生物陶瓷人工椎体系统重建椎体缺损的研究

目的检测由脊柱前路解剖型固定钢板,生物陶瓷与骨水泥等组成的生物陶瓷人工椎体系统临床应用的可行性。方法选健康2～4岁山羊14只,平均体重28．6kg,经氯胺酮诱导,气管插管,安氟醚吸入麻醉后,取右下腹腹膜外斜切口,前路切除L4椎体后,应用钛合金解剖型固定钢板、骨水泥、磁性生物陶瓷组成的“生物陶瓷人工椎体”植入体内。结果一般情况：所有试验动物均成活,术后8h即可恢复站立,行走（不使用任何外固定支架）;24h后恢复正常行走,进食。术后6个月,腹部彩色B超检查未见血拴形成,腹部大血管血供正常。定期X线检查,肉眼大体标本观察,光境观察,扫描电镜（SEM）观察,材料与骨实现“生物愈合”。结论“生物陶瓷人工椎体系统”是一个制约性固定结构,类似于“钢筋骨水泥”,稳定性极强,能够保证生物材料与椎骨的“生物愈合”,形成“生物固定”,减少了长期固定“松动”发生的可能,整个系统操作简单,使用安全。具有极大的临床使用价值。     

可吸收颈椎融合器在山羊颈椎融合动物模型中的应用

目的对聚-L-乳酸／羟基磷灰石复合材料(HA／PLLA)颈椎椎间融合器进行山羊颈椎融合试验研究。方法12只成年雄性山羊,支气管内麻醉,于C3、4椎间隙植入HA／PLLA颈椎椎间融合器,术后3、6、9、12个月进行放射学观察、生物力学评价。结果12只雄性山羊均存活良好,术后即开始正常行走,未见明显神经系统并发症,体重、饮食均无异常,术后12个月所有山羊均发生了融合(3级),融合率明显高于钛合金颈椎椎间融合器组。结论可吸收颈椎椎间融合器具有并发症少、融合率高、人工可吸收等特点,是今后较理想的颈椎融合材料。     

陈旧性创伤性腰椎管狭窄症的后路手术治疗

[目的] 探讨采用椎板减压、髓核摘除、椎体间植骨融合并CAPSTONE融合器植入、椎弓根螺钉内固定的方法(TLIF)对陈旧性创伤性腰椎管狭窄、腰椎轻度后突、椎间隙狭窄的后路手术治疗.[方法] 因创伤造成下腰椎椎管、椎间隙狭窄,腰椎轻度后突畸形20例,男13例,女7例;年龄22～49岁,平均31.4岁.其中L3、44例,L4、5,10例,L5S16例.1例患者为伤后4年接受手术,3例患者为伤后9～15个月手术,6例患者为伤后3～6个月手术,10例患者为伤后1～3个月手术.所有病例均采用狭窄部位的椎板扩大减压,髓核摘除、椎体问植骨融合并CAP-STONE融合器植入、椎弓根螺钉内固定的方法(TLIF)进行手术治疗.术后1周,病人配带胸腰髂支具下床活动.[结果] 经上述手术方法处理的病例,术后1周内病人的腰痛、下肢疼痛、肌力及感觉的减退均有不同程度的恢复,术后x线片证实,狭窄的腰椎间隙恢复,同时恢复了腰椎的生理弯曲.经1～3年的临床随访,20例患者均有明显的神经功能恢复和改善,平均Frankel分级改善1.4级.复查X线片,20例患者植骨均愈合,椎间隙高度及生理弯曲角度没有丢失.[结论] 对陈旧性、创伤性腰椎管狭窄患者,恢复椎体原有的高度已不可能,在进行减压解除对神经压迫的同时,进行椎体间的植骨,同时植入椎问融合器,用椎弓根钉棒系统进行固定,既有利于植骨愈合,恢复椎间隙高度,恢复腰椎的生理弯曲,又有利于病人早期下床进行功能锻炼,防止卧床带来的并发症.此方法简单,操作便利,临床并发症少,值得临床推广.     

腰椎体复位融合器的研制与临床应用

目的：探索一种预防和治疗椎体滑脱和下腰椎不稳的新方法。方法：应用自行研制的框架式腰椎体复位器和螺旋式椎体融合器，经过实验室测试及标本实验后应用于临床。结果：融椎器能使椎间关节界面骨与植入融椎器内骨组织紧密接触，利于骨性愈合。要５２例１～４年临床观察，植骨无吸收，融椎器无移位，椎间隙保持或恢复正常高度，经摄Ｘ线片观察椎体无滑脱，腰椎生理弧度明显恢复，优良率达９５．４％。结论：框架式复位器使椎体复位固定满意，螺旋式椎体融合器使椎体间融合可靠，是一种治疗腰椎体滑脱症较满意的新方法     

扩张型椎间融合器治疗腰椎不稳定的临床观察

[目的]通过对腰椎不稳定患者使用扩张型椎间融合器治疗的临床观察，探讨其在腰椎不稳定中的治疗效果、适应证和注意事项。[方法]对42例患者均采用后路椎管减压，椎间盘组织切除，扩张型椎间融合器植入椎间融合，观察治疗效果。[结果]术后经6个月～6年随访，JOA评分优良率为95％，椎间隙高度恢复率、复位率、骨愈合率均达98．6％。[结论]正确选择手术适应证，注意术中技术操作，扩张型椎间融合器治疗腰椎不稳定可有效恢复椎间隙高度，提高骨愈合率。对Ⅰ-Ⅱ度腰椎滑脱可有效复位，保持腰椎稳定，改善临床症状，是一种治疗腰椎不稳定的理想方法。     

rhBMP-2/CPC对骨质疏松骨缺损的治疗作用的研究

目的 探讨磷酸钙骨水泥复合rhBMP-2对骨质疏松骨缺损的治疗作用.方法 以卵巢切除法对10只成年山羊去势,低钙膳食6个月后建立骨质疏松模型;手术去除每只动物L2、L4椎体部分侧方骨质,造成约5 mm×10 mm×10mm大小骨缺损,将动物随机分成2组,一组植入rhBMP-2/CPC作为实验组,另一组植入CPC作为对照组;术后1周、9周分别采用双能x线吸收骨密度仪检测手术椎体骨密度、CT三维成像观察骨缺损愈合情况,术后9周手术椎体进行牛物力学检测,制作椎体不脱钙切片进行骨组织计量学分析.结果 术后骨密度检测实验组与对照组间差异无显著性,但实验组在骨缺损愈合状况、骨小梁微结构及骨牛物力学性能等方面均显著优于对照组.结论 应用rhBMP-2/CPC能改善局部骨质疏松,促进骨质疏松骨缺损愈合,达到治疗骨质疏松骨折骨缺损的目的 .     

椎弓根钉系统固定联合单枚融合器椎间植骨融合治疗腰椎滑脱症

治疗腰椎椎体滑脱症的手术方法很多,经后路椎体间融合术(posterior lum-bar interbody fusion,PLIF)因具有有效撑开椎间隙,恢复前、中柱承重及融合率高等优点,已在国内外得到公认[1].我院自2004-03-2007-05,采用椎弓根钉置入同时行单枚融合器椎间植骨融合术治疗腰椎滑脱症,术中采用先半椎板或全椎板减压,椎弓根螺钉固定.撑开椎间隙,体外辅助提拉复位同时行钉棒复位,椎间隙前1/4植入骨粒再行单枚融合器椎间植骨融合术治疗腰椎滑脱症28例,取得良好疗效,现报告如下:     

后路单枚椎间融合器附加椎弓根螺钉治疗峡部型腰椎滑脱症的疗效观察

目的探讨单枚CAGE椎间融合器后路斜向植入附加椎弓根螺钉治疗峡部型腰椎滑脱症的临床疗效。方法对12例Ⅱ°～Ⅲ°峡部型腰椎滑脱症患者行CAGE后路斜向植入椎体间融合术附加短节段椎弓根螺钉内固定术。结果所有患者术后滑脱有不同程度复位,椎间隙增高,滑脱角改善;随访12～28个月,平均20个月,矫正程度无丢失,CAGE无下陷、滑移,椎间隙高度无丢失,所有病例术后12～18月均获骨性愈合。结论CAGE椎间融合器能使滑脱椎体间接复位,直接撑开椎体前中柱,恢复椎间隙高度,维持腰椎的生理弧度,提高融合率;椎弓根螺钉系统有直接复位滑脱椎体,两者结合能提供内在稳定和支撑作用,疗效满意,适用于峡部型腰椎滑脱症的治疗。     

前路腰椎椎体间融合术的生物力学研究

前路腰椎椎体间融合术(ALIF)具有诸多优势,临床应用越来越多.关于ALIF的生物力学稳定性研究国外开展较多,但结果并不完全一致.应根据不同需要合理选择ALIF试验模型,人类尸体,动物尸体、有限元模型、其他替代模型等各有优缺点.单纯ALIF术后椎间获得即刻稳定性是根据"撑开一压缩"原理.前路椎间植入融合器后能够增加除了后伸动作以外的其他各方向稳定性,目前大多数关于ALIF的生物力学测试均针对即刻稳定性,然而融合器植入椎间隙后纤维环弹性逐渐丧失及融合器陷入终板内均会使椎间稳定性逐渐降低,因此椎间融合稳定性还取决于界面骨长入速度等术后因素.影响ALIF稳定性的因素有预负荷、辅助内固定、相邻椎体骨质量等.     

异种骨椎间融合器椎弓根钉固定腰椎体间融合术的生物力学评价

[目的]评价异种骨椎间融合器行后路腰椎椎体间融合的即刻稳定效果及自身强度.[方法]取16具新鲜成年男性L1～5腰椎标本,分别对完整L1～5（正常组）;模拟后路间盘L3、4摘除置融合器（对照1组）;模拟后路间盘L3、4、L4、5摘除置融合器（对照2组）;模拟后路间盘L3、4摘除置融合器附加椎弓根钉固定（对照3组）;模拟后路间盘L3、4、L4、5摘除置融合器附加椎弓根钉固定（对照4组）进行前屈、后伸、扭转、轴向压缩和腰椎移位时融合器的最大拨出力及粘弹性实验研究.[结果]显示椎间融合器植入后腰椎压缩、前屈、后伸、位移和扭转角度较正常组有一定差异,但不显著（P＞0.05）;而椎间植入融合器附加椎弓根固定,压缩、前屈、后伸、位移、扭转角度较正常组差异显著（P＜0.05）.腰椎移位时拨出力实验结果表明,对照1、2融合器植入椎体移位时最大拨出力为1.83KN.对照1、2、3、4组7 200s三应力松驰量和蠕变量较正常组差异不显著（P＞0.05）,对照3、4组初始蠕变量明显低于正常组和（1、2组）.[结论]异种骨椎间融合器具有足够的支撑、抗滑、维持或增加椎间隙高度的功能,符合生物力学及临床要求.     

Influence of orthopedic implant structure on adjacent bone density and on stability

We evaluated the ability of a porous metallic interbody fusion implant made with porous nitinol (PNT) to achieve intervertebral fusion and the capacity of stabilization at the implantation site 3, 6, and 12 months after implantation. Sixteen sheep each received 1 PNT implant and 1 titanium (TiAIV) cage at intervertebral lumbar levels L2-L3 and L4-L5; 3 other sheep were used as untreated controls. The TiAIV cage was used as a control implant. After animal sacrifice, computed tomography was used to study peri-implant bone mineral density (BMD), and histologic slices were used to evaluate implant osseointegration. BMD around PNT implants was close to physiological (control value) BMD, whereas BMD around TiAIV cages was usually higher (sclerosis) than physiological BMD. Histologic analysis showed better osseointegration with PNT implants than with TiAIV cages. Sclerosis might result from bone acting to stabilize implants in their implantation sites. Compared with PNT implants, TiAIV cages seemed to be unstable in their implantation sites. For PNT implants, osseointegration was successful, and surrounding BMD was close to physiologic BMD.     

Osseointegration study of porous nitinol versus titanium orthopaedic implants

The functionality of a new metallic interbody fusion implant manufactured out of porous nitinol (PNT) was evaluated in sheep and compared to a conventional titanium (TiAIV) intervertebral cage packed with autologous iliac crest bone. Both device types were implanted at two non-contiguous intervertebral lumbar sites. The objective was to evaluate the osseointegration capacity after 3, 6 and 12 months of implantation in the presence of these two implant types subjected to the same mechanical loads. Two-dimensional radiology, computer tomography and histology were used as techniques of parameter evaluation. The results indicated that PNT obtained a better intervertebral osseointegration capacity compared to the TiAlV cage. The functional difficulties of the titanium implant were related to its instability at the implantation site possibly due to a biofunctionality problem. The biocompatibility of both implants seemed comparable, however.     

Influence of biomaterial structure and hardness on its osseo-integration: histomorphometric evaluation of porous nitinol and titanium implants

The aim of this research was to evaluate and compare the bone integration and apposition capacities of two metallic intervertebral fusion implants, porous nitinol (PNT: porous Nickel Titanium Naval Ordonance Laboratory) and titanium intervertebral cage, in the sheep lumbar spine. Sixteen sheep received two implants each at L2–L3 and L4–L5 lumbar levels so as to subject both the implants to the same mechanical loads. The sheep were then sacrificed at 3, 6 and 12 months post-implantation periods. Lumbar segments were then harvested. A qualitative (macroscopic and microscopic observation) and quantitative (histomorphometric) analysis of bone integration and apposition was carried out on histological slides. The results indicated that the PNT obtained the better bone integration and apposition compared to titanium cage. The osseo-integration of each implant seemed to be influenced by its structure and its hardness. However, the biocompatibility of two implants seemed comparable.     

Traumatic intervertebral disc lesion – magnetic resonance imaging as a criterion for or against intervertebral fusion

Lesions of the intervertebral disc accompanying vertebral fractures are the subject of controversy and discussion regarding the extent and manner of surgical intervention. The question of when to perform disc resection and intervertebral fusion, in particular, has not been answered satisfactorily. In order to evaluate short- and medium-term lesions of the discoligamentous complex associated with thoracolumbar burst fractures, magnetic resonance images made after stabilisation and again after implant removal were compared. Between 1997 and 1998, 20 patients who had suffered thoracolumbar burst fractures (AO classification A3 and B1 [26]) underwent posterior reduction and stabilisation using a Universal Spine System (USS, Synthes, Switzerland) titanium internal fixator. The implant was removed after an average of 10 months. Magnetic resonance imaging (MRI) scans were performed 1 week after both operations, allowing the changes in a total of 40 intervertebral discs adjacent to the fractured vertebral body to be investigated. The analysis was based on signal intensity of the intervertebral disc in T2-weighted scans and on morphological criteria. A total of 81% of the discs with initially normal T2-weighted signal showed the same signal after implant removal; 5 discs with initially increased signal intensity in T2-weighted scans normalised, 5 showed a decrease in intensity and 3 suffered a partial loss of signal. Among the 9 discs with initially decreased T2-weighted signal, only one had normalised by the time the implant was removed. A total of 86% of the 14 morphologically intact discs retained their structural integrity. Of the 25 discs with minor defects, only one could be considered as intact after implant removal, 15 remained the same and 9 deteriorated in structure. No disruption of the fibrous ring or of the posterior longitudinal ligament was observed, nor was there any prolapse of intervertebral discs. When the intervertebral disk is intact and has normal morphology and a normal T2-weighted MRI signal, resection or fusion of the fracture adjacent discs appears unjustified. In our opinion, the results do not support the possibility of predicting degradation in those discs that showed an altered T2-weighted signal after the first operation.     

SOLIS在颈椎前路融合术中的应用

目的 探讨新型颈椎前路融合器(SOLIS)在颈椎前路融合术中的应用效果.方法 对18例脊髓型颈椎病、12例颈椎间盘突出症采用颈椎前路减压融合术,小切口入路(3～4 cm),椎间盘及部分椎体后缘切除后保留椎体终板,植人带自体松质骨的SOLIS.以手术前后X线片及JOA评分评价疗效.结果 30例随访6～18个月,平均12.5个月.置人的SOLIS位置良好,无移动及脱出迹象;病变椎间隙高度恢复正常,未见椎间高度丢失;所有节段均于术后3～8个月骨性融合.术前JOA评分平均10.4分,术后平均14.9分,两者有统计学意义(P＜0.01).结论 颈椎前路融合器SOLIS具有良好的生物相容性,手术创伤小,能有效地恢复颈椎高度,融合率高,融合后稳定性好,神经功能改善优良率高.     

帽式颈椎椎间融合器的活体实验研究

目的 本研究在活体山羊颈椎上从椎间支撑能力、二期生物力学稳定性及椎间融合组织学方面比较三面皮质骨、Harms椎间融合器（cage）、Carboncage及自行所研制的帽式颈椎椎间融合器（hat　type　cervical　intervertebral　fusion　cage,HCIFC）的术后效果。方法　取32头山羊随机平均分为4组：第1组自体三面皮质髂骨;第2组Harmscage;第3组Carboncage;第4组HCIFC。分别行C3,4椎间盘切除术并分别植入以上内植物。术后共观察12周并测量平均椎间高度（DSH）、椎间角（IVA）及前凸角（LA）,处死后进行影像学、生物力学及组织学评估。结果 术后1周方盒形HCIFC、Carboncage组的平均DSH、IVA及LA要显著大于垂直圆柱体Harmscage和三面皮质骨组（P〈0．05）;术后12周时3个cage组的平均DSH、IVA及LA显著高于三面皮质骨组（P〈0．05）。垂直圆柱体Harmscage轴向旋转和侧屈时平均刚度显著大于其他组（P〈0．001）,轴向旋转时的最大活动度要显著低于其他组（P〈0．05）。与三面皮质骨组相比,3个cage组的椎间融合效果略好。结论HCIFC的椎间支撑能力、生物力学性能及椎间融合效果均适合于临床使用。     

颈椎椎间融合器融合效果的在体动物研究

目的在活体山羊颈椎上比较三面皮质自体骨、垂直圆柱体Harmscage及方盒形Carboncage的椎间融合效果。方法取24只成年雄性山羊,随机分为三组:自体骨组、Harmscage组及Car-boncage组。所有动物均行C3-4椎间盘切除术并分别植入以上内植物。于术前、术后即刻及术后1、2、4、8、12周摄颈椎正侧位X线片,于侧位X线片上测量平均椎间高度、椎间角及前凸角;术后12周处死动物,取C3,4节段标本进行组织学评估。结果术后1周Carboncage组的平均椎间高度、椎间角及前凸角大于Harmscage组和自体骨组(P<0.05);术后12周两个cage组的平均椎间高度、椎间角及前凸角均大于自体骨组,差异有统计学意义(P<0.05)。术后12周依据融合分级标准对三组进行影像学评估,和自体骨组比较,两个cage组的骨融合效果略好,但无统计学意义;组织形态学亦发现两个cage组的椎间融合效果较好,但与自体骨组比较差异无统计学意义。垂直圆柱体Harmscage中形成的新生骨量多于方盒形Carboncage。结论方盒形Carboncage具有良好的椎间支撑能力,而垂直圆柱体Harmscage的椎间融合效果更好。     

In vivo experimental study of hat type cervical intervertebral fusion cage (HCIFC)

The purpose of this study was to compare the characteristics of interbody fusion achieved using the hat type cervical intervertebral fusion cage (HCIFC) with those of an autologous tricortical iliac crest graft, Harms cage and the carbon cage in a goat cervical spine model. Thirty-two goats underwent C3-4 discectomy and fusion. They were subdivided into four groups of eight goats each: group 1, autologous tricortical iliac crest bone graft; group 2, Harms cage filled with autologous iliac crest graft; group 3, carbon cage filled with autologous iliac bone; and group 4, HCIFC filled with autologous iliac graft. Radiography was performed pre- and postoperatively and after one, two, four, eight and 12 weeks. At the same time points, disc space height, intervertebral angle, and lordosis angle were measured. After 12 weeks, the goats were killed and fusion sites were harvested. Biomechanical testing was performed in flexion, extension, axial rotation, and lateral bending to determine the stiffness and range of motion. All cervical fusion specimens underwent histomorphological analyses. One week after operation, the disc space height (DSH), intervertebral angle (IVA) and lordosis angle (LA) of HCIFC and carbon cage were statistically greater than those of autologous iliac bone graft and Harms cage. Significantly higher values for DSH, IVA and LA were shown in cage-treated goats than in those that received bone graft over a 12-week period. The stiffness of Harms cage in axial rotation and lateral bending were statistically greater than that of other groups. Radiographic and histomorphological evaluation showed better fusion results in the cage groups than in the autologous bone group. HCIFC can provide a good intervertebral distractability and sufficient biomechanical stability for cervical fusion.