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球囊扩张骨水泥填充治疗股骨头缺血坏死的实验性研究
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摘要
研究背景:股骨头缺血性坏死是指不同原因导致股骨头血供破坏或骨细胞变性导致骨的有活力成分死亡的病理过程。依据发病原因包括创伤性非创伤性两种,但其病理过程和自我修复的过程都是相似的,都是导致股骨头的松质骨和软骨下骨出现坏死,纤维性修复后其力学强度逐步下降。在早期并不出现明显的骨结构和力学性能的改变,但在股骨头负重情况下,由于修复坏死区域的力学性能差,不能承重和传递应力,导致股骨头塌陷。如果不及时进行有效治疗,80%的股骨头坏死患者会在1~3年内发生股骨头塌陷,严重者不得不接受关节置换手术治疗。对于中青年股骨头缺血性坏死的病人应用人工关节置换术并发症发生率高,远期效果不理想。对于股骨头缺血性坏死的患者,采用保留股骨头的治疗方法,预防或延缓股骨头的塌陷,可以使患者免除或者延缓人工关节置换术。
     保留股骨头的外科手术治疗术式较多。早期降低股骨头内的压力,改善股骨头的血运,利用股骨头的自我修复能力修复坏死区。研究认为坏死区域的力学性能的下降是导致继发出现股骨头塌陷的主要原因,因而设想通过骨移植对股骨头软骨下进行力学支撑,来预防或延缓塌陷的发生。但是单纯的骨移植术由于移植物的力学性能不足以即刻支撑股骨头负重,带血管蒂骨瓣转移术的术式需要较高的显微外科技术,且供区致病率高。多孔钽棒植入术对于坏死范围广泛和多发病变,以及合并慢性疾患需长期应用激素治疗的患者,其治疗效果不佳。总之,现有的各种保留股骨头的外科手术方法,对防治股骨头坏死塌陷都存在不同程度的不足之处。
     骨水泥或者骨替代材料填充骨坏死的缺损部位是股骨头缺血性坏死的一种治疗方法,其基本操作是清除股骨头坏死区坏死组织并填充骨水泥成分或者其他替代材料,使塌陷的软骨面复位,重建股骨头的球形轮廓,并且增加股骨头坏死区域的强度,避免再次出现塌陷。目前对其具体的机制尚不清楚。椎体后凸成型技术经皮穿刺后,利用球囊扩张后对压缩的椎体复位并在椎体内形成空隙,在低压下缓慢注入骨水泥。后凸成型技术具有微创、改善疼痛症状好,安全,便于操作等优点,被广泛接受和应用。应用后凸成型技术的微创操作技术,经皮穿刺,将球囊通过穿刺的工作管道植入股骨头的坏死区域,行球囊扩张后,恢复股骨头塌陷的外形,并在局部造成空隙,可以在低压状态下注入骨水泥或者相应替代物填充空隙,对股骨头软骨下骨进行有效支撑,可能会通过增加股骨头坏死区域的力学强度,改善股骨头的力学性能,避免或者延迟出现股骨头塌陷的时间。
     目的:建立球囊扩张骨水泥填充和股骨头缺血性坏死的三维有限元分析模型,采用有限元分析方法模拟加载,分析股骨头股骨头不同部位应力分布情况,并进行标本生物力学测试进行验证,探讨球囊扩张骨水泥填充对缺血性坏死股骨头的生物力学影响。
     方法:
     1.建立球囊扩张骨水泥填充和股骨头缺血性坏死的三维有限元分析模型。采用新鲜人股骨头坏死标本,在C形臂下模拟穿刺、球囊扩张手术过程,穿刺进入股骨头坏死区域后,球囊扩张并注入骨水泥。采用双源螺旋CT薄层扫描,采集扫描的图像,利用计算机软件辅助建立球囊扩张骨水泥填充和股骨头缺血坏死区的三维有限元模型。
     2.通过三维有限元模型对比分析在模拟生理负荷下,模拟加载及求解,采用模拟平地步行单髋的峰值受力情况。对股骨头缺血坏死模型、球囊扩张骨水泥成型模型进行有限元分析。测定股骨头顶端、股骨头负重区和股骨颈的Von-Mises应力值,对比骨水泥填充前后应力的变化和分布情况。
     3.采用生物力学测试仪器分别记录在载荷为100N,200N,300N,400N,500N,600N和700N情况下,股骨头标本的位移情况,采用自身对照研究,对不同载荷下的两组(坏死模型和骨水泥模型)的位移对比验。分析股骨头刚度的变化,并对有限分析的结果进行验证。
     检验方法对有限元分析模型的所采集的股骨头不同区域的应力结果采用非参数分析的秩和检验,对生物力学测试的股骨头刚度的结果采用配对T检验,统计软件采用SPSS17.0进行数据分析,采用p<0.05为两组有统计学差异,p<0.01为显著统计学差异。
     结果:
     1.在骨水泥填充于股骨头的坏死区域后,股骨头的负重区表面的应力水平有明显下降。负重区的应力显著下降,改变了股骨头的力学结构,有利于周围骨组织的修复,从而降低了进一步出现股骨头塌陷的几率,这为骨水泥填充的术式提供了理论支持。
     2.在填充骨水泥后,骨水泥成分由于其刚度高于周围的松质骨,骨应力向骨水泥的填充部位增加,证实骨水泥能够有效承担载荷,骨水泥的作用是股骨头支撑力得到加强的原因。
     3.股骨头内填充骨水泥后,发现骨水泥填充后的股骨头最大位移的范围较坏死范围增大,表明有效载荷面积增大,单位面积内应力下降,也可能是骨水泥填充后负重区域应力下降的原因。
     4.水泥模型的标准差股骨颈周围应力的标准差明显小于坏死模型,提示其应力离散程度明显较坏死模型低,表明水泥模型其应力分布更加均匀。按照4分区对比不同股骨颈区域骨水泥模型和坏死模型的应力变化,发现股骨颈内侧承担了更多的压应力,外侧承担的应力水平有下降。因此,骨水泥填充后,股骨颈周围的应力分布更加均匀,降低了出现股骨颈应力集中。
     5.对股骨头标本进行载荷-位移下力学测定,结果骨水泥填充组和坏死模型的载荷-移位变化均呈现类似线性的改变。比较标本生物力学测试和有限元模型分析的研究结果发现,两种研究方法均能够呈现出坏死模型和骨水泥模型在不同应力下的线性改变趋势相近,同等条件的应力条件下,骨水泥模型其发生的应变位移小于坏死模型。这一方面表明填充骨水泥后,坏死的股骨头的刚度增加,对抗变形的能力增强;另外一方面也验证了有限元模型能够较好的模拟标本生物力学实验。
     结论:
     1.经皮球囊扩张骨水泥填充股骨头坏死区域,骨水泥能够有效承载负荷,减轻负重区的承载负荷,股骨头应力分散改善股骨头的承载能力,对股骨头进行有效的支持以预防塌陷进展;
     2.经皮球囊扩张骨水泥填充股骨头坏死区域,股骨颈周围应力分布均匀,理论上降低出现股骨颈骨折并发症的几率;
     3.经皮球囊扩张骨水泥填充股骨头坏死区域可以增加股骨头的刚度,增加对载荷的变形能力。
     4.有限元分析模型能够有效模拟经皮球囊扩张骨水泥填充股骨头坏死区域的生物力学变化。
     总之,经皮球囊扩张骨水泥填充股骨头坏死区域,改变了股骨头、颈在承重是的生物力学机制,增强了股骨头的支撑能力,能够有效抵抗股骨头塌陷,避免股骨头塌陷进一步进展。
Background:Avascular necrosis of femoral head refers to the pathological process of boneactive ingredient loss due to destruction in blood supply or bone cells degeneration. Bothtraumatic and none traumatic causes share the same basic pathological process of necrosis ofcancellous bone and subchondral bone, fibrous repaired followed by mechanical strengthdeclination. At first, there’s no obvious bone structure and mechanical property changing, butthe mechanical property of the area of necrosis is poor, cannot load and transfer stress, leadingto the collapse of femoral head. The femoral head would collapse in80%patients during1to3years if not effectively treated. Some severed patients would have to be operated by total hipreplacement. The complications of THR occurred in young patients are much higher thanothers and the long-term effect is poor. The femoral head reserved surgery can prevent or retaincollapse, avoid or delay the artificial joint replacement.
     There are many different head reserved surgeries. Blood supply can be improved in earlystages by decreasing the pressure inside the femoral head, self-repairing in the femoral necroticarea. Studies suggest that the mechanical property of the necrotic area in the femoral headdecreasing would be the main reason for the collapse. It’s assumed that transfer of bone graft tofemoral subchondral area can support the head to prevent or retain collapse. But bone graftalone can’t support femoral head immediately due to poor mechanical properties. Transfer ofvascular pedicle bone flap needs high microsurgical technique and the complications at donorarea are high. Porous tantalum rod implantation is not effective for large and multiple lesions,hormones induced necrosis or ANFH combined with chronic diseases. In brief, all kinds ofhead reserved surgeries have different deficiencies.
     Bone cement or bone graft substitutes filling in the defects of osteonecrosis area is a kindof treatment. Fundamental techniques includes debridement of necrotic tissue, filling with bone cement or substitutes and reduction of cartilage surface collapse.Reconstruction of thefemoral head spherical contour and increasing the intensity of the necrotic area are assumed toavoid collapse again.The mechanism of the treatment is unclear yet. Kyphoplasty canreducethe heigh of compressed vertebral body by balloon inflating percutaneously and fill thecave with bone cement under low pressure. It is widely accepted and used for it’s amini-invasive process which can relief pain safely and easy to manipulate. It is assumedkyphoplasty technique can be used to treat ANFH. Balloon can be inserted into necrotic area ofthe femoral head to reduce collapsed head by inflating and cause local cave. Then bone cementor bone graft substitutes can be filled into the cave to support subchondral bone effectively.It’s assumed that mechanical strength of the necrotic area may increase and mechanicalproperties may be improved so that the collapse of the femoral head may be avoided orpostponed.
     Objective: To evaluate the effect of balloon inflating and cement filling in treatment ofavauscular necrosis of femoral head. Establish a three-dimensional computer simulated modeland use finite element analysis techniques to simulate load and calculate the changes of stresspre-and postoperation. To verify finite element analysis by biomechanical testing of femoralhead specimens.
     Methods:
     1. Establish a three-dimensional finite element analysis model of the balloon inflatingand bone cement filling procedure in the treatment of avascular necrosis. Select freshspecimens of femoral head necrosis of human, simulate percutaneous puncture and ballooninfalting procedure under C-arm fluoroscopy, after entering the necrotic area, inflate theballoon and fill in the bone cement. Use dual sources spiral CT thin-layer scan and collect allscanned images, apply computer aid technique to establish balloon inflating and bone cementfilling procedure and avascular necrosis three-dimensional finite element model.
     2. Analyze physiological load using three-dimensional finite element model, simulatingload and calculating stress, and applying the peak load force of the hip during flat groundwalking. Apply finite element analysis on the avascular necrosis model and balloon augmentbone cement filling model to measure the Von-Mises force of the top, neck and the weight bearing area of the femoral head, in order to compare the alternation of force before and afterthe filling of bone cement.
     3. Use biomechanical tester to record the displacement of the femoral head specimen atthe loads100N,200N,300N,400N,500N,600N and700N, compare the displacement ofthe two models (necrosis model and bone cement model) under control study. Analyze thestiffness chages of the femoral head and verify the result of the finite element analysis.
     The study applies non-parametric rank sum examination in the inspection of the load resulton different femoral head areas collected by finite element analysis model. Paired Texamination is applied in the inspection of biomechanic testing results of the femoral headstiffness. Statistical software uses SPSS17.0in data analysis, p <0.05represents statisticaldifference of the two groups, p <0.01represents significant difference.
     Results:
     1. After bone cement filled in the necrosis area, the load reduced significantly on theweight bearing area of the femoral head. The reduction in the load alternated the mechanicalstructure of the femoral head that promotes repair of surrounding bone tissue. This lowers thecollapse rate of the femoral head and provides theoretical support for the balloon augment bonecement filling procedure in the treatment of avascular necrosis.
     2. The filled bone cement shares higher stiffness than the surrounding cancellous bone, sothe loading force concentrates on the bone cement portion. The bone cement is proven toeffectively bear load, the support force of the femoral head is reinforced by the load bearing ofthe bone cement.
     3. The maximum movement range of the femoral head increased after the filling of bonecement that proves the incensement effective load bearing area. The reduction of stress per unitarea could also be responsible for the load declination of the weight bearing area.
     4. The standard deviation of the bone cement model and the stress load of the femoral neckare significantly lower that the necrosis model that implies the bone cement model shares lessstress dispersion degree and more stress uniformity than the necrosis model. Test the stressload of the femoral neck of the bone cement model and the necrosis model in4divisions. Theresult reflected less stress on the inner side of the femoral neck and more stress on the outer side of the femoral neck. Hence, the load distribution became more uniformed on the femoralneck after bone cement filling that reduces the force concentration on the femoral neck.
     5. Both the bone cement model and the necrosis model display similar linear change underload-displacement examination of the femoral head. Comparing the results of finite elementanalysis and bio-mechanical testing, conclusion can be drawn that both methods could displaythe similar linear change of the bone cement model and the necrosis model under various loads.Also, the study discovered the bone cement model shares less displacement that the necrosismodel under the same load condition. This proves that the stiffness and the anti-deformationability of the necrosis femoral head increases after bone cement filling. On the other hand, thesimilarity of the linear changes verifyed that finite element model could highly simulatebiomechanical examination of human specimens.
     Conclusions:
     1. Percutaneous balloon inflating and bone cement filling of the necrosis area in femoralhead can carry load effectively, reduce load of the weight-loading area, disperse the stress onthe surface, improve supporting capacity and prevent collapse progressing.
     2. Percutaneous balloon inflating and bone cement filling in the necrosis area of femoralhead can diverse the stress on femoral neck surface, reduce risks of neck fracture complicationsin theoretically.
     3. Percutaneous balloon inflating and bone cement filling in the necrosis area of femoralhead can increase stiffness of femoral head, increase the support capacity under load.
     4. Finite element model could simulate biomechanical changes of percutaneous ballooninflating and bone cement filling procedure accurately.
     In brief, percutaneous balloon inflating and bone cement filling in the necrosis area offemoral head can change the biomechanics mechanism of femoral head and neck, improvesupporting capacity under load, resist and prevent head collapse progressing.
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