Material changes in osteoporotic human cancellous bone following infiltration with acrylic bone cement for a vertebral cement augmentation

Bone cement infiltration can be effective at mechanically augmenting osteoporotic vertebrae. While most published literature describes the gain in mechanical strength of augmented vertebrae, we report the first measurements of viscoelastic material changes of cancellous bone due to cement infiltration. We infiltrated cancellous core specimen harvested from osteoporotic cadaveric spines with acrylic bone cement. Bone specimen before and after cement infiltration were subjected to identical quasi-static and relaxation loading in confined and free compression. Testing data were fitted to a linear viscoelastic model of compressible material and the model parameters for cement, native cancellous bone, and cancellous bone infiltrated (composite) with cement were identified. The fitting demonstrated that the linear viscoelastic model presented in this paper accurately describes the mechanical behaviour of cement and bone, before and after infiltration. Although the composite specimen did not completely adopt the properties of bulk bone cement, the stiffening of cancellous bone due to cement infiltration is considerable. The composite was, for example, 8.5 times stiffer than native bone. The local stiffening of cancellous bone in patients may alter the load transfer of the augmented motion segment and may be the cause of subsequent fractures in the vertebrae adjacent to the ones infiltrated with cement. The material model and parameters in this paper, together with an adequate finite-element model, can be helpful to investigate the load shift, the mechanism for subsequent fractures, and filling patterns for ideal cement infiltration.     

椎体静脉稀疏区注入骨水泥对PVP术中骨水泥渗漏的影响

目的:探讨椎体静脉稀疏区注入骨水泥对骨质疏松椎体压缩性骨折患者行经皮穿刺椎体成形术(percutaneous vertebroplasty,PVP)术中骨水泥渗漏的影响。方法:选择西安交通大学第二附属医院2014年1月至2018年6月收治的61例骨质疏松椎体压缩性骨折患者,根据骨水泥注入区域的不同,将所有患者分为A组(30例)及B组(31例),A组骨水泥注入区域为椎体静脉密集区(椎体中1/3平面处),B组骨水泥注入区域为椎体静脉稀疏区(椎体上1/3及下1/3平面处),对比两组的骨水泥渗漏率,术前、术后6个月时的视觉模拟评分(Visual analogue scale,VAS),治疗中的骨水泥用量、椎体高度恢复率及cobb角恢复度数。结果:B组的骨水泥渗漏率及骨水泥用量均明显低于A组(P0.05)。两组的VAS评分、椎体高度恢复率、cobb角恢复情况对比差异无统计学意义(P0.05)。结论:与椎体静脉密集区相比,在椎体静脉稀疏区注入骨水泥可显著降低骨质疏松椎体压缩性骨折患者PVP术中骨水泥渗漏率,椎体静脉稀疏区可作为PVP术中骨水泥注射的一个相对安全区域。     

A Particle Model for Prediction of Cement Infiltration of Cancellous Bone in Osteoporotic Bone Augmentation

Femoroplasty is a potential preventive treatment for osteoporotic hip fractures. It involves augmenting mechanical properties of the femur by injecting Polymethylmethacrylate (PMMA) bone cement. To reduce the risks involved and maximize the outcome, however, the procedure needs to be carefully planned and executed. An important part of the planning system is predicting infiltration of cement into the porous medium of cancellous bone. We used the method of Smoothed Particle Hydrodynamics (SPH) to model the flow of PMMA inside porous media. We modified the standard formulation of SPH to incorporate the extreme viscosities associated with bone cement. Darcy creeping flow of fluids through isotropic porous media was simulated and the results were compared with those reported in the literature. Further validation involved injecting PMMA cement inside porous foam blocks — osteoporotic cancellous bone surrogates — and simulating the injections using our proposed SPH model. Millimeter accuracy was obtained in comparing the simulated and actual cement shapes. Also, strong correlations were found between the simulated and the experimental data of spreading distance (R² = 0.86) and normalized pressure (R² = 0.90). Results suggest that the proposed model is suitable for use in an osteoporotic femoral augmentation planning framework.     

Experimental and theoretical investigation of directional permeability of human vertebral cancellous bone for cement infiltration

The use of acrylic polymers in infiltrating the porous bone structure is an emerging procedure for the augmentation of osteoporotic vertebrae. Although this procedure is employed frequently, it is performed based on empirical knowledge, and therefore, does not take into consideration the porosity-dependent permeability of human vertebral cancellous bone. The purpose of this study was to: (a). experimentally and theoretically investigate interdependence of the vertebral cancellous bone permeability and porosity, and (b). examine if the bone permeability of spinal cancellous bone can be predicted using bone mineral density measurements. If these relations can be established, they can be useful in optimizing the injection conditions for predicable cement infiltration. To determine the porosity-dependent and directional permeability, 34 bone cores-20 samples in the superior-inferior (SI) direction and 14 in the anterior-posterior (AP) direction-were cut from 20 lumbar vertebrae and infiltrated with silicone oil with a viscosity matching that of PMMA. The permeability of the cores was determined based on Darcy's law. The mean permeability of SI and AP cores was 4.45+/-1.72 x 10(-8) and 3.44+/-1.26 x 10(-8)m(2), respectively. An interesting finding of this study was that the permeability of the AP cores was approximately 78% of that of SI cores, though the porosity of the SI and AP cores taken from the same vertebra was approximately equal. In addition, we provided a theoretical model for the porosity-dependent permeability that accurately described non-linear dependency of the bone permeability and porosity in both directions. Although the relation of the bone permeability and porosity was established, bone mineral density was a weak predictor of the bone permeability. The experimental and theoretical results of this study can be used to understand polymer flow in cement infiltration procedures.     

Enhanced bone screw fixation with biodegradable bone cement in osteoporotic bone model

Purpose: The purpose of this study was to study the potential of novel biodegradable PCL bone cement to improve bone screw fixation strength in osteoporotic bone. Methods: The biomechanical properties of bone cement (ε-polycaprolactone, PCL) and fixation strength were studied using biomechanical tests and bone screws fixed in an osteoporotic bone model. Removal torques and pullout strengths were assessed for cortical, self-tapping, and cancellous screws inserted in the osteoporotic bone model (polyurethane foam blocks with polycarbonate plate) with and without PCL bone cement. Open cell and cellular rigid foam blocks with a density of 0.12 g/cm3 were used in this model. Results: Removal torques were significantly (more than six-fold) improved with bone cement for cancellous screws. Furthermore, the bone cement improved pullout strengths three to 12 times over depending on the screw and model material.?Conclusions: Biodegradable bone cement turned out to be a very potential material to stabilize screw fixation in osteoporotic bone. The results warrant further research before safe clinical use, especially to clarify clinically relevant factors using real osteoporotic bone under human body conditions and dynamic fatigue testing for long-term performance.     

Mechanism of fractures of adjacent and augmented vertebrae following simulated vertebroplasty

Percutaneous vertebroplasty (VP) is a minimally invasive procedure that is used to treat osteoporosis-induced vertebral compression fractures (OVCFs). Frequently observed complications are fractures of adjacent and augmented vertebrae. In the present work, mechanisms for these fractures are presented. Fresh 4-level osteoporotic thoracic motion segments were tested. Both ends of the specimen were mounted. The lower level of the free vertebra was compressively fractured and followed by an injection of a 3.5 mL of a PMMA bone cement. Three steps of fatigue loading (5 Hz for 5 h) were incrementally and vertically applied on the specimens from 650 N to 950 N to 1150 N. Specimens of intact, compressively fractured, cement augmented and post-fatigued loading were radiographed for the measurement of deformations of the vertebra, the canal, and the foramen. At the end of fatigue loading, the vertebrae were sliced for micro morphologic analysis. The largest height loss after fatigue loading was at the posterior region of the augmented vertebra. In the augmented vertebra, fissures were found along the bone-cement interface. These fissures split the cement and the trabeculae and propagated into the vertebrae and the endplates. The compactness ratio of the trabeculae region of the adjacent cranial vertebra was higher than that for intact and adjacent caudal ones. We attribute the fracture of the augmented vertebra, following simulated VP, to the initiation of fissures along the cement-bone interface, which, in turn, may be due to uneven deformation of the vertebra. Fracture of the adjacent cranial vertebra is attributed to collapse of its trabeculae.     

经皮骨水泥注入对老年骨质疏松性椎体压缩性骨折患者的治疗效果

目的:探讨经皮骨水泥注入治疗老年骨质疏松性椎体压缩性骨折的临床疗效。方法:选取我院收治的老年骨质疏松性椎体压缩性骨折患者90例,随机分为对照组及实验组,对照组以传统钉棒系统内固定术治疗,实验组以经皮骨水泥注入术治疗。观察并比较两组患者的手术时间、术中出血量、术后镇痛药量、创口面积、术后48 h及6个月椎体高度及Cobb角、骨水泥量、渗漏及不足的发生率等。结果:与对照组比较,实验组手术时间、出血量、创口面积、镇痛药量、骨水泥渗漏及不足率均低于对照组,差异具有统计学意义(P0.05)。与术前比较,术后两组患者椎体高度均提高,差异具有统计学意义(P0.05);实验组术后48 h及6个月椎体高度均高于对照组,差异具有统计学意义(P0.05);与术前比较,术后两组Cobb角均减小,差异具有统计学意义(P0.05);实验组术后48 h及6个月Cobb角均小于对照组,差异具有统计学意义(P0.05)。结论:经皮骨水泥注入术操作简便,测量精准,内固定支撑牢靠,术中止血效果理想,远期内固定支撑效果显著,值得临床推广应用。     

Mechanical variables affecting balloon kyphoplasty outcome--a finite element study

It is still unclear how a vertebral fracture should be stabilised and strengthened without endangering the remaining intact bone of the augmented vertebra or the adjacent vertebrae. Numerical modelling may provide insight. To date, however, few finite element (FE) spine models have been developed which are both multi-segmental and capture a more complete anatomy of the vertebrae. A 3-D, two-functional unit, CT-based, lumbar spine, FE model was developed and used to predict load transfer and likelihood of fracture following balloon kyphoplasty. The fractured anterior wall and injected cement were modelled in a two-functional spinal unit model with osteoporotic bone properties. Parameters investigated included: cement stiffness, cement volume and height restoration. Models were assessed based on stresses and a user-defined fracture-predicting field. Augmentation altered the stress distribution; shielding was dependent on positioning of the cement; and fracture algorithm found incomplete height restoration to increase the likelihood of fracture, particularly in adjacent vertebrae.     

犬完整骨及骨水泥重建骨缺损微波灭活后的生物力学研究

目的:研究微波消融(microwave ablation)对结构正常及缺损后骨水泥修复重建的犬骨生物力学性能的影响.方法:取成年犬股骨12对,随机分为完整组和重建组,再随机选取每对股骨的一侧作为对照组,另一侧为实验组,试验由此分为四组:完整对照组,完整微波组,重建对照组,重建微波组.然后将每根股骨制作成两个不同的骨标本,分别长3 cm和6 cm.两种微波组的标本均进行微波灭活,两种重建组的标本均制备成缺损模型并行骨水泥修复重建.然后分别对3、6 cm两种标本行压缩和三点弯曲试验.结果:完整对照组与完整微波组之间,重建对照组与重建微波组之间的最大压缩力、最大压缩位移、最大弯曲力及最大挠度等均无显著性差异.结论:微波消融对结构正常的犬骨的生物力学性能无明显影响,且不会加剧对重建犬骨的力学强度的破坏.     

骨水泥凝固前有无血液环境对骨水泥与骨界面稳定性的影响

目的:研究在有血和无血环境下粘合骨水泥和骨,比较两种粘合骨水泥的方式对骨与骨水泥界面稳定性影响的区别。方法:选取新鲜猪肱骨头20块,随机分成两组:实验组在有血的环境下用骨水泥将股骨头与金属粘合;对照组在无血的环境下用骨水泥将肱骨头和金属粘合,再将两组实验材料分别做拉伸试验,至骨与骨水泥界面断裂,最后再沿垂直于截骨面的方向做骨切片,在扫描电镜下观察并测量出每个实验对象中骨水泥的最大浸润深度。比较两组实验过程中拉力的最大载荷和断裂时的拉力以及骨水泥最大浸润深度。结果:实验组10个实验对象拉力最大载荷平均为738.50±262.15 N,断裂时的拉力平均为656.50±242.88N,骨水泥最大浸润深度平均为1.22±0.19 MM;对照组10个实验对象实验过程中拉力最大载平均为739.60±306.98 N,断裂时的拉力平均为658.80±264.56 N,骨水泥最大浸润深度平均为1.22±0.21 MM。20个实验对象在实验过程中均无意外断裂的情况发生,均在骨与骨水泥界面发生断裂。两组实验的拉力最大载荷与断裂拉力以及骨水泥最大浸润深度,均无统计学差异(P0.05)。结论:血液环境不能增加骨与骨水泥界面的不稳定因素。因此,与应用止血带相比,在TKA手术中不用止血带可能不会对骨与骨水泥界面稳定性和假体的寿命产生影响。     

骨水泥填充治疗桡骨远端骨质疏松骨折

目的:探讨骨水泥填充治疗桡骨远端骨质疏松骨折的方法。方法:对本科2000以来对8例桡骨远端骨质疏松骨行有限切开、关节面撬拨复位后注入骨水泥填充关节软骨下缺损治疗。结果:全部病例获得随访10-68月,平均22月。所有患者术后1周内肿胀消失,3～4周功能恢复接近正常。X线检查显示骨折愈合良好,无延迟愈合或不愈合。患者自我感觉5例表示满意,2例表示基本满意,1例表示不满意,满意率87.5%。结论:有限切开、关节面撬拨复位后注入骨水泥填充关节软骨下缺损是治疗桡骨远端骨质疏松骨折的有效方法。     

Mechanics of bone/PMMA composite structures: an in vitro study of human vertebrae

The goal of this study was to provide material property data for the cement/bone composite resulting from the introduction of PMMA bone cement into human vertebral bodies. A series of quasistatic tensile and compressive mechanical tests were conducted using cement/bone composite structures machined from cement-infiltrated vertebral bodies. Experiments were performed both at room temperature and at body temperature. We found that the modulus of the composite structures was lower than bulk cement (p<0.0001). For compression at 37( composite function)C: composite =2.3+/-0.5GPa, cement =3.1+/-0.2GPa; at 23( composite function)C: composite =3.0+/-0.3GPa, cement =3.4+/-0.2GPa. Specimens tested at room temperature were stiffer than those tested at body temperature (p=0.0004). Yield and ultimate strength factors for the composite were all diminished (55-87%) when compared to cement properties. In general, computational models have assumed that cement/bone composite had the same modulus as cement. The results of this study suggest that computational models of cement infiltrated vertebrae and cemented arthroplasties could be improved by specifying different material properties for cement and cement/bone composite.     

Simulated influence of osteoporosis and disc degeneration on the load transfer in a lumbar functional spinal unit

As life expectancy increases, age-related disorders and the search for related medical care will expand. Osteoporosis is the most frequent skeletal disease in this context with the highest fracture risk existing for vertebrae. The aging process is accompanied by systemic changes, with the earliest degeneration occurring in the intervertebral discs. The influence of various degrees of disc degeneration on the load transfer was examined using the finite element method. The effect of different possible alterations of the bone quality due to osteoporosis was simulated by adjusting the corresponding material properties and their distribution and several loadings were applied. An alteration of the load transfer, characterised by changed compression stiffness and strain distributions as well as magnitudes, due to osteoporotic bone and degenerated discs was found. When osteoporosis was simulated, the stiffness was substantially decreased, larger areas of the cancellous bone were subjected to higher strains and strain maxima were increased. Increasing ratios of transverse isotropy in the osteoporotic bone yielded smaller effects than reduced bone properties. Including a degenerated disc mainly altered the strain distribution. Combining osteoporosis and degenerated discs reduced the areas of cancellous bone subjected to substantial strain. Based on these results, it can be concluded that the definition of a healthy disc in osteoporotic spines might be considered as a worst-case scenario. One attempt to evaluate the progress of osteoporosis can be made by introducing increasing degrees of anisotropy. If several parameters in a model are changed to simulate degeneration, it should be pointed out how each individual definition influences the overall result.     

不同黏度骨水泥治疗骨质疏松性椎体压缩性骨折疗效比较

目的:探讨不同黏度骨水泥治疗骨质疏松性椎体压缩性骨折的临床疗效。方法:选择2016年1月～2018年6月滁州市第一人民医院收治的骨质疏松性椎体压缩性骨折患者90例,按照随机数字表法分为高黏度组42例和低黏度组48例,分别采用高黏度骨水泥经皮椎体后凸成形术和低黏度骨水泥经皮椎体后凸成形术治疗。比较两组单个椎体手术时间、骨水泥注入量、骨水泥渗漏发生情况。所有患者术后随访3个月,比较两组术前、术后3个月疼痛数字评分量表(NRS)评分、Oswestry功能(ODI)评分、椎体中间高度和Cobb角变化。结果:高黏度组单个椎体手术时间少于低黏度组(P0.05),两组骨水泥注入量、骨水泥弥散体积比较无统计学差异(P0.05)。高黏度组骨水泥总渗漏率低于低黏度组(P0.05)。两组患者术前NRS评分、ODI评分、椎体中间高度和Cobb角比较差异无统计学意义(P0.05);术后3个月两组NRS评分、ODI评分和Cobb角较术前降低,椎体中间高度较术前升高,且高黏度组NRS评分、ODI评分和Cobb角低于低黏度组,椎体中间高度高于低黏度组(P0.05)。结论:高黏度骨水泥经皮椎体后凸成形术治疗骨质疏松性椎体压缩性骨折的疗效较低黏度骨水泥更佳,术后总渗漏率更低,脊柱畸形矫正、脊柱功能恢复更佳,同时疼痛也明显降低,适于临床推广。     

A new evolutionary optimization method for osteoporotic bone augmentation

Bone augmentation is a preventative osteoporosis intervention, comprising the injection of bone cement into an osteoporotic bone. As injection of excessive amounts of bone cement may result into thermal necrosis of bone tissue or even embolism, the minimum cement volume required to achieve a predefined level of augmentation must be sought. To this end, the present paper introduces a new evolutionary optimization method, applicable to any osteoporotic bone. The method was numerically evaluated through a typical case of femoral augmentation and compared to another powerful optimization method. The results demonstrate the efficiency and low computational cost of the proposed method.     

Interfacial Strength of Cement Lines in Human Cortical Bone

In human cortical bone, cement lines (or reversal lines) separate osteons from the interstitial bone tissue, which consists of remnants of primary lamellar bone or fragments of remodeled osteons. There have been experimental evidences of the cement line involvement in the failure process of bone such as fatigue and damage. However, there are almost no experimental data on interfacial properties of cement lines in human cortical bone. The objective of this study is to design and assemble a precision and computer controlled osteon pushout microtesting system, and to experimentally determine the interfacial strength of cement lines in human cortical bone by performing osteon pushout tests. Thirty specimens were prepared from humeral diaphyses of four human subjects. Twenty specimens were tested under the condition of a small hole in the supporting plate, in which the cement line debonding occurred. The cement line interfacial strength ranged from 5.38 MPa to 10.85 MPa with an average of 7.31±1.73 MPa. On the other hand, ten specimens were tested under the condition of a large hole in the supporting plate, in which the shear failure inside osteons was observed. The specimens tested under the condition of the large hole resulted in an average shear strength of 73.71±15.06 MPa, ranging from 45.97 MPa to 93.74 MPa. Therefore, our results suggest that the cement line interface between osteon and interstitial bone tissue is weaker than that between bone tissue lamellae.     

Straining of the intact and fractured proximal humerus under physiological-like loading

Surgical treatment of proximal humeral fractures remains challenging in elderly patients, primarily due to insufficient implant fixation. Both bone quality and physiological-like loading conditions are commonly overlooked during pre-clinical in vitro evaluation. However, this knowledge is necessary in order to improve surgical treatment of the proximal humerus and the mechanical behavior of implants, particularly in patients with complex fractures and weak bone stock. We hypothesize that the bone quality has a high influence on the bone straining, independent of the arm position. The goal of this study was to determine the straining of the intact and fractured proximal humerus under physiological-like loading conditions. Furthermore, the impact of augmentation on tissue straining was evaluated.

Two representative humeri were selected for this study, one osteoporotic and one reference quality, and scanned using both QCT and DEXA (average DEXA VALUE=0.26 and 0.49 g/cm² respectively). Subcaptial defects were generated, then stabilized with a plate prior to mechanical stiffness testing. From the QCT data, finite element models were generated and the in vitro stiffness tests analytically simulated. Under physiological-like loading conditions, the straining of the bone and implant were analyzed for 0°, 90° forward flexion, and 90° abduction.

Maximal strain values were found for the intact and fractured bone at 90° abduction. This study demonstrates that the straining in a fractured bone of poor quality leads to considerably higher bone strains (up to +30%) than in a more healthy bone. Augmentation of a central void under physiological-like loading with commercial cement led to mechanical failure at the bone–cement interface.

New concepts for the surgical treatment of complex fractures of the proximal humerus should take bone distribution into account and thereby allow effective treatment of fractures in osteoporotic patients. The ultimate salvage procedure of augmentation has mechanical limitations as long as current cement materials are used in osteoporotic patients.     

单侧与双侧PVP治疗骨质疏松性椎体压缩骨折临床疗效比较及骨水泥渗漏的危险因素分析

摘要 目的：比较单侧与双侧经皮椎体成形术（PVP）治疗骨质疏松性椎体压缩骨折（OVCF）的临床疗效,并分析骨水泥渗漏的危险因素。方法：回顾性分析2019年5月~2020年12月期间本院收治的205例OVCF患者的临床资料,根据入路方式的不同分为单侧组和双侧组,例数分别为104例和101例。对比两组围术期指标、视觉模拟评分（VAS）、Oswestry功能障碍指数（ODI）、Cobb''s角和椎体前缘高度,记录两组骨水泥渗漏及其他并发症发生情况,采用单因素及多因素Logistic回归分析骨水泥渗漏的影响因素。结果：与双侧组相比,单侧组手术时间缩短,骨水泥注入量、术中透视次数减少（P<0.05）。两组术前、术后3个月、末次随访时VAS、ODI评分均呈下降趋势（P<0.05）。与术前相比,两组术后3个月及末次随访时的椎体前缘高度均升高,Cobb''s角均缩小（P<0.05）。两组并发症发生率组间对比无统计学差异（P>0.05）。PVP患者骨水泥渗漏与骨水泥黏度、皮质断裂、骨折严重程度、骨折位置、年龄、CT值、骨水泥注入量有关（P<0.05）。骨水泥渗漏的危险因素主要有骨水泥注入量>6 mL、骨折严重程度为重度、CT值>63HU、骨水泥黏度为低、皮质断裂（P<0.05）。结论：单侧与双侧PVP治疗OVCF效果相当。其中单侧可减少骨水泥注入量,缩短手术时间,减轻术后疼痛,促进术后功能恢复。而PVP手术最常见的并发症为骨水泥渗漏,受到骨折严重程度、皮质断裂、骨水泥黏度等因素的影响。     

Effect of vertebral body stiffness before and after vertebroplasty on intradiscal pressure]

Fractures of osteoporotic vertebral bodies are increasingly stabilized with bone cement. The effects of vertebral-body stiffness before and after augmentation with bone cement and of wedge-shaped vertebral body fractures on intradiscal pressure are insufficiently known. In a finite element model of the lumbar spine the elastic modulus of cancellous bone as well as the amount and the elastic modulus of bone cement were varied and the dependency of intradiscal pressure on these parameters was calculated. In addition, a wedge-shaped vertebral-body fracture was simulated. The bulge of the vertebral-body endplate and thus the intradiscal pressure depends strongly on the grade of osteoporosis in the vertebral body. The influence of amount and elastic modulus of bone cement on intradiscal pressure is small. A wedge-shaped vertebral-body fracture causes an anterior shift of upper-body centre of gravity. If this shift is not compensated, it leads to an increased flexion moment that has to be balanced by muscle forces. In addition, this shift leads to a stronger increase of intradiscal pressure than the augmentation of the vertebral body with bone cement.