Design considerations for ceramic resurfaced femoral head: effect of interface characteristics on failure mechanisms

Ceramic hip resurfacing may offer improved wear resistance compared to metallic components. The study is aimed at investigating the effects of stiffer ceramic components on the stress/strain-related failure mechanisms in the resurfaced femur, using three-dimensional finite element models of intact and resurfaced femurs with varying stem–bone interface conditions. Tensile stresses in the cement varied between 1 and 5 MPa. Postoperatively, 20–85% strain shielding was observed inside the resurfaced head. The variability in stem–bone interface condition strongly influenced the stresses and strains generated within the resurfaced femoral head. For full stem–bone contact, high tensile (151–158 MPa) stresses were generated at the cup–stem junction, indicating risk of fracture. Moreover, there was risk of femoral neck fracture due to elevated bone strains (0.60–0.80% strain) in the proximal femoral neck region. Stresses in the ceramic component are reduced if a frictionless gap condition exists at the stem–bone interface. High stresses, coupled with increased strain shielding in the ceramic resurfaced femur, appear to be major concerns regarding its use as an alternative material.     

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.     

Pre-clinical validation of a new partially cemented femoral prosthesis by synergetic use of numerical and experimental methods

The present work reports the pre-clinical validation of an innovative partially cemented femoral prosthesis called cement-locked uncemented (CLU) prosthesis. The inventors of the device under investigation claimed that, when compared to a comparable fully cemented stem, the new stem would present various advantages. Two previous experimental studies confirmed that primary stability and stress shielding were comparable to those of cemented stems. Aim of the present study was to investigate if the remaining claims were confirmed as well. A complete finite element model of the bone-implant complex was created from CT data. The model was validated against in vitro measurements of bone surface strains as well as against primary stability measurements. The peak stresses predicted in the CLU cement mantle were not found significantly lower than those reported in other studies on fully cemented stems. However, once the cement inlet geometry is optimised and the associated stress risers are eliminated, the CLU cement mantle should be subjected to much lower stresses. The stress induced in the stems by both load cases was well below the fatigue limit of the Ti6Al4V alloy. Finite element models predicted for all load cases relative motion between cement and metal lower than 60 microm. This amplitude may be fully accommodated by elastic deformations of the cement micro-ridges. The experimental and numerical results showed the validity of the new fixation concept, although a further optimisation of the geometry of the cement pockets is needed in order to further reduce the stresses in the cement.     

The influence of cement mantle thickness and stem geometry on fatigue damage in two different cemented hip femoral prostheses

Experimental models can be used for pre-clinical testing of cemented and other type of hip replacements. Total hip replacement (THR) failure scenarios include, among others, cement damage accumulation and the assessment of accurate stress and strain magnitudes at the cement mantle interfaces (stem-cement and cement-bone) can be used to predict mechanical failure. The aseptic loosening scenario in cemented hip replacements is currently not fully understood, and methods of evaluating medical devices must be developed to improve clinical performance. Different results and conclusions concerning the cement micro-cracking mechanism have been reported.The aim of this study was to verify the in vitro behavior of two cemented femoral stems with respect to fatigue crack formation. Fatigue crack damage was assessed at the medial, lateral, anterior and posterior sides of the Lubinus SPII and Charnley stems. All stems were loaded and tested in stair climbing fatigue loading during one million cycles at 2 Hz. After the experiments each implanted synthetic femur was sectioned and analyzed. We observed more damage (cracks per area) for the Lubinus SPII stem, mainly on the proximal part of the cement mantle. The micro-cracking formation initiated in the stem–cement interface and grew towards the direction of cortical bone of the femur.Overall, the cement–bone interface seems to be crucial for the success of the hip replacement. The Charnley stem provoked more damage on the cement–bone interface. A failure index (maximum length of crack/maximum thickness of cement) considered was higher for the cement–stem interface of the Lubinus SPII stem. For a cement mantle thickness higher than 5 mm, cracking initiated at the cement–bone interface and depended on the opening canal process (reaming procedure and instrumentation). The analysis also showed that fatigue-induced damage on the cement mantle, increasing proximally, and depended on the axial position of the stem. The cement thickness is an important factor for the success of THR and this study evidenced that cement thickness higher than 2 mm apparently does not affect the mechanical behavior of the cement mantel and induce more crack formation on the cement–bone interface.     

Stem surface roughness alters creep induced subsidence and 'taper-lock' in a cemented femoral hip prosthesis

The clinical success of polished tapered stems has been widely reported in numerous long term studies. The mechanical environment that exists for polished tapered stems, however, is not fully understood. In this investigation, a collarless, tapered femoral total hip stem with an unsupported distal tip was evaluated using a 'physiological' three-dimensional (3D) finite element analysis. It was hypothesized that stem-cement interface friction, which alters the magnitude and orientation of the cement mantle stress, would subsequently influence stem 'taper-lock' and viscoelastic relaxation of bone cement stresses. The hypothesis that creep-induced subsidence would result in increases to stem-cement normal (radial) interface stresses was also examined. Utilizing a viscoelastic material model for the bone cement in the analysis, three different stem-cement interface conditions were considered: debonded stem with zero friction coefficient (mu=0) (frictionless), debonded stem with stem-cement interface friction (mu=0.22) ('smooth' or polished) and a completely bonded stem ('rough'). Stem roughness had a profound influence on cement mantle stress, stem subsidence and cement mantle stress relaxation over the 24-h test period. The frictionless and smooth tapered stems generated compressive normal stress at the stem-cement interface creating a mechanical environment indicative of 'taper-lock'. The normal stress increased with decreasing stem-cement interface friction but decreased proximally with time and stem subsidence. Stem subsidence also increased with decreasing stem-cement interface friction. We conclude that polished stems have a greater potential to develop 'taper-lock' fixation than do rough stems. However, subsidence is not an important determinant of the maintenance of 'taper-lock'. Rather subsidence is a function of stem-cement interface friction and bone cement creep.     

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.     

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.     

Strain shielding in proximal tibia of stemmed knee prosthesis: experimental study

Theoretical concerns about the use of cemented or press-fit stems in revision total knee arthroplasty (TKA) include stress shielding with adverse effects on prosthesis fixation. Revision TKA components are commonly stemmed to protect the limited autogenous bone stock remaining. Revision procedures with the use of stems can place abnormal stresses through even normal bone by their constrained design, type of materials and fixation method and may contribute for bone loss. Experimental quantification of strain shielding in the proximal synthetic tibia following TKA is the main purpose of the present study. In this study, cortical bone strains were measured experimentally with tri-axial strain gauges in synthetic tibias before and after in vitro knee surgery. Three tibias were implanted with cemented and press-fit stem augments and solely with a tibial tray (short monobloc stem) of the P.F.C. Sigma Modular Knee System. The difference between principal strains of the implanted and the intact tibia was calculated for each strain gauge position. The results demonstrated a pronounced strain-shielding effect in the proximal level, close to tibial tray with the cemented stem augment. The press-fit stem presented a minor effect of strain shielding but was more extensively throughout the stem. An increase of strains closely to the distal tip of the cemented and the press-fit stem augment was observed. This suggests for a physiological condition, a potential effect of bone resorption at the proximal region for the cemented stem augment. The localized increase of strains in stems tip can be related with the clinical finding of the pain, at the end of stem after revision TKA.     

Measurement of transient and residual stresses during polymerization of bone cement for cemented hip implants

The initial fixation of a cemented hip implant relies on the strength of the interface between the stem, bone cement and adjacent bone. Bone cement is used as grouting material to fix the prosthesis to the bone. The curing process of bone cement is an exothermic reaction where bone cement undergoes volumetric changes that will generate transient stresses resulting in residual stresses once polymerization is completed. However, the precise magnitude of these stresses is still not well documented in the literature. The objective of this study is to develop an experiment for the direct measurement of the transient and residual radial stresses at the stem-cement interface generated during cement polymerization. The idealized femoral-cemented implant consists of a stem placed inside a hollow cylindrical bone filled with bone cement. A sub-miniature load cell is inserted inside the stem to make a direct measurement of the radial compressive forces at the stem-cement interface, which are then converted to radial stresses. A thermocouple measures the temperature evolution during the polymerization process. The results show the evolution of stress generation corresponding to volumetric changes in the cement. The effect of initial temperature of the stem and bone as well as the cement-bone interface condition (adhesion or no adhesion) on residual radial stresses is investigated. A maximum peak temperature of 70 degrees C corresponds to a peak in transient stress during cement curing. Maximum radial residual stresses of 0.6MPa in compression are measured for the preheated stem.     

Finite-element modelling of femoral shaft fracture fixation techniques post total hip arthroplasty.

The presence of a femoral prosthesis superior to a shaft fracture severely complicates fixation and treatment. This study uses two-dimensional, multithickness, plane stress finite-element models of a femur with prosthesis to investigate the stresses developed with the application of three popular fixation techniques: revision to a long stem prosthesis, lateral plating with a cortical bone allograft strut and cerclage wires, and custom plate application with proximal Parham band fixation with distal cortical screws (Ogden plate). The plate and bone contact as well as the fracture site contact were modelled by using orthotropic elements with custom-fit moduli so that only the normal stress to the interface was significant. A thermal analogy was used to model the cerclage and Parham band preloads so that representative preloads in the proximal fixation of the two types of plate treatments could be modelled. A parametric study was performed with the long-prosthesis model to show variations in stem lengths of one, two and three femoral diameters distal to the fracture site. The Ogden plate model showed a transfer of tensile stress near the proximal-most band, with the highest tensile stress being at the fracture site with evidence of stress shielding of the proximal lateral cortex. The cortical bone strut model showed a transfer of tensile stress to the bone strut but showed less shielding of the proximal cortex. The cerclage wires at the base of the bone strut showed the highest changes in load with the distalmost wire increasing to almost four times its original preload.(ABSTRACT TRUNCATED AT 250 WORDS)     

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.     

Evaluation of cement stresses in finite element analyses of cemented orthopaedic implants.

Stress analysis of the cement fixation of orthopaedic implants to bone is frequently carried out using finite element analysis. However the stress distribution in the cement layer is usually intricate, and it is difficult to report it in a way that facilitates comparison of implants for pre-clinical testing. To study this problem, and make recommendations for stress reporting, a finite element analysis of a hip prosthesis implanted into a synthetic composite femur is developed. Three cases are analyzed: a fully bonded implant, a debonded implant, and a debonded implant where the cement is removed distal to the stem tip. In addition to peak stresses, and contour and vector plots, a stressed volume and probability-of-failure analysis is reported. It is predicted that the peak stress is highest for the debonded stem, and that removal of the distal cement more than halves this peak stress. This would suggest that omission of the distal cement is good for polished prostheses (as practiced for the Exeter design). However, if the percentage of cement stressed above a certain threshold (say 3 MPa) is considered, then the removal of distal cement is shown to be disadvantageous because a higher volume of cement is stressed to above the threshold. Vector plots clearly demonstrate the different load transfer for bonded and debonded prostheses: A bonded stem generates maximum tensile stresses in the longitudinal direction, whereas a debonded stem generates most tensile stresses in the hoop direction, except near the tip where tensile longitudinal stresses occur due to subsidence of the stem. Removal of the cement distal to the tip allows greater subsidence but alleviates these large stresses at the tip, albeit at the expense of increased hoop stresses throughout the mantle. It is concluded that a thorough analysis of cemented implants should not report peak stress, which can be misleading, but rather stressed volume, and that vector plots should be reported if a precise analysis of the load transfer mechanism is required.     

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.     

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.     

In vitro interface and cement mantle analysis of different femur stem designs

The aim of this study is to define stem design related factors causing both gaps in the metal-bone cement interface and cracks within the cement mantle. Six different stem designs (Exeter; Lubinus SP II; Ceraver Osteal; Mueller-straight stem; Centega; Spectron EF) (n=15 of each design) were cemented into artificial femur bones. Ten stems of each design were loaded, while five stems served as an unloaded control. Physiologically adapted cyclical loading (DIN ISO 7206-4) was performed with a hip simulator. After loading both interfaces and the bone cement itself were analysed regarding gaps and cracks in the cement mantle. Significant differences between the stem designs concerning gaps in the metal-bone cement interface and cracks in the cement mantle became apparent. Additionally, a high correlation between gaps in the metal-bone cement interface and cracks within the cement mantle could be proven. Gaps in the metal-bone cement interface but no cracks within the cement mantle were seen in the unloaded specimens. Differences between the unloaded control groups and the cyclical loaded stems regarding the longitudinal extension and width of gaps in the metal-bone cement interface were obvious. The designs of cemented femoral stems have an influence on both the quality of the metal-bone cement contact and the failure rate of the cement mantle. Less interface gaps and less cement defects were found with anatomically formed, collared, well-rounded stem designs without undercuttings.     

The biomechanical effect of the collar of a femoral stem on total hip arthroplasty

To investigate the biomechanical effect of collars, finite element analyses are carried out through two hip joints that are implanted using collared and collarless stems, respectively, and an intact hip joint model. For the analyses, the sacrum, coxal bone, and the cancellous and cortical bones of a femur are modelled using finite elements based on X-ray computed tomographic images taken from a 27-year-old woman. From the results, it is found that a collar with perfect calcar contact prevents stem subsidence and decreases the proximal–lateral gap and the lateral stem tilting. Therefore, it can impart reasonable biomechanical stability for total hip arthroplasty. However, its low load transmission ability and increased stem tilting effect due to the imperfect contact between the collar and the calcar are found to be serious problems that need to be solved. Results of clinical follow-up are presented for supporting the computational results.     

Sensitivity analysis of a cemented hip stem to implant position and cement mantle thickness

Patient-specific finite element models of the implanted proximal femur can be built from pre-operative computed tomography scans and post-operative X-rays. However, estimating three-dimensional positioning from two-dimensional radiographs introduces uncertainty in the implant position. Further, accurately measuring the thin cement mantle and the degree of cement–bone interdigitation from imaging data is challenging. To quantify the effect of these uncertainties in stem position and cement thickness, a sensitivity study was performed. A design-of-experiment study was implemented, simulating both gait and stair ascent. Cement mantle stresses and bone–implant interface strains were monitored. The results show that small variations in alignment affect the implant biomechanics, especially around the most proximal and most distal ends of the stem. The results suggest that implant position is more influential than cement thickness. Rotation around the medial–lateral axis is the dominant factor in the proximal zones and stem translations are the dominant factors around the distal tip.     

Modelling the fibrous tissue layer in cemented hip replacements: experimental and finite element methods

The long-term fixation of cemented femoral components may be jeopardised by the presence of a fibrous tissue layer at the bone-cement interface. This study used both experimental and finite element (FE) methods to investigate the load transfer characteristics of two types of cemented hip replacements (Lubinus SPII and Müller-Curved) with a fibrous tissue layer.The experimental part investigated six stems of each type, where these were implanted in composite femurs with a specially selected silicone elastomer modelling the soft interfacial layer. Two fibrous tissue conditions were examined: a layer covering the full cement mantle, representing a revision condition; and a layer covering the proximal portion of the cement mantle, representing a non-revised implant with partial debonding and fibrous tissue formation. The FE method was used to model the full fibrous tissue layer condition, for both implants. The layer was modelled as a homogeneous, linearly isotropic material. A cross-comparison was performed of the experimental and FE findings.Agreement between experimental and FE models was verified to be within 15%. Varying the stiffness parameter of the FE soft tissue layer had little influence on the cortical bone strains, though had considerable effect on the cement strains. Stress shielding occurred for both stems under both fibrous tissue conditions, with the greatest reduction around the calcar. However, the cortical bone strains were generally larger than those for the equivalent well-fixed stems. The fibrous tissue layer was not found to increase the general strain pattern of the cement mantle, though localised regions of high stress were detected.     

Residual stresses at the stem-cement interface of an idealized cemented hip stem

During the operation of total hip arthroplasty, when the cement polymerizes between the stem implant and the bone, residual stresses are generated in the cement. The purpose of this study was to determine whether including residual stresses at the stem-cement interface of cemented hip implants affected the cement stress distributions due to externally applied loads. An idealized cemented hip implant subjected to bending was numerically investigated for an early post-operative situation. The finite element analysis was three-dimensional and used non-linear contact elements to represent the debonded stem-cement interface. The results showed that the inclusion of the residual stresses at the interface had up to a 4-fold increase in the von Mises cement stresses compared to the case without residual stresses.     

Novel methods to study functional loading micromechanics at the stem–cement and cement–bone interface in cemented femoral hip replacements

We have developed a technique to directly observe the micromechanics of the stem–cement and cement–bone interfaces of cemented femoral stems under physiologically relevant loading conditions. Thick transverse sections of a stem–cement–femur construct were fixed to the base of a test frame. Ante- and retro-verting torques were applied to the femoral stem by screwing the stem (via a pair of through holes) to an axle, which was turned using a lever arm actuated by the test frame cross-head. The surface of each transverse section was serially digitally imaged during loading. The displacements of the stem, cement and bone were determined using digital image correlation. These data were then used to calculate the relative displacements across the interfaces. This method provides a path to more thorough understanding of load-transfer from femoral stem to femur.