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.     

Use of a statistical model of the whole femur in a large scale,multi-model study of femoral neck fracture risk

Interpatient variability is often overlooked in orthopaedic computational studies due to the substantial challenges involved in sourcing and generating large numbers of bone models. A statistical model of the whole femur incorporating both geometric and material property variation was developed as a potential solution to this problem. The statistical model was constructed using principal component analysis, applied to 21 individual computer tomography scans. To test the ability of the statistical model to generate realistic, unique, finite element (FE) femur models it was used as a source of 1000 femurs to drive a study on femoral neck fracture risk. The study simulated the impact of an oblique fall to the side, a scenario known to account for a large proportion of hip fractures in the elderly and have a lower fracture load than alternative loading approaches. FE model generation, application of subject specific loading and boundary conditions, FE processing and post processing of the solutions were completed automatically. The generated models were within the bounds of the training data used to create the statistical model with a high mesh quality, able to be used directly by the FE solver without remeshing. The results indicated that 28 of the 1000 femurs were at highest risk of fracture. Closer analysis revealed the percentage of cortical bone in the proximal femur to be a crucial differentiator between the failed and non-failed groups. The likely fracture location was indicated to be intertrochantic. Comparison to previous computational, clinical and experimental work revealed support for these findings.     

Automated three-dimensional finite element modelling of bone: a new method

Three-dimensional finite element stress analysis of bone is a key to understanding bone remodelling, assessing fracture risk, and designing prostheses; however, the cost and complexity of predicting the stress field in bone with accuracy has precluded the routine use of this method. A new, automated method of generating patient-specific three-dimensional finite element models of bone is presented — it uses digital computed tomographic (CT) scan data to derive the geometry of the bone and to estimate its inhomogeneous material properties. Cubic elements of a user-specified size are automatically defined and then individually assigned the CT scan-derived material properties. The method is demonstrated by predicting the stress, strain, and strain energy in a human proximal femur in vivo. Three-dimensional loading conditions corresponding to the stance phase of gait were taken from the literature and applied to the model. Maximum principal compressive stresses of 8–23 MPa were computed for the medial femoral neck. Automated generation of additional finite element models with larger numbers of elements was used to verify convergence in strain energy.     

Variation of trabecular architecture in proximal femur of postmenopausal women

This investigation of microstructure in the human proximal femur probes the relationship between the parameters of the FRAX index of fracture risk and the parameters of bone microstructure. The specificity of fracture sites at the proximal femur raises the question of whether trabecular parameters are site-specific during post-menopause, before occurrence of fragility fracture. The donated proximal femurs of sixteen post-menopausal women in the sixth and seventh decades of life, free of metabolic pathologies and therapeutic interventions that could have altered the bone tissue, constituted the material of the study. We assessed bone mineral density of the proximal femurs by dual energy X-ray absorptiometry and then sectioned the femurs through the center of the femoral head and along the femoral neck axis. For each proximal femur, morphometry of trabeculae was conducted on the plane of the section divided into conventional regions and sub-regions consistent with the previously identified trabecular families that provide regions of relatively homogeneous microstructure. Mean trabecular width and percent bone area were calculated at such sites. Our findings indicate that each of mean trabecular width and percent bone area vary within each proximal femur independently from each other, with dependence on site. Both trabecular parameters show significant differences between pairs of sites. We speculate that a high FRAX index at the hip corresponds to a reduced percent bone area among sites that gives a more homogeneous and less site-specific quality to the proximal femur. This phenomenon may render the local tissue less able to carry out the expected mechanical function.     

Concept and development of an orthotropic FE model of the proximal femur

PURPOSE: In contrast to many isotropic finite-element (FE) models of the femur in literature, it was the object of our study to develop an orthotropic FE "model femur" to realistically simulate three-dimensional bone remodelling. METHODS: The three-dimensional geometry of the proximal femur was reconstructed by CT scans of a pair of cadaveric femurs at equal distances of 2mm. These three-dimensional CT models were implemented into an FE simulation tool. Well-known "density-determined" bony material properties (Young's modulus; Poisson's ratio; ultimate strength in pressure, tension and torsion; shear modulus) were assigned to each FE of the same "CT-density-characterized" volumetric group.In order to fix the principal directions of stiffness in FE areas with the same "density characterization", the cadaveric femurs were cut in 2mm slices in frontal (left femur) and sagittal plane (right femur). Each femoral slice was scanned into a computer-based image processing system. On these images, the principal directions of stiffness of cancellous and cortical bone were determined manually using the orientation of the trabecular structures and the Haversian system. Finally, these geometric data were matched with the "CT-density characterized" three-dimensional femur model. In addition, the time and density-dependent adaptive behaviour of bone remodelling was taken into account by implementation of Carter's criterion. RESULTS: In the constructed "model femur", each FE is characterized by the principal directions of the stiffness and the "CT-density-determined" material properties of cortical and cancellous bone. Thus, on the basis of anatomic data a three-dimensional FE simulation reference model of the proximal femur was realized considering orthotropic conditions of bone behaviour. CONCLUSIONS: With the orthotropic "model femur", the fundamental basis has been formed to realize realistic simulations of the dynamical processes of bone remodelling under different loading conditions or operative procedures (osteotomies, total hip replacements, etc).     

The biomechanics of human femurs in axial and torsional loading: comparison of finite element analysis, human cadaveric femurs, and synthetic femurs

To assess the performance of femoral orthopedic implants, they are often attached to cadaveric femurs, and biomechanical testing is performed. To identify areas of high stress, stress shielding, and to facilitate implant redesign, these tests are often accompanied by finite element (FE) models of the bone/implant system. However, cadaveric bone suffers from wide specimen to specimen variability both in terms of bone geometry and mechanical properties, making it virtually impossible for experimental results to be reproduced. An alternative approach is to utilize synthetic femurs of standardized geometry, having material behavior approximating that of human bone, but with very small specimen to specimen variability. This approach allows for repeatable experimental results and a standard geometry for use in accompanying FE models. While the synthetic bones appear to be of appropriate geometry to simulate bone mechanical behavior, it has not, however, been established what bone quality they most resemble, i.e., osteoporotic or osteopenic versus healthy bone. Furthermore, it is also of interest to determine whether FE models of synthetic bones, with appropriate adjustments in input material properties or geometric size, could be used to simulate the mechanical behavior of a wider range of bone quality and size. To shed light on these questions, the axial and torsional stiffness of cadaveric femurs were compared to those measured on synthetic femurs. A FE model, previously validated by the authors to represent the geometry of a synthetic femur, was then used with a range of input material properties and change in geometric size, to establish whether cadaveric results could be simulated. Axial and torsional stiffnesses and rigidities were measured for 25 human cadaveric femurs (simulating poor bone stock) and three synthetic "third generation composite" femurs (3GCF) (simulating normal healthy bone stock) in the midstance orientation. The measured results were compared, under identical loading conditions, to those predicted by a previously validated three-dimensional finite element model of the 3GCF at a variety of Young's modulus values. A smaller FE model of the 3GCF was also created to examine the effects of a simple change in bone size. The 3GCF was found to be significantly stiffer (2.3 times in torsional loading, 1.7 times in axial loading) than the presently utilized cadaveric samples. Nevertheless, the FE model was able to successfully simulate both the behavior of the 3GCF, and a wide range of cadaveric bone data scatter by an appropriate adjustment of Young's modulus or geometric size. The synthetic femur had a significantly higher stiffness than the cadaveric bone samples. The finite element model provided a good estimate of upper and lower bounds for the axial and torsional stiffness of human femurs because it was effective at reproducing the geometric properties of a femur. Cadaveric bone experiments can be used to calibrate FE models' input material properties so that bones of varying quality can be simulated.     

Effect of boundary conditions,impact loading and hydraulic stiffening on femoral fracture strength

Patient specific quantitative CT (QCT) imaging data together with the finite element (FE) method may provide an accurate prediction of a patient's femoral strength and fracture risk. Although numerous FE models investigating femoral fracture strength have been published, there is little consent on the effect of boundary conditions, dynamic loading and hydraulic strengthening due to intra-medullary pressure on the predicted fracture strength. We developed a QCT-derived FE model of a proximal femur that included node-specific modulus assigned based on the local bone density. The effect of three commonly used boundary conditions published in literature were investigated by comparing the resulting strain field due to an applied fracture load. The models were also augmented with viscoelastic material properties and subject to a realistic impact load profile to determine the effect of dynamic loads on the strain field. Finally, the effect of hydraulic strengthening was investigated by including node specific permeability and performing a coupled pore diffusion and stress analysis of the FE model. Results showed that all boundary conditions yield the same strain field patterns, but peak strains were 22% lower and fracture load was 18% higher when loaded at the greater trochanter than when loaded at the femoral head. Comparison of the dynamic models showed that material viscoelasticity was important, but inertial effects (vibration and shock) were not. Finally, pore pressure changes did not cause significant hydraulic strengthening of bone under fall impact loading.     

Assessment of the 3-D shape and mechanics of the proximal femur using a shape template and a bone mineral density image

Measurement of bone mineral density (BMD) by DXA (dual-energy X-ray absorptiometry) is generally considered to be the clinical golden standard technique to diagnose osteoporosis. However, BMD alone is only a moderate predictor of fracture risk. Finite element analyses of bone mechanics can contribute to a more accurate prediction of fracture risk. In this study, we applied a method to estimate the 3D geometrical shape of bone based on a 2D BMD image and a femur shape template. Proximal femurs of eighteen human cadavers were imaged with computed tomography (CT) and divided into two groups. Image data from the first group (N = 9) were applied to create a shape template by using the general Procrustes analysis and thin plate splines. This template was then applied to estimate the shape of the femurs in the second group (N = 9), using the 2D BMD image projected from the CT image, and the geometrical errors of the shape estimation method were evaluated. Finally, finite element analysis with stance loading condition was conducted based on the original CT and the estimated geometrical shape to evaluate the effect of the geometrical errors on the outcome of the simulations. The volumetric errors induced by the shape estimation method itself were low (<0.6%). Increasing the number of bone specimens used for the template decreased the geometrical errors. When nine bones were used for the template, the mean distance difference (±SD) between the estimated and the CT shape surfaces was 1.2 ± 0.3 mm, indicating that the method was feasible for estimating the shape of the proximal femur. Small errors in geometry led systematically to larger errors in the mechanical simulations. The method could provide more information of the mechanical characteristics of bone based on 2D BMD radiography and could ultimately lead to more sensitive diagnosis of osteoporosis.     

Estimation of 3D shape, internal density and mechanics of proximal femur by combining bone mineral density images with shape and density templates

Measurement of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) alone is only a moderate predictor of fracture risk. Finite element analysis (FEA) of bone mechanics, based on DXA images, may improve the prediction of fracture risk. We developed a method to estimate the 3D shape and density distribution of the proximal femur, using a 2D BMD image and a femur shape template. Proximal femurs of eighteen human cadavers were imaged using computed tomography and divided into two sets (N = 9 + 9). The template was created from the samples in first set by using 3D generalized Procrustes analysis and thin-plate splines. Subsequently, the template and 2D BMD image were utilized to estimate the shape and internal density distribution of the femurs in the second set. Finally, FEA was conducted based on the original and the estimated bone models to evaluate the effect of geometrical and density distributional errors on the mechanical strength. The volumetric errors induced by the estimation itself were low (<1.4%). In the estimation of bones in the second set, the mean distance difference between the estimated and the original bone surfaces was 0.80 ± 0.19 mm, suggesting feasible estimation of the femoral shape. The mean absolute error in voxel-by-voxel BMD was 120±8 mg cm?3. In FEA, the stiffness of the proximal femur differed by -7±16% between the original and estimated bones. The present method, in comparison with methods used in previous studies, improved the prediction of the geometry, the BMD distribution and the mechanical characteristics of the proximal femur. Potentially, the proposed method could ultimately improve the determination of bone fracture risk.     

Prediction of the mechanical response of the femur with uncertain elastic properties

A mandatory requirement for any reliable prediction of the mechanical response of bones, based on quantitative computer tomography, is an accurate relationship between material properties (usually Young's modulus E) and bone density ρ. Many such E-ρ relationships are available based on different experiments on femur specimens with a large spread due to uncertainties. The first goal of this study is to pool and analyze the relevant available experimental data and develop a stochasticE-ρ relationship. This analysis highlights that there is no experimental data available to cover the entire density range of the human femur and that some "popular" E-ρ relationships are based on data that contains extreme scatter, while others are based on a very limited amount of information. The second goal is to use the newly developed stochastic E-ρ relationship in high-order finite element analyses (FEAs) for the computation of strains and displacements in two human proximal femurs, mimicking in vitro experiments. When compared with the experimental observations, the FEA predictions using the median of the stochastic E-ρ relationship follow the underlying distribution of the stochastic E-ρ relationship. Thus, most deviations of the FEA predictions from experimental observations can possibly be explained by uncertain elastic properties of the femur.     

Accuracy of finite element predictions in sideways load configurations for the proximal human femur

Subject-specific finite element models have been used to predict stress-state and fracture risk in individual patients. While many studies analysed quasi-axial loading configurations, only few works simulated sideways load configurations, such as those arising in a fall. The majority among these latter directly predicted bone strength, without assessing elastic strain prediction accuracy. The aim of the present work was to evaluate if a subject-specific finite element modelling technique from CT data that accurately predicted strains in quasi-axial loading configurations is suitable to accurately predict strains also when applying low magnitude loads in sideways configurations. To this aim, a combined numerical-experimental study was performed to compare finite element predicted strains with strain-gauge measurements from three cadaver proximal femurs instrumented with sixteen strain rosettes and tested non-destructively under twelve loading configurations, spanning a wide cone (0-30° for both adduction and internal rotation angles) of sideways fall scenarios. The results of the present study evidenced a satisfactory agreement between experimentally measured and predicted strains (R(2) greater than 0.9, RMSE% lower than 10%) and displacements. The achieved strain prediction accuracy is comparable to those obtained in state of the art studies in quasi-axial loading configurations. Still, the presence of the highest strain prediction errors (around 30%) in the lateral neck aspect would deserve attention in future studies targeting bone failure.     

Sensitivity of periprosthetic stress-shielding to load and the bone density-modulus relationship in subject-specific finite element models

Subject-specific finite element (FE) computer models of the proximal femur in hip replacement could potentially predict stress-shielding and subsequent bone loss in individual patients. Before such predictions can be made, it is important first to determine if between subject differences in stress-shielding are sensitive to poorly defined parameters such as the load and the bone material properties. In this study we investigate if subject-specific FE models provide consistent stress-shielding patterns in the bone, independent of the choice of the loading conditions and the bone density-modulus relationship used in the computer model. FE models of two right canine femurs with and without implants were constructed based on contiguous computed tomography (CT) scans so that subject-specific estimates of stress-shielding could be calculated. Four different loading conditions and two bone density-modulus relationships were tested. Stress-shielding was defined as the decrease of strain energy per gram bone mass in the femur with the implant in place relative to the intact femur.The analyses showed that for the four loading conditions and two bone density-modulus relationships the difference in stress-shielding between the two subjects was essentially constant (1% variation) when the same loading condition and density-modulus relationship was used for both subjects. The severity of stress-shielding within a subject was sensitive to these input parameters, varying up to 20% in specific regions with a change in loading conditions and up to 10% for a change in the assumed density-modulus relationship. We conclude that although the choice of input parameters can substantially affect stress-shielding in an individual, this choice had virtually no effect on the relative differences in femoral periprosthetic stress-shielding between individuals. Thus, while care should be taken in the interpretation of the absolute value of stress-shielding calculated with these type of models, subject-specific FE models may be useful for explaining the variation in bone adaptation responsiveness between different subjects in experimental or clinical studies.     

Fracture prediction for the proximal femur using finite element models: Part I--Linear analysis.

Over 90 percent of the more than 250,000 hip fractures that occur annually in the United States are the result of falls from standing height. Despite this, the stresses associated with femoral fracture from a fall have not been investigated previously. Our objectives were to use three-dimensional finite element models of the proximal femur (with geometries and material properties based directly on quantitative computed tomography) to compare predicted stress distributions for one-legged stance and for a fall to the lateral greater trochanter. We also wished to test the correspondence between model predictions and in vitro strain gage data and failure loads for cadaveric femora subjected to these loading conditions. An additional goal was to use the model predictions to compare the sensitivity of several imaging sites in the proximal femur which are used for the in vivo prediction of hip fracture risk. In this first of two parts, linear finite element models of two unpaired human cadaveric femora were generated. In Part II, the models were extended to include nonlinear material properties for the cortical and trabecular bone. While there was poor correspondence between strain gage data and model predictions, there was excellent agreement between the in vitro failure data and the linear model, especially using a von Mises effective strain failure criterion. Both the onset of structural yielding (within 22 and 4 percent) and the load at fracture (within 8 and 5 percent) were predicted accurately for the two femora tested. For the simulation of one-legged stance, the peak stresses occurred in the primary compressive trabeculae of the subcapital region.(ABSTRACT TRUNCATED AT 250 WORDS)     

Validation of subject-specific automated p-FE analysis of the proximal femur

Background: The use of subject-specific finite element (FE) models in clinical practice requires a high level of automation and validation. In Yosibash et al. [2007a. Reliable simulations of the human proximal femur by high-order finite element analysis validated by experimental observations. J. Biomechanics 40, 3688–3699] a novel method for generating high-order finite element (p-FE) models from CT scans was presented and validated by experimental observations on two fresh frozen femurs (harvested from a 30 year old male and 21 year old female). Herein, we substantiate the validation process by enlarging the experimental database (54 year old female femur), improving the method and examine its robustness under different CT scan conditions.Approach: A fresh frozen femur of a 54 year old female was scanned under two different environments: in air and immersed in water (dry and wet CT). Thereafter, the proximal femur was quasi-statically loaded in vitro by a 1000 N load. The two QCT scans were manipulated to generate p-FE models that mimic the experimental conditions. We compared p-FE displacements and strains of the wet CT model to the dry CT model and to the experimental results. In addition, the material assignment strategy was reinvestigated. The inhomogeneous Young's modulus was represented in the FE model using two different methods, directly extracted from the CT data and using continuous spatial functions as in Yosibash et al. [2007a. Reliable simulations of the human proximal femur by high-order finite element analysis validated by experimental observations. J. Biomechanics 40, 3688–3699].Results: Excellent agreement between dry and wet FE models was found for both displacements and strains, i.e. the method is insensitive to CT conditions and may be used in vivo. Good agreement was also found between FE results and experimental observations. The spatial functions representing Young's modulus are local and do not influence strains and displacements prediction. Finally, the p-FE results of all three fresh frozen human femurs compare very well to experimental observations exemplifying that the presented method may be in a mature stage to be used in clinical computer-aided decision making.     

Experimental and probabilistic analysis of distal femoral periprosthetic fracture: a comparison of locking plate and intramedullary nail fixation. Part B: probabilistic investigation

The following is Part B of a two-part study. Part A evaluated, biomechanically, intramedullary (IM) nails versus locking plates for fixation of an extra-articular, metaphyseal wedge fracture in synthetic osteoporotic bone. Part B of this study introduces deterministic finite element (FE) models of each construct type in synthetic osteoporotic bone and investigates the probability of periprosthetic fracture of the locking plate compared with the retrograde IM nail using Monte Carlo simulation. Deterministic FE models of the fractured femur implanted with IM nail and locking plate, respectively, were developed and validated using experimental data presented in Part A of this study. The models were validated by comparing the load-displacement curve of the experimental data with the load-displacement curve of the FE simulation with a root-mean square error of less than 3?mm. The validated FE models were then modified by defining the cortical and cancellous bone modulus of elasticity as uncertain variables that could be assumed to vary randomly. Monte Carlo simulation was used to evaluate the probability of fracture (POF) of each fixation. The POF represents the cumulative probability that the predicted shear stresses in the cortical bone will exceed the expected shear strength of the cortical bone. This investigation provides information regarding the significance of post-operative damage accumulation on the POF of the implanted bones when the two fixations are used. The probabilistic analysis found the locking plate fixation to have a higher POF than the IM nail fixation under the applied loading conditions (locking plate 21.8% versus IM nail 0.019%).     

Specimen-specific modeling of hip fracture pattern and repair

Hip fracture remains a major health problem for the elderly. Clinical studies have assessed fracture risk based on bone quality in the aging population and cadaveric testing has quantified bone strength and fracture loads. Prior modeling has primarily focused on quantifying the strain distribution in bone as an indicator of fracture risk. Recent advances in the extended finite element method (XFEM) enable prediction of the initiation and propagation of cracks without requiring a priori knowledge of the crack path. Accordingly, the objectives of this study were to predict femoral fracture in specimen-specific models using the XFEM approach, to perform one-to-one comparisons of predicted and in vitro fracture patterns, and to develop a framework to assess the mechanics and load transfer in the fractured femur when it is repaired with an osteosynthesis implant. Five specimen-specific femur models were developed from in vitro experiments under a simulated stance loading condition. Predicted fracture patterns closely matched the in vitro patterns; however, predictions of fracture load differed by approximately 50% due to sensitivity to local material properties. Specimen-specific intertrochanteric fractures were induced by subjecting the femur models to a sideways fall and repaired with a contemporary implant. Under a post-surgical stance loading, model-predicted load sharing between the implant and bone across the fracture surface varied from 59%:41% to 89%:11%, underscoring the importance of considering anatomic and fracture variability in the evaluation of implants. XFEM modeling shows potential as a macro-level analysis enabling fracture investigations of clinical cohorts, including at-risk groups, and the design of robust implants.     

Three-dimensional micro-level computational study of Wolff's law via trabecular bone remodeling in the human proximal femur using design space topology optimization

The law of bone remodeling, commonly referred to as Wolff's Law, asserts that the internal trabecular bone adapts to external loadings, reorienting with the principal stress trajectories to maximize mechanical efficiency creating a naturally optimum structure. The goal of the current study was to utilize an advanced structural optimization algorithm, called design space optimization (DSO), to perform a micro-level three-dimensional finite element bone remodeling simulation on the human proximal femur and analyse the results to determine the validity of Wolff's hypothesis. DSO optimizes the layout of material by iteratively distributing it into the areas of highest loading, while simultaneously changing the design domain to increase computational efficiency. The result is a "fully stressed" structure with minimized compliance and increased stiffness. The large-scale computational simulation utilized a 175 μm mesh resolution and the routine daily loading activities of walking and stair climbing. The resulting anisotropic trabecular architecture was compared to both Wolff's trajectory hypothesis and natural femur samples from literature using a variety of visualization techniques, including radiography and computed tomography (CT). The results qualitatively revealed several anisotropic trabecular regions, that were comparable to the natural human femurs. Quantitatively, the various regional bone volume fractions from the computational results were consistent with quantitative CT analyses. The global strain energy proceeded to become more uniform during optimization; implying increased mechanical efficiency was achieved. The realistic simulated trabecular geometry suggests that the DSO method can accurately predict bone adaptation due to mechanical loading and that the proximal femur is an optimum structure as the Wolff hypothesized.     

Assessment of the bilateral asymmetry of human femurs based on physical,densitometric, and structural rigidity characteristics

The purpose of this study was to perform a comprehensive geometric, densitometric, biomechanical, and statistical analysis of paired femurs for an adult population over a wide age range using three imaging modalities to quantify the departure from symmetry in size, bone mineral density, and cross-sectional structural rigidities.Femur measurements were obtained from 20 pairs of cadaveric femurs. Dimensions of these anatomic sites were measured using calipers directly on the bone and plain radiographs. Dual energy X-ray absorptiometry was used to measure bone mineral density. Bone mineral content and axial and bending rigidities were determined from the CT imaging.No differences were observed between the geometric measurements, DXA based bone mineral density and axial and bending rigidities of left and right femurs (P>0.05 for all cases). Left and right proximal femurs are not significantly different based on geometric, densitometric, and structural rigidity measurements. However, absolute left–right differences for individual patients can be substantial. When using the contralateral femur as a control, the number of femur pairs required to assess significant changes in anatomic dimensions and structural properties induced by a tumor, infection, fracture, or implanted device can range from 3 to 165 pairs depending on the desired effect size or sensitivity (5% or 10% difference).This information is important both for femoral arthroplasty implant design and the use of the contralateral femur as an intra-subject control for clinical assessment and research studies. In addition, our statistical analysis provides sample size estimates for planning future orthopedic research studies.     

Reliable simulations of the human proximal femur by high-order finite element analysis validated by experimental observations

Background: The mechanical response of patient-specific bone to various load conditions is of major clinical importance in orthopedics. Herein we enhance the methods presented in Yosibash et al. [2007. A CT-based high-order finite element analysis of the human proximal femur compared to in-vitro experiments. ASME Journal of Biomechanical Engineering 129(3), 297–309.] for the reliable simulations of the human proximal femur by high-order finite elements (FEs) and validate the simulations by experimental observations.

Method of approach: A fresh-frozen human femur was scanned by quantitative computed tomography (QCT) and thereafter loaded (in vitro experiments) by a quasi-static force of up to 1250 N. QCT scans were manipulated to generate a high-order FE bone model with distinct cortical and trabecular regions having inhomogeneous isotropic elastic properties with Young's modulus represented by continuous spatial functions. Sensitivity analyses were performed to quantify parameters that mostly influence the mechanical response. FE results were compared to displacements and strains measured in the experiments.

Results: Young moduli correlated to QCT Hounsfield Units by relations in Keyak and Falkinstein [2003. Comparison of in situ and in vitro CT scan-based finite element model predictions of proximal femoral fracture load. Medical Engineering and Physics 25, 781–787.] were found to provide predictions that match the experimental results closely. Excellent agreement was found for both the displacements and strains. The presented study demonstrates that reliable and validated high-order patient-specific FE simulations of human femurs based on QCT data are achievable for clinical computer-aided decision making.     

In vitro replication of spontaneous fractures of the proximal human femur

Spontaneous fractures (i.e. caused by sudden loading and muscle contraction, not by trauma) represent a significant percentage of proximal femur fractures. They are particularly relevant as may occur in elderly (osteoporotic) subjects, but also in relation to epiphyseal prostheses. Despite its clinical and legal relevance, this type of fracture has seldom been investigated. Studies concerning spontaneous fractures are based on a variety of loading scenarios. There is no evidence, nor consensus on the most relevant loading scenario. The aim of this work was to develop and validate an experimental method to replicate spontaneous fractures in vitro based on clinically relevant loading. Primary goals were: (i) repeatability and reproducibility, (ii) clinical relevance. A validated numerical model was used to identify the most critical loading scenario that can lead to head-neck fractures, and to determine if it is necessary to include muscle forces when the head-neck region is under investigation. The numerical model indicated that the most relevant loading scenario is when the resultant joint force is applied to the head at 8 degrees from the diaphysis. Furthermore, it was found that it is not essential to include the muscles when investigating head-neck fractures. The experimental setup was consequently designed. The procedure included high-speed filming of the fracture event. Clinically relevant fracture modes were obtained on 10 cadaveric femurs. Failure load should be reported as a fraction of donor's body-weight to reduce variability. The proposed method can be used to investigate the reason and mechanism of failure of natural and operated proximal femurs.