n=30). There was no significant difference in preoperative general condition between two groups.The imaging and clinical outcome in the two groups were compared.
Results:
There was no significant difference in operative time , blood loss and walking time between two groups (P>0.05). there were significant difference preoperative and 1 month postoperative (P<0.05), while no significant difference in both groups(P>0.05). The clinical outcomes were determined using a Macnab criteria, which revealed that the excellent and good rate 90.0% in experimental group and 93.3% in control group(P>0.05). Both neuroforamen height and lumbar space height are ameliorated and maintained efficiently, there were significant difference preoperative and 1 month postoperative (P<0.05), while no significant difference postperative and 1 month postoperative in both index (P>0.05).The bony fusion rate was 90.0% in experimental group, 93.3% in control group(P>0.05).
Conclusion
Autogenous morselized bone graft impaction with pedicle screw fixation in posterior lumbar interbody fusion is a safe ,effective treatment for degenerated lumbar instability, because of its complete decompress,instant stability, reliable bony fusion, low complication rate, and worthy of popularization.
研究目的
本研究通过进行体外动物模型生物力学实验,模拟使用自行研发的器械(自体骨椎间融合成形器),制备自体骨腰椎椎间融合器,比较自体骨腰椎椎间融合器内固定与PEEK(聚醚醚酮)椎间融合器内固定的生物力学即刻稳定性,为临床上自体骨腰椎椎间融合器内固定术的应用及相关器械改良提供理论依据和实验指导。
材料与方法
1.选取12具健康成年猪的腰段均一脊柱标本(L1-L4),排除骨病后随机分为两组:自体骨腰椎椎间融合器结合椎弓根螺钉内固定组(实验组),PEEK椎间融合器结合椎弓根螺钉内固定组(对照组),每组6只。
2.利用树脂包埋法及腰椎后路附件逐级破坏、椎间盘切除术制作腰椎不稳模型。实验组标本采用自体骨腰椎椎间融合器椎弓根螺钉内固定,对照组标本采用PEEK椎间融合器椎弓根螺钉内固定。使用脊柱三维运动测试模拟机对两组标本在正常、不稳、融合3个状态下进行前屈、后伸、左右侧屈、左右旋转等各个活动的生物力学测试。记录不同载荷下不稳节段的运动范围(Range ofmotion,ROM),并用SPSS16.0软件对数据进行比较分析。
3.待两组标本三维运动逐一测量完毕后,再依次将标本置于MTS858材料试验机上进行拔出实验。记录每个样本的最大拔出力,并用SPSS16.0软件对数据进行比较分析。
结果
1.在正常及不稳状态下,实验组与对照组两组间比较各稳定度指标无统计学差异(P>0.05);两组内不稳状态各稳定度指标明显差于正常状态(P<0.05);融合后两组间L2-3节段椎间各稳定度指标无统计学差异(P>0.05)。
2.在进行融合器最大拔出力测试中,实验组(自体骨椎间融合器)的最大拔出阻力为111.83±9.11N,对照组(PEEK椎间融合器)的最大拔出阻力为118.173±8.17N,两组最大拔出力比较无统计学差异(P>0.05);
结论
本研究所制备的自体骨腰椎椎间融合器,植入椎间后,结合椎弓根内固定,具有较好的生物力学即刻稳定性,为临床应用提供了力学基础。
第二部分后路自体颗粒骨打压植骨椎间融合内固定术治疗下腰椎退变性不稳
目的
探讨后路自体颗粒骨打压植骨椎间融合内固定术治疗下腰椎退变性不稳的可行性及临床疗效。
方法
2007年1月至2010年1月收治下腰椎退变性不稳并神经根管狭窄患者60例。随机分为实验组和对照组各30例30节段。其中实验组行后路自体颗粒骨打压植骨椎间融合内固定术,对照组行椎间融合器植骨融合内固定术。两组患者术前一般资料比较差异无统计学意义(P >0.05)。比较两组患者手术资料、影像学结果及临床疗效。
结果
两组手术时间、术中出血量、下地时间差异无统计学意义(P >0.05);两组JOA及ODI评分均较术前改善(P<0.05),两组间差异无统计学意义(P >0.05);采用Macnab标准评价临床结果实验组优良率为90.0%,对照组为93.3%,两组间差异无统计学意义(P >0.05);两组术后一个月与术前相比椎间隙高度、椎间孔高度得到恢复(P<0.05),末次随访椎间隙高度、椎间孔高度均有丢失,但两组差异无统计学意义(P >0.05)。末次随访时实验组融合率为90%,对照组为93.3%,两组间差异无统计学意义(P >0.05);
结论
后路自体颗粒骨打压植骨腰椎椎体间融合术结合椎弓根螺钉系统固定可达到彻底减压、神经根松解、腰椎稳定性的重建、满意植骨合率的目的,具有并发症少的优点,是治疗下腰椎退变性不稳的安全、有效方法之一,值得推广应用。
PartⅠPreparation and Biomechanical Research of Autogeneous Bone Lumbar Interbody Fusion Cage
Objective
The research made animal model building with pig spine. To produce autogeneous bone lumbar interbody fusion cage made by special instrument. To analyze and compare the biomechanical initial stability properties of the lumbar interbody fusion cage with vertebral pedicle screw fixation, PEEK cage with vertebral pedicle screw fixation, so as to provide theoretical basis and experiment guidance in clinical use of autogeneous bone lumbar interbody fusion cage with vertebral pedicle screw fixation in PLIF.
Methods
1. 12 fresh adult pigs separated the lumbarvertebrae involved 4 vertebrae segments (L1-L4) were obtained. To take the posteroanterior and lateral radiograph, removing muscles tissue carefully with the ligament and disc reserved. Randomly divided these specimens into 2 groups: autogeneous bone lumbar interbody fusion cage with vertebral pedicle screw fixation (experimental group), PEEK cage with vertebral pedicle screw fixation (control group).
2.Resin embedding method and graded facetectomy and discectomy were made to model the types of Spinal Instability. Experimental group used autogeneous bone lumbar interbody fusion cage with vertebral pedicle screw fixation; control group used PEEK cage with vertebral pedicle screw fixation. The 3-dimensional motion of specimens were tested in intacted state, instability state and fusion state, which the flexion, extension, bilateral bending and axial rotation loading were applied to the specimens and the range of motion(ROM) were determined by the 3-dimensional laser scanner. Analyzed the data with SPSS 16.0 software.
3. After the 3-dimensional motional stability test finished, the specimens were measured on the MTS testing system.The pullout test was performed on MTS testing system. Recorded the largest pullout force and analyzed data with SPSS 16.0 software.
Results
1. There was no significant difference in all stability index between two groups in intact state (P>0.05). Compare with intact state,there was significant difference in all stability index in instable state in both groups(P<0.05). After PLIF,there was no significant difference in all stability index between two group(P>0.05).
2. In the largest pullout force test of lumbar interbody fusion cage, the mean force of the experimental group was 111.83±9.11N,weaker than 118.173±8.17N that of control group(P>0.05).
Conclusion
The produced autogeneous bone lumbar interbody fusion cage with vertebral pedicle screw fixation can provide the good biomechanical initial stability properties.
PartⅡApplication of Posterior Lumbar Interbody Fusion(PLIF) with Autogenous Morselized Bone Graft Impaction in Degenerated Lumbar Instability
Objective:
To investigate the clinical feasibility and outcomes of patients for degenerated lumbar instability with foraminal stenosis treated by PLIF with autogenous morselized bone graft impaction.
Methods
Between January 2007 and January 2010,60 consecutive patients seeking PLIF treatment for degenerated lumbar instability with foraminal stenosis in our department were included in this study. All patients were randomized to autogenous morselized bone graft impaction fusion group (n=30) and to PEEK cage fusion group (n=30). There was no significant difference in preoperative general condition between two groups.The imaging and clinical outcome in the two groups were compared.
Results:
There was no significant difference in operative time , blood loss and walking time between two groups (P>0.05). there were significant difference preoperative and 1 month postoperative (P<0.05), while no significant difference in both groups(P>0.05). The clinical outcomes were determined using a Macnab criteria, which revealed that the excellent and good rate 90.0% in experimental group and 93.3% in control group(P>0.05). Both neuroforamen height and lumbar space height are ameliorated and maintained efficiently, there were significant difference preoperative and 1 month postoperative (P<0.05), while no significant difference postperative and 1 month postoperative in both index (P>0.05).The bony fusion rate was 90.0% in experimental group, 93.3% in control group(P>0.05).
Conclusion
Autogenous morselized bone graft impaction with pedicle screw fixation in posterior lumbar interbody fusion is a safe ,effective treatment for degenerated lumbar instability, because of its complete decompress,instant stability, reliable bony fusion, low complication rate, and worthy of popularization.
引文
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[1] Iguchi T,Kanemura A,Kasabara K,et a1.Lumbar instability and clinical symptoms:which is the nlore critical factor for symptoms:sagittal translation or segment angulation[J].J SpinalDisord Tech,2004,17(4):284-290.
[2] White AA,Panjabi MM.Clinical Biomechanics of the Spine,2nd edn [M]. Philadelphia,PA:Lippineott,1990.23-45.
[3] Hosono N, Namekata M, Makino T, et al. Perioperative complications of primary posterior lumbar interbody fusion for nonisthmic spondylolisthesis: analysis of risk factors[J].J Neurosurg Spine. 2008;9(5):403-407.
[4] Cinotti G,De Santis P,Nofroni I,et a1.Stenosis of lumbar intervertebral foramen:anatomic study on predisposing factors[J].Spine,2002,27(3):223-229.
[5] Matsumura A,Taneichi H,Suda K,et al.Comparative study of radiographic disc height changes using two different interbody devices for transforaminal lumbar interbody fusion:open box vs.fenestrated tube interbody Cage[J].Spine. 2006; 1(23): E871-876.
[6] Groth AT,Kuk1o TR,Klemme WR,et al.Comparison of sagittal contour and posterior disc height following interbody fusion:threaded cylindrical Cages versus structural allograft versus vertical Cages.J Spinal Disord Tech.2005;l8(4): 332-336.
[7]李浩鹏,杨保辉,张国安,等.退行性腰椎不稳发病相关因素的临床研究[J].实用骨科杂志,2009,15(5):0339-0342.
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[10] Crandall,Dennis G,Revella,et al. Transforaminal Lumbar Interbody Fusion Versus Anterior Lumbar Interbody Fusion as an Adjunct to Posterior Instrumented Correction of Degenerative Lumbar Scoliosis: Three Year Clinical and Radiographic Outcomes[J]. Spine, 2009,34(20):2126-2133.
[11] Aoki, Yasuchika; Yamagata,et al. Posterior Migration of Fusion Cages in Degenerative Lumbar Disease Treated With Transforaminal Lumbar Interbody Fusion: A Report of Three Patients[J]. Spine,2009,34(1):E54-E58.
[12] Xiuxin Han,Yue Zhu,Cui Cui,et al. A Meta-Analysis of Circumferential Fusion Versus Instrumented Posterolateral Fusion in the Lumbar Spine[J]. Spine, 2009, 34(17): E618-E625.
[13] Ido K, Asada Y, Sakamoto T, et al. Use of an autologous cortical bone graft sandwiched between two intervertebral spacers in posterior lumbar interbody fusion[J]. Neruosurg Rev, 2001,24(23):119-122.
[14]李健,钟志宏,张平,等.椎弓根螺钉置入内固定联合自体颗粒骨移植治疗退行性腰椎病变[J].中国组织工程研究与临床康复,2010,14(13):2421-2424.
[15]张志,李健,杨波,等.椎弓根钉置入内固定与两种不同椎间植骨融合治疗退行性下腰椎不稳:同一机构4年27例资料回顾[J].中国组织工程研究与临床康复,2010,14(30):5658-5661.
[16]张庆明,沈惠良,曹立,等.颗粒骨打压植骨在腰椎后路融合手术中的应用[J].中国矫形外科杂志,2008,16(11):801-806
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[20] Larsen JM,Rimoldi RL,Capen DA,et al. Assessment of Pseudarthrosis in Pedicle Screw Fusion: A Prospective Study Comparing Plain Radiographs, Flexion/Extension Radiographs, CT Scanning, and Bone Scintigraphy with Operative Findings[J] J Spine Disord,1996:9(2):117-120.
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[1] Iguchi T,Kanemura A,Kasabara K,et a1.Lumbar instability and clinical symptoms:which is the nlore critical factor for symptoms:sagittal translation or segment angulation[J].J SpinalDisord Tech,2004,17(4):284-290.
[2] White AA,Panjabi MM.Clinical Biomechanics of the Spine,2nd edn [M]. Philadelphia,PA:Lippineott,1990.23-45.
[3] Hosono N, Namekata M, Makino T, et al. Perioperative complications of primary posterior lumbar interbody fusion for nonisthmic spondylolisthesis: analysis of risk factors[J].J Neurosurg Spine. 2008;9(5):403-407.
[4] Cinotti G,De Santis P,Nofroni I,et a1.Stenosis of lumbar intervertebral foramen:anatomic study on predisposing factors[J].Spine,2002,27(3):223-229.
[5] Matsumura A,Taneichi H,Suda K,et al.Comparative study of radiographic disc height changes using two different interbody devices for transforaminal lumbar interbody fusion:open box vs.fenestrated tube interbody Cage[J].Spine. 2006; 1(23): E871-876.
[6] Groth AT,Kuk1o TR,Klemme WR,et al.Comparison of sagittal contour and posterior disc height following interbody fusion:threaded cylindrical Cages versus structural allograft versus vertical Cages.J Spinal Disord Tech.2005;l8(4): 332-336.
[7]李浩鹏,杨保辉,张国安,等.退行性腰椎不稳发病相关因素的临床研究[J].实用骨科杂志,2009,15(5):0339-0342.
[8] Lee K K ,Teo, E C,Qiu, T X,et al. Effect of Facetectomy on Lumbar Spinal Stability Under Sagittal Plane Loadings[J].Spine,2004, 29(15):1624-1631.
[9]张记恩,彭松明.腰椎间盘突出症合并腰椎退变不稳的手术治疗[J].中国脊柱脊髓杂志2006,1(1):56.
[10] Crandall,Dennis G,Revella,et al. Transforaminal Lumbar Interbody Fusion Versus Anterior Lumbar Interbody Fusion as an Adjunct to Posterior Instrumented Correction of Degenerative Lumbar Scoliosis: Three Year Clinical and Radiographic Outcomes[J]. Spine, 2009,34(20):2126-2133.
[11] Aoki, Yasuchika; Yamagata,et al. Posterior Migration of Fusion Cages in Degenerative Lumbar Disease Treated With Transforaminal Lumbar Interbody Fusion: A Report of Three Patients[J]. Spine,2009,34(1):E54-E58.
[12] Xiuxin Han,Yue Zhu,Cui Cui,et al. A Meta-Analysis of Circumferential Fusion Versus Instrumented Posterolateral Fusion in the Lumbar Spine[J]. Spine, 2009, 34(17): E618-E625.
[13] Ido K, Asada Y, Sakamoto T, et al. Use of an autologous cortical bone graft sandwiched between two intervertebral spacers in posterior lumbar interbody fusion[J]. Neruosurg Rev, 2001,24(23):119-122.
[14]李健,钟志宏,张平,等.椎弓根螺钉置入内固定联合自体颗粒骨移植治疗退行性腰椎病变[J].中国组织工程研究与临床康复,2010,14(13):2421-2424.
[15]张志,李健,杨波,等.椎弓根钉置入内固定与两种不同椎间植骨融合治疗退行性下腰椎不稳:同一机构4年27例资料回顾[J].中国组织工程研究与临床康复,2010,14(30):5658-5661.
[16]张庆明,沈惠良,曹立,等.颗粒骨打压植骨在腰椎后路融合手术中的应用[J].中国矫形外科杂志,2008,16(11):801-806
[17]张绍东,吴小涛,唐天驷.腰椎间融合器的现状及发展方向[J].中国脊柱脊髓杂志2005,15(7):443-446.
[18]李健,钟志宏.后路自体颗粒骨打压植骨腰椎椎体间融合内固定的生物力学及临床研究[D].广州医学院硕士学位论文,2010,35.
[19] Amold PM,Klemp JA. Assessment of malunion in spinal fusion[J]. Neurosurgery Quarterly,2005:15(4):239-247.
[20] Larsen JM,Rimoldi RL,Capen DA,et al. Assessment of Pseudarthrosis in Pedicle Screw Fusion: A Prospective Study Comparing Plain Radiographs, Flexion/Extension Radiographs, CT Scanning, and Bone Scintigraphy with Operative Findings[J] J Spine Disord,1996:9(2):117-120.
[21] Zdeblick TA,Philips FM. Interbody cage devices [J].Spine,2003,28(15Suppl): S2-S7.
[22] Wai EK,Santos ER,Morcom RA,et al. Magnetic resonance imaging 20 years after anterior lumbar interbody fusion[J]. Spine,2006,31(17):1952-1956.
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