腰椎单侧TLIF与双侧TLIF治疗腰椎退行性病变的比较研究
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摘要
目的
本研究包括生物力学与临床应用研究两部分。生物力学研究部分旨在研究人尸体腰椎单节段单侧TLIF的生物力学特性,以进一步明确单侧TLIF是否能够获得融合固定的即刻稳定性,为其应用于临床提供理论指导；临床应用部分通过回顾腰椎单侧TLIF与双侧TLIF治疗腰椎退行性病的病例,比较两种术式的手术时间、手术出血量以及中远期临床疗效、椎间骨性融合率,探讨对于腰椎单侧TLIF治疗腰椎退行性病变的临床可行性。
Ⅰ生物力学研究部分
材料与方法
人新鲜尸体腰椎标本6具,剔除标本上的肌肉组织,保留椎间盘、韧带及骨性结构完整,作为A组,正常对照组；然后模拟TLIF手术,并采用不同的内固定方式分为：B组,双侧钉棒组；C组,单侧钉棒组,应用ElectroForce材料力学试验机(美国BOSE公司)；高性能计算机图像Mimics分析软件系统和6台高速红外摄像机,计算出模拟人体产生屈伸、侧弯、轴向旋转3个平面6个方向的生理运动的角位移动范围(range of motion,ROM)。数据以x±s表示,用SPSS 13.0软件处理,多组数据之间比较采用完全随机设计资料的单向方差分析(One-way ANONA),当F值有意义时,采用两两比较的LSD检验法进行统计学比较。
结果
1.以完整的腰椎运动单元为参照,两种固定组的ROM值均小于对照组,差异有统计学意义(P<0.05)。2.两种固定组合间的比较：其中双侧钉棒组在各工况下ROM值均较低,与单侧钉棒组比较差异有统计学意义(P<0.05)。
Ⅱ临床应用研究部分
资料与方法
40例单一腰椎间盘退行病变性患者自2009年2月1日至2010年12月31日期间在我院接受腰椎TLIF手术的回顾性的分析,单侧TLIF手术组(A组)20例,其中男14例,女6例,平均年龄47.35±13.48岁；双侧TLIF手术组(B组)20例,其中男8例,女12例,平均年龄46.35±12.42岁。所有患者病程6个月到12年,症状加重半个月到6个月,术前均经过较为规范的保守治疗效果不佳或者反复发作。A组病变累及L4-5节段10例,L5-S1节段10例；B组病变累及L4-5节段11例,L5-S1节段8例,L1-2节段1例。40例患者术前均有不同程度腰痛,同时伴有单侧下肢神经根症状。手术方式A组采用单侧TLIF,其中14例行常规开放手术入路,6例采用X-tube扩张管微创入路；B组采用双侧TLIF,其中15例行常规开放手术入路,5例采用X-tube扩张管微创入路。术后卧床一周后佩戴腰部支具下地行走。
结果
单侧组平均手术时间186.0±36.0分钟,双侧组平均手术时间230±37.5分钟,单侧组平均术中出血量280.0±20.0ml,双侧组平均术中出血量521.5±264.6ml。l例发生硬脊膜撕裂,经修补后术后无脑脊液漏,术后腰痛基本消失,下肢放射痛均消失、麻木症状于术后逐渐恢复,无1例出现对侧下肢神经根症状。单侧组20例有12例获得随访,随访时间12-19个月,平均15.3±4.9个月；双侧组20例病人13例获得随访,随访时间10-18个月,平均随访13.8±4.3个月。两组术前与术后1周的Oswestry评分有统计学差异(p<0.05),术后3个月,6个月和12个月的Oswestry评分显示：A组和B组无显着差异,P>0.05。随访期间对两组患者进行X线检查均未发现有Cage的移位及下沉、没有椎弓根螺钉、钛棒松动及断裂,根据复查过伸过屈位未发现手术节段不稳,单侧TLIF组12例患者CT检查结果显示10例完全骨性融合,2例部分融合；双侧TLIF组13例患者CT检查结果显示11例完全骨性融合,2例部分融合,两组差异无统计学意义(P>0.05)。
结论
通过生物力学与临床应用两个部分的研究,可以得出以下结论：
1.与完整对照组相比,无论是单钉棒还是双钉棒固定,腰椎功能单位的力学稳定性都明显高于完整对照组,其中双钉棒优于同侧单钉棒组。从理论上讲,在TLIF术式下,虽然单枚融合器辅以同侧的单钉棒固定与双侧钉棒固定组比较,单钉棒方式仍然存在差距,但其生物力学强度是足够的。
2.中长期的临床研究结果表明单侧TLIF应用于单侧神经根症状的单节段腰椎退行性病变合并轻度不稳的患者是一种安全有效的治疗方法,中长期随访未发现内固定失败及不融合表现。
Objectives
Our research includes two parts of biomechanical study and clinical applicative research. The purpose of biomechanical study is to analyze the efficacy of Unilateral TLIF on one-level human cadaveric lumbar spine model. This study is proposed that Unilateral TLIF can achieve identical initial stability to Bilateral TLIF on one-level lumbar fusion segments. What is more, it is expected less change of biomechanical mode at adjacent segments, which can provide theoretical guidance for the clinical application of this technique. The purpose of the clinical study is to discussing the clinical feasibility of Unilateral TLIF on lumbar degenerative disease by reviewing the cases of unilateral TLIF and bilateral TLIF on lumbar degenerative disease, compare the operating time, blood loss, the long-term clinical efficacy, and fusion rates between them.
PartⅠBiomechanical Study
Materials and methods
Six fresh adult cadaveric lumbar spines were tested in such sequential order:
A:Intact group
B:Unilateral instability group
C:Bilateral instability group Each specimen was nondestructively tested in flexion-extension, lateral bending, and axial rotation by ElectroForce, which were recorded by a six-camera motion analysis system.
Results
①Compared with the compact function unit, the ROM in all fixation group are lower clearly, the difference show static significance. (P<0.05)。②The ROM of group C in all working state is lower than group B, the difference show static significance. (P<0.05)
PartⅡClinical Study
Materials and methods
During Febuary 2009 and December 2009.40 cases with lumbar degenerative diseases had underwent TLIF surgery in our department. We arranged the patients to unilateral group (Group A) or bilateral group (Group B) by randomize. Among Group A, there were 14 male and 6 female. The mean age was 47.35±14.48. The L4-5 level was involved in 10, the L5-S1 level was involved in 10. Among Group B, there were 8 male and 12 female. The mean age was 46.35±12.42. The L4-5 level was involved in 11, the L5-S1 level was involved in 8, the L1-2 level was involved in 1.All patients experienced a combination of mechanical back pain and unilateral radiculopathy. All patients in Group A were treated with unilateral TLIF.14 of 20 were treated by conventional open approach, and the other 6 were treated by X-tube minimal invasive approach. All patients in Group B were treated with bilateral TLIF.15 of 20 were treated by conventional open approach, and the other 5 were treated by X-tube minimal invasive approach.
Results
The mean operation duration of Group A was 186.0±36.0 minutes and th e mean blood loss amount was 280.0±20.0 ml. And the mean operation durat ion of Group B was 230±37.5 minutes and the mean blood loss amount was 5 21.5±264.6 ml. Dural tear happened in 1 but no leakage of cerebrospinal fluid happened. Lumbar pain almost eliminated and radicular pain in lower extremity totally disappeared postoperativey. The numbness in lower extr emity disappeared gradually, no worsen numbness and no contralateral radic ulopathy happened postoperatively. The ODI of the patients shows signific ant differences between preparative and 1 week after operative among Grou p A and Group B(P<0.05). The ODI of the patients which collected at 3 mon ths,6months, and 12 months shows no significant differences between Group A and Group B(P>0.05).No cage translation or subsidence occured, and no pedicle screws breakage happened during follow-up. There was no instabil ity sign on dynamic radiographic images. According to sagittal and corona 1 CT imager taken at last follow-up, complete bony fusion was shown in 10, incomplete bony fusion was shown in 2 in Group A, while complete bony fus ion was shown in 11, incomplete bony fusion was shown in 2 in Group B, it shows no significant differences between Group A and Group B(P>0.05)
Conelusions
Different fixation method all could add the biomechanic stability for minimally invasive TLIF, and the group B>group C. In the minimally invasive TLIF surgical, single cage with same side pedicle screw fixation, the biomechanical strength is adequate.
As to the existent slight instability preoperatively, it is effective to perform unilateral TLIF for one-level lumbar degenerative diseases with u nilateral radiculopathy. There is no sign of non fusion or mental failure during our long-term follow-up.
本研究包括生物力学与临床应用研究两部分。生物力学研究部分旨在研究人尸体腰椎单节段单侧TLIF的生物力学特性,以进一步明确单侧TLIF是否能够获得融合固定的即刻稳定性,为其应用于临床提供理论指导；临床应用部分通过回顾腰椎单侧TLIF与双侧TLIF治疗腰椎退行性病的病例,比较两种术式的手术时间、手术出血量以及中远期临床疗效、椎间骨性融合率,探讨对于腰椎单侧TLIF治疗腰椎退行性病变的临床可行性。
Ⅰ生物力学研究部分
材料与方法
人新鲜尸体腰椎标本6具,剔除标本上的肌肉组织,保留椎间盘、韧带及骨性结构完整,作为A组,正常对照组；然后模拟TLIF手术,并采用不同的内固定方式分为：B组,双侧钉棒组；C组,单侧钉棒组,应用ElectroForce材料力学试验机(美国BOSE公司)；高性能计算机图像Mimics分析软件系统和6台高速红外摄像机,计算出模拟人体产生屈伸、侧弯、轴向旋转3个平面6个方向的生理运动的角位移动范围(range of motion,ROM)。数据以x±s表示,用SPSS 13.0软件处理,多组数据之间比较采用完全随机设计资料的单向方差分析(One-way ANONA),当F值有意义时,采用两两比较的LSD检验法进行统计学比较。
结果
1.以完整的腰椎运动单元为参照,两种固定组的ROM值均小于对照组,差异有统计学意义(P<0.05)。2.两种固定组合间的比较：其中双侧钉棒组在各工况下ROM值均较低,与单侧钉棒组比较差异有统计学意义(P<0.05)。
Ⅱ临床应用研究部分
资料与方法
40例单一腰椎间盘退行病变性患者自2009年2月1日至2010年12月31日期间在我院接受腰椎TLIF手术的回顾性的分析,单侧TLIF手术组(A组)20例,其中男14例,女6例,平均年龄47.35±13.48岁；双侧TLIF手术组(B组)20例,其中男8例,女12例,平均年龄46.35±12.42岁。所有患者病程6个月到12年,症状加重半个月到6个月,术前均经过较为规范的保守治疗效果不佳或者反复发作。A组病变累及L4-5节段10例,L5-S1节段10例；B组病变累及L4-5节段11例,L5-S1节段8例,L1-2节段1例。40例患者术前均有不同程度腰痛,同时伴有单侧下肢神经根症状。手术方式A组采用单侧TLIF,其中14例行常规开放手术入路,6例采用X-tube扩张管微创入路；B组采用双侧TLIF,其中15例行常规开放手术入路,5例采用X-tube扩张管微创入路。术后卧床一周后佩戴腰部支具下地行走。
结果
单侧组平均手术时间186.0±36.0分钟,双侧组平均手术时间230±37.5分钟,单侧组平均术中出血量280.0±20.0ml,双侧组平均术中出血量521.5±264.6ml。l例发生硬脊膜撕裂,经修补后术后无脑脊液漏,术后腰痛基本消失,下肢放射痛均消失、麻木症状于术后逐渐恢复,无1例出现对侧下肢神经根症状。单侧组20例有12例获得随访,随访时间12-19个月,平均15.3±4.9个月；双侧组20例病人13例获得随访,随访时间10-18个月,平均随访13.8±4.3个月。两组术前与术后1周的Oswestry评分有统计学差异(p<0.05),术后3个月,6个月和12个月的Oswestry评分显示：A组和B组无显着差异,P>0.05。随访期间对两组患者进行X线检查均未发现有Cage的移位及下沉、没有椎弓根螺钉、钛棒松动及断裂,根据复查过伸过屈位未发现手术节段不稳,单侧TLIF组12例患者CT检查结果显示10例完全骨性融合,2例部分融合；双侧TLIF组13例患者CT检查结果显示11例完全骨性融合,2例部分融合,两组差异无统计学意义(P>0.05)。
结论
通过生物力学与临床应用两个部分的研究,可以得出以下结论：
1.与完整对照组相比,无论是单钉棒还是双钉棒固定,腰椎功能单位的力学稳定性都明显高于完整对照组,其中双钉棒优于同侧单钉棒组。从理论上讲,在TLIF术式下,虽然单枚融合器辅以同侧的单钉棒固定与双侧钉棒固定组比较,单钉棒方式仍然存在差距,但其生物力学强度是足够的。
2.中长期的临床研究结果表明单侧TLIF应用于单侧神经根症状的单节段腰椎退行性病变合并轻度不稳的患者是一种安全有效的治疗方法,中长期随访未发现内固定失败及不融合表现。
Objectives
Our research includes two parts of biomechanical study and clinical applicative research. The purpose of biomechanical study is to analyze the efficacy of Unilateral TLIF on one-level human cadaveric lumbar spine model. This study is proposed that Unilateral TLIF can achieve identical initial stability to Bilateral TLIF on one-level lumbar fusion segments. What is more, it is expected less change of biomechanical mode at adjacent segments, which can provide theoretical guidance for the clinical application of this technique. The purpose of the clinical study is to discussing the clinical feasibility of Unilateral TLIF on lumbar degenerative disease by reviewing the cases of unilateral TLIF and bilateral TLIF on lumbar degenerative disease, compare the operating time, blood loss, the long-term clinical efficacy, and fusion rates between them.
PartⅠBiomechanical Study
Materials and methods
Six fresh adult cadaveric lumbar spines were tested in such sequential order:
A:Intact group
B:Unilateral instability group
C:Bilateral instability group Each specimen was nondestructively tested in flexion-extension, lateral bending, and axial rotation by ElectroForce, which were recorded by a six-camera motion analysis system.
Results
①Compared with the compact function unit, the ROM in all fixation group are lower clearly, the difference show static significance. (P<0.05)。②The ROM of group C in all working state is lower than group B, the difference show static significance. (P<0.05)
PartⅡClinical Study
Materials and methods
During Febuary 2009 and December 2009.40 cases with lumbar degenerative diseases had underwent TLIF surgery in our department. We arranged the patients to unilateral group (Group A) or bilateral group (Group B) by randomize. Among Group A, there were 14 male and 6 female. The mean age was 47.35±14.48. The L4-5 level was involved in 10, the L5-S1 level was involved in 10. Among Group B, there were 8 male and 12 female. The mean age was 46.35±12.42. The L4-5 level was involved in 11, the L5-S1 level was involved in 8, the L1-2 level was involved in 1.All patients experienced a combination of mechanical back pain and unilateral radiculopathy. All patients in Group A were treated with unilateral TLIF.14 of 20 were treated by conventional open approach, and the other 6 were treated by X-tube minimal invasive approach. All patients in Group B were treated with bilateral TLIF.15 of 20 were treated by conventional open approach, and the other 5 were treated by X-tube minimal invasive approach.
Results
The mean operation duration of Group A was 186.0±36.0 minutes and th e mean blood loss amount was 280.0±20.0 ml. And the mean operation durat ion of Group B was 230±37.5 minutes and the mean blood loss amount was 5 21.5±264.6 ml. Dural tear happened in 1 but no leakage of cerebrospinal fluid happened. Lumbar pain almost eliminated and radicular pain in lower extremity totally disappeared postoperativey. The numbness in lower extr emity disappeared gradually, no worsen numbness and no contralateral radic ulopathy happened postoperatively. The ODI of the patients shows signific ant differences between preparative and 1 week after operative among Grou p A and Group B(P<0.05). The ODI of the patients which collected at 3 mon ths,6months, and 12 months shows no significant differences between Group A and Group B(P>0.05).No cage translation or subsidence occured, and no pedicle screws breakage happened during follow-up. There was no instabil ity sign on dynamic radiographic images. According to sagittal and corona 1 CT imager taken at last follow-up, complete bony fusion was shown in 10, incomplete bony fusion was shown in 2 in Group A, while complete bony fus ion was shown in 11, incomplete bony fusion was shown in 2 in Group B, it shows no significant differences between Group A and Group B(P>0.05)
Conelusions
Different fixation method all could add the biomechanic stability for minimally invasive TLIF, and the group B>group C. In the minimally invasive TLIF surgical, single cage with same side pedicle screw fixation, the biomechanical strength is adequate.
As to the existent slight instability preoperatively, it is effective to perform unilateral TLIF for one-level lumbar degenerative diseases with u nilateral radiculopathy. There is no sign of non fusion or mental failure during our long-term follow-up.
引文
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[18]Brantigan JW, Neidre A, Toohey JS. The Lumbar I/F Cage for posterior lumbar interbody fusion with the variable screw placement system:10-year results of a Food and Drug Administration clinical reial[J]. Spine J,2004,4(6):681-688.
[19]Hsu CJ, Chou WY, Chang WN, et al. Clinical follow up after instrumentation-augmented lumbar spinal surgery in patients with unsatisfactory outcomes[J]. J Neurosurg Spine,2006,5(4):281-286.
[20]Skaf G, Bouclaous C, Alaraj A, ea al. Clinical outcome of surgical treatment of failed back surgery syndrome [J]. Surg Neurol,2005,64(6):483-489.
[21]Fischgrund JS. Mackay M,Herkowitz HN, et al. Degenerative lumbar pondylolisthesis with spinal stenosis:a prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation[J]. Spine,1997,22(24):2807-2812.
[22]Fager CA, Freidberg SR.Analysis of failures and poor results of lumbar spine surgery[J]. Spine,1980:5(1):87-94.
[23]Fritsch EW, Heisel J, Rupp S.The failed back surgery syndrome: reasons, intraoperative findings, and long-term results:a report of 182 operative treatments [J]. Spine,1996,21(5):626-633.
[24]Waguespack A, Schofferman J, Slosar P, Reynolds J.Etiology of long-term failures of lumbar spine surgery[J]. Pain Med,2002,3(1):18-22.
[25]Gillet P. The fate of the adjacent motion segments after lumbar fusion [J].J Spinal Disord Tech,2003,16(4):338-345.
[26]Ha K-Y, Schendel MJ, Lewis JL, et al. Effect of immobili- zation and configuration on lumbar adjacent-segment biomechanics [J]. J Spinal Disord, 1993,6(2):99-105.
[27]. Nagata H, Schendel MJ, Transfeldt EE,et al.The effects of immobilization of long segments of the spine on the adjacent and distal facet force and lumbosacral motion [J].Spine,1993,18(16):2471-2479.
[28]Fogel GR, Toohey JS, Neidre A, et al. Is one cage enough in posterior lumbar interbody fusion:a comparison of unilateral single cage interbody fusion to bilateral cages [J]. J pinal Disord Tech,2007,20(1):60-65.
[29]Lee CS, Hwang CJ, Lee SW.et al. Risk factors for adjacent segment disease after lumbar fusion [J].Eur Spine J,2009,18(11):1637-1643.
[30]Cardoso MJ, Dmitriev AE, Helgeson M, et al. Does superior-segment facet violation or laminectomy destabilize the adjacent level in lumbar transpedicular fixation? An in vitro human cadaveric assessment [J]. Spine,33(26):2868-2873.
[31]Hilibrand AS, Robbins M. Adjacent segment degeneration and adjacent segment disease:the consequences of spinal fusion [J]?Spine J,2004,4(6Suppl):190-194.
[32]ParK P, Garton HJ, Gala VC, et al. Adjacent segment disease after lumbar or lumbosacral fusion:review of the literature [J].Spine,2004,29(17):1938-1944.
[33]Zhou Y, Zhang C, Wang J, et al. Endoscopic transforaminal lumbar decompression, interbody fusion and pedicle screw fixation-a report of 42 cases.Chin J Traumatol.2008;11 (4):225-31.
[34]Blume HG. Unilateral posterior lumbar interbody fusion:simplified dowel technique [J].Clin Orthop Relat Res,1985,193:75-84.
[35]Shin HC, Yi S, Kim KN,et al. Posterior lumbar interbody fusion via a unilateral approach [J].Yonsei med J,2006,47(3):319-325.
[36]Hambly MF, Wiltse LL, Peek RD, et al. Unilateral lumbar fusion [J]. Spine, 1991,16 (6S):S295-297.
[37]Lowe TG, Tahernia AD,O'Brien MF, et al. Unilateral transforaminal posterior lumbar interbody fusion (TLIF):indications, technique, and 2-year results [J].J Spinal Disord Tech,2002,15(1):31-38.
[38]Lowe TG, Tahernia AD. Unilateral transforaminal posterior lumbar interbody fusion [J].Dlin Orthop,2002,394:64-72.
[39]Lowe TG, Coe JD. Bioresorbable polymer impoants in the unilateral transforaminal lumbar interbody fusion procedure [J]. Orthopedics,2002,25(10Suppl):1179-1183.
[40]Rodriguez-Olaverri JC, Zimick NC, Merola A, et al. Comparing the clinical and radiological outcomes of pedicular transvertebral screw fixation of the lumbosacral spine in spondylolisthesis versus unilateral transforaminal lumbar interbody fusion (TLIF) with posterior fixation using anterior cager [J]. Spine,2008,33(18):1977-1981.
[41]Taneichi H, Sda K, Kajion T, et al. Unilateral transforaminal lumbar interbody fusion and vilateral anterior-column fixation with two Brantigan I/F cages per level:clinical outcomes during a minimum 2-year follow-up period [J].J Neurosurg Spine,2006,4(3):198-205.
[42]Javernick MA, Kuklo TR. Polly DW jr.Transforaminal lumbar interbody fusion:unilateral versus bilateral disk removal--an in vivo study [J].Am JOrthop,2003,32(7):344-348.
[44]Zhao J, Wang X, Hou T, et al. One versus two BAK fusion cages in posterior lumbar interbody fusion to L4-L5 degenerative spondylolisthesis:a randomized, controlled pros- pective study in 25 patients with minimum two-year follow-up [J]. Spine,2002,27(24):2753-2757.
[45]Zhao J, Hai Y, Ordway N R, et al. Posterior lumbar interbody fusion using posterolateral placement of a single cylindrical threaded cage [j]. Spine,2000,25(4):425-430.
[46]Zhao J, Hou T, Wang X, et al. Posterior lumbar interbody fusion ruing one diagonal fusion cage with transpedicular screw rod fixation [J].Eur spine,2003,12(2):173-177.
[47]Suk KS, Lee HM, Kim NH, et al. Unilateral versus bilateral pedicle screw fixation in lumbar spinal fusion [J]. Spine,2000,25(14):1843-1847.
[48]Tuttle J, Shakir A, Choudhri HF. Paramedian approach for transforaminal lumbar interbody fusion with unilateral pedicle screw fixation. Technical note and preliminary report on 47 cases [J]. Neurosurg Focus,2006,20(3):E5.
[49]Foley K T, Holly LT, Schwender JD. Minimally invasive lumbar fusion [J]. Spine,2003,28(15 Suppl):26-35.
[50]Deutsch H, Musacchio MJ Jr. Minimally invasive transforaminal lumbar interbody fusion with unilateral pedicle screw fixation [J]. Neurosurg Focus.2006,20(3):E10.
[51]Beringer WF, Mobasser JP. Unilateral pedicle screw instrumentation for minimally invasive transforaminal lumbar interbody fusion [J]. Neurosurg Focus,2006,20(3):E4.
[52]Kabins MB, Weinstein JN, Spratt KF, et al. Isolated L4-L5 fusions using the variable screw placement system:unilateral versus bilateral [J]. J Spinal Disord,1992,5(1):39-49.
[53]Moreland DB, Asch HL, Czajka GA, et al. Posterior lumbar interbody fusion:comparison of single intervertebral cage and single side pedicle screw fixation versus vilateral cages and screw fixation [J]. Minim Invasive Neurosurg,2009,52(3):132-136.
[54]Mariano FF, Pedro S, Hernan R, et al.A prospective randomized study of unilateral versus bilateral instrumented posterolateral lumbar fusion in degenerative spondylolisthesis[J].Spine,2007,32(4):395-401.