Finite element and experimental cortex strains of the intact and implanted tibia

Finite Element (FE) models for the simulation of intact and implanted bone find their main purpose in accurately reproducing the associated mechanical behavior. FE models can be used for preclinical testing of joint replacement implants, where some biomechanical aspects are difficult, if not possible, to simulate and investigate in vitro. To predict mechanical failure or damage, the models should accurately predict stresses and strains. Commercially available synthetic femur models have been extensively used to validate finite element models, but despite the vast literature available on the characteristics of synthetic tibia, numerical and experimental validation of the intact and implant assemblies of tibia are very limited or lacking. In the current study, four FE models of synthetic tibia, intact and reconstructed, were compared against experimental bone strain data, and an overall agreement within 10% between experimental and FE strains was obtained. Finite element and experimental (strain gauge) models of intact and implanted synthetic tibia were validated based on the comparison of cortex bone strains. The study also includes the analysis carried out on standard tibial components with cemented and noncemented stems of the P.F.C Sigma Modular Knee System. The overall agreement within 10% previously established was achieved, indicating that FE models could be successfully validated. The obtained results include a statistical analysis where the root-mean-square-error values were always <10%. FE models can successfully reproduce bone strains under most relevant acting loads upon the condylar surface of the tibia. Moreover, FE models, once properly validated, can be used for preclinical testing of tibial knee replacement, including misalignment of the implants in the proximal tibia after surgery, simulation of long-term failure according to the damage accumulation failure scenario, and other related biomechanical aspects.     

Surface pretreatment for prolonged survival of cemented tibial prosthesis components: full- vs. surface-cementation technique

Background  

One of few persisting problems of cemented total knee arthroplasty (TKA) is aseptic loosening of tibial component due to degradation of the interface between bone cement and metallic tibial shaft component, particularly for surface cemented tibial components. Surface cementation technique has important clinical meaning in case of revision and for avoidance of stress shielding. Degradation of the interface between bone cement and bone may be a secondary effect due to excessive crack formation in bone cement starting at the opposite metallic surface.     

The influence of tibial component fixation techniques on resorption of supporting bone stock after total knee replacement

Periprosthetic bone resorption after tibial prosthesis implantation remains a concern for long-term fixation performance. The fixation techniques may inherently aggravate the "stress-shielding" effect of the implant, leading to weakened bone foundation. In this study, two cemented tibial fixation cases (fully cemented and hybrid cementing with cement applied under the tibial tray leaving the stem uncemented) and three cementless cases relying on bony ingrowth (no, partial and fully ingrown) were modelled using the finite element method with a strain-adaptive remodelling theory incorporated to predict the change in the bone apparent density after prosthesis implantation. When the models were loaded with physiological knee joint loads, the predicted patterns of bone resorption correlated well with reported densitometry results. The modelling results showed that the firm anchorage fixation formed between the prosthesis and the bone for the fully cemented and fully ingrown cases greatly increased the amount of proximal bone resorption. Bone resorption in tibial fixations with a less secure anchorage (hybrid cementing, partial and no ingrowth) occurred at almost half the rate of the changes around the fixations with a firm anchorage. The results suggested that the hybrid cementing fixation or the cementless fixation with partial bony ingrowth (into the porous-coated prosthesis surface) is preferred for preserving proximal tibial bone stock, which should help to maintain post-operative fixation stability. Specifically, the hybrid cementing fixation induced the least amount of bone resorption.     

Design, calibration and pre-clinical testing of an instrumented tibial tray

An instrumented tibial tray was developed that enables the measurement of six load components in a total knee arthroplasty (TKA). The design is fully compatible with a commonly available knee arthroplasty product since it uses the original tibial insert and femoral component. Two plates with hollow stems made from titanium alloy are separated by a small gap. Six semiconductor strain gages are used for measuring the load-dependent deformation of the inner hollow stem. A 9-channel telemetry unit with a radio-frequency transmitter is encapsulated hermetically in the cavity of the prosthesis. The telemetry is powered inductively and strain gage signals are transmitted via a small antenna at the tip of the implant. The mean sampling rate is 125Hz. The calibration of the prosthesis resulted in an accuracy better than 2% mean measuring error. Fatigue testing of the implant was performed up to 10 million loading cycles and showed no failure. The pending in vivo application will give further insight into the kinetics of TKA. The measured values will enhance the quality of future pre-clinical testing, numerical modeling in knee biomechanics and the patients' physiotherapy and rehabilitation.     

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.     

Effect of varus/valgus malalignment on bone strains in the proximal tibia after TKR: an explicit finite element study

Malalignment is the main cause of tibial component loosening. Implants that migrate rapidly in the first two post-operative years are likely to present aseptic loosening. It has been suggested that cancellous bone stresses can be correlated with tibial component migration. A recent study has shown that patient-specific finite element (FE) models have the power to predict the short-term behavior of tibial trays. The stresses generated within the implanted tibia are dependent on the kinematics of the joint; however, previous studies have ignored the kinematics and only applied static loads. Using explicit FE, it is possible to simultaneously predict the kinematics and stresses during a gait cycle. The aim of this study was to examine the cancellous bone strains during the stance phase of the gait cycle, for varying degrees of varus/valgus eccentric loading using explicit FE. A patient-specific model of a proximal tibia was created from CT scan images, including heterogeneous bone properties. The proximal tibia was implanted with a commercial total knee replacement (TKR) model. The stance phase of gait was simulated and the applied loads and boundary conditions were based on those used for the Stanmore knee simulator. Eccentric loading was simulated. As well as examining the tibial bone strains (minimum and maximum principal strain), the kinematics of the bone-implant construct are also reported. The maximum anterior-posterior displacements and internal-external rotations were produced by the model with 20 mm offset. The peak minimum and maximum principal strain values increased as the load was shifted laterally, reaching a maximum magnitude for -20 mm offset. This suggests that when in varus, the load transferred to the bone is shifted medially, and as the bone supporting this load is stiffer, the resulting peak bone strains are lower than when the load is shifted laterally (valgus). For this particular patient, the TKR design analyzed produced the highest cancellous bone strains when in valgus. This study has provided an insight in the variations produced in bone strain distribution when the axial load is applied eccentrically. To the authors' knowledge, this is the first time that the bone strain distribution of a proximal implanted tibia has been examined, also accounting for the kinematics of the tibio-femoral joint as part of the simulation. This approach gives greater insight into the overall performance of TKR.     

Epiphyseal-based designs for tibial plateau components--II. Stress analysis in the sagittal plane

A two-dimensional, finite element study was undertaken to establish the stresses in the proximal tibia before and after total knee arthroplasty. Equivalent-thickness models in a sagittal plane were created for the natural, proximal tibia and for the proximal tibia with two different types of tibial plateau components. All components simulated bony ingrowth fixation, i.e. no cement layer existed between component and bone. In addition, the interface between component and bone was assumed to be intimately connected, representing complete bony ingrowth and a rigid state of fixation. Two load cases were considered: a joint reaction force acting in conjunction with a patellar ligament force, simulating the knee at 40 degrees of flexion; and a joint reaction force directed along the long axis of the tibia. For the natural tibia model, the pattern of principal stresses for loadcase 1 more closely corresponds to the epiphyseal plate geometry and trabecular morphology than do the principal stress patterns for loadcase 2. Judging from the distribution of principal stresses, loadcase 1 represents a more severe test of implant design than does loadcase 2. The model of the component with a peg predicted that the trabecular bone near the tip of the peg will experience higher than normal stresses, while the bone stresses near the posterior aspect adjacent to the metal tray will be reduced. A component without pegs that incorporates a posterior chamfer and an anterior lip lead to stress distributions closer to those existing in the natural tibia. The interface geometry for this design is based upon the contour of the epiphyseal plate.     

A combined RSA and FE study of the implanted proximal tibia: correlation of the post-operative mechanical environment with implant migration

There is strong evidence to suggest that inducible displacements, migration and implant loosening are closely related to the initial mechanical environment of the implanted tibia. If this is true, then it should be possible to predict the likelihood of implant migration using patient-specific finite element models. Finite element models of the proximal implanted tibiae were analysed based on pre-operative quantitative computed tomography data of four patients entered into a radiographic migration study. These four patients were also part of an radiostereometric analysis (RSA) study. A variety of load cases were analysed and the risk of bone failure determined for a 2 mm layer of bone immediately beneath the tibial tray. The results were compared with the RSA data measured 1 year post-operatively for each patient. For each patient, an appropriate load case was selected based on patient weight and on the varus-valgus migrations observed in the migration study. The two patients with press-fit implants were predicted to have the highest risk of failure and were found to migrate the most. The two patients with bonded implants (one HA coated and one cemented) were found to have a low risk of failure and these implants migrated the least. This study suggests that the degree of implant migration is dependent on the initial mechanical environment and can be determined using patient-specific finite element analysis.     

Influence of interface condition and implant design on bone remodelling and failure risk for the resurfaced femoral head

Resurfacing of the femur has experienced a revival, particularly in younger and more active patients. The implant is generally cemented onto the reamed trabecular bone and theoretical remodelling for this configuration, as well as uncemented variations, has been studied with relation to component positioning for the most common designs. The purpose of this study was to investigate the influence of different interface conditions, for alternative interior implant geometries, on bone strains in comparison to the native femur, and its consequent remodelling. A cylindrical interior geometry, two conical geometries and a spherical cortex-preserving design were compared with a standard implant (ASR, DePuy International, Ltd., UK), which has a 3° cone. Cemented as well as uncemented line to line and press-fit conditions were modelled for each geometry. A patient-specific finite element model of the proximal femur was used with simulated walking loads. Strain energy density was compared between the reference and resurfaced femur, and input into a remodelling algorithm to predict density changes post-operatively. The common cemented designs (cylindrical, slightly conical) had strain shielding in the superior femoral head (>35% reduction) as well as strain concentrations (strain>5%) in the neck regions near the implant rim. The cortex-preserving (spherical) and strongly conical designs showed less strain shielding. In contrast to the cemented implants, line to line implants showed a density decrease at the centre of the femoral head, while all press-fit versions showed a density increase (>100%) relative to the native femur, which suggests that uncemented press-fit implants could limit bone resorption.     

Finite element assessment of block-augmented total knee arthroplasty

Loosening and migration of tibial prostheses have been identified as causes of early total knee replacement (TKR) failure. The problem is made more complex when defects occur in the proximal tibia compromising fixation and alignment. Clinical studies using metal augments have shown these to be an alternative to other means of defect treatment. Finite element (FE) analysis can be used to identify regions that may be prone to loosening and migration. In the current work, 3D FE models of TKR uncontained type-2 defects treated with block augments have been constructed and analysed. It has been shown that a metal augment is the most suitable. The use of bone cement (PMMA) to fill proximal defects is not considered suitable as stresses carried by the cement block exceed those of the fatigue limit of bone cement. It has been shown that the stresses in the proximal cancellous bone of block-augmented models are significantly below levels likely to cause damage due to overloading. Furthermore, the use of stem extensions has been shown to reduce the cancellous bone stresses in the proximal region thus increasing the likelihood of bone resorption. Given this, it is recommended that stem extensions are not required unless necessary to mitigate some other problem.     

Strains and micromotions of press-fit femoral stem prostheses

Average femoral geometry was determined from sections of 25 human femurs. A 'stem design program' was used to determine the largest femoral stem that could be introduced into the canal. The stem was fine tuned by observations of fit in Plexiglass models of the 25 femurs. This stem was called the 'Exact-Fit'. Type 1 stem was formed by grinding the anterior and posterior faces flat. Type 2 stem was formed by additionally grinding the medial and lateral faces flat. Four fresh femurs were used for the experiments. Strain gages were located on the proximal medial area and level with the distal lateral tip. Displacement transducers were mounted proximally to measure stem-bone micromotion. Vertical and anterior-posterior forces were applied to the femoral head and normal strain data obtained. The stems were then inserted in sequence and the strains and micromotions were measured. After the uncemented stems had been tested, a smaller size of 'exact-fit' stem was cemented and the tests repeated. The strains with the uncemented stems were closer to normal than with the cemented stems. For example, compressive calcar strains averaged 56% of normal uncemented compared with 30% cemented for the different loadings. The micromotion was higher uncemented, but was still at a low level. The 'exact-fit' stem gave less resultant micromotion than the type 1 and type 2 stems. The high variation of the strain results was attributed to variations in stem-bone contact and fit. The study provided information of direct application to press-fit stems in hip replacement surgery.     

Epiphyseal-based designs for tibial plateau components--I. Stress analysis in the frontal plane

Two-dimensional, finite element studies were conducted of the proximal tibia before and after joint arthroplasty. Equivalent-thickness models projected onto the mid-frontal plane were created for the natural, proximal tibia and for the proximal tibia with four different types of tibial plateau components. All components simulated bony ingrowth fixation, i.e. no cement layer existed between component and bone. In addition, the interface between component and bone was assumed to be intimately connected, representing complete bony ingrowth and a rigid state of fixation. Loads consisted of bi-condylar and uni-condylar forces. Results indicated that conventional plateau designs with central posts or multiple pegs led to higher stress magnitudes in the trabecular bone near the distal ends of the post/pegs and stress shielding at more proximal locations. A design without posts or pegs whose interface geometry mimics the epiphyseal plate minimizes bone stress shielding. An implant consisting of separate components covering each condyle was found effective in limiting component tilting and the consequent tensile stresses caused by non-symmetrical, uni-condylar loading.     

Primary rotational stability of cylindrical and conical revision hip stems as a function of femoral bone defects: an in vitro comparison

Bone stock losses in cementless femoral stem revisions compromise a stable fixation. The surgeon has to rely on his wealth of experience in deciding which stem shape to use. The aim of our study was to compare the primary rotational stability of cylindrical and conical revision hip stems subjected to femoral defects. Four current prostheses (two cylindrical, two conical) were implanted into four synthetic femora. Micro-motion was measured under torque application and femoral neck osteotomy and segmental AAOS Type I and III defects were simulated. The relative movements of all prostheses were significantly influenced by the extent of bone loss (p<0.01). Major differences were seen in fixation behavior (p<0.01). The main fixation area of conical stems is within the distal femoral isthmus, whereas cylindrical implants are dependent on proximal bone stock. In our study, cylindrical stems are advantageous for minor defects because they provide a proximal fixation. In cases of extensive substance loss, the conical implants showed lesser relative movements. These findings should be taken into account for clinical decisions.     

Cortical bone viscoelasticity and fixation strength of press-fit femoral stems: an in-vitro model

Cementless total hip femoral components rely on press-fit for initial stability and bone healing and remodeling for secondary fixation. However, the determinants of satisfactory press-fit are not well understood. In previous studies, human cortical bone loaded circumferentially to simulate press-fit exhibited viscoelastic, or time dependent, behavior. The effect of bone viscoelastic behavior on the initial stability of press-fit stems is not known. Therefore, in the current study, push-out loads of cylindrical stems press-fit into reamed cadaver diaphyseal femoral specimens were measured immediately after assembly and 24 h with stem-bone diametral interference and stem surface treatment as independent variables. It was hypothesized that stem-bone interference would result in a viscoelastic response of bone that would decrease push-out load thereby impairing initial press-fit stability. Results showed that push-out load significantly decreased over a 24 h period due to bone viscoelasticity. It was also found that high and low push-out loads occurred at relatively small amounts of stem-bone interference, but a relationship between stem-bone interference and push-out load could not be determined due to variability among specimens. On the basis of this model, it was concluded that press-fit fixation can occur at relatively low levels of diametral interference and that stem-bone interference elicits viscoelastic response that reduces stem stability over time. From a clinical perspective, these results suggest that there could be large variations in initial press-fit fixation among patients.     

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.     

Biomechanical evaluation of porous biodegradable scaffolds for revision knee arthroplasty

Tibial bone defect is a critical problem for revision knee arthroplasty. Instead of using metallic spacer or cement, biodegradable scaffolds could be an alternative solution. A numerical model of a revision knee arthroplasty was thus developed to estimate the mechanical resistance of the scaffold in this demanding situation. The tibia, scaffold, and prosthesis were represented by simplified parameterised geometries. The maximal gait cycle force was applied asymmetrically to simulate a critical loading. Several parameters were analysed: 1) inter-individual variability, 2) cortical bone stiffness, 3) cortical bone thickness, 4) prosthesis fixation quality, and 5) scaffold thickness. The calculated scaffold strain was compared to its experimental ultimate strain. Among the tested parameters, failure was only predicted with scaffold thickness below 5 mm. This study suggests that biodegradable bone scaffolds could be used to fill bone defects in revision knee arthroplasty, but scaffold size seems to be the limiting factor.     

Computational biomechanics of articular cartilage of human knee joint: Effect of osteochondral defects

Articular cartilage and its supporting bone functional conditions are tightly coupled as injuries of either adversely affects joint mechanical environment. The objective of this study was set to quantitatively investigate the extent of alterations in the mechanical environment of cartilage and knee joint in presence of commonly observed osteochondral defects. An existing validated finite element model of a knee joint was used to construct a refined model of the tibial lateral compartment including proximal tibial bony structures. The response was computed under compression forces up to 2000 N while simulating localized bone damage, cartilage–bone horizontal split, bone overgrowth and absence of deep vertical collagen fibrils.Localized tibial bone damage increased overall joint compliance and substantially altered pattern and magnitude of contact pressures and cartilage strains in both tibia and femur. These alterations were further exacerbated when bone damage was combined with base cartilage split and absence of deep vertical collagen fibrils. Local bone boss markedly changed contact pressures and strain patterns in neighbouring cartilage. Bone bruise/fracture and overgrowth adversely perturbed the homeostatic balance in the mechanical environment of articulate cartilage surrounding and opposing the lesion as well as the joint compliance. As such, they potentially contribute to the initiation and development of post-traumatic osteoarthritis.     

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.     

Experimental and Numerical Analyses of the Pull-out Response of a Steel Post/Bovine Bone Cementless Fixation

Effect of initial interference fit on pull-out strength in cementless fixation between bovine tibia and smooth stainless steel post was investigated in this study.Compressive behavior of bovine spongious bone was studied using mechanical testing in order to evaluate the elastic-plastic properties in different regions of the proximal tibia.Friction tests were carried out in the aim to evaluate the friction behavior of the contact between bovine spongious bone and stainless steel.A cylindrical stainless steel post inserted in a pre-drilled bovine tibia with an initial interference fit was taken as an in vitro model to assess the contribution of post fixation to the initial stability of the Total Knee Arthroplasty (TKA) tibial component.Pull-out experiments were carried out for different initial interference fits.Finite Element Models (FEM) using local elastic-plastic properties of the bovine bone were developed for the analysis of the experimental ultimate pull-out force results.At the post/bone interface,Coulomb friction was considered in the FEM calculations with pressure-dependent friction coefficient.It was found that the FEM results of the ultimate force are in good agreement with the experimental results.The analysis of the FEM interfacial stresses indicates that the micro-slip initiation depends on the local bone properties.     

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)