Topological optimization in hip prosthesis design

With particular interest on total hip arthroplasty (THA), optimization of orthopedic prostheses is employed in this work to minimize the probability of implant failure or maximize prosthesis reliability. This goal is often identified with the reduction of stress concentrations at the interface between bone and these devices. However, aseptic loosening of the implant is mainly influenced by bone resorption phenomena revealed in some regions of the femur when a prosthesis is introduced. As a consequence, bone resorption appears due to stress shielding, that is to say the decrease of the stress level in the implanted femur caused by the significant load carrying of the prosthesis due to its higher stiffness. A maximum stiffness topological optimization-based (TO) strategy is utilized for non-linear static finite element (FE) analyses of the femur–implant assembly, with the goal of reducing stress shielding in the femur and to furnish guidelines for re-designing hip prostheses. This is accomplished by employing an extreme accuracy for both the three-dimensional reconstruction of the femur geometry and the material properties maps assigned as explicit functions of the local densities.     

Analysis of a femoral hip prosthesis designed to reduce stress shielding

The natural stress distribution in the femur is significantly altered after total hip arthroplasty (THA). When an implant is introduced, it will carry a portion of the load, causing a reduction of stress in some regions of the remaining bone. This phenomenon is commonly known as stress shielding. In response to the changed mechanical environment the shielded bone will remodel according to Wolff's law, resulting in a loss of bone mass through the biological process called resorption. Resorption can, in turn, cause or contribute to loosening of the prosthesis. The problem is particularly common among younger THA recipients. This study explores the hypothesis that through redesign, a total hip prosthesis can be developed to substantially reduce stress shielding. First, we describe the development of a new femoral hip prosthesis designed to alleviate this problem through a new geometry and system of proximal fixation. A numerical comparison with a conventional intramedullary prosthesis as well as another proximally fixed prosthesis, recently developed by Munting and Verhelpen (1995. Journal of Biomechanics 28(8), 949–961) is presented. The results show that the new design produces a more physiological stress state in the proximal femur.     

Load-shift--numerical evaluation of a new design philosophy for uncemented hip prostheses

All hip replacement prostheses alter the load transfer from the hip joint into the femur by changing the mechanical loading of the proximal femur from an externally to an internally loaded system. This alteration of the load transfer causes stress shielding and might lead to severe bone loss, especially with uncemented prostheses. To minimize these effects, load transfer to the femur should occur as proximal as possible. In order to support sufficient primary stability, however, directly post operative (PO) distal stabilization is reasonable. Consequently, the prostheses have to alter its mechanical characteristics after implantation. This concept is referred to as load-shift concept. Primary stability during the early PO state is provided by a prosthesis shaft, which is widened at the tip by a biodegradable pin. After resorption of the pin load transfer occurs no longer distally. The objective of this study was the numerical evaluation of the load-shift concept. The analysis was performed with a finite element model. Three-dimensional non-linear dynamic gait analyses data were used to evaluate whether the load transfer during walking can be altered effectively by insertion and resorption of a distal pin. Directly PO 38% of the transverse load is transferred through the prosthesis shaft and micromotion of the proximal prostheses tip is below 55 microm. After resorption of the pin, no transverse loads are transferred through the prosthesis shaft. Therefore, the loading of the proximal bone tissue is far more pronounced than in the case of a standard prosthesis, demonstrating the feasibility of the load-shift concept. A balanced degradation of the pin simultaneously with the ingrowth of the prosthesis is expected to reduce hip replacement complications.     

基于CT的股骨有限元模型的建立及髋关节中空多孔假体植入后受力分布的初步研究

利用有限元分析的方法,对髋关节中空多孔假体植入后的受力分布改变进行研究,为改进中空多孔人工关节假体的设计提供依据.建立了股骨和假体三维有限元模型,应用有限元分析软件Ansys5.7模拟单腿负重状态,考察应力分布并进行比较.使用SPSS Statistics 17.0软件进行分析处理,绘制折线图.结果表明:a.开孔后张力侧最大压应力有所减小,开孔部位的应力水平变化不明显.b.与周围骨质形成连接后孔缘局部应力增加,张力侧受力改变不明显.c.短柄假体受力模式仍为远端应力集中;张力侧应力减小,开孔部位应力明显增加.d.下孔受力均大于上孔,受力方向基本一致.     

Comparison of different hip prosthesis shapes considering micro-level bone remodeling and stress-shielding criteria using three-dimensional design space topology optimization

Since the late 1980s, computational analysis of total hip arthroplasty (THA) prosthesis components has been completed using macro-level bone remodeling algorithms. The utilization of macro-sized elements requires apparent bone densities to predict cancellous bone strength, thereby, preventing visualization and analysis of realistic trabecular architecture. In this study, we utilized a recently developed structural optimization algorithm, design space optimization (DSO), to perform a micro-level three-dimensional finite element bone remodeling simulation on the human proximal femur pre- and post-THA. The computational simulation facilitated direct performance comparison between two commercially available prosthetic implant stems from Zimmer Inc.: the Alloclassic and the Mayo conservative. The novel micro-level approach allowed the unique ability to visualize the trabecular bone adaption post-operation and to quantify the changes in bone mineral content by region. Stress-shielding and strain energy distribution were also quantified for the immediate post-operation and the stably fixated, post-remodeling conditions. Stress-shielding was highest in the proximal region and remained unchanged post-remodeling; conversely, the mid and distal portions show large increases in stress, suggesting a distal shift in the loadpath. The Mayo design conserves bone mass, while simultaneously reducing the incidence of stress-shielding compared to the Alloclassic, revealing a key benefit of the distinctive geometry. Several important factors for stable fixation, determined in clinical evaluations from the literature, were evident in both designs: high levels of proximal bone loss and distal bone densification. The results suggest this novel computational framework can be utilized for comparative hip prosthesis shape, uniquely considering the post-operation bone remodeling as a design criterion.     

Stress analysis and failure prediction in the proximal femur before and after total hip replacement

An investigation was performed to determine the effects of the presence of two lengths of proximal Müller prosthesis on predicted failure loads, as compared to those for an intact femur. Three-dimensional stresses in a bone/cement/prosthesis system were determined using finite element methods, with both isotropic and transversely isotropic material properties used for the diaphyseal cortex. Significant increases in prosthesis stem stresses were found when the transversely isotropic material properties were employed in the diaphyseal cortex. This leads to the conclusion that accurate anisotropic material properties for bone are essential for precise stress determination and optimum design in prosthetic implants. Failure loads were also predicted for vertical compression and axial torque, similar to available experimental conditions, and were within the range of the experimental failure data found in the literature. The technique developed herein can be used to systematically assess existing as well as future implant designs, taking into account the complex three-dimensional interaction effects of the overall bone/cement/prosthesis system.     

Effect of interface conditions on the behaviour of a Freeman hip endoprosthesis

The femoral element of a total hip replacement is a composite structure of two, or perhaps three, components — the endoprosthesis, the bone and, where present, the cement. The interfacial conditions are such that complete structural continuity does not necessarily obtain. That this is so has often been suspected due to the observed loosening which can occur in vivo. In modelling the system, typically for finite element analysis, it has usually been considered to be monolithic, such that tensile and shear stresses could be transmitted across the interfaces as well as the normal compressive stress. Here the femoral component of a Freeman hip replacement is considered, implanted without bone cement, and analyses are carried out under monolithic, i.e. fully bonded, and non-bonded assumptions. Simultaneously the effect of retaining the neck of the femur, one of the features of using this particular prosthesis, is also examined.     

Numerical analysis of an osseointegrated prosthesis fixation with reduced bone failure risk and periprosthetic bone loss

Currently available implants for direct attachment of prosthesis to the skeletal system after transfemoral amputation (OPRA system, Integrum AB, Sweden and ISP Endo/Exo prosthesis, ESKA Implants AG, Germany) show many advantages over the conventional socket fixation. However, restraining biomechanical issues such as considerable bone loss around the stem and peri-prosthetic bone fractures are present. To overcome these limiting issues a new concept of the direct intramedullary fixation was developed. We hypothesize that the new design will reduce the peri-prosthetic bone failure risk and adverse bone remodeling by restoring the natural load transfer in the femur. Generic CT-based finite element models of an intact femur and amputated bones implanted with 3 analyzed implants were created and loaded with a normal walking and a forward fall load. The strain adaptive bone remodeling theory was used to predict long-term bone changes around the implants and the periprosthetic bone failure risk was evaluated by the von Mises stress criterion. The results show that the new design provides close to physiological distribution of stresses in the bone and lower bone failure risk for the normal walking as compared to the OPRA and the ISP implants. The bone remodeling simulations did not reveal any overall bone loss around the new design, as opposed to the OPRA and the ISP implants, which induce considerable bone loss in the distal end of the femur. This positive outcome shows that the presented concept has a potential to considerably improve safety of the rehabilitation with the direct fixation implants.     

A method of quantification of stress shielding in the proximal femur using hierarchical computational modeling

Stress shielding is a biomechanical phenomenon causing adaptive changes in bone strength and stiffness around metallic implants, which potentially lead to implant loosening. Accordingly, there is a need for standard, objective engineering measures of the “stress shielding” performances of an implant that can be employed in the process of computer-aided implant design. To provide and test such measures, we developed hierarchical computational models of adaptation of the trabecular microarchitecture at different sites in the proximal femur, in response to insertion of orthopaedic screws and in response to hypothetical reductions in hip joint and gluteal muscle forces. By identifying similar bone adaptation outcomes from the two scenarios, we were able to quantify the stress shielding caused by screws in terms of analogous hypothetical reductions in hip joint and gluteal muscle forces. Specifically, we developed planar lattice models of trabecular microstructures at five regions of interest (ROI) in the proximal femur. The homeostatic and abnormal loading conditions for the lattices were determined from a finite element model of the femur at the continuum scale and fed to an iterative algorithm simulating the adaptation of each lattice to these loads. When screws were inserted to the femur model, maximal simulated bone loss (17% decrease in apparent density, 10% decrease in thickness of trabeculae) was at the greater trochanter and this effect was equivalent to the effect of 50% reduction in gluteal force and normal hip joint force. We conclude that stress shielding performances can be quantified for different screw designs using model-predicted hypothetical musculoskeletal load fractions that would cause a similar pattern and extent of bone loss to that caused by the implants.     

The effects of total hip arthroplasty on the structural and biomechanical properties of adult bone

The responsiveness of bone to mechanical stimuli changes throughout life, with adaptive potential generally declining after skeletal maturity is reached. This has led some to question the importance of bone functional adaptation in the determination of the structural and material properties of the adult skeleton. A better understanding of age-specific differences in bone response to mechanical loads is essential to interpretations of long bone adaptation. The purpose of this study is to examine how the altered mechanical loading environment and cortical bone loss associated with total hip arthroplasty affects the structural and biomechanical properties of adult bone at the mid-shaft femur. Femoral cross sections from seven individuals who had undergone unilateral total hip arthroplasty were analyzed, with intact, contralateral femora serving as an approximate internal control. A comparative sample of individuals without hip prostheses was also included in the analysis. Results showed a decrease in cortical area in femora with prostheses, primarily through bone loss at the endosteal envelope; however, an increase in total cross-sectional area and maintenance of the parameters of bone strength, I(x), I(y), and J, were observed. No detectable differences were found between femora of individuals without prostheses. We interpret these findings as an adaptive response to increased strains caused by loading a bone previously diminished in mass due to insertion of femoral prosthesis. These results suggest that bone accrued through periosteal apposition may serve as an important means by which adult bone can functional adapt to changes in mechanical loading despite limitations associated with senescence.     

A method of quantification of stress shielding in the proximal femur using hierarchical computational modeling

Stress shielding is a biomechanical phenomenon causing adaptive changes in bone strength and stiffness around metallic implants, which potentially lead to implant loosening. Accordingly, there is a need for standard, objective engineering measures of the "stress shielding" performances of an implant that can be employed in the process of computer-aided implant design. To provide and test such measures, we developed hierarchical computational models of adaptation of the trabecular microarchitecture at different sites in the proximal femur, in response to insertion of orthopaedic screws and in response to hypothetical reductions in hip joint and gluteal muscle forces. By identifying similar bone adaptation outcomes from the two scenarios, we were able to quantify the stress shielding caused by screws in terms of analogous hypothetical reductions in hip joint and gluteal muscle forces. Specifically, we developed planar lattice models of trabecular microstructures at five regions of interest (ROI) in the proximal femur. The homeostatic and abnormal loading conditions for the lattices were determined from a finite element model of the femur at the continuum scale and fed to an iterative algorithm simulating the adaptation of each lattice to these loads. When screws were inserted to the femur model, maximal simulated bone loss (17% decrease in apparent density, 10% decrease in thickness of trabeculae) was at the greater trochanter and this effect was equivalent to the effect of 50% reduction in gluteal force and normal hip joint force. We conclude that stress shielding performances can be quantified for different screw designs using model-predicted hypothetical musculoskeletal load fractions that would cause a similar pattern and extent of bone loss to that caused by the implants.     

Selection of an animal model for implant fixation studies: anatomical aspects.

A number of different animal models have been employed by investigators to study the biology of the bone-cement interface as it relates to the problem of hip implant loosening in humans. This study compares to the human three species (baboon, dog, and sheep) currently under use as experimental animal models from an anatomical point of view. A number of parameters, important for the dimensional design of a femoral prosthesis, loads at the hip joint and its subsequent performance, were used for comparing external and internal femoral anatomy. The baboon and dog femora were found to be most similar to the human femur in their external anatomy. The quantification of cancellous bone distribution within the medullary canal revealed that, of the species studied, the sheep femur provided the least support to the prosthesis. The results suggest that the dog and baboon are anatomically appropriate for studying hip implant biomechanics experimentally. Thus, from an anatomical point of view, the current extensive use of the dog as an experimental animal appears appropriate.     

A finite element study of the effect of diametral interface gaps on the contact areas and pressures in uncemented cylindrical femoral total hip components

Uncemented femoral total hip components rely entirely on contact with the prepared femur for their initial fixation. The contact areas and stresses between a straight tubular bone and a metal cylindrical prosthesis 12.5 cm long and 13 mm in diameter were calculated in a finite element model which includes uniform diametral gaps varying from 20 to 500 microns, using transverse loads from 100 to 2000 N. Frictionless three-dimensional contact elements were used between the bone and the prosthesis. Contact stresses were high and irregular in all cases, and the contact areas were small. Two regions of contact were apparent for lower loads and larger gaps. A third region of contact occurred near the distal tip of the implant at higher loads. This region of contact markedly increased the contact stresses at the distal tip of the prosthesis. A 20 microns overlap between bone and implant was modelled to assess a slight interference fit. The contact stress distribution in this case was markedly different from the stress distribution with a 20 microns diametral gap. The data collectively indicates that gaps of less than 20 microns between bone and implant can substantially change contact stress distributions.     

On the optimal shape of hip implants

The success of a total hip arthroplasty is strongly related to the initial stability of the femoral component and to the stress shielding effect. In fact, for cementless stems, initial stability is essential to promote bone ingrowth into the stem coating. An inefficient primary stability is also a cause of thigh pain. In addition, the bone adaptation after the surgery can lead to an excessive bone loss and, consequently, can compromise the success of the implant. These factors depend on prosthesis design, namely on material, interface conditions and shape. Although, surgeons use stems with very different geometries, new computational tools using structural optimization methods have been used to achieve a better design in order to improve initial stability and therefore, the implant durability. In this work, a multi-criteria shape optimization process is developed to study the relationship between implants performance and geometry. The multi-criteria objective function takes into account the initial stability of the femoral stem and the effect of stress shielding on bone adaptation after the surgery. Then, the optimized stems are tested using a concurrent model for bone remodeling and osseointegration to evaluate long-term performance. Additionally, the sensitivity to misalignments is analyzed, since femoral stems are often placed in varus or valgus position. Results show that the different criteria are contradictory resulting in different characteristics for the hip stem. However, the multi-criteria formulation leads to compromise solutions, with a combination of the geometric characteristics obtained for each criterion separately.     

A Femur-Implant Model for the Prediction of Bone Remodeling Behavior Induced by Cementless Stem

Bone remodeling simulation is an effective tool for the prediction of long-term effect of implant on the bone tissue, as well as the selection of an appropriate implant in terms of architecture and material. In this paper, a finite element model of proximal femur was developed to simulate the structures of internal trabecular and cortical bones by incorporating quantitative bone functional adaptation theory with finite element analysis. Cementless stems made of titanium, two types of Functionally Graded Material (FGM) and flexible ‘iso-elastic’ material as comparison were implanted in the structure of proximal femur respectively to simulate the bone remodeling behaviors of host bone. The distributions of bone density, von Mises stress, and interface shear stress were obtained. All the prosthetic stems had effects on the bone remodeling behaviors of proximal femur, but the degrees of stress shielding were different. The amount of bone loss caused by titanium implant was in agreement with the clinical observation. The FGM stems caused less bone loss than that of the titanium stem, in which FGM I stem (titanium richer at the top to more HAP/Col towards the bottom) could relieve stress shielding effectively, and the interface shear stresses were more evenly distributed in the model with FGM I stem in comparison with those in the models with FGM II (titanium and bioglass) and titanium stems. The numerical simulations in the present study provided theoretical basis for FGM as an appropriate material of femoral implant from a biomechanical point of view. The next steps are to fabricate FGM stem and to conduct animal experiments to investigate the effects of FGM stem on the remodeling behaviors using animal model.     

Anchoring problems in cemented total hip endoprosthesis--a review of the literature]

The question as to what constitutes the most suitable material for the cemented total hip endoprosthesis has not yet been decided. Owing to the different modules of elasticity of titanium and CoCr alloy, the characteristics of force transmission into the proximal femur vary. Titanium alloys load the proximal femur earlier and more markedly, and therefore counteract possible bone degeneration; whereas the CoCr alloys are associated with less stressing of the bone cement in the critical region of the calcar femorale. This paper is a review of the various analytical, experimental and clinical publications on the subject. Besides the question of material, the problems of bone cement and its application are also discussed.     

Response of human femur to mechanical vibration

The effect of mechanical vibration in the frequency range 0–500 Hz on the cadaveric human femur was assessed. It was found that when the bone was fixed at both ends, its resonant frequency was markedly affected by end loading and damping. If the conditions of the experiment were designed to simulate the condition of the femur when prepared for a total hip replacement, it was found that the bone did not resonate but behaved in a mass-like mode. The significance of this observation is that in the event of vibration being applied to enhance the penetration of bone cement, the movement induced in the bone will be proportional to the force applied regardless of frequency. This also demonstrates that the concep of designing a prosthesis so that it is isoelastic with the femur is complex and potentially flawed, since the stiffness of the femur will vary during the walking cycle.     

Joint prostheses

Since 34 years, many improvement occurred. Joint prosthesis have to be anatomic, simple, thin and not a large foreign body. New material are warranted for their solidity. Many types are manufactured. The most used are hip prosthesis. Junction between bone and prosthesis is not solved as yet. Acrylic cement was on interface junction but in order to solve the failures, new porous or rough surface materials allowed anchorage by the bone itself. Prosthesis longevity is limited by bone prosthesis interface. Prosthesis replacement is possible and will develop.     

A finite element analysis of the vibration behaviour of a cementless hip system

An early diagnosis of aseptic loosening of a total hip replacement (THR) by plain radiography, scintigraphy or arthography has been shown to be less reliable than using a vibration technique. However, it has been suggested that it may be possible to distinguish between a secure and a loose prosthesis using a vibration technique. In fact, vibration analysis methods have been successfully used to assess dental implant stability, to monitor fracture healing and to measure bone mechanical properties. Several studies have combined the vibration technique with the finite element (FE) method in order to better understand the events involved in the experimental technique. In the present study, the main goal is to simulate the change in the resonance frequency during the osseointegration process of a cementless THR (Zweymüller). The FE method was used and a numerical modal analysis was conducted to obtain the natural frequencies and mode shapes under vibration. The effects were studied of different bone and stem material properties, and different contact conditions at the bone–implant interface. The results were in agreement with previous experimental and computational observations, and differences among the different cases studied were detected. As the osseointegration process at the bone–implant interface evolved, the resonance frequency values of the femur–prosthesis system also increased. In summary, vibration analysis combined with the FE method was able to detect different boundary conditions at the bone–implant interface in cases of both osseointegration and loosening.     

3 种不同弹性模量钛合金股骨假体在羊股骨置换模型中应力分布的三维 有限元分析

目的:通过三维有限元分析方法来观察并比较3种不同弹性模量钛合金股骨假体在羊股骨置换模型中von-Mises应力分布的情况。方法:采用64排螺旋CT对一健康成年羊的下肢股骨进行全长的CT扫描,扫描层厚为0.5 mm,扫描所得的数据存储为DICOM文件。将得到的DICOM文件导入到CT图像分析软件Mimics 10.0,然后利用Mimics 10.0软件来生成股骨的骨质点云数据,再将生成的骨质点云数据导入到Simpleware分析软件,通过机械加工反求中的复杂曲面造型技术建立起精确的三维实体模型。对三维实体模型进行网格划分,确定了髓腔的形状,并根据羊下肢股骨髓腔的形状设计了作者实验用的羊股骨假体模型,然后在ANSYS 12.1软件中进行网格划分。给予加载缓慢行走载荷以及扭转载荷,分析并比较羊股骨以及3种不同弹性模量钛合金股骨假体在股骨置换模型中von-Mises应力分布的情况。结果:在缓慢行走载荷以及扭转载荷条件下,3种不同弹性模量钛合金股骨假体von-Mises应力分布变化趋势一致,假体的柄颈结合部以及假体柄上1/3为应力集中区域。3种不同弹性模量的最大应力集中点均位于柄颈结合部,60 GPa弹性模量的股骨假体植入后假体的最大应力最小(37.8 MPa、29.1 MPa),股骨的最大应力最大(12.6 MPa、24.5 MPa);80 GPa的次之,假体的最大应力(38.4 MPa、33.4 MPa),股骨的最大应力(12.5 MPa、24.5 MPa);110 GPa的股骨假体植入后假体的最大应力最大(38.9 MPa、38.1 MPa),股骨的最大应力最小(12.3 MPa、24.5 MPa)。60 GPa弹性模量的股骨假体植入后的假体最大位移和相对位移均最小(缓慢行走载荷下假体最大位移为0.551 mm、相对位移为0.008 mm,扭转载荷下假体最大位移为0.730 mm、相对位移为0.011 mm)。结论:较低弹性模量的钛合金股骨假体(60 GPa)由于其弹性模量更接近于骨组织的弹性模量,股骨假体与股骨间的"应力遮挡"效应较小,更有利于应力在股骨假体及股骨间的传递,增加了股骨假体的早期稳定性,延长了其临床寿命。