Bone ingrowth simulation for a concept glenoid component design

Glenoid component loosening is the major problem of total shoulder arthroplasty. It is possible that uncemented component may be able to achieve superior fixation relative to cemented component. One option for uncemented glenoid is to use porous tantalum backing. Bone ingrowth into the porous backing requires a degree of stability to be achieved directly post-operatively. This paper investigates the feasibility of bone ingrowth with respect to the influence of primary fixation, elastic properties of the backing and friction at the bone prosthesis interface. Finite element models of three glenoid components with different primary fixation configurations are created. Bone ingrowth into the porous backing is modelled based on the magnitude of the relative interface micromotions and mechanoregulation of the mesenchymal stem cells that migrated via the bonded part of the interface. Primary fixation had the most influence on bone ingrowth. The simulation showed that its major role was not to firmly interlock the prosthesis, but rather provide such a distribution of load, that would result in reduction of the peak interface micromotions. Should primary fixation be provided, friction has a secondary importance with respect to bone ingrowth while the influence of stiffness was counter intuitive: a less stiff backing material inhibits bone ingrowth by higher interface micromotions and stimulation of fibrous tissue formation within the backing.     

Analysis of bone–prosthesis interface micromotion for cementless tibial prosthesis fixation and the influence of loading conditions

A lack of initial stability of the fixation is associated with aseptic loosening of the tibial components of cementless knee prostheses. With sufficient stability after surgery, minimal relative motion between the prosthesis and bone interfaces allows osseointegation to occur thereby providing a strong prosthesis-to-bone biological attachment. Finite element modelling was used to investigate the bone–prosthesis interface micromotion and the relative risk of aseptic loosening. It was anticipated that by prescribing different joint loads representing gait and other activities, and the consideration of varying tibial–femoral contact points during knee flexion, it would influence the computational prediction of the interface micromotion. In this study, three-dimensional finite element models were set up with applied loads representing walking and stair climbing, and the relative micromotions were predicted. These results were correlated to in-vitro measurements and to the results of prior retrieval studies. Two load conditions, (i) a generic vertical joint load of 3×body weight with 70%/30% M/L load share and antero-posterior/medial-lateral shear forces, acted at the centres of the medial and lateral compartments of the tibial tray, and (ii) a peak vertical joint load at 25% of the stair climbing cycle with corresponding antero-posterior shear force applied at the tibial–femoral contact points of the specific knee flexion angle, were found to generate interface micromotion responses which corresponded to in-vivo observations. The study also found that different loads altered the interface micromotion predicted, so caution is needed when comparing the fixation performance of various reported cementless tibial prosthetic designs if each design was evaluated with a different loading condition.     

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

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

How plate positioning impacts the biomechanics of the open wedge tibial osteotomy; A finite element analysis

A numerical model of the medial open wedge tibial osteotomy based on the finite element method was developed. Two plate positions were tested numerically. In a configuration, (a), the plate was fixed in a medial position and (b) in an anteromedial position. The simulation took into account soft tissues preload, muscular tonus and maximal gait load.

The maximal stresses observed in the four structural elements (bone, plate, wedge, screws) of an osteotomy with plate in medial position were substantially higher (1.13–2.8 times more) than those observed in osteotomy with an anteromedial plate configuration. An important increase (1.71 times more) of the relative micromotions between the wedge and the bone was also observed. In order to avoid formation of fibrous tissue at the bone wedge interface, the osteotomy should be loaded under 18.8% (～50 kg) of the normal gait load until the osteotomy interfaces union is achieved.     

How plate positioning impacts the biomechanics of the open wedge tibial osteotomy; a finite element analysis

A numerical model of the medial open wedge tibial osteotomy based on the finite element method was developed. Two plate positions were tested numerically. In a configuration, (a), the plate was fixed in a medial position and (b) in an anteromedial position. The simulation took into account soft tissues preload, muscular tonus and maximal gait load.The maximal stresses observed in the four structural elements (bone, plate, wedge, screws) of an osteotomy with plate in medial position were substantially higher (1.13-2.8 times more) than those observed in osteotomy with an anteromedial plate configuration. An important increase (1.71 times more) of the relative micromotions between the wedge and the bone was also observed. In order to avoid formation of fibrous tissue at the bone wedge interface, the osteotomy should be loaded under 18.8% (approximately 50 kg) of the normal gait load until the osteotomy interfaces union is achieved.     

Finite Element Analysis of Tibial Implants - Effect of Fixation Design and Friction Model

A three dimensional nonlinear finite element model was developed to investigate tibial fixation designs and friction models (Coulomb's vs nonlinear) in total knee arthroplasty in the immediate postoperative period with no biological attachment. Bi-directional measurement-based nonlinear friction constitutive equations were used for the bone-porous coated implant interface. Friction properties between the polyethylene and femoral components were measured for this study. Linear elastic isotropic but heterogeneous mechanical properties taken from literature were considered for the bone. The Tensile behaviour of polyethylene was measured and subsequently modeled by an elasto-plastic model. Based on the earlier finite element and experimental pull-out studies, pegs and screws were also realistically modeled. The geometry of every component was obtained through measurement. The PCA tibial baseplate with three different configurations was considered; one with three screws, one with one screw and two short inclined porous-coated pegs, and a third one with no fixation for the sake of comparison. The axial load of 2000N was applied through the femoral component on the medial plateau of articular insert. It was found that Coulomb's friction significantly underestimates the relative micromotion at the bone-implant interface. The lowest micromotion and lift-off were found for the design with screws. Relative micromotion and stress transfer at the bone-implant interface depended significantly on the friction model and on the baseplate anchorage configuration. Cortical and cancellous bones carried, respectively, 10-13% and 65-86% of the axial load depending on the fixation configuration used. The remaining portion was transmitted as shear force by screws and pegs. Normal and Mises stresses as well as contact area in the polyethylene insert were nearly independent of the baseplate fixation design. The Maximum Mises stress in the polyethylene exceeded yield and was found 1-2 mm below the contact surface for all designs.     

Experimental and computational analysis of micromotions of an uncemented femoral knee implant using elastic and plastic bone material models

It is essential to calculate micromotions at the bone-implant interface of an uncemented femoral total knee replacement (TKR) using a reliable computational model. In the current study, experimental measurements of micromotions were compared with predicted micromotions by Finite Element Analysis (FEA) using two bone material models: linear elastic and post-yield material behavior, while an actual range of interference fit was simulated. The primary aim was to investigate whether a plasticity model is essential in order to calculate realistic micromotions. Additionally, experimental bone damage at the interface was compared with the FEA simulated range.TKR surgical cuts were applied to five cadaveric femora and micro- and clinical CT- scans of these un-implanted specimens were made to extract geometrical and material properties, respectively. Micromotions at the interface were measured using digital image correlation. Cadaver-specific FEA models were created based on the experimental set-up. The average experimental micromotion of all specimens was 53.1 ± 42.3 µm (mean ± standard deviation (SD)), which was significantly higher than the micromotions predicted by both models, using either the plastic or elastic material model (26.5 ± 23.9 µm and 10.1 ± 10.1 µm, respectively; p-value < 0.001 for both material models). The difference between the two material models was also significant (p-value < 0.001). The predicted damage had a magnitude and distribution which was comparable to the experimental bone damage. We conclude that, although the plastic model could not fully predict the micro motions, it is more suitable for pre-clinical assessment of a press-fit TKR implant than using an elastic bone model.     

Strain shielding in proximal tibia of stemmed knee prosthesis: experimental study

Theoretical concerns about the use of cemented or press-fit stems in revision total knee arthroplasty (TKA) include stress shielding with adverse effects on prosthesis fixation. Revision TKA components are commonly stemmed to protect the limited autogenous bone stock remaining. Revision procedures with the use of stems can place abnormal stresses through even normal bone by their constrained design, type of materials and fixation method and may contribute for bone loss. Experimental quantification of strain shielding in the proximal synthetic tibia following TKA is the main purpose of the present study. In this study, cortical bone strains were measured experimentally with tri-axial strain gauges in synthetic tibias before and after in vitro knee surgery. Three tibias were implanted with cemented and press-fit stem augments and solely with a tibial tray (short monobloc stem) of the P.F.C. Sigma Modular Knee System. The difference between principal strains of the implanted and the intact tibia was calculated for each strain gauge position. The results demonstrated a pronounced strain-shielding effect in the proximal level, close to tibial tray with the cemented stem augment. The press-fit stem presented a minor effect of strain shielding but was more extensively throughout the stem. An increase of strains closely to the distal tip of the cemented and the press-fit stem augment was observed. This suggests for a physiological condition, a potential effect of bone resorption at the proximal region for the cemented stem augment. The localized increase of strains in stems tip can be related with the clinical finding of the pain, at the end of stem after revision TKA.     

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

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

Constraints and fixation for implanted joint replacements

Observations made on both cemented and uncemented joint prostheses after about two years of use show a layer of fibrous tissue next to the bone. This fibrous layer smooths over surface features up to l mm in size, and must be assumed to be weak in tension and shear. Prosthesis-bone interfaces should therefore be designed to transmit all forces acting on the prosthesis as compressive stresses. The forces acting across prostheses are controlled by the constraints exerted by the articulating surfaces; if the useful ligaments present are allowed to do their job of transmitting tension, the articulating surfaces can be designed to transmit only such forces and moments as can safely be transmitted across the prosthesis-bone interfaces.     

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

Background  

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

Strains and micromotions of press-fit femoral stem prostheses

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

Influence of ingrowth regions on bone remodelling around a cementless hip resurfacing femoral implant

Hip resurfacing arthroplasty is an alternative to traditional hip replacement that can conserve proximal bone stock and has gained popularity but bone resorption may limit implant survival and remains a clinical concern. The goal of this study was to analyze bone remodelling patterns around an uncemented resurfacing implant and the influence of ingrowth regions on resorption. A computed tomography-derived finite element model of a proximal femur with a virtually implanted resurfacing component was simulated under peak walking loads. Bone ingrowth was simulated by six interface conditions: fully bonded; fully friction; bonded cap with friction stem; a small bonded region at the stem-cup intersection with the remaining surface friction; fully frictional, except for a bonded band along the distal end of the cap and superior half of the cap bonded with the rest frictional. Interface condition had a large influence on remodelling patterns. Bone resorption was minimized when no ingrowth occurred at the bone-implant interface. Bonding only the superior half of the cap increased bone resorption slightly but allowed for a large ingrowth region to improve secondary stability.     

A nonlinear homogenized finite element analysis of the primary stability of the bone–implant interface

Stability of an implant is defined by its ability to undergo physiological loading–unloading cycles without showing excessive tissue damage and micromotions at the interface. Distinction is usually made between the immediate primary stability and the long-term, secondary stability resulting from the biological healing process. The aim of this research is to numerically investigate the effect of initial implantation press-fit, bone yielding, densification and friction at the interface on the primary stability of a simple bone–implant system subjected to loading–unloading cycles. In order to achieve this goal, human trabecular bone was modeled as a continuous, elasto-plastic tissue with damage and densification, which material constants depend on bone volume fraction and fabric. Implantation press-fit related damage in the bone was simulated by expanding the drilled hole to the outer contour of the implant. The bone–implant interface was then modeled with unilateral contact with friction. The implant was modeled as a rigid body and was subjected to increasing off-axis loading cycles. This modeling approach is able to capture the experimentally observed primary stability in terms of initial stiffness, ultimate force and progression of damage. In addition, it is able to quantify the micromotions around the implant relevant for bone healing and osseointegration. In conclusion, the computationally efficient modeling approach used in this study provides a realistic structural response of the bone–implant interface and represents a powerful tool to explore implant design, implantation press-fit and the resulting risk of implant failure under physiological loading.     

Finite Element Analysis of Tibial Implants — Effect of Fixation Design and Friction Model

Abstract

A three dimensional nonlinear finite element model was developed to investigate tibial fixation designs and friction models (Coulomb's vs nonlinear) in total knee arthroplasty in the immediate postoperative period with no biological attachment. Bi-directional measurement-based nonlinear friction constitutive equations were used for the bone-porous coated implant interface. Friction properties between the polyethylene and femoral components were measured for this study. Linear elastic isotropic but heterogeneous mechanical properties taken from literature were considered for the bone. The Tensile behaviour of polyethylene was measured and subsequently modeled by an elasto-plastic model. Based on the earlier finite element and experimental pull-out studies, pegs and screws were also realistically modeled. The geometry of every component was obtained through measurement. The PCA tibial baseplate with three different configurations was considered; one with three screws, one with one screw and two short inclined porous-coated pegs, and a third one with no fixation for the sake of comparison. The axial load of 2000N was applied through the femoral component on the medial plateau of articular insert. It was found that Coulomb's friction significantly underestimates the relative micromotion at the bone-implant interface. The lowest micromotion and lift-off were found for the design with screws. Relative micromotion and stress transfer at the bone-implant interface depended significantly on the friction model and on the baseplate anchorage configuration. Cortical and cancellous bones carried, respectively, 10–13% and 65–86% of the axial load depending on the fixation configuration used. The remaining portion was transmitted as shear force by screws and pegs. Normal and Mises stresses as well as contact area in the polyethylene insert were nearly independent of the baseplate fixation design. The Maximum Mises stress in the polyethylene exceeded yield and was found 1–2 mm below the contact surface for all designs.     

Influence of the stiffness of bone defect implants on the mechanical conditions at the interface--a finite element analysis with contact

The study focused on the influence of the implant material stiffness on stress distribution and micromotion at the interface of bone defect implants. We hypothesized that a low-stiffness implant with a modulus closer to that of the surrounding trabecular bone would yield a more homogeneous stress distribution and less micromotion at the interface with the bony bed. To prove this hypothesis we generated a three-dimensional, non-linear, anisotropic finite element (FE) model. The FE model corresponded to a previously developed animal model in sheep. A prismatic implant filled a standardized defect in the load-bearing area of the trabecular bone beneath the tibial plateau. The interface was described by face-to-face contact elements, which allow press fits, friction, sliding, and gapping. We assumed a physiological load condition and calculated contact pressures, shear stresses, and shear movements at the interface for two implants of different stiffness (titanium: E=110GPa; composite: E=2.2GPa). The FE model showed that the stress distribution was more homogeneous for the low-stiffness implant. The maximum pressure for the composite implant (2.1 MPa) was lower than for the titanium implant (5.6 MPa). Contrary to our hypothesis, we found more micromotion for the composite (up to 6 microm) than for the titanium implant (up to 4.5 microm). However, for both implants peak stresses and micromotion were in a range that predicts adequate conditions for the osseointegration. This was confirmed by the histological results from the animal studies.     

Influence of material coupling and assembly condition on the magnitude of micromotion at the stem-neck interface of a modular hip endoprosthesis

Hip prostheses with a modular neck exhibit, compared to monobloc prostheses, an additional interface which bears the risk of fretting as well as corrosion. Failures at the neck adapter of modular prostheses have been observed for a number of different designs. It has been speculated that micromotions at the stem-neck interface were responsible for these implant failures. The purpose of this study was to investigate the influence of material combinations and assembly conditions on the magnitude of micromotions at the stem-neck interface during cyclic loading. Modular (n = 24) and monobloc (n = 3) hip prostheses of a similar design (Metha, Aesculap AG, Tuttlingen, Germany) were subjected to mechanical testing according to ISO 7206-4 (F(min) = 230N, F(max) = 2300N, f = 1Hz, n = 10,000 cycles). The neck adapters (Ti-6Al-4V or Co-Cr29-Mo alloy) were assembled with a clean or contaminated interface. The micromotion between stem and neck adapter was calculated at five reference points based on the measurements of the three eddy current sensors. The largest micromotions were observed at the lateral edge of the stem-neck taper connection, which is in accordance with the crack location of clinically failed prostheses. Titanium neck adapters showed significantly larger micromotions than cobalt-chromium neck adapters (p = 0.005). Contaminated interfaces also exhibited significantly larger micromotions (p < 0.001). Since excessive micromotions at the stem-neck interface might be involved in the process of implant failure, special care should be taken to clean the interface prior to assembly and titanium neck adapters with titanium stems should generally be used with caution.     

Increased initial cement–bone interlock correlates with reduced total knee arthroplasty micro-motion following in vivo service

Aseptic loosening of cemented tibial components in total knee arthroplasty (TKA) has been related to inadequate cement penetration into the trabecular bone bed during implantation. Recent postmortem retrieval work has also shown there is loss of interlock between cement and bone by resorption of trabeculae at the interface. The goal of this study was to determine if TKAs with more initial interlock between cement and bone would maintain more interlock with in vivo service (in the face of resorbing trabeculae) and have less micro-motion at the cement–bone interface. The initial (created at surgery) and current (after in vivo service) cement–bone interlock morphologies of sagittal implant sections from postmortem retrieved tibial tray constructs were measured. The implant sections were then functionally loaded in compression and the micro-motion across the cement–bone interface was quantified. Implant sections with less initial interdigitation between cement and bone and more time in service had less current cement–bone interdigitation (r²=0.86, p=0.0002). Implant sections with greater initial interdigitation also had less micro-motion after in vivo service (r²=0.36, p=0.0062). This work provides direct evidence that greater initial interlock between cement and bone in tibial components of TKA results in more stable constructs with less micro-motion with in vivo service.     

Chronic changes in the rabbit tibial plateau following blunt trauma to the tibiofemoral joint

The knee is often a site of injury that can often lead to a chronic disease known as osteoarthritis (OA). The disease may be initiated, in part, by acute injuries to joint cartilage and its cells. In a recent study by this laboratory, using Flemish Giant rabbits, an impact compressive load on the tibial femoral joint was shown to cause significant levels of acute damage to chondrocytes in cartilage of the medial and lateral tibial plateaus. In the current study, using the same model, histological and mechanical data from the plateaus were documented at 6 and 12 months post impact, and compared to the unimpacted control limbs and a limb from unimpacted, control animals. The mechanical properties of cartilage were measured with indentation relaxation tests on the medial and lateral plateaus in regions covered and uncovered by the meniscus. The histological studies on impacted limbs showed surface lesions on both plateaus, thickening of the underlying subchondral bone at 12 months and numerous occult microcracks at the calcified cartilage–subchondral bone interface at 6 and 12 months, without significant changes in cartilage thickness or its mechanical properties versus controls. Yet, there was an increase in both the matrix and fiber moduli and a decrease in the permeability of uncovered, medial plateau cartilage in both limbs of impacted animals between 6 and 12 months post impact that was not documented in control animals.     

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

Aseptic loosening of tibial components due to degradation of the interface between bone cement and metallic tibial shaft component is still a persistent problem, particularly for surface-cemented tibial components. The surface cementation technique has important clinical meaning in case of revision and for avoidance of stress shielding. This study was done to prove crack formation in the bone cement near the metallic surface when this is not coated. We propose a newly developed coating process by SiOx-PVD layering to avoid crack formation. A biomechanical model for a vibration fatigue test was done to prove that crack formation can be significantly reduced in the case of coated surfaces. It was found that coated tibial components showed a highly significant reduction of cement cracking near the metal/bone cement interface (p < 0.01) and a significant reduction of gap formation in the metal-to-bone cement interface (p < 0.05). Coating dramatically reduces hydrolytic- and stress-related crack formation at the prosthesis metal/bone cement interface. This leads to a more homogenous load transfer into the cement mantle which should reduce the frequency of loosening in the metal/bone cement/bone interfaces. With surface coating of the tibial component it should become possible that surface-cemented TKAs reveal similar loosening rates as TKAs both surface- and stem-cemented. This would be an important clinical advantage since it is believed that surface cementing reduces metaphyseal bone loss in the case of revision and stress shielding for a better bone health.