Stiffness optimisation of cement and stem materials in total hip replacement

It is acknowledged that bone resorption and fatigue fracture of cement in total hip replacement may cause feature problems. The solution is frequently sought associated with the stiffness of cement and stem. The purpose of this paper is firstly to describe the effect of changes in modulus of elasticity of the cement material for the implanted prosthesis on the fatigue notch factor (Kf). The paper further describes a method of numerical optimisation to determine the optimal stiffness characteristics of cement and stem materials, which minimises the probability of fatigue fracture of cement at all interfaces with the stem and the bone, while limiting the amount of bone resorbed. The parameters describing the elastic moduli of cement and stem were considered as design variables. The method was applied to an equivalent 2D finite element model of femoral hip replacement in combination with an optimisation procedure using the ANSYS program. The results of the first study suggest that lower modulus of elasticity of cement material decreases Kf in the cement at all interfaces and proximal bone while higher values increase Kf. For the second aim, Young's moduli of about 0.6 and 22 GPa are optimal for cement and stem materials, respectively. These characteristics decreased the probability of fatigue fracture of cement at all interfaces with the stem and the bone as a result of decreasing Kf in cement at all interfaces, while limiting the amount of bone resorbed as a result of increasing Kf in the proximal bone.     

Shape optimization of metal backing for cemented acetabular cup

Stresses are generated in implant materials and bone, and at their interfaces. These stresses may affect the structural properties of the implant/bone system, or bring it to failure at some time in the postoperative period. Due to these stresses, acetabular cup loosening becomes an important problem for long term survival of total hip arthroplasty. It was found that metal backing would tend to reduce stresses in the underlying acrylic cement and bone. Yet, recent studies of load transfer around acetabular cups have shown that metal backing generates higher stress peaks in cement at the cup edges, while generates lower stress peaks in bone at the central part of acetabulum (dome), thus the bone at the dome becomes more stress shielded. In this study a numerical shape optimization procedure in combination with an axisymmetric finite element model was used in order to optimize the shape of a stainless steel metal backing shell. The design was to minimize fatigue notch factor in cement along cement/bone and cement/metal backing interfaces in order to prevent failure of cement mantel and loosening of acetabular components, at the same time increasing fatigue notch factor in bone at the center of acetabulum to prevent stress shielding. The results of this study indicate that cemented acetabular cup designs can be improved by using metal backing shells of non-uniform thickness, thick at the dome and thin at edges. Fatigue notch factor in cement was reduced by 2.3% at cement/metal backing interface and increased by 1.3% in the central bone of acetabulum. Von Mises stresses in the cement edge were reduced by 17.8% and 19.3% along cement/bone and cement/metal backing interfaces, respectively. Thus the optimal design will reduce the possibility of fatigue fracture of cement and decrease the stress shielding effect and the likely incidence of bone resorption, whereby extend the expected life of the prostheses.     

人工股骨柄形状和表面处理对置换术后假体和人体股骨应力分布影响的有限元分析

目的建立人工髋关节置换术后的三维有限元模型,分析研究人工股骨柄、骨水泥和人体股骨的应力分布。方法应用三维重建软件及Pro/Engineer建模软件和ABAQUS有限元分析软件计算分析人工股骨柄中空形状和柄部预处理范围对置换术后假体和人体股骨应力分布的影响。结果(1)倒立圆锥形中空特征的骨水泥固定型股骨柄的应力最小,其股骨柄周围骨水泥近端应力亦较低。(2)具有上涂层骨水泥的股骨柄可使骨水泥近端产生的应力减小,且股骨柄与骨水泥二者之间的剪力和相对滑动亦较小。(3)随着非骨水泥固定型股骨柄微孔涂层范围的增加,人体股骨上的应力范围下移,人体股骨近端的应力减小。结论(1)采用倒立圆锥形中空特征的人工股骨柄有助于降低人体股骨近端与假体接触区的应力遮挡效应。(2)采用股骨柄上涂层骨水泥的方法,可增强股骨柄与骨水泥界面的结合强度,有利于降低人工髋关节置换术后的假体松动。(3)非骨水泥固定型股骨柄微孔涂层范围对人体股骨的应力有明显的影响,微孔涂层范围过大不利于保持适中的人体股骨的应力和股骨柄的固定。     

Cement mantle stress under retroversion torque at heel-strike

The paper presents a theory of fixation failure and loosening in cemented total hip prostheses and proceeds to investigate this using an experimentally validated finite element model and two prosthesis types, namely the Charnley and the C-Stem. The study investigates the effects of retroversion torque occurring at heel-strike in combination with a loss of proximal cement/bone support and distal implant/cement support with a good distal cement/bone interface. A 3D finite element model was validated by comparison of femoral surface strains with those measured in an in vitro experimental simulation using an implanted Sawbone femur loaded in the heel-strike position and including a simplified representation of muscle forces. Results showed that the heel-strike position applies a high retroversion torque to the femoral stem that when combined with proximal debonding of the cement/bone interface and distal debonding of the implant/cement interface increases the strain transfer to the cement that may ultimately lead to the breakdown of the cement mantle leading on to osteolysis and loosening of the prostheses. Experimental fatigue testing of the implanted Charnely stem in a Sawbone femur produced cracks within the cement mantle that were located in positions of maximum stress supporting the finite element analysis results and theory of failure.     

Does Increased Bone–Cement Interface Strength have Negative Consequences for Bulk Cement Integrity? A Finite Element Study

Implant loosening is one of the most important modes of failure of cemented total hip replacement. It may be related to the cement strength, cement–prosthesis interface, cement–bone interface, surgical technique, or stem design. The main purpose of this study is to investigate the effect of bone–cement interface mechanical properties on cement degradation. The computational methodology proposed herein combines a previously developed bone–cement interface damage model and an accumulative damage model for bulk cement. This has been applied to a finite element model of an Exeter cemented hip implant. A higher strength of the bone–cement interface due to a higher amount of interdigitated bone results in faster cement deterioration. Over time, damage both at the bone–cement interface and in the cement mantle worsens. Also, a larger debonded area was predicted proximally, as observed in clinical practice. We conclude that the computational model proposed herein allows a realistic simulation of the bone–cement interface debonding and cement degradation, being a useful tool in the design of this kind of medical devices.     

Parameteric optimisation of materials for acetabular cup

This paper describes a method of parametric optimisation to determine the optimal stiffness characteristics of cement, metal backing and UHMWPE (Ultra High Molecular Weight Polyethylene) materials, which minimises the probability of fatigue fracture of cement at all interfaces with the metal backing and the bone, while limiting the amount of bone resorbed. The parameters describing the elastic moduli of cement, metal backing and UHMWPE were considered as design variables. The method was applied to an axisymmetric finite element model of acetabular cup in combination with an optimisation procedure using the ANSYS program. Young's moduli of about 0.63, 207 and 0.72 GPa are optimal materials for cement, metal backing (MB) and UHMWPE, respectively. These characteristics decreased fatigue notch factor Kf in cement by 8.2 and 10.6% and also decreased the maximum von Mises stress in cement by 21 and 27% at cement/bone and cement/metal backing interfaces, respectively. The optimal design reduces the probability of fatigue fracture of cement at all interfaces with the bone and the metal backing while limiting the amount of bone resorbed as a result of increasing von Mises stress and Kf in the central bone of the acetabulum by 34 and 30.6%, respectively.     

The effect of elastic modulus of the backing material on the fatigue notch factor and stress

In cemented acetabular cup design it is acknowledged that bone resorption and fatigue fracture of cement may cause the most common problems after total hip replacement. Previous studies have optimized the shape of metal backing (MB) shell used in cemented acetabular components in order to minimize the fatigue notch factor (Kf) in cement, whilst at the same time maximizing Kf in bone at the central part of acetabulum to prevent stress shielding and subsequent bone resorption [1]. The optimal shape was found to be thin at the edges and thick at the dome. The present study describes the effect of changing the elastic modulus of the backing material on Kf and stresses as predicted by the initial shape of the backing shell of (3 mm) thick, and the optimized backing shape of non-uniform thickness in order to find the optimal material for the backing shell. It is recommended to use a backing shell material with elastic modulus equals 70 GPa (which can be readily attained using a fiber reinforced polymer composite). It is shown that such a material will decrease the fatigue notch factor and the stresses in cement at cup edges, at the same time it will increase the stresses and the fatigue notch factor in bone at the central part of acetabulum. Thereby, reducing the possibility of fatigue fracture of cement, whilst at the same time decreasing the stress shielding effect and the resulting bone resorption. The effect of lower bone resorption and lower probability of fatigue fracture of the cement will also reduce the incidence of loosening and premature revision operations.     

Effects of pre-cooling and pre-heating procedures on cement polymerization and thermal osteonecrosis in cemented hip replacements

Numerical studies were performed to investigate bone cement polymerization, temperature history and thermal osteonecrosis in cemented hip replacements with finite element methods. In this paper, the effects of pre-cooling and pre-heating of the prosthesis and/or the cement prior to implantation were simulated. It was found that the cement polymerization initiated near the bone-cement interface and progressed toward the prosthesis when both the cement and prosthesis were initially at room temperature. When the prosthesis and/or cement were pre-cooled, a reduction of the peak temperature at the bone-cement interface resulted, and this may reduce thermal osteonecrosis. However, this also slowed the polymerization process, and may result in a weaker bone cement. If the prosthesis was significantly initially heated, bone cement polymerization reversed reaction direction, started from the cement-prosthesis interface and proceeded toward the bone. Such polymerization direction may reduce or eliminate the formation of voids at the cement-prosthesis interface. Numerical results also showed that pre-heating seemed unlikely to produce significant thermal damage to the bone. The method of pre-heating the prosthesis prior to implantation may decrease the likelihood of cement-prosthesis loosening and increase the life of total hip arthroplasty.     

全髋关节置换术对股骨近端骨重建的影响

目的 采用Wolff骨重建理论分析全髋关节置换（total hip arthroplasty,THA）对股骨近端骨重建进程的影响。方法 根据骨重建控制方程,利用Python语言编写骨重建程序。在ABAQUS软件中分别建立术前股骨模型与术后股骨及假体有限元模型。对比THA手术前后骨重建进程,分析假体植入对THA术后中远期股骨力学性能的影响。结果 假体植入后,股骨近端应力持续降低,受力点由股骨头转移到假体,出现明显的应力遮挡现象。应力遮挡区域内骨丢失现象严重。股骨干皮质骨变薄,应力遮挡有所缓解。假体底端内侧受挤压,应力显著高于外侧,此处骨质分布不均。结论 THA术后股骨近端内侧出现明显的应力遮挡,导致骨丢失,造成假体松动;假体底端两侧应力水平存在差异,引起骨质分布不均,导致假体与股骨配合不紧密,造成术后患者大腿中段的疼痛。     

人工股骨柄的力学研究现状

背景：临床表明,全髋关节重建涉及假体、骨水泥和股骨整体的应力分布,针对减少各个组件的应力以减少置换关节失效风险研究有了很大的进展。 目的：对髋关节置换后各组件应力分布的研究现状及进展作一综述。 方法：应用计算机检索CNKI,EI Village和ELSEVER数据库中2001-01/2011-01关于髋关节置换和股骨柄应力的文章,在标题和摘要中以“股骨柄,应力,全髋关节置换”或“stem,prosthesis,stress,Total Hip Replacement”为检索词进行检索。入选34篇文献和2本书籍进行综述。 结果与结论：人工髋关节固定需亟待解决的关键问题是髋关节置换后各组件应力非均匀传递而引起的界面剪滞效应,并将最终导致界面松动失效。研究股骨-柄松动原因和增强股骨-柄界面的自锁能力,应是提高人工髋关节的稳定性和延长置换后髋关节寿命的发展方向。     

The effects of curing history on residual stresses in bone cement during hip arthroplasty

During cement curing in total hip arthroplasty, residual stresses are introduced in the cement mantle as a result of curing shrinkage, thermal shrinkage, and geometrical constraints. These high residual stresses are capable of initiating cracks in the mantle of cemented hip replacements. The purpose of this study was to determine the residual stresses in the cemented hip replacements. The finite element method was developed to predict the residual stresses built up in joint arthroplasties. Experimental tests were then performed to validate the numerical methodology. Then the effects of curing history on the residual stress distribution were investigated with finite element simulations. Results showed that the predictions of the thermal shrinkage residual stresses by the developed method agreed with the experimental tests very well. The residual stress buildup was shown to depend on the curing history. By preheating the prosthesis stem prior to implantation, a desired low-level residual stress at the critical prosthesis-cement interface was obtained. As a result, this article provides a numerical tool for the quantitative simulation of residual stress and for examining and refining new designs computationally.     

Evaluation of the effects of implant materials and designs on thermal necrosis of bone in cemented hip arthroplasty

The exothermic polymerization of bone cement may induce thermal necrosis of bone in cemented hip arthroplasty. A finite element formulation was developed to predict the evolution of the temperature with time in the cemented hip replacement system. The developed method is capable of taking into account both the chemical reaction that generates heat during bone cement polymerization (through a kinetic model) and the physical process of heat conduction (with an energy balance equation). The possibility of thermal necrosis of bone was then evaluated based on the temperature history in the bone and an appropriate damage criterion. Specifically, we evaluate the role of implant materials and designs on the thermal response of the system. Results indicated that the peak temperature at the bone/cement interface with a metal prosthesis was lower than that with a polymer or a composite prosthesis in hip replacement systems. Necrosis of bone was predicted to occur with a polymer or a composite prosthesis while no necrosis was predicted with a metal prosthesis in the simulated conditions. When reinforcing osteoporotic hips with injected bone cement in the cancellous core of the femur, the volume of bone cement implanted is increased which may increase the risk of thermal necrosis of bone. We evaluate whether this risk can be decreased through the use of an insulator to contain the bone cement. No thermal necrosis of bone was predicted with a 3 mm thick polyurethane insulator while more damage is predicted for the use of bone cement without the insulator. This method provides a numerical tool for the quantitative simulation of the thermal behavior of bone-cement-prosthesis designs and for examining and refining new designs computationally.     

Modelling evaluation of the testing condition influence on the maximum stress induced in a hip prosthesis during ISO 7206 fatigue testing

In vivo fatigue failure of hip prosthesis stems has been extensively reported in literature. The ISO 7206 international standard has been developed to assess the fatigue reliability of hip prostheses. It describes the fatigue testing apparatus and procedure and it is currently adopted by several testing laboratories throughout the world. In this work we evaluate the maximum stress in a titanium alloy commercial stem in different testing conditions, ranging within the standard specification, using the finite element method applied to a 3D model of the stem. The calculated maximum von Mises stress ranges from +4.5 to -1.5% (for different cement constraint levels) and from +6.7 to -6.8% (for different stem angular orientations) with respect to that calculated at the nominal testing conditions. The results suggest that the ISO 7206 testing specification will give experimental data of reasonable accuracy, with probably no more scatter than that found in typical specimen test results. This is particularly important in the case of components manufactured from materials showing a fatigue resistance highly sensitive to stress variations, such as the Ti6A14V alloy, for which a small increase of the maximum applied stress corresponds to a significant decrease of the statistical fatigue life.     

Mechanical evaluation of a bio-active bone cement for total hip arthroplasty

A new bio-active bone cement, known as CAP, has been developed as an alternative to acrylic bone cement. CAP has improved mechanical properties, with a high modulus that is over five times that of PMMA. The effects of this high modulus are examined by finite element analysis, when the CAP is used in place of PMMA to fix the femoral component in total hip prostheses. The results show a higher tensile stress of 8.76 MPa in the CAP cement, compared with 1.99 MPa in the PMMA cement. However, it is also shown that CAP has a superior fatigue strength of approximately 40 MPa, obtained from a cyclic loading test.     

Finite element analysis of a three-dimensional model of a proximal femur-cemented femoral THJR component construct: influence of assigned interface conditions on strain energy density

A finite element analysis of the stresses in a construct, comprising a three-dimensional model of the proximal human femur in which the stem of a total hip joint replacement was cemented, was performed. The one-legged standing condition was used, with all applied forces on the proximal femur being considered. These forces were the resultant hip joint reaction force and the forces due to the activation of the abductor, ilio-psoas, and ilio-tibialis muscles. The cortical and cancellous bones were assigned anisotropic elastic properties. It was found that the mean value of the strain energy density at each of the regions considered was considerably higher when debonding was considered at both the cancellous bone-acrylic bone cement and bone cement-stem interfaces (represented using surface-to-surface Coulomb friction, coefficient of friction = 0.22) compared to when perfect bonding conditions were taken to exist at these interfaces. The significance of this finding, together with the study limitations, is discussed.     

The relationship between cement fatigue damage and implant surface finish in proximal femoral prostheses

The majority of cemented femoral hip replacements fail as a consequence of loosening. One design feature that may affect loosening rates is implant surface finish. To determine whether or not surface finish effects fatigue damage accumulation in a bone cement mantle, we developed an experimental model of the implanted proximal femur that allows visualisation of damage growth in the cement layer. Five matt surface and five polished surface stems were tested. Pre-load damage and damage after two million cycles was measured. Levels of pre-load (shrinkage) damage were the same for both matt and polished stems; furthermore damage for matt vs. polished stems was not significantly different after two million cycles. This was due to the large variability in damage accumulation rates. Finite element analysis showed that the stress is higher for the polished (assumed debonded) stem, and therefore we must conclude that either the magnitude of the stress increase is not enough to appreciably increase the damage accumulation rate or, alternatively, the polished stem does not debond immediately from the cement. Significantly (P=0.05) more damage was initiated in the lateral cement compared to the medial cement for both kinds of surface finish. It was concluded that, despite the higher cement stresses with debonded stems, polished prostheses do not provoke the damage accumulation failure scenario.     

人工髋关节置换前后股骨及假体的生物力学分析

目的:研究人工髋关节置换前后股骨及假体的应力分布以及假体设计参数对应力的影响。方法:建立股骨和假体有限元模型,分析在步行峰值关节载荷和主要肌肉载荷作用下,完整股骨和置换后股骨及假体的应力水平。结果:完整股骨中上部内侧受压应力,外侧受张应力,中下部外侧受压应力,内侧受张应力,股骨应力峰值位于中下部;置换后股骨受力总体模式不变,近端应力遮挡显著。随颈干角增加,假体及股骨应力水平降低;柄长对假体应力影响不大,股骨上的应力随柄长增大略有增加。结论:假体设计时可适当增大颈干角,在骨组织条件允许的情况下可适当增加假体柄长,以减轻术后的应力遮挡效应。     

Influence of Charnley hip neck-angle inclination on the stresses at stem/cement and bone/cement interfaces

The present work aims to elucidate the influence of neck-stem angle inclination on the principal normal and shear stress distributions and values along the interfaces of the stem/cement and bone/cement in a cemented Charnley curved back femoral component. The same stresses were also examined for the intact bone that was considered as a reference for the obtained results. The interface is considered the weakest link in the structure and its endurance limit to failure is much less than the limit of the adjacent materials. Interface loading is by far the influential aspect governing the induced interface stresses in femoral total hip replacement. Therefore, higher values and nonuniform distribution of stresses at the interface may lead to loosening and crack initiation and propagation that usually precede the stem fracture.     

Design of a biomimetic polymer-composite hip prosthesis

A new biomimetic composite hip prosthesis (stem) was designed to obtain properties similar to those of the contiguous bone, in particular stiffness, to allow normal loading of the surrounding femoral bone. This normal loading would reduce excessive stress shielding, known to result in bone loss, and micromotions at the bone-implant interface, leading to aseptic prosthetic loosening. The design proposed is based on a hollow substructure made of hydroxyapatite-coated, continuous carbon fiber (CF) reinforced polyamide 12 (PA12) composite with an internal soft polymer-based core. Different composite configurations were studied to match the properties of host tissue. Nonlinear three-dimensional analysis of the hip prosthesis was carried out using a three-dimensional finite element bone model based on the composite femur. The performance of composite-based hip and titanium alloy-based (Ti-6Al-4V) stems embedded into femoral bone was compared. The effect of core stiffness and ply configuration was also analyzed. Results show that stresses in composite stem are lower than those in Ti stem, and that the femoral bone implanted with composite structure sustains more load than the one implanted with Ti stem. Micromotions in the composite stem are significantly smaller than those in Ti stem over the entire bone-implant surface because of the favorable interfacial stress distribution.     

Fatigue of the cement/bone interface: the surface texture of bone and loosening

Loosening is recognized as one of the primary sources of total hip replacement (THR) failure. In this study the influence of the bone surface texture on loosening of the cement/bone interface was studied. Model cemented hip replacements were prepared and subjected to cyclic loads that induced pure shear fatigue of the cement/bone interface. The femoral canals were textured with the use of specific cutting tools to achieve a desired surface topography. Loosening of the implant with cyclic loading was characterized in terms of the initial migration (Region I), steady-state loosening (Region II), and unstable loosening (Region III). Results from the experiments showed that the initial migration and rate of steady-state loosening were dependent upon the bone surface topography. The apparent fatigue strength ranged from 0.8 to 5.1 MPa, and denotes the cyclic shear stress required for loosening of 1 mm within 10 million cycles. Regardless of the bone surface topography the ratio of apparent fatigue strength and ultimate shear strength of the interfaces was approximately 0.24. In general, the apparent fatigue strength increased proportional to the average surface roughness of the femoral canal and the corresponding volume available for cement interdigitation. In addition, there was a strong correlation between the normalized initial migration and the apparent fatigue strength (i.e., specimens with the highest initial migration exhibited the lowest fatigue strength).