Bone remodelling around the tibia due to total ankle replacement: effects of implant material and implant–bone interfacial conditions

Abstract

One of the major causes of implant loosening is due to excessive bone resorption surrounding the implant due to bone remodelling. The objective of the study is to investigate the effects of implant material and implant–bone interface conditions on bone remodelling around tibia bone due to total ankle replacement. Finite element models of intact and implanted ankles were developed using CT scan data sets. Bone remodelling algorithm was used in combination with FE analysis to predict the bone density changes around the ankle joint. Dorsiflexion, neutral, and plantar flexion positions were considered, along with muscle force and ligaments. Implant–bone interfacial conditions were assumed as debonded and bonded to represent non-osseointegration and fully osseointegration at the porous coated surface of the implant. To investigate the effect of implant material, three finite element models having different material combinations of the implant were developed. For model 1, tibial and talar components were made of Co–Cr–Mo, and meniscal bearing was made of UHMWPE. For model 2, tibial and talar components were made of ceramic and meniscal bearing was made of UHMWPE. For model 3, tibial and talar components were made of ceramic and meniscal bearing was made of CFR-PEEK. Changes in implant material showed no significant changes in bone density due to bone remodelling. Therefore, ceramic appears to be a viable alternative to metal and CFR-PEEK can be used in place of UHMWPE. This study also indicates that proper bonding between implant and bone is essential for long-term survival of the prosthetic components.     

Cartilage thickness distribution affects computational model predictions of cervical spine facet contact parameters

With motion-sparing disk replacement implants gaining popularity as an alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of certain spinal degenerative disorders, recent laboratory investigations have studied the effects of disk replacement and implant design on spinal kinematics and kinetics. Particularly relevant to cervical disk replacement implant design are any postoperative changes in solid stresses or contact conditions in the articular cartilage of the posterior facets, which are hypothesized to lead to adjacent-level degeneration. Such changes are commonly investigated using finite element methods, but significant simplification of the articular geometry is generally employed. The impact of such geometric representations has not been thoroughly investigated. In order to assess the effects of different models of cartilage geometry on load transfer and contact pressures in the lower cervical spine, a finite element model was generated using cadaver-based computed tomography imagery. Mesh resolution was varied in order to establish model convergence, and cadaveric testing was undertaken to validate model predictions. The validated model was altered to include four different geometric representations of the articular cartilage. Model predictions indicate that the two most common representations of articular cartilage geometry result in significant reductions in the predictive accuracy of the models. The two anatomically based geometric models exhibited less computational artifact, and relatively minor differences between them indicate that contact condition predictions of spatially varying thickness models are robust to anatomic variations in cartilage thickness and articular curvature. The results of this work indicate that finite element modeling efforts in the lower cervical spine should include anatomically based and spatially varying articular cartilage thickness models. Failure to do so may result in loss of fidelity of model predictions relevant to investigations of physiological import.     

Contact forces in several TKA designs during squatting: A numerical sensitivity analysis

Total knee arthroplasty (TKA) is a very successful procedure, but pain or difficulties during activities still persist in patients. Patient outcomes in TKA surgery can be affected by implant design, alignment or patient-related anatomical factors. This paper presents a numerical sensitivity analysis of several TKA types: a fixed bearing, posterior stabilized prosthesis, a high flexion fixed bearing guided motion prosthesis, a mobile bearing prosthesis and a hinge prosthesis. Each prosthesis was virtually implanted on the same cadaver leg model and it underwent a loaded squat, in 10s, between 0° and 120°, similar to several previous experimental tests performed on knee kinematics simulators. The aim of this examination was to investigate the sensitivity of the patello-femoral (PF) and tibio-femoral (TF) contact forces to patient-related anatomical factors, and component position in the different implant types. The following parameters were used for the sensitivity study: the proximo-distal patellar position, the patellar component tilting, the tibial component position and orientation, the locations of the medial and lateral collateral ligaments with respect to femur and tibia and the patellar tendon length. The sensitivity analysis showed that PF contact forces are mostly affected by patella height (increases up to 67% for one TKA type in patella-alta configuration), by an anterior tibial component translation (increases up to 30%), and by patellar component tilting (increases up to 29%); TF contact forces are mostly affected by the anterior displacement of the insertion points of the medial collateral ligament with respect to the reference position (increases up to 48%).     

Patient-specific simulation of a stentless aortic valve implant: the impact of fibres on leaflet performance

In some cases of aortic valve leaflet disease, the implant of a stentless biological prosthesis represents an excellent option for aortic valve replacement (AVR). In particular, if compared with the implant of mechanical valves, it provides a more physiological haemodynamic performance and a reduced thrombogeneticity, avoiding the use of anticoagulants. The clinical outcomes of AVR are strongly dependent on an appropriate choice of both prosthesis size and replacement technique, which is, at present, strictly related to surgeon's experience and skill. This represents the motivation for patient-specific finite element analysis able to virtually reproduce stentless valve implantation. With the aim of performing reliable patient-specific simulations, we remark that, on the one hand, it is not well established in the literature whether bioprosthetic leaflet tissue is isotropic or anisotropic; on the other hand, it is of fundamental importance to incorporate an accurate material model to realistically predict post-operative performance. Within this framework, using a novel computational methodology to simulate stentless valve implantation, we test the impact of using different material models on both the stress pattern and post-operative coaptation parameters (i.e. coaptation area, length and height). As expected, the simulation results suggest that the material properties of the valve leaflets affect significantly the post-operative prosthesis performance.     

人工半骨盆假体置换联合腰椎椎弓根螺钉固定术后生物力学的有限元分析

目的:建立人工半骨盆假体置换与联合腰椎椎弓根螺钉固定后的三维有限元模型,评价腰骶段生物力学改变后半骨盆假体力学结构的特点。方法:采用CT薄层扫描采集原始数据,分别建立正常骨盆、半骨盆假体置换术后以及半骨盆假体置换联合腰椎椎弓根螺钉固定术后骨盆的三维有限元模型,分别在第4腰椎上终板平面施以500 N的垂直纵向载荷,分析不同骨盆模型的应力分布特点。结果:与正常骨盆有限元模型相比,半骨盆假体置换术后健侧骨盆应力分布以骶髂关节、髋臼窝及耻骨为主,置换侧半骨盆假体以耻骨连接棒、髋臼杯及髂骨座为主,最大应力出现在耻骨连接棒,应力峰值为65.62 MPa。联合腰椎椎弓根螺钉固定后健侧应力相对减小,置换侧髂骨固定座与骶骨固定处应力相对减小,应力分布以腰椎椎弓根钉棒、耻骨连接棒及髋臼杯为主,最大应力出现在椎弓根螺钉,应力峰值为107 MPa。结论:半骨盆假体置换联合腰椎椎弓根螺钉固定后钉棒分担了半骨盆置换后健侧骨盆及置换侧髂骨固定座与骶骨固定处附近的部分应力,缓解应力集中现象,降低术后骨盆破坏风险,一定程度上增加了半骨盆置换后骨盆的稳定性。     

Evaluating knee replacement mechanics during ADL with PID-controlled dynamic finite element analysis

Validated computational knee simulations are valuable tools for design phase development of knee replacement devices. Recently, a dynamic finite element (FE) model of the Kansas knee simulator was kinematically validated during gait and deep flexion cycles. In order to operate the computational simulator in the same manner as the experiment, a proportional–integral–derivative (PID) controller was interfaced with the FE model to control the quadriceps actuator excursion and produce a target flexion profile regardless of implant geometry or alignment conditions. The controller was also expanded to operate multiple actuators simultaneously in order to produce in vivo loading conditions at the joint during dynamic activities. Subsequently, the fidelity of the computational model was improved through additional muscle representation and inclusion of relative hip–ankle anterior–posterior (A–P) motion. The PID-controlled model was able to successfully recreate in vivo loading conditions (flexion angle, compressive joint load, medial–lateral load distribution or varus-valgus torque, internal–external torque, A–P force) for deep knee bend, chair rise, stance-phase gait and step-down activities.     

Tibio-femoral kinematics in different total knee arthroplasty designs during a loaded squat: A numerical sensitivity study

Total Knee Arthroplasty (TKA) is a very successful surgical procedure but clinical outcomes were reported to be affected by implant design, ligament balancing, alignment or patient-related anatomical factors. It was recently demonstrated that malpositioning of the TKA components and patient related anatomical factors can considerably alter tibio-femoral (TF) and patellofemoral maximum contact forces. However, up to now, how a component malpositioning and different soft-tissue anatomy changes TF knee kinematics was not yet fully investigated. The goal of this study was to evaluate how sensitive TF kinematics are to these factors during a simulated loaded squat for different TKA designs. Four TKA types (a fixed bearing, posterior stabilized prosthesis; a high flexion fixed bearing guided motion prosthesis; a mobile bearing prosthesis and a hinge prosthesis) were virtually implanted on the same virtual cadaver leg model which underwent a loaded squat between 0° and 120°. The reference models were then modified to simulate either component malpositioning in several directions or changes in ligaments geometry by change in the collateral ligament insertions. The results showed that, for all implant designs, TF kinematics were affected by changes in implant positioning and anatomical factors. While the ranges of motion predicted for all tested configurations were generally similar to the reference configuration for each type of TKA, the modifications resulted in shifts in the maximum and minimum values for the TF rotations and translations.     

Development and validation of a weight-bearing finite element model for total knee replacement

Total knee arthroplasty (TKA) is a successful procedure for osteoarthritis. However, some patients (19%) do have pain after surgery. A finite element model was developed based on boundary conditions of a knee rig. A 3D-model of an anatomical full leg was generated from magnetic resonance image data and a total knee prosthesis was implanted without patella resurfacing. In the finite element model, a restarting procedure was programmed in order to hold the ground reaction force constant with an adapted quadriceps muscle force during a squat from 20° to 105° of flexion. Knee rig experimental data were used to validate the numerical model in the patellofemoral and femorotibial joint. Furthermore, sensitivity analyses of Young’s modulus of the patella cartilage, posterior cruciate ligament (PCL) stiffness, and patella tendon origin were performed. Pearson’s correlations for retropatellar contact area, pressure, patella flexion, and femorotibial ap-movement were near to 1. Lowest root mean square error for retropatellar pressure, patella flexion, and femorotibial ap-movement were found for the baseline model setup with Young’s modulus of 5 MPa for patella cartilage, a downscaled PCL stiffness of 25% compared to the literature given value and an anatomical origin of the patella tendon. The results of the conducted finite element model are comparable with the experimental results. Therefore, the finite element model developed in this study can be used for further clinical investigations and will help to better understand the clinical aspects after TKA with an unresurfaced patella.     

Contact stresses and fatigue life in a knee prosthesis: comparison between in vitro measurements and computational simulations

The evaluation of contact areas and pressures in total knee prosthesis is a key issue to prevent early failure. The first part of this study is based on the hypothesis that the patterns of contact stresses on the tibial insert of a knee prosthesis at different stages of the gait cycle could be an indicator of the wear performances of a knee prosthesis. Contact stresses were calculated for a mobile bearing knee prosthesis by means of finite element method (FEM). Contact areas and stresses were also measured through in vitro tests using Fuji Prescale film in order to support the FEM findings.The second part of this study addresses the long-term structural integrity of metal tibial components in terms of fatigue life by means of experimental tests and FEM simulations. Fatigue experimental evaluations were performed on Cr-Co alloy tibial tray, based on ISO standards. FEM models were used to calculate the stress patterns. The failure risk was estimated with a standard fatigue criterion on the basis of the results obtained from the FEM calculations. Experimental and computational results showed a positive matching.     

The influence and biomechanical role of cartilage split line pattern on tibiofemoral cartilage stress distribution during the stance phase of gait

This study presents an evaluation of the role that cartilage fibre ‘split line’ orientation plays in informing femoral cartilage stress patterns. A two-stage model is presented consisting of a whole knee joint coupled to a tissue-level cartilage model for computational efficiency. The whole joint model may be easily customised to any MRI or CT geometry using free-form deformation. Three ‘split line’ patterns (medial–lateral, anterior–posterior and random) were implemented in a finite element model with constitutive properties referring to this ‘split line’ orientation as a finite element fibre field. The medial–lateral orientation was similar to anatomy and was derived from imaging studies. Model predictions showed that ‘split lines’ are formed along the line of maximum principal strains and may have a biomechanical role of protecting the cartilage by limiting the cartilage deformation to the area of higher cartilage thickness.     

A validated computational framework to evaluate the stiffness of 3D printed ankle foot orthoses

The purpose of this study was to create and validate a standardized framework for the evaluation of the ankle stiffness of two designs of 3D printed ankle foot orthoses (AFOs). The creation of four finite element (FE) models allowed patient-specific quantification of the stiffness and stress distribution over their specific range of motion during the second rocker of the gait. Validation was performed by comparing the model outputs with the results obtained from a dedicated experimental setup, which showed an overall good agreement with a maximum relative error of 10.38% in plantarflexion and 10.66% in dorsiflexion. The combination of advanced computer modelling algorithms and 3D printing techniques clearly shows potential to further improve the manufacturing process of AFOs.     

The effect of kinematic and kinetic changes on meniscal strains during gait

The menisci play an important role in load distribution, load bearing, joint stability, lubrication, and proprioception. Partial meniscectomy has been shown to result in changes in the kinematics and kinetics at the knee during gait that can lead to progressive meniscal degeneration. This study examined changes in the strains within the menisci associated with kinematic and kinetic changes during the gait cycle. The gait changes considered were a 5 deg shift toward external rotation of the tibia with respect to the femur and an increased medial-lateral load ratio representing an increased adduction moment. A finite element model of the knee was developed and tested using a cadaveric specimen. The cadaver was placed in positions representing heel-strike and midstance of the normal gait, and magnetic resonance images were taken. Comparisons of the model predictions to boundaries digitized from images acquired in the loaded states were within the errors produced by a 1 pixel shift of either meniscus. The finite element model predicted that an increased adduction moment caused increased strains of both the anterior and posterior horns of the medial meniscus. The lateral meniscus exhibited much lower strains and had minimal changes under the various loading conditions. The external tibial rotational change resulted in a 20% decrease in the strains in the posterior medial horn and increased strains in the anterior medial horn. The results of this study suggest that the shift toward external tibial rotation seen clinically after partial medial meniscectomy is not likely to cause subsequent degenerative medial meniscal damage, but the consequence of this kinematic shift on the pathogenesis of osteoarthritis following meniscectomy requires further consideration.     

Finite element analysis of a total ankle replacement during the stance phase of gait

Total ankle replacement (TAR) designs have still several important issues to be addressed before the treatment becomes fully acceptable clinically. Very little is known about the performance, in terms of the contact pressures and kinematics of TAR when subjected to daily activities such as level gait. For this purpose, an explicit finite element model of a novel 3-component TAR was developed, which incorporated a previously validated mechanical model of the ankle ligament apparatus. The intermediate mobile polyethylene meniscal bearing was modelled as an elastic-plastic continuum while the articulating surfaces of the tibial and talar metal components as rigid bodies. Overall kinematics, contact pressures and ligament forces were analysed during passive, i.e. virtually unloaded, and active, i.e. stance phase of gait, conditions. Simulation of passive motion predicted similar kinematics as reported previously in an analytical four-bar linkage model. The meniscal bearing was observed to move 5.6 mm posteriorly during the simulated stance and the corresponding antero-posterior displacement of the talar component was 8.3 mm. The predicted pattern and the amount (10.6 degrees ) of internal-external rotation of the ankle complex were found to be in good agreement with corresponding in vivo measurements on normal ankles. A peak contact pressure of 16.8 MPa was observed, with majority of contact pressures below 10 MPa. For most ligaments, reaction forces remain within corresponding physiological ranges. A first realistic representation of the biomechanical behaviour of the human ankle when replaced by prosthetic joints is provided. The applied methodology can potentially be applied to other TAR designs.     

Validation of model-predicted tibial tray-synthetic bone relative motion in cementless total knee replacement during activities of daily living

As fixation of cementless total knee replacement components during the first 4–6 weeks after surgery is crucial to establish bony ingrowth into the porous surface, several studies have quantified implant-bone micromotion. Relative motion between the tray and bone can be measured in vitro, but the full micromotion contour map cannot typically be accessed experimentally. Finite element models have been employed to estimate the full micromotion map, but have not been directly validated over a range of loading conditions. The goal of this study was to develop and validate computational models for the prediction of tray-bone micromotion under simulated activities of daily living. Gait, stair descent and deep knee bend were experimentally evaluated on four samples of a cementless tibial tray implanted into proximal tibial Sawbones™ constructs. Measurements of the relative motion between the tray and the anterior cortical shell were collected with digital image correlation and used to validate a finite element model that replicated the experiment. Additionally, a probabilistic analysis was performed to account for experimental uncertainty and determine model sensitivity to alignment and frictional parameters. The finite element models were able to distinguish between activities and capture the experimental trends. Best-matching simulations from the probabilistic analysis matched measured displacement with an average root mean square (RMS) difference of 14.3 µm and Pearson-product correlation of 0.93, while the mean model presented an average RMS difference of 27.1 µm and a correlation of 0.8. Maximum deviations from average experimental measurements were 40.5 and 87.1 µm for the best-matching and average simulations, respectively. The computational pipeline developed in this study can facilitate and enhance pre-clinical assessment of novel implant components.     

Limited rotation of the mobile-bearing in a rotating platform total knee prosthesis

The hypothesis of this study was that the polyethylene bearing in a rotating platform total knee prosthesis shows axial rotation during a step-up motion, thereby facilitating the theoretical advantages of mobile-bearing knee prostheses. We examined 10 patients with rheumatoid arthritis who had a rotating platform total knee arthroplasty (NexGen LPS mobile, Zimmer Inc. Warsaw, USA). Fluoroscopic data was collected during a step-up motion six months postoperatively. A 3D-2D model fitting technique was used to reconstruct the in vivo 3D kinematics. The femoral component showed more axial rotation than the polyethylene mobile-bearing insert compared to the tibia during extension. In eight knees, the femoral component rotated internally with respect to the tibia during extension. In the other two knees the femoral component rotated externally with respect to the tibia. In all 10 patients, the femur showed more axial rotation than the mobile-bearing insert indicating the femoral component was sliding on the polyethylene of the rotating platform during the step-up motion. Possible explanations are a too limited conformity between femoral component and insert, the anterior located pivot location of the investigated rotating platform design, polyethylene on metal impingement and fibrous tissue formation between the mobile-bearing insert and the tibial plateau.     

The influence of implant number and abutment design on the biomechanical behaviour of bone for an implant-supported fixed prosthesis: a finite element study in the upper anterior region

It is always recommended to use more implants for supporting a prosthesis in the immediate loading condition than in the classical two-stage treatment procedure. By means of the finite element (FE) method, the influence of the number of implants used in immediately loaded fixed partial prosthesis (FPP) on the load distribution was investigated, considering the abutment geometry. Two 3D FE models were studied employing four implants to support a FPP in the premaxilla. One model was designed with straight abutments and the other with 20°-angled abutments. The results concerning implant displacements, stresses and strains were compared with those of two implant-supported FPPs, obtained in a previous study. A noticeable reduction in the determined biomechanical bone loading was observed with the use of more implants in supporting an immediately loaded prosthesis. This study confirms that the use of additional numbers of implants in an immediately loaded prosthesis is highly recommended.     

Primary stability of uncemented femoral resurfacing implants for varying interface parameters and material formulations during walking and stair climbing

Primary stability of uncemented resurfacing prosthesis is provided by an interference fit between the undersized implant and the reamed bone. Dependent on the magnitude of interference, the implantation process causes high shear forces and large strains which can exceed the elastic limit of cancellous bone. Plastification of the bone causes reduced stiffness and could lead to bone damage and implant loosening. The purpose in this study was to determine press-fit conditions which allow implantation without excessive plastic bone deformation and sufficient primary stability to achieve bone ingrowth. In particular, the influence of interference, bone quality and friction on the micromotion during walking and stair-climbing was investigated. Therefore elastic and plastic finite element (FE) models of the proximal femur were developed. Implantation was realized by displacing the prosthesis onto the femur while monitoring the contact pressure, plastic bone deformation as well as implantation forces. Subsequently a physiologic gait and stair-climbing cycle was simulated calculating the micromotion at the bone-implant interface. Results indicate that plastic deformation starts at an interference of 30 μm and the amount of plastified bone at the interface increases up to 90% at 150 μm interference. This effect did not reduce the contact pressure if interference was below 80 μm. The micromotion during walking was similar for the elastic and plastic FE models. A stable situation allowing bony ingrowth was achieved for both constitutive laws (elastic, plastic) for walking and stair climbing with at least 60 μm press-fit, which is feasible with clinically used implantation forces of 4 kN.     

The effect of the interface on the bone stresses beneath tibial components

It was proposed that the stresses in the layer of bone immediately beneath a tibial component are an important determinant of fixation durability. Using finite element analysis, (ANSYS), the stresses were determined as a function of the amount of bone resection, the localization or completeness of implant-bone contact, and the interface material. The model was of two-dimensional sagittal slices consisting of quadrilateral elements (1 mm) with a range of seventeen material properties determined by CT scans. Typical prosthesis designs shifted the center of pressure more centrally rather than posteriorly, and thus increased anterior bone stresses. Resection up to 10 mm could actually decrease bone stresses due to an increase in bone surface area as long as complete coverage was obtained. A cement interface or direct metal on bone produced identical stresses. However a 1 mm complian: interface significantly reduced stresses in regions of high elastic modulus gradient. For rigid interfaces, the contact can be irregular, which leads to areas of over and understressing of bone. These conclusions have implications related to implant design.     

Experimental validation of a finite element model of a human cadaveric tibia

Finite element (FE) models of long bones are widely used to analyze implant designs. Experimental validation has been used to examine the accuracy of FE models of cadaveric femurs; however, although convergence tests have been carried out, no FE models of an intact and implanted human cadaveric tibia have been validated using a range of experimental loading conditions. The aim of the current study was to create FE models of a human cadaveric tibia, both intact and implanted with a unicompartmental knee replacement, and to validate the models against results obtained from a comprehensive set of experiments. Seventeen strain rosettes were attached to a human cadaveric tibia. Surface strains and displacements were measured under 17 loading conditions, which consisted of axial, torsional, and bending loads. The tibia was tested both before and after implantation of the knee replacement. FE models were created based on computed tomography (CT) scans of the cadaveric tibia. The models consisted of ten-node tetrahedral elements and used 600 material properties derived from the CT scans. The experiments were simulated on the models and the results compared to experimental results. Experimental strain measurements were highly repeatable and the measured stiffnesses compared well to published results. For the intact tibia under axial loading, the regression line through a plot of strains predicted by the FE model versus experimentally measured strains had a slope of 1.15, an intercept of 5.5 microstrain, and an R(2) value of 0.98. For the implanted tibia, the comparable regression line had a slope of 1.25, an intercept of 12.3 microstrain, and an R(2) value of 0.97. The root mean square errors were 6.0% and 8.8% for the intact and implanted models under axial loads, respectively. The model produced by the current study provides a tool for simulating mechanical test conditions on a human tibia. This has considerable value in reducing the costs of physical testing by pre-selecting the most appropriate test conditions or most favorable prosthetic designs for final mechanical testing. It can also be used to gain insight into the results of physical testing, by allowing the prediction of those variables difficult or impossible to measure directly.