The primary stability of a cementless PEEK femoral component is sensitive to BMI: A population-based FE study.

The use of polyetheretherketone (PEEK) for cementless femoral total knee arthroplasty (TKA) components is of interest due to several potential advantages, e.g. the use in patients with metal hypersensitivity. Additionally, the stiffness of PEEK closer resembles the stiffness of bone, and therefore, peri-prosthetic stress-shielding may be avoided. When introducing a new implant material for cementless TKA designs, it is important to study its effect on the primary fixation, which is required for the long-term fixation. Finite element (FE) studies can be used to study the effect of PEEK as implant material on the primary fixation, which may be dependent on patient factors such as age, gender and body weight index (BMI). Therefore, the research objectives of this study were to investigate the effect of PEEK vs cobalt-chrome (CoCr) and patient characteristics on the primary fixation of a cementless femoral component. 280 FE models of 70 femora were created with varying implant material and gait and squat activity. Overall, the PEEK models generated larger peak micromotions than the CoCr models. Distinct differences were seen in the micromotion distributions between the PEEK and CoCr models for both the gait and squat models. The micromotions of all femoral models significantly increased with BMI. Neither gender nor age of the patients had a significant effect on the micromotions. This population study gives insights into the primary fixation of a cementless femoral component in a cohort of FE models with varying implant material and patient characteristics.

The Effect of Patient-Related Factors on the Primary Fixation of PEEK and Titanium Tibial Components: A Population-Based FE Study.

Polyetheretherketone (PEEK) is of interest as implant material for cementless tibial total knee arthroplasty (TKA) components due to its potential advantages. One main advantage is that the stiffness of PEEK closely resembles the stiffness of bone, potentially avoiding peri-prosthetic stress-shielding. When introducing a new implant material for cementless TKA designs, it is essential to study its effect on the primary fixation. The primary fixation may be influenced by patient factors such as age, gender, and body mass index (BMI). Therefore, the research objectives of this finite element (FE) study were to investigate the effect of material (PEEK vs. titanium) and patient characteristics on the primary fixation (i.e., micromotions) of a cementless tibial tray component. A total of 296 FE models of 74 tibiae were created with either PEEK or titanium material properties, under gait and squat loading conditions. Overall, the PEEK models generated larger peak micromotions than the titanium models. Differences were seen in the micromotion distributions between the PEEK and titanium models for both the gait and squat models. The micromotions of all tibial models significantly increased with BMI, while gender and age did not influence micromotions.

Quantification of long-term nonlinear stress relaxation of bovine trabecular bone.

The reliability of computational models in orthopedic biomechanics depends often on the accuracy of the bone material properties. It is widely recognized that the mechanical response of trabecular bone is time-dependent, yet it is often ignored for the sake of simplicity. Previous investigations into the viscoelastic properties of trabecular bone have not explored the relationship between nonlinear stress relaxation and bone mineral density. The inclusion of this behavior could enhance the accuracy of simulations of orthopedic interventions, such as of primary fixation of implants. Although methods to quantify the viscoelastic behavior are known, the time period during which the viscoelastic properties should be investigated to obtain reliable predictions is currently unclear. Therefore, this study aimed to: 1) Investigate the duration of stress relaxation in bovine trabecular bone; 2) construct a material model that describes the nonlinear viscoelastic behavior of uniaxial stress relaxation experiments on trabecular bone; and 3) implement bone density into this model. Uniaxial compressive stress relaxation experiments were performed with cylindrical bovine femoral trabecular bone samples (n = 16) with constant strain held for 24 h. Additionally, multiple stress relaxation experiments with four ascending strain levels with a holding time of 30 min, based on the results of the 24-h experiment, were executed on 18 bovine bone cores. The bone specimens used in this study had a mean diameter of 12.80 mm and a mean height of 28.70 mm. A Schapery and a Superposition model were used to capture the nonlinear stress relaxation behavior in terms of applied strain level and bone mineral density. While most stress relaxation happened in the first 10 min (up to 53 %) after initial compression, the stress relaxation continued even after 24 h. Up to 69 % of stress relaxation was observed at 24 h. Extrapolating the results of 30 min of experimental data to 24 h provided a good fit for accuracy with much improved experimental efficiency. The Schapery and Superposition model were both capable of fitting the repeated stress relaxation in a sample-by-sample approach. However, since bone mineral density did not influence the time-dependent behavior, only the Superposition model could be used for a group-based model fit. Although the sample-by-sample approach was more accurate for an individual specimen, the group based approach is considered a useful model for general application.

The effect of periprosthetic bone loss on the failure risk of tibial total knee arthroplasty.

The effect of long-term periprosthetic bone loss on the process of aseptic loosening of tibial total knee arthroplasty (TKA) is subject to debate. Contradicting studies can be found in literature, reporting either bone resorption or bone formation before failure of the tibial tray. The aim of the current study was to investigate the effects of bone resorption on failure of tibial TKA, by simulating clinical postoperative bone density changes in finite element analysis (FEA) models and FEA models were created of two tibiae representing cases with good and poor initial bone quality which were subjected to a walking configuration and subsequently to a traumatic stumbling load. Bone failure was simulated using a crushable foam model incorporating progressive yielding. Repetitive loading under a level walking load did not result in failure of the periprosthetic bone in neither the good nor poor bone quality tibia at the baseline bone densities. When applying a stumble load, a collapse of the tibial reconstruction was noticed in the poor bone quality model. Incorporating postoperative bone loss led to a significant increase of the failure risk, particularly for the poor bone quality model in which subsidence of the tibial component was substantial. Our results suggest bone loss can lead to an increased risk of a collapse of the tibial component, particularly in case of poor bone quality at the time of surgery. The study also examined the probability of medial or lateral subsidence of the implant and aimed to improve clinical implications. The FEA model simulated plastic deformation of the bone and implant subsidence, with further validation required via mechanical experiments.

The sensitivity of the stiffness and thickness of a titanium inlay in a cementless PEEK femoral component to the micromotions and bone strain energy density.

Polyetheretherketone (PEEK) has been proposed as alternative material for total knee arthroplasty implants due to its low stiffness, which may reduce stress-shielding. In cementless fixation, a proper primary fixation is required for long-term fixation. Previous research showed that the lower stiffness of a cementless PEEK femoral component results in larger micromotions at the implant-bone interface compared to a cobalt-chrome femoral component. A titanium inlay on the PEEK implant surface may improve the primary fixation while maintaining the favourable stiffness properties. Therefore, the effect of thickness and stiffness of a titanium inlay on the primary fixation and stress-shielding was investigated. A finite element model of the femur and femoral component was created with five titanium inlay variants. The micromotions and strain energy density (SED) were quantified as outcome measures. The distal thin - proximal thick variant showed the largest resulting micromotions (51.2 µm). Relative to the all-PEEK femoral component, the addition of a titanium inlay reduced the micromotions with 30 % to 40 % without considerably affecting the stress-shielding capacity (strain energy difference of 6 % to 10 %). Differences in micromotions (43.0-51.2 µm) and SED between the variants were relatively small. In conclusion, the addition of a titanium inlay could lead to a reduction of the micromotions without substantially affecting the SED distribution.

The application of an isotropic crushable foam model to predict the femoral fracture risk.

For biomechanical simulations of orthopaedic interventions, it is imperative to implement a material model that can realistically reproduce the nonlinear behavior of the bone structure. However, a proper material model that adequately combines the trabecular and cortical bone response is not yet widely identified. The current paper aims to investigate the possibility of using an isotropic crushable foam (ICF) model dependent on local bone mineral density (BMD) for simulating the femoral fracture risk. The elastoplastic properties of fifty-nine human femoral trabecular cadaveric bone samples were determined and combined with existing cortical bone properties to characterize two forms of the ICF model, a continuous and discontinuous model. Subsequently, the appropriateness of this combined material model was evaluated by simulating femoral fracture experiments, and a comparison with earlier published results of a softening Von-Mises (sVM) material model was made. The obtained mechanical properties of the trabecular bone specimens were comparable to previous findings. Furthermore, the ultimate failure load predicted by the simulations of femoral fractures was on average 79% and 90% for the continuous and discontinuous forms of the ICF model and 82% of the experimental value for the sVM material model. Also, the fracture locations predicted by ICF models were comparable to the experiments. In conclusion, a nonlinear material model dependent on BMD was characterized for human femoral bone. Our findings indicate that the ICF model could predict the femoral bone strength and reproduce the variable fracture locations in the experiments.

A Patient-Specific Fracture Risk Assessment Tool for Femoral Bone Metastases: Using the Bone Strength (BOS) Score in Clinical Practice.

Patients with femoral metastases are at risk of fracturing bones. It is important to prevent fractures in order to maintain mobility and quality of life. The BOne Strength (BOS) score is based on a computed tomography (CT)-based patient-specific finite element (FE) computer model that objectively calculates bone strength. In this pilot study, the added clinical value of the BOS score towards treatment-related decision making was assessed. In December 2019, the BOS score was implemented in four radiotherapy centers. The BOS scores and fracture risks of individual patients were calculated and returned to the physician to assist in treatment decisions. The physicians filled out a questionnaire, which was qualitatively analyzed. A follow-up to identify fractures and/or death was performed after six months. Until June 2021, 42 BOS scores were delivered (20 high, 9 moderate, and 13 low fracture risk). In 48%, the BOS score led to an adaptation of treatment plans. Physicians indicated that the BOS score provided objective insight into fracture risk, was reassuring for physicians and patients, and improved multidisciplinary discussions and shared decision making. In conclusion, the BOS score is an objective tool to assess fracture risk in femoral bone metastases and aids physicians and patients in making a more informed decision regarding the most appropriate treatment.

A FE study on the effect of interference fit and coefficient of friction on the micromotions and interface gaps of a cementless PEEK femoral component.

The use of a more compliant material, such as polyetheretherketone (PEEK), for a cementless femoral component is a potential solution to prevent aseptic loosening caused by peri-prosthetic stress-shielding. Long-term fixation of a cementless femoral component is achieved by a proper primary fixation of the bone-implant interface, which is influenced by the interference fit and frictional properties of the implant surface. This computational study investigates the sensitivity of micromotions and interface gaps of a cementless PEEK femoral component to the interference fit and coefficient of friction. 24 finite element models of the femur and femoral component were created with variations in implant material, interference fit and coefficient of friction. Peak loads of a jogging activity were applied on the models. Micromotions and interface gaps were both sensitive to the interference fit, coefficient of friction and implant material. Besides the implant material, the micromotions and interface gaps of the implant were most sensitive to the interference fit. Compared to the cobalt-chrome (CoCr) femoral component, the PEEK femoral component generated higher micromotions and interface gaps when equal interference fit and friction values were applied. However, increasing the interference fit and friction of the PEEK component resulted in micromotion values comparable with the CoCr component. This result leads to possibilities using cementless PEEK femoral components.

Dual-functional porous and cisplatin-loaded polymethylmethacrylate cement for reconstruction of load-bearing bone defect kills bone tumor cells.

Malignant bone tumors are usually treated by resection of tumor tissue followed by filling of the bone defect with bone graft substitutes. Polymethylmethacrylate (PMMA) cement is the most commonly used bone substitute in clinical orthopedics in view of its reliability. However, the dense nature of PMMA renders this biomaterial unsuitable for local delivery of chemotherapeutic drugs to limit the recurrence of bone tumors. Here, we introduce porosity into PMMA cement by adding carboxymethylcellulose (CMC) to facilitate such local delivery of chemotherapeutic drugs, while retaining sufficient mechanical properties for bone reconstruction in load-bearing sites. Our results show that the mechanical strength of PMMA-based cements gradually decreases with increasing CMC content. Upon incorporation of ≥3% CMC, the PMMA-based cements released up to 18% of the loaded cisplatin, in contrast to cements containing lower amounts of CMC which only released less than 2% of the cisplatin over 28 days. This release of cisplatin efficiently killed osteosarcoma cells in vitro and the fraction of dead cells increased to 91.3% at day 7, which confirms the retained chemotherapeutic activity of released cisplatin from these PMMA-based cements. Additionally, tibias filled with PMMA-based cements containing up to 3% of CMC exhibit comparable compressive strengths as compared to intact tibias. In conclusion, we demonstrate that PMMA cements can be rendered therapeutically active by introducing porosity using CMC to allow for release of cisplatin without compromising mechanical properties beyond critical levels. As such, these data suggest that our dual-functional PMMA-based cements represent a viable treatment option for filling bone defects after bone tumor resection in load-bearing sites.

Development of a crushable foam model for human trabecular bone.

Finite element (FE) simulations can be used to evaluate the mechanical behavior of human bone and allow for quantitative prediction of press-fit implant fixation. An adequate material model that captures post-yield behavior is essential for a realistic simulation. The crushable foam (CF) model is a constitutive model that has recently been proposed in this regard. Compression tests under uniaxial and confined loading conditions were performed on 59 human trabecular bone specimens. Three essential material parameters were obtained as a function of bone mineral density (BMD) to develop the isotropic CF model. The related constitutive rule was implemented in FE models and the results were compared to the experimental data. The CF model provided an accurate simulation of uniaxial compression tests and the post-yield behavior of the stress-strain was well-matched with the experimental results. The model was able to reproduce the confined response of the bone up to 15% of strain. This model allows for simulation of the mechanical behavior of the cellular structure of human bone and adequately predicts the post-yield response of trabecular bone, particularly under uniaxial loading conditions. The model can be further improved to simulate bone collapse due to local overload around orthopaedic implants.

The effects of manufacturing tolerances and assembly force on the volumetric wear at the taper junction in modular total hip arthroplasty.

Fretting and corrosion at the taper-head interface in total hip arthroplasty has been reported as a potential cause of early failure of the implant system. The finite element (FE) method can be used to study the mechanics at the taper junction that are difficult to assess experimentally. Taper mismatch is one of the factors that can influence the performance of the taper junction. In this study we have assessed the effect of taper mismatch, in combination with assembly force on the volumetric wear. The study showed that higher assembly forces and smaller mismatches result in the least volumetric wear.

Case-specific non-linear finite element models to predict failure behavior in two functional spinal units.

Current finite element (FE) models predicting failure behavior comprise single vertebrae, thereby neglecting the role of the posterior elements and intervertebral discs. Therefore, this study aimed to develop a more clinically relevant, case-specific non-linear FE model of two functional spinal units able to predict failure behavior in terms of (i) the vertebra predicted to fail; (ii) deformation of the specimens; (iii) stiffness; and (iv) load to failure. For this purpose, we also studied the effect of different bone density-mechanical properties relationships (material models) on the prediction of failure behavior. Twelve two functional spinal units (T6-T8, T9-T11, T12-L2, and L3-L5) with and without artificial metastases were destructively tested in axial compression. These experiments were simulated using CT-based case-specific non-linear FE models. Bone mechanical properties were assigned using four commonly used material models. In 10 of the 11 specimens our FE model was able to correctly indicate which vertebrae failed during the experiments. However, predictions of the three-dimensional deformations of the specimens were less promising. Whereas stiffness of the whole construct could be strongly predicted (R2 = 0.637-0.688, p < 0.01), we obtained weak correlations between FE predicted and experimentally determined load to failure, as defined by the total reaction force exhibiting a drop in force (R2 = 0.219-0.247, p > 0.05). Additionally, we found that the correlation between predicted and experimental fracture loads did not strongly depend on the material model implemented, but the stiffness predictions did. In conclusion, this work showed that, in its current state, our FE models may be used to identify the weakest vertebra, but that substantial improvements are required in order to quantify in vivo failure loads. © 2018 The Authors. Journal of Orthopaedic Research® Published by Wiley Periodical, Inc. on behalf of Orthopaedic Research Society. J Orthop Res 36:3208-3218, 2018.

Finite element wear prediction using adaptive meshing at the modular taper interface of hip implants.

The use of modular components in total hip arthroplasty introduced an additional interface with the potential for fretting and corrosion to occur. Fretting and corrosion at this interface have been reported as a potential cause of early failure of the implant system. Using finite element (FE) analyses the mechanics at the taper junction can be studied. However, most FE studies are based on a single load condition and do not take geometry changes over time into account. Therefore, in this study an FE routine was developed, in which adaptations to the implant geometry are made to account for material removal during the fretting process. Material removal was simulated based on Archard's Law, incorporating contact pressure, micromotions and a wear factor which used input from in vitro fretting tests. A wear factor of 2.7*10-5mm3/Nmm was used to match the FE predicted volumetric wear to the measured experimental volumetric wear of 0.79mm3 after 10 million cycles. The maximum experimental wear depth found was 30.5 ± 17µm, while the FE predicted a maximum wear depth of 27µm. The adaptive meshing method has delivered results that are more similar to the experimental test data in comparison to the results from modelling a single cycle without adaptive meshing.

A combined experimental and finite element approach to analyse the fretting mechanism of the head-stem taper junction in total hip replacement.

Fretting corrosion at the taper interface of modular hip implants has been implicated as a possible cause of implant failure. This study was set up to gain more insight in the taper mechanics that lead to fretting corrosion. The objectives of this study therefore were (1) to select experimental loading conditions to reproduce clinically relevant fretting corrosion features observed in retrieved components, (2) to develop a finite element model consistent with the fretting experiments and (3) to apply more complicated loading conditions of activities of daily living to the finite element model to study the taper mechanics. The experiments showed similar wear patterns on the taper surface as observed in retrievals. The finite element wear score based on Archard's law did not correlate well with the amount of material loss measured in the experiments. However, similar patterns were observed between the simulated micromotions and the experimental wear measurements. Although the finite element model could not be validated, the loading conditions based on activities of daily living demonstrate the importance of assembly load on the wear potential. These findings suggest that finite element models that do not incorporate geometry updates to account for wear loss may not be appropriate to predict wear volumes of taper connections.