非融合棘突间撑开器治疗腰椎早期退变性腰痛的三维有限元分析

目的建立非融合棘突间撑开器(IPD)及腰椎L4、5节段有限元模型,对撑开器植入前后力学环境进行研究。方法腰椎行CT扫描,根据CT生成实体模型,与撑开器模型一起导入PATRAN生成有限元模型,施加中立位及后伸负荷分析椎间盘受力。结果中立位负荷时IPD受力小;后伸时IPD可分担椎间盘负荷,但L5椎弓根负荷增大。结论基于CT及CAD可建立非融合棘突间撑开器及腰椎的有限元模型,棘突间撑开器可分担后伸时椎间盘的负荷,但可能会增加L5椎弓根崩裂的危险。     

棘突撑开与小关节、椎间孔形态变化关系的初步实验研究

目的 观察棘突撑开程度与小关节移位、椎间孔形态变化的关系.方法 使用6具新鲜腰椎尸体,制作标本,保留关节突周围关节囊韧带及棘间韧带,通过分别撑开L3/4,L4/5棘突,测量相应节段小关节间相对位移、椎间孔高度及宽度改变.结果 棘突撑开2 mm、4 mm后,L3/4、L4/5腰椎间孔高度增大、小关节位移改善均有明显差异,椎间孔宽度的改变在撑开2 mm无明显差异,在撑开4 mm时宽度增大有统计学差异.结论 棘突撑开能有效改善小关节位移、增加椎间孔高度,但对于椎间孔宽度的增加需要撑开足够距离.     

小关节、椎间孔形态变化与棘突撑开的相关性研究

目的探讨小关节、椎间孔形态变化与棘突撑开的相关性,以期为临床脊柱疾病治疗提供有效依据。方法使用3具存在不同程度腰椎退行性变新鲜尸体作为标本,暴露出关节突周围关节囊韧带和棘间韧带,撑开L3～L4、L4～L5棘突,比较不同撑开高度时椎间孔高度和宽度以及小关节位移的改变。结果在撑开2 mm、4 mm后椎间孔高度和小关节位移较原始状态均有明显改善(P 0. 05);椎间孔宽度上撑开2 mm后较原始状态无统计学差异(P 0. 05),而在撑开4 mm后椎间孔宽度较原始状态差异有统计学意义(P 0. 05)。结论撑开棘突可有效改善小关节位移,增加椎间孔高度,但对椎间孔宽度的改善需足够的距离才有效。     

Caspar型颈椎撑开器在颈椎间减压手术中的应用研究

目的:探讨使用Caspar型颈椎撑开器在颈前路椎间减压手术中对颈椎椎间角度、椎间孔大小的影响。方法:取10具C2~C7成人颈椎标本,将Caspar型颈椎撑开器的2枚固定螺钉分别在C4、C5椎体正中相互平行置入,按照Smith-Robinson手术方法进行C4/5间隙减压,用颈椎撑开器加压2mm和撑开2mm、4mm,分别在CR机上摄颈椎侧、斜位片,Pacsout程序软件测量C4/5椎间孔面积和椎间角度,SAS6.12软件包进行统计分析。结果:颈椎撑开器压缩2mm,椎间孔面积无明显改变,椎间角度减小39.7%;撑开2mm时,椎间孔面积增加28.3%,椎间角度增加67.6%;撑开4mm时,椎间孔面积增加33.3%,椎间角度增加136.8%。结论:颈椎撑开器撑开椎间隙时扩大了椎间孔面积,同时也增加了椎间角度;提示不应强求使用颈椎撑开器过度撑开椎间隙的方法来增加椎间孔面积。     

经皮置入式腰椎棘突间撑开器的生物力学测试

目的:评价经皮置入式腰椎棘突间撑开器对置入节段及其邻近节段活动度的影响。方法:选取6具新鲜人体腰椎标本(L1～L5),剔除附着肌肉,保留各韧带及骨骼,将标本的头尾端固定在MTS生物力学试验测试机上,对标本施加400N的轴向压力,然后以0.5°/s速度施加六个方向(前屈/后伸、左右侧屈、左右轴向旋转)±7.5Nm的力矩,测量L2/3、L3/4节段各个运动方向的运动范围(ROM,完整状态组);于L3/4节段置入Bullet棘突间撑开器,按照同样方法测试标本各个方向的活动度(置入撑开器组)。测试后以2Hz频率循环加载,屈伸20 000次、侧屈15 000次、旋转5 000次,摄X线片观察内置物位置及棘突有无骨折,肉眼观察内置物有无变形和破损。结果:L3/4节段完整状态下前屈和后伸的平均ROM值分别为4.62°±2.26°和4.07°±1.92°,置入撑开器后前屈和后伸的平均ROM值分别为3.87°±2.06°和2.57°±2.06°,两组比较差异有统计学意义(P<0.05);两组侧方屈曲和旋转的平均ROM值差异均无统计学意义。在完整状态和置入撑开器后L2/3节段各个运动方向的平均ROM值差异均无统计学意义。循环加载至预定加载次数后X线片示撑开器无移位,棘突无骨折;未发现棘突撑开装置变形或出现裂缝。结论:经皮置入式棘突间撑开器能够使置入节段前屈和后伸的活动度明显减少,但轴向旋转和侧向弯曲不受影响,且对邻近上位节段的活动度无影响。     

腰椎后路微创动态内固定技术的研究进展

<正>近年来,腰椎后路动态内固定技术的研发及应用发展迅速,其种类繁多,主要包括动态内固定器械的设计及新材料的应用,但绝大多数需行开放手术。与传统开放减压植骨融合固定术比较,微创减压附加非融合固定的Hybrid手术日益得到重视。笔者针对几种可经皮微创置入的腰椎后路动态内固定技术综述如下。1微创动态内固定装置1,1微创棘突间撑开装置通过在棘突间置入撑开装置,在棘突间持续加载一定程度的撑开力,基本保留了椎间的生理活动,扩大了椎     

椎板开窗减压Coflex动态固定治疗中度腰椎管狭窄症的疗效评价

【摘要】 目的：探讨椎板开窗减压Coflex棘突间撑开装置动态固定治疗中度腰椎管狭窄症的疗效。方法：2007年10月至2008年7月,采用椎板开窗减压后Coflex棘突间撑开装置动态固定治疗32例中度腰椎管狭窄症患者,均为L4/5节段。男14例,女18例,年龄38~60岁,平均47岁。对患者术前、术后及不同随访时间分别摄腰椎正侧位及动力位X线片,测量手术间隙椎间隙前、后缘高度,椎间孔高度及活动范围,同时对患者进行Os?鄄westry功能障碍指数（ODI）和疼痛视觉模拟评分（VAS）评定。结果：术后随访19     

不同的棘突间撑开高度对置入节段椎间盘压力分布及关节突关节应力影响的体外生物力学实验研究

目的测量棘突间不同的撑开程度情况下节段椎间盘负荷分布及关节突关节应力情况,以指导其使用。方法 6具腰椎标本,测量SMIPD置入前后椎间盘及关节突关节的受力,分为7组:①空白组,②～⑦SMIPD支撑组,每组间隔2 mm。结果高度10 mm对置入节段椎间盘及关节突关节的压力分布无显著性影响;12 mm过伸时分担46%的椎间盘后纤维环负荷,降低关节突关节压力;14 mm降低后环及关节突关节负荷,但增大前环负荷;16～20 mm后环及关节突关节负荷显著降低,前环负荷增大。结论支撑高度等于或略大于中立位棘突间高度的IPD可分担椎间盘后环及关节突关节负荷并使椎间盘应力更均匀分布;但支撑高度过大会明显增大前环的负荷,如果用于NIC患者的椎间孔撑开,可能会加快椎间盘的退变。     

棘突间撑开系统的研究现状

正腰椎退变性疾病包括腰椎不稳、腰椎椎间盘突出、腰椎椎管狭窄、退行性腰椎滑脱等,非手术治疗无效时需手术干预。传统椎管减压融合术可能带来腰椎活动度缺失、生物力学特征改变、邻近节段退变(ASD)不同程度加速等不良后果~([1])。因此,非融合术式应运而生。棘突间撑开系统作为非融合系统之一,在棘突间提供持久的撑开力,可限制腰椎后伸活动、增加椎间高度、减轻椎间盘后部压力、减少黄韧带皱褶、扩大神经根管空间,通过替代应用于责任节     

单节段前后路联合手术治疗难复性下颈椎脱位

目的 介绍应用短节段固定使难复性下颈椎脱位复位稳定的方法。方法 2003年5月～2004年4月我院采用单节段前后路联合手术治疗难复性下颈椎脱位的患者15例，所有的患者外伤超过4周，有Facet关节交锁，牵引难以复位。我们通过后路关节突松解，棘突间用爱昔康1号线紧缩。前路椎间撑开人工骨植入，AO板内固定。结果 所有患者通过后路关节松解，前路椎间撑开植入人工骨，均得到满意的复位和良好的颈椎序列。结论 通过后路关节松解联合前路椎间撑开复位使颈椎得到复位和序列。     

Interspinous process spacers

The patient with neurogenic claudication resulting from lumbar spinal stenosis who fails to experience satisfactory relief from nonsurgical measures has limited treatment options. Lumbar epidural steroid injections and surgical laminectomy are generally accepted alternatives for the patient with moderate to severe symptoms. Interspinous process spacers, a relatively new class of technology, are proposed for use in the patient who prefers less invasive surgery or in whom medical comorbidities preclude a major surgical procedure. Early data from biomechanical and clinical studies support the short-term efficacy of interspinous process spacers in treating claudication related to spinal stenosis. Sufficient medium- and long-term data are lacking, however, particularly with respect to durability of symptomatic relief and the risk of device migration or dislocation. Although interspinous process spacers are a promising new technology, the results of longer-term clinical follow-up studies are needed to more clearly define their role in the management of lumbar spinal stenosis.     

Development of percutaneously insertable/removable interspinous process spacer for treatment of posture-dependent lumbar spinal-canal stenosis: preclinical feasibility study using porcine model

Purpose

A procedure using an interspinous process spacer (IPS) was recently developed for the treatment of posture-dependent lumbar spinal-canal stenosis (LSS) patients. We developed a novel IPS which can be inserted with simpler procedures and removed percutaneously. The objectives of this study were: (1) to evaluate the feasibility and safety of this novel technique, and (2) to assess the effectiveness of this spacer in terms of preventing an increase of epidural pressure in lumbar extension using a porcine model.

Methods

Eight young pigs were used. Under general anesthesia and image guidance, the spacers were inserted. Three months after operation, MR images were taken and all spacers were removed. Blood samples were obtained before and 1, 3, 7 days after surgery. After killing the animals, the lumbar spines were observed macroscopically. Another six animals were used. Under general anesthesia and image guidance, a flexible pressure transducer was inserted into the epidural space and epidural pressure was measured in neutral and at maximum extension with and without spacer insertion.

Results

Percutaneous insertion and removal of the spacer was successful for all animals through small skin incisions. MR images showed minimal damage to the muscle. No significant up-regulation of Interleukin-6 (IL-6) and CRP was detected. Macroscopic observation of the lumbar spine 3 months after the operation revealed that the area of the interspinous process contacting with the inserted spacer showed some bone erosion/remodeling. Insertion of the spacer did not affect the epidural pressure in neutral but significantly prevented an increase of epidural pressure in lumber extension.

Conclusions

This study demonstrated that the percutaneous insertion and removal of a novel IPS was feasible and safe using a simple technique. Furthermore, this procedure can be recognized as minimally invasive surgery from the viewpoint of skin incision, short insertion track, inflammatory mediators, and muscle damage. Improvements should be attempted in future studies using softer or more elastic materials for the spacer to lessen bone erosion/remodeling at contacting area of the inserted spacer.     

Dynamic lumbar stabilization with the Wallis interspinous implant

The primary goal of the Wallis system is to relieve or prevent low back pain that accompanies intervertebral segment (IVS) instability by increasing stiffness of the mobile segment, and unloading the disc and facet joints. Furthermore, restoring a more physiological biomechanical environment to the degenerate lumbar segment with the Wallis implant may foster healing of the disc and slow the degenerative cascade of adjacent segments. The implant, consisting of an interspinous process spacer that limits extension and two flexion-limiting bands, is intended to improve the stability of the treated intervertebral lumbar segment while preserving its mobility and local lordosis. Because the operation leaves all the anatomical elements intact except for the interspinous ligament, the entire range of other surgical options remains open, including more invasive surgical solutions such as total disc replacement or fusion. Most often associated with decompressive procedures, i.e., discectomy, undercutting to enlarge the spinal canal, or both, intervertebral stabilization using the Wallis implant takes less than 15 minutes. This stabilizing procedure is detailed in the present paper.     

Percutaneous interspinous spacer versus open decompression: a 2-year follow-up of clinical outcome and quality of life

Purpose

Percutaneous interspinous stand-alone spacers offer a simple and effective technique to treat lumbar spinal stenosis with neurogenic claudication. Nonetheless, open decompressive surgery remains the standard of care. This study compares the effectiveness of both techniques and the validity of percutaneous interspinous spacer use.

Methods

Forty-five patients were included in this open prospective non-randomized study, and treated either with percutaneous interspinous stand-alone spacers (Aperius^®) or bilateral open microsurgical decompression at L3/4 or L4/5. Patient data, operative data, COMI, SF-36, PCS and MCS, ODI, and walking distance were collected 6 weeks, 3, 6, 9, 12, and 24 months post-surgery.

Results

Group 1 (n = 12) underwent spacer implantation, group 2 (n = 33) open decompression. Five patients from group 1 required implant removal and open decompression during follow-up (FU); one patient was lost to FU. From group 2, seven patients were lost to FU. Remaining patients were assessed as above. After 2 years, back pain, leg pain, ODI, and quality of life improved significantly for group 2. Remaining group 1 patients (n = 6) reported worse results. Walking distance improved for both groups.

Conclusion

Decompression proved superior to percutaneous stand-alone spacer implantation in our two observational cohorts. Therapeutic failure was too high for interspinous spacers.     

棘突间固定系统与融合固定系统联合应用治疗腰椎退变性疾患

目的 探讨棘突间固定系统和融合固定系统联合应用治疗腰椎退变性疾患的可行性和临床效果.方法 2007年9月至2008年9月,联合应用棘突间固定系统和融合固定系统治疗腰椎退变性疾患患者16例.术前术后进行腰痛VAS评分,下肢痛VAS评分,腰椎JOA评分(29分法)评定,观察临床症状改善情况;采用Prolo腰椎功能评定标准评定术后功能改善情况;术后拍摄腰椎正侧位X线片判定内固定物的位置及有无棘突骨折;测量植入棘突间固定系统节段屈伸活动度和以及非融合固定节段与融合固定节段中间正常节段的屈伸活动度.结果 16例患者均获得完整随访,随访时间平均17.6个月(10～22个月).末次随访时腰痛VAS评分、下肢痛VAS评分、腰椎JOA评分和Prolo功能评分与术前相比差异均有统计学意义(P<0.01);末次随访时植入棘突间固定系统节段屈伸活动度(9.8±4.2)°;非融合固定节段与融合固定节段之间正常节段屈伸活动度为(13.2±3.5)°.结论 棘突间固定系统和融合固定系统联合应用治疗腰椎退变性疾患为临床避免腰椎长节段固定融合及相关并发症提供了新的思路,短期临床效果满意.     

Wirbelsäule: Implantate und Revisionen

Non-fusion spinal implants are designed to reduce the commonly occurring risks and complications of spinal fusion surgery, e.g. long duration of surgery, high blood loss, screw loosening and adjacent segment disease, by dynamic or movement preserving approaches. This principle could be shown for interspinous spacers, cervical and lumbar total disc replacement and dynamic stabilization; however, due to the continuing high rate of revision surgery, the indications for surgery require as much attention and evidence as comparative data on the surgical technique itself.     

In-Space经皮棘突间撑开系统治疗腰椎不稳症的初步效果分析

 目的 探讨In-Space经皮棘突间撑开系统治疗腰椎不稳症的初期临床效果。方法 回顾性分析2009年5月至2011年6月采用In-Space经皮棘突间撑开系统治疗腰椎不稳18例患者资料,男10例,女8例;年龄39～58岁,平均48.6岁;L_3,4 5例,L_4,5 13例。患者均伴有不同程度的腰椎过伸性腰背疼痛症状,并伴有一侧下肢的节段性放射性疼痛,屈曲位时缓解。采用视觉模拟评分(visual analogue scale,VAS)对手术前后疼痛进行评估;采用Oswestry功能障碍指数(Oswestry disability index,ODI)对手术前后腰椎功能进行评价。测量术前及术后手术节段棘突间距离、椎间隙前后缘高度、椎间孔高度和宽度、前凸角以及活动度,并进行比较。结果 18例患者均获得随访,随访时间18～36个月,平均(25±2.9)个月。术后6周及末次随访VAS评分为(3.1±1.3)分和(1.5±0.8)分,与术前(7.9±2.1)分比较,差异有统计学意义;术后6周及末次随访ODI为54.7%±14.8%和10.1%±2.5%,与术前82.1%±13.1%比较差异有统计学意义。术后棘突间距离为(9.29±1.43) mm,椎间隙后缘高度为(11.28±0.85) mm,椎间孔高度和宽度分别为(21.27±1.01) mm和(10.83±0.73) mm;节段前凸角及节段活动度分别为7.62°±0.74°和6.34°±0.81°。患者切口均一期愈合,无一例发生棘突骨折、脊髓损伤、脑脊液漏及装置移位、脱出等并发症。结论 In-Space棘突间撑开系统治疗腰椎不稳退行性疾病简便安全,初期随访疗效良好。     

MRI evaluation of dural sac enlargement by interspinous process spacers in patients with lumbar spinal stenosis: Does it play a role in the long term?

BackgroundTo investigate dural sac enlargements and spinal alignments in patients who underwent indirect decompression with interspinous spacers.MethodsThe subjects were 20 patients who underwent indirect decompression using an interspinous spacer (X-STOP) without laminectomy. Of these 20 patients, 1 patient underwent implant removal surgery 1 month after X-STOP surgery and two patients dropped out. Ultimately, 17 patients were included in this study. MRI and X-ray images were investigated before surgery, 1 week after surgery, 3 months after surgery, and 2 years after surgery.ResultsOn MRI, the mean cross-sectional areas of the dural sac were 52.7 mm² before surgery, 73.2 mm² 1 week after surgery, 62.4 mm² 3 months after surgery, and 58.3 mm² 2 years after surgery. There was a significant 37% increase at 1 week postoperatively compared with that before surgery, but there were no significant differences between 3 months postoperatively and 2 years postoperatively. The disc angle in an extension posture was significantly decreased at 1 week after surgery compared with that before surgery, but there were no significant differences between before surgery, 3 months after surgery, and 2 years after surgery.ConclusionsThe interspinous process spacer increased the dural sac area by 37% 1 week after surgery, but the enlargement was not maintained at 3 months or 2 years after surgery. The use of interspinous process spacers produced an enlargement of the dural sac by limiting extension of the stenotic level only. However, its effect diminished 2 years after surgery.     

Interspinous spacers versus posterior lumbar interbody fusion for degenerative lumbar spinal diseases: a meta-analysis of prospective studies

Purpose

Our aim is to evaluate the safety and effectiveness of interspinous spacers versus posterior lumbar interbody fusion (PLIF) for degenerative lumbar spinal diseases.

Methods

A comprehensive literature search was performed using PubMed, Web of Science and Cochrane Library through September 2015. Included studies were performed according to eligibility criteria. Data of complication rate, post-operative back visual analogue scale (VAS) score, Oswestry Disability Index (ODI) score, estimated blood loss (EBL), operative time, length of hospital stay (LOS), range of motion (ROM) at the surgical, proximal and distal segments were extracted and analyzed.

Results

Ten studies were selected from 177 citations. The pooled data demonstrated the interspinous spacers group had a lower estimated blood loss (weighted mean difference [WMD]: ?175.66 ml; 95 % confidence interval [CI], ?241.03 to ?110.30; p?<?0.00001), shorter operative time (WMD: ?55.47 min; 95%CI, ?74.29 to ?36.65; p?<?0.00001), larger range of motion (ROM) at the surgical segment (WMD: 3.97 degree; 95%CI, ?3.24 to ?1.91; p?<?0.00001) and more limited ROM at the proximal segment (WMD: ?2.58 degree; 95%CI, 2.48 to 5.47; p?<?0.00001) after operation. Post-operative back VAS score, ODI score, length of hospital stay, complication rate and ROM at the distal segment showed no difference between the two groups.

Conclusions

Our meta-analysis suggested that interspinous spacers appear to be a safe and effective alternative to PLIF for selective patients with degenerative lumbar spinal diseases. However, more randomized controlled trials (RCT) are still needed to further confirm our results.