3-D finite element model of the impaction of a press-fitted femoral stem under various biomechanical environments.

BACKGROUND: Uncemented femoral stem insertion into the bone is achieved by applying successive impacts on an inserter tool called "ancillary". Impact analysis has shown to be a promising technique to monitor the implant insertion and to improve its primary stability. METHOD: This study aims to provide a better understanding of the dynamic phenomena occurring between the hammer, the ancillary, the implant and the bone during femoral stem insertion, to validate the use of impact analyses for implant insertion monitoring. A dynamic 3-D finite element model of the femoral stem insertion via an impaction protocol is proposed. The influence of the trabecular bone Young's modulus (Et), the interference fit (IF), the friction coefficient at the bone-implant interface (µ) and the impact velocity (v0) on the implant insertion and on the impact force signal is evaluated. RESULTS: For all configurations, a decrease of the time difference between the two first peaks of the impact force signal is observed throughout the femoral stem insertion, up to a threshold value of 0.23 ms. The number of impacts required to reach this value depends on Et, v0 and IF and varies between 3 and 8 for the set of parameters considered herein. The bone-implant contact ratio reached after ten impacts varies between 60% and 98%, increases as a function of v0 and decreases as a function of IF, µ and Et. CONCLUSION: This study confirms the potential of an impact analyses-based method to monitor implant insertion and to retrieve bone-implant contact properties.

Characterization of the concentration of agar-based soft tissue mimicking phantoms by impact analysis.

In various medical fields, a change of soft tissue stiffness is associated with its physio-pathological evolution. While elastography is extensively employed to assess soft tissue stiffness in vivo, its application requires a complex and expensive technology. The aim of this study is to determine whether an easy-to-use method based on impact analysis can be employed to determine the concentration of agar-based soft tissue mimicking phantoms. Impact analysis was performed on soft tissue mimicking phantoms made of agar gel with a mass concentration ranging from 1% to 5%. An indicator Δt is derived from the temporal variation of the impact force signal between the hammer and a small beam in contact with the sample. The results show a non-linear decrease of Δt as a function of the agar concentration (and thus of the sample stiffness). The value of Δt provides an estimation of the agar concentration with an error of 0.11%. This sensitivity of the impact analysis based method to the agar concentration is of the same order of magnitude than results obtained with elastography techniques. This study opens new paths towards the development of impact analysis for a fast, easy and relatively inexpensive clinical evaluation of soft tissue elastic properties.

Debonding of coin-shaped osseointegrated implants: Coupling of experimental and numerical approaches.

While cementless implants are now widely used clinically, implant debonding still occur and is difficult to anticipate. Assessing the biomechanical strength of the bone-implant interface can help improving the understanding of osseointegration phenomena and thus preventing surgical failures. A dedicated and standardized implant model was considered. The samples were tested using a mode III cleavage device to assess the mechanical strength of the bone-implant interface by combining experimental and numerical approaches. Four rough (Sa = 24.5 µm) osseointegrated coin-shaped implants were left in sheep cortical bone during 15 weeks of healing time. Each sample was experimentally rotated at 0.03°/sec until complete rupture of the interface. The maximum values of the torque were comprised between 0.48 and 0.72 N m, while a significant increase of the normal force from 7-12 N to 31-43 N was observed during the bone-implant interface debonding, suggesting the generation of bone debris at the bone-implant interface. The experimental results were compared to an isogeometric finite element model describing the adhesion and debonding phenomena through a modified Coulomb's law, based on a varying friction coefficient to represent the transition from an unbroken to a broken bone-implant interface. A good agreement was found between numerical and experimental torques, with numerical friction coefficients decreasing from 8.93 to 1.23 during the bone-implant interface rupture, which constitutes a validation of this model to simulate the debonding of an osseointegrated bone-implant interface subjected to torsion.

Detection of periprosthetic fractures around the femoral stem by resonance frequency analysis: An in vitro study.

Periprosthetic femoral bone fractures are frequent complications of Total Hip Arthroplasty (THA) and may occur during the insertion of uncemented Femoral Stems (FS), due to the nature of the press-fit fixation. Such fracture may lead to the surgical failure of the THA and require a revision surgery, which may have dramatic consequences. Therefore, an early detection of intra-operative fractures is important to avoid worsening the fracture and/or to enable a peroperative treatment. The aim of this in vitro study is to determine the sensitivity of a method based on resonance frequency analysis of the bone-stem-ancillary system for periprosthetic fractures detection. A periprosthetic fracture was artificially created close to the lesser-trochanter of 10 femoral bone mimicking phantoms. The bone-stem-ancillary resonance frequencies in the range (2-12) kHz were measured on an ancillary instrumented with piezoelectric sensors, which was fixed to the femoral stem. The measurements were repeated for different fracture lengths from 4 to 55 mm. The results show a decrease of the resonance frequencies due to the fracture occurrence and propagation. The frequency shift reached up to 170 Hz. The minimum fracture length that can be detected varies from 3.1±1.7 mm to 5.9±1.9 mm according to the mode and to the specimen. A significantly higher sensitivity (p = 0.011) was obtained for a resonance frequency around 10.6 kHz, corresponding to a mode vibrating in a plane perpendicular to the fracture. This study opens new paths toward the development of non-invasive vibration-based methods for intra-operative periprosthetic fractures detection.

Influence of the biomechanical environment on the femoral stem insertion and vibrational behavior: a 3-D finite element study.

The long-term success of cementless surgery strongly depends on the implant primary stability. The femoral stem initial fixation relies on multiple geometrical and material factors, but their influence on the biomechanical phenomena occurring during the implant insertion is still poorly understood, as they are difficult to quantify in vivo. The aim of the present study is to evaluate the relationship between the resonance frequencies of the bone-implant-ancillary system and the stability of the femoral stem under various biomechanical environments. The interference fit IF, the trabecular bone Young's modulus [Formula: see text] and the bone-implant contact friction coefficient [Formula: see text] are varied to investigate their influence on the implant insertion phenomena and on the system vibration behavior. The results exhibit for all the configurations, a nonlinear increase in the bone-implant contact throughout femoral stem insertion, until the proximal contact is reached. While the pull-out force increases with [Formula: see text], IF and [Formula: see text], the bone-implant contact ratio decreases, which shows that a compromise on the set of parameters could be found in order to achieve the largest bone-implant contact while maintaining sufficient pull-out force. The modal analysis on the range [2-7] kHz shows that the resonance frequencies of the bone-implant-ancillary system increase with the bone-implant contact ratio and the trabecular bone Young's modulus, with a sensitivity that varies over the modes. Both the pull-out forces and the vibration behavior are consistent with previous experimental studies. This study demonstrates the potential of using vibration methods to guide the surgeons for optimizing implant stability in various patients and surgical configurations.

Modeling the debonding process of osseointegrated implants due to coupled adhesion and friction.

Cementless implants have become widely used for total hip replacement surgery. The long-term stability of these implants is achieved by bone growing around and into the rough surface of the implant, a process called osseointegration. However, debonding of the bone-implant interface can still occur due to aseptic implant loosening and insufficient osseointegration, which may have dramatic consequences. The aim of this work is to describe a new 3D finite element frictional contact formulation for the debonding of partially osseointegrated implants. The contact model is based on a modified Coulomb friction law by Immel et al. (2020), that takes into account the tangential debonding of the bone-implant interface. This model is extended in the direction normal to the bone-implant interface by considering a cohesive zone model, to account for adhesion phenomena in the normal direction and for adhesive friction of partially bonded interfaces. The model is applied to simulate the debonding of an acetabular cup implant. The influence of partial osseointegration and adhesive effects on the long-term stability of the implant is assessed. The influence of different patient- and implant-specific parameters such as the friction coefficient [Formula: see text], the trabecular Young's modulus [Formula: see text], and the interference fit [Formula: see text] is also analyzed, in order to determine the optimal stability for different configurations. Furthermore, this work provides guidelines for future experimental and computational studies that are necessary for further parameter calibration.

Mechanical micromodeling of stress-shielding at the bone-implant interphase under shear loading.

Inserting a titanium implant in the bone tissue may modify its physiological loading and therefore cause bone resorption, via a phenomenon called stress-shielding. The local stress field around the bone-implant interphase (BII) created under shear loading may be influenced by different parameters such as the bone-implant contact (BIC) ratio, the bone Young's modulus, the implant roughness and the implant material. A 2-D finite element model was developed to model the BII and evaluate the impact of the aforementioned parameters. The implant roughness was described by a sinusoidal function (height 2Δ, wavelength λ), and different values of the BIC ratio were simulated. A heterogeneous distribution of the maximum shear stress was evidenced in the periprosthetic bone tissue, with high interfacial stress for low BIC ratios and low implant roughness and underloaded regions near the roughness valleys. Both phenomena may lead to stress-shielding-related effects, which were concentrated within a distance lower than 0.8λ from the implant surface. Choosing an implant material with mechanical properties matching those of bone tissue leads to a homogenized shear stress field and could help to prevent stress-shielding effects. Finally, the equivalent shear modulus of the BII was derived to replace its complex behavior with a simpler analytical model in future studies. Schematic illustrations of the 2-D finite element model used in the present study and spatial variation of the maximal shear stress in the periprosthetic bone tissue for different implant roughness and bone-implant contact ratios.

Ultrasonic Evaluation of the Bone-Implant Interface.

While implant surgical interventions are now routinely performed, failures still occur and may have dramatic consequences. The clinical outcome depends on the evolution of the biomechanical properties of the bone-implant interface (BII). This chapter reviews studies investigating the use of quantitative ultrasound (QUS) techniques for the characterization of the BII.First, studies on controlled configurations evidenced the influence of healing processes and of the loading conditions on the ultrasonic response of the BII. The gap of acoustical properties at the BII increases (i) during healing and (ii) when stress at the BII increases, therefore inducing a decrease of the reflection coefficient at the BII.Second, an acoustical model of the BII is proposed to better understand the parameters influencing the interaction between ultrasound and the BII. The reflection coefficient is shown to decrease when (i) the BII is better osseointegrated, (ii) the implant roughness decreases, (iii) the frequency of QUS decreases and (iv) the bone mass density increases.Finally, a 10 MHz device aiming at assessing dental implant stability was validated in vitro, in silico and in vivo. A comparison between QUS and resonance frequency analysis (RFA) techniques showed a better sensitivity of QUS to changes of the parameters related to the implant stability.

Modal Analysis of the Ancillary During Femoral Stem Insertion: A Study on Bone Mimicking Phantoms.

The femoral stem primary stability achieved by the impaction of an ancillary during its insertion is an important factor of success in cementless surgery. However, surgeons still rely on their proprioception, making the process highly subjective. The use of Experimental Modal Analysis (EMA) without sensor nor probe fixation on the implant or on the bone is a promising non destructive approach to determine the femoral stem stability. The aim of this study is to investigate whether EMA performed directly on the ancillary could be used to monitor the femoral stem insertion into the bone. To do so, a cementless femoral stem was inserted into 10 bone phantoms of human femurs and EMA was carried out on the ancillary using a dedicated impact hammer for each insertion step. Two bending modes could be identified in the frequency range [400-8000] Hz for which the resonance frequency was shown to be sensitive to the insertion step and to the bone-implant interface properties. A significant correlation was obtained between the two modal frequencies and the implant insertion depth (R2 = 0.95 ± 0.04 and R2 = 0.94 ± 0.06). This study opens new paths towards the development of noninvasive vibration based evaluation methods to monitor cementless implant insertion.

Ultrasonic assessment of osseointegration phenomena at the bone-implant interface using convolutional neural network.

Although endosseous implants are widely used in the clinic, failures still occur and their clinical performance depends on the quality of osseointegration phenomena at the bone-implant interface (BII), which are given by bone ingrowth around the BII. The difficulties in ensuring clinical reliability come from the complex nature of this interphase related to the implant surface roughness and the presence of a soft tissue layer (non-mineralized bone tissue) at the BII. The aim of the present study is to develop a method to assess the soft tissue thickness at the BII based on the analysis of its ultrasonic response using a simulation based-convolution neural network (CNN). A large-annotated dataset was constructed using a two-dimensional finite element model in the frequency domain considering a sinusoidal description of the BII. The proposed network was trained by the synthesized ultrasound responses and was validated by a separate dataset from the training process. The linear correlation between actual and estimated soft tissue thickness shows excellent R2 values equal to 99.52% and 99.65% and a narrow limit of agreement corresponding to [ -2.56, 4.32 µm] and [ -15.75, 30.35 µm] of microscopic and macroscopic roughness, respectively, supporting the reliability of the proposed assessment of osseointegration phenomena.

Determinants of the primary stability of cementless acetabular cup implants: A 3D finite element study.

Primary stability of cementless implants is crucial for the surgical success and long-term stability. However, primary stability is difficult to quantify in vivo and the biomechanical phenomena occurring during the press-fit insertion of an acetabular cup (AC) implant are still poorly understood. The aim of this study is to investigate the influence of the cortical and trabecular bone Young's moduli Ec and Et, the interference fit IF and the sliding friction coefficient of the bone-implant interface µ on the primary stability of an AC implant. For each parameter combination, the insertion of the AC implant into the hip cavity and consequent pull-out are simulated with a 3D finite element model of a human hemi-pelvis. The primary stability is assessed by determining the polar gap and the maximum pull-out force. The polar gap increases along with all considered parameters. The pull-out force shows a continuous increase with Ec and Et and a non-linear variation as a function of µ and IF is obtained. For µ > 0.6 and IF > 1.4 mm the primary stability decreases, and a combination of smaller µ and IF lead to a better fixation. Based on the patient's bone stiffness, optimal combinations of µ and IF can be identified. The results are in good qualitative agreement with previous studies and provide a better understanding of the determinants of the AC implant primary stability. They suggest a guideline for the optimal choice of implant surface roughness and IF based on the patient's bone quality.

Stress shielding at the bone-implant interface: Influence of surface roughness and of the bone-implant contact ratio.

Short and long-term stabilities of cementless implants are strongly determined by the interfacial load transfer between implants and bone tissue. Stress-shielding effects arise from shear stresses due to the difference of material properties between bone and the implant. It remains difficult to measure the stress field in periprosthetic bone tissue. This study proposes to investigate the dependence of the stress field in periprosthetic bone tissue on (i) the implant surface roughness, (ii) the material properties of bone and of the implant, (iii) the bone-implant contact ratio. To do so, a microscale two-dimensional finite element model of an osseointegrated bone-implant interface was developed where the surface roughness was modeled by a sinusoidal surface. The results show that the isostatic pressure is not affected by the presence of the bone-implant interface while shear stresses arise due to the combined effects of a geometrical singularity (for low surface roughness) and of shear stresses at the bone-implant interface (for high surface roughness). Stress-shielding effects are likely to be more important when the bone-implant contact ratio value is low, which corresponds to a case of relatively low implant stability. Shear stress reach a maximum value at a distance from the interface comprised between 0 and 0.1 time roughness wavelength λ and tend to 0 at a distance from the implant surface higher than λ, independently from bone-implant contact ratio and waviness ratio. A comparison with an analytical model allows validating the numerical results. Future work should use the present approach to model osseointegration phenomena.

Analytical modeling of the interaction of an ultrasonic wave with a rough bone-implant interface.

Quantitative ultrasound can be used to characterize the evolution of the bone-implant interface (BII), which is a complex system due to the implant surface roughness and to partial contact between bone and the implant. The determination of the constitutive law of the BII would be of interest in the context of implant acoustical modeling in order to take into account the imperfect characteristics of the BII. The aim of the present study is to propose an analytical effective model describing the interaction between an ultrasonic wave and a rough BII. To do so, a spring model was considered to determine the equivalent stiffness K of the BII. The stiffness contributions related (i) to the partial contact between the bone and the implant and (ii) to the presence of soft tissues at the BII during the process of osseointegration were assessed independently. K was found to be comprised between 1013 and 1017 N/m3 depending on the roughness and osseointegration of the BII. Analytical values of the reflection and transmission coefficients at the BII were derived from values of K. A good agreement with numerical results obtained through finite element simulation was obtained. This model may be used for future finite element bone-implant models to replace the BII conditions.

Ultrasonic Propagation in a Dental Implant.

Ultrasound techniques can be used to characterize and stimulate dental implant osseointegration. However, the interaction between an ultrasonic wave and the implant-bone interface (IBI) remains unclear. This study-combining experimental and numerical approaches-investigates the propagation of an ultrasonic wave in a dental implant by assessing the amplitude of the displacements along the implant axis. An ultrasonic transducer was excited in a transient regime at 10 MHz. Laser interferometric techniques were employed to measure the amplitude of the displacements, which varied 3.2-8.9 nm along the implant axis. The results demonstrated the propagation of a guided wave mode along the implant axis. The velocity of the first arriving signal was equal to 2110 m.s-1, with frequency components lower than 1 MHz, in agreement with numerical results. Investigating guided wave propagation in dental implants should contribute to improved methods for the characterization and stimulation of the IBI.

Interaction of ultrasound waves with bone remodelling: a multiscale computational study.

Ultrasound stimulation is thought to influence bone remodelling process. But recently, the efficiency of ultrasound therapy for bone healing has been questioned. Despite an extensive literature describing the positive effect of ultrasound on bone regeneration-cell cultures, animal models, clinical studies-there are more and more reviews denouncing the inefficiency of clinical devices based on low-intensity pulsed ultrasound stimulation (LIPUS) of the bone healing. One of the reasons to cause controversy comes from the persistent misunderstanding of the underlying physical and biological mechanisms of ultrasound stimulation of bone repair. As ultrasonic waves are mechanical waves, the process to be studied is the one of the mechanotransduction. Previous studies on the bone mechanotransduction have demonstrated the key role of the osteocytes in bone mechano-sensing. Osteocytes are bone cells ubiquitous inside the bone matrix; they are immersed in the interstitial fluid (IF) inside the lacuno-canalicular network (LCN). They are considered as particularly sensitive to a particular type of mechanical stress: wall shear stress on osteocytes due to the IF flow in the LCN. Inspired from these findings and observations, the present work investigates the effect of LIPUS on the cortical bone from the tissue to the osteocytes, considering that the impact of the ultrasound stimulation applied at the tissue scale is related to the mechanical stress experimented by the bone cells. To do that simulations based on the finite element method are carried out in the commercial software Comsol Multiphysics to assess the wall shear stress levels induced by the LIPUS on the osteocytes. Two formulations of the wall shear stress were investigated based on two IF flow models inside the LCN and associated with two different values of the LCN permeability. The wall shear stress estimate is very different depending on the assumption considered. One of these two models provides wall shear stress values in accordance with previous works published on bone mechanotransduction. This study presents the preliminary results of a computational model that could provide keys to understanding the underlying mechanisms of the LIPUS.

Reflection of an ultrasonic wave on the bone-implant interface: Comparison of two-dimensional and three-dimensional numerical models.

Quantitative ultrasound is used to characterize osseointegration at the bone-implant interface (BII). However, the interaction between an ultrasonic wave and the implant remains poorly understood. Hériveaux, Nguyen, and Haiat [(2018). J. Acoust. Soc. Am. 144, 488-499] recently employed a two-dimensional (2D) model of a rough BII to investigate the sensitivity of the ultrasonic response to osseointegration. The present letter aimed at assessing the validity of the 2D assumption. The values of the reflection coefficient of the BII obtained with two and three-dimensional models were found not to be significantly different for implant roughness lower than 20 µm. 2D modeling is sufficient to describe the interaction between ultrasound and the BII.

A modified Coulomb's law for the tangential debonding of osseointegrated implants.

Cementless implants are widely used in orthopedic and dental surgery. However, debonding-related failure still occurs at the bone-implant interface. It remains difficult to predict such implant failure since the underlying osseointegration phenomena are still poorly understood. Especially in terms of friction and adhesion at the macroscale, there is a lack of data and reliable models. The aim of this work was to present a new friction formulation that can model the tangential contact behavior between osseointegrated implants and bone tissue, with focus on debonding. The classical Coulomb's law is combined with a state variable friction law to model a displacement-dependent friction coefficient. A smooth state function, based on the sliding distance, is used to model implant debonding. The formulation is implemented in a 3D nonlinear finite element framework, and it is calibrated with experimental data and compared to an analytical model for mode III cleavage of a coin-shaped, titanium implant (Mathieu et al. in J Mech Behav Biomed Mater 8(1):194-203, 2012). Overall, the results show a close agreement with the experimental data, especially the peak and the softening part of the torque curve with a relative error of less than 2.25%. In addition, better estimates of the bone's shear modulus and the adhesion energy are obtained. The proposed model is particularly suitable to account for partial osseointegration.

Micromechanical modeling of the contact stiffness of an osseointegrated bone-implant interface.

BACKGROUND: The surgical success of cementless implants is determined by the evolution of the biomechanical properties of the bone-implant interface (BII). One difficulty to model the biomechanical behavior of the BII comes from the implant surface roughness and from the partial contact between bone tissue and the implant. The determination of the constitutive law of the BII would be of interest in the context of implant finite element (FE) modeling to take into account the imperfect characteristics of the BII. The aim of the present study is to determine an effective contact stiffness [Formula: see text] of an osseointegrated BII accounting for its micromechanical features such as surface roughness, bone-implant contact ratio (BIC) and periprosthetic bone properties. To do so, a 2D FE model of the BII under normal contact conditions was developed and was used to determine the behavior of [Formula: see text]. RESULTS: The model is validated by comparison with three analytical schemes based on micromechanical homogenization including two Lekesiz's models (considering interacting and non-interacting micro-cracks) and a Kachanov's model. [Formula: see text] is found to be comprised between 1013 and 1015 N/m3 according to the properties of the BII. [Formula: see text] is shown to increase nonlinearly as a function of the BIC and to decrease as a function of the roughness amplitude for high BIC values (above around 20%). Moreover, [Formula: see text] decreases as a function of the roughness wavelength and increases linearly as a function of the Young's modulus of periprosthetic bone tissue. CONCLUSIONS: These results open new paths in implant biomechanical modeling since this model may be used in future macroscopic finite element models modeling the bone-implant system to replace perfectly rigid BII conditions.

Elastography of the bone-implant interface.

The stress distribution around endosseous implants is an important determinant of the surgical success. However, no method developed so far to determine the implant stability is sensitive to the loading conditions of the bone-implant interface (BII). The objective of this study is to investigate whether a quantitative ultrasound (QUS) technique may be used to retrieve information on compressive stresses applied to the BII. An acousto-mechanical device was conceived to compress 18 trabecular bovine bone samples onto coin-shaped implants and to measure the ultrasonic response of the BII during compression. The biomechanical behavior of the trabecular bone samples was modeled as Neo-Hookean. The reflection coefficient of the BII was shown to decrease as a function of the stress during the elastic compression of the trabecular bone samples and during the collapse of the trabecular network, with an average slope of -4.82 GPa-1. The results may be explained by an increase of the bone-implant contact ratio and by changes of bone structure occurring during compression. The sensitivity of the QUS response of the BII to compressive stresses opens new paths in the elaboration of patient specific decision support systems allowing surgeons to assess implant stability that should be developed in the future.

Dependence of the primary stability of cementless acetabular cup implants on the biomechanical environment.

Biomechanical phenomena occurring at the bone-implant interface during the press-fit insertion of acetabular cup implants are still poorly understood. This article presents a nonlinear geometrical two-dimensional axisymmetric finite element model aiming at describing the biomechanical behavior of the acetabular cup implant as a function of the bone Young's modulus Eb, the diametric interference fit (IF), and the friction coefficient µ. The numerical model was compared with experimental results obtained from an in vitro test, which allows to determine a reference configuration with the parameter set: µ* = 0.3, Eb*=0.2GPa, and IF* = 1 mm for which the maximal contact pressure tN = 10.7 MPa was found to be localized at the peri-equatorial rim of the acetabular cavity. Parametric studies were carried out, showing that an optimal value of the pull-out force can be defined as a function of µ, Eb, and IF. For the reference configuration, the optimal pull-out force is obtained for µ = 0.6 (respectively, Eb = 0.35 GPa and IF = 1.4 mm). For relatively low value of µ (µ < 0.2), the optimal value of IF linearly increases as a function of µ independently of Eb, while for µ > 0.2, the optimal value of IF has a nonlinear dependence on µ and decreases as a function of Eb. The results can be used to help surgeons determine the optimal value of IF in a patient specific manner.