Introduction

Special high-flexion prosthetic designs show a small increase in postoperative flexion compared to standard designs and some papers show increased anterior knee pain with these prosthesis. However, no randomised controlled trails have been published which investigate difference in postoperative complaints of anterior knee pain. To assess difference in passive and active postoperative flexion and anterior knee pain we performed a randomized clinical trial including the two extremes of knee arthroplasty designs, being a high flex posterior stabilized rotating platform prosthesis versus a traditional cruciate retaining fixed bearing prosthesis. We hypothesised that the HF-PS design would allow more flexion, due to increased femoral rollback with less anterior knee pain than the CR design. We specifically assessed the following hypotheses:

A durable biological fixation between implant and bone depends largely on the micro-motions [Pilliar et al., 1986]. Finite element analysis (FEA) is a numerical tool to calculate micro-motions during physiological loading. However, micromotions can be simulated and calculated in various ways. Generally, only a single peak force of an activity is applied, but it is also possible to apply discretized loads occurring during a continuous activity, offering the opportunity to analyze incremental micro-motions as well. Moreover, micro-motions are affected by the initial press-fit. We therefore aimed to evaluate the effect of different loading conditions and calculation methods on the micro-motions of an uncemented femoral knee component, while varying the interference-fit.

We created an FE model of a distal femur based on calibrated CT-scans. A Sigma® Cruciate-Retaining Porocoat® (DePuy Synthes, Leeds, UK) was placed following the surgical instructions. A range of interference-fits (0–100 µm) was applied, while other contact parameters were kept unchanged. Micro-motions were calculated by tracking the projection of implant nodes onto the bone surface. We defined three different micro-motions measures: micro-motions between consecutive increments of a full loading cycle (incremental), micro-motions for each increment relative to the initial position (reference), and the largest distance between projected displacements, occurring during a discretized full cycle (resulting) (Fig. 1A). Four consecutive cycles of normal gait and squat movements were applied, in different configurations. In the first configuration, incremental tibiofemoral and patellofemoral contact forces were applied, which were derived from Orthoload database using inverse dynamics [Fitzpatrick et al., 2012]. Secondly, we applied the same loads without the patellofemoral force, which is often used in experimental set-ups. Finally, only the peak tibiofemoral force was applied, as a single loading instance. We calculated the average of micro-motions of all nodes per increment to compare different calculation techniques. The percentage of area with resulting micro-motions less than 5 µm was also calculated.

The percentage of surface area was increased non-linearly when the interference fit changed from 0 to 100 µm particularly for squat movement. Tracking nodes over multiple cycles showed implant migration with interference-fits lower than 30µm (Fig. 1A). Loading configurations without the patellofemoral force, and with only the peak tibiofemoral force slightly overestimated and underestimated the resulting micro-motions of squat movement, respectively; although, the effect was less obvious for the gait simulation when no patella force was applied. Both incremental and reference micro-motions underestimated the resulting micro-motions (Fig. 1B). Interestingly, the reference micro-motions followed the pattern of the tibiofemoral contact force (Fig. 1B).

The calculation technique has a substantial effect on the micro-motions, which means there is a room for interpretation of micro-motions analyses. This furthermore stresses the importance of validation of the predicted micro-motions against experimental set-ups. In addition, the minor effect of loading configurations indicates that a simplified loading condition using only the peak tibiofemoral force is suitable for experimental studies. From a clinical perspective, the migration pattern of femoral components implanted with a low interference fit stresses the role of an adequate surgical technique, to obtain a good initial stability.

Femoral knee implants have promising outcomes, although some high-flex designs have shown rather high loosening rates (Han et al., 2007). In uncemented implants, it is vital to limit micromotions at the implant-bone interface, to facilitate secondary fixation through bone ingrowth (kienapfel et al., 1999). Hence, it is essential to investigate how micromotions of different uncemented implants are affected by various loading conditions when a range of bone qualities as a patient-related factor is applied.

Using finite element (FE) analysis, we simulated implant-bone interface micromotions during four consecutive cycles of normal gait and squat movements. An FE model of a distal femur was generated based on calibrated CT-scans, after which Sigma® and LCS® Cruciate-Retaining Porocoat® components (DePuy Synthes, Leeds, UK) were implanted. Using a frictional contact algorithm (µ=0.95), an initial press-fit fixation was simulated, which was previously validated against experimental data. The micromotions were calculated by tracking the projection of implant nodes on the bone surface excluding overhang area. The applied loading patterns were based on discretized simulations, providing incremental loads for each activity based on implant-specific kinematics, which was derived from Orthoload database using inverse dynamics (Fitzpatrick et al., 2012). This provided the opportunity to calculate incremental micromotions, but also the resulting micromotions for each single cycle, for both activities. In addition, the percentage of implant surface area with resulting micromotions less than a defined threshold was calculated.

Regardless of the type of loading, in all simulations, the predicted micromotions were highest in the first cycle, suggesting settling of the implant during initial cycle. The Sigma®implant displayed a 30% larger area with micromotions below the threshold of 5 microns, for both loading conditions (Fig. 1A). The highest micromotions occurred at the anterior flange, regardless of type of activity or design. Squatting had a more detrimental effect on the primary stability, with smaller areas of low micromotions as compared to the gait load (Fig. 1B). Bone stiffness had a minor effect, which was more apparent for squatting (Fig. 1B).

We found acceptable low ranges of micromotions in both implant designs, although demanding activities such as squatting generated higher motions. In addition, LCS® experienced higher micromotions, probably caused by the smaller contact area at bone-implant interface compared with Sigma®. Nevertheless, the predicted micromotions were all below the clinically relevant threshold for bone ingrowth (<40 microns) (kienapfel et al., 1999). Furthermore, our simulated settling behavior stresses the necessity for simulating multiple loading cycles, rather than just a single cycle. The effect of bone stiffness was evident, but only to a limited extent. The main current limitation of our study is the utilization of an elastic material model for the bone which is probably the reason to predict a low range of micromotions. We are planning to make the material model more realistic, by including plasticity and viscoelastic bone behavior.

Introduction

Conventional implant designs in total knee arthroplasty (TKA) are based on metal on UHMWPE bearing couples. Although this procedure is quite successful, early loosening is still a matter of concern. One of the causes for early failure is stress shielding, leading to loss of bone stock, periprosthetic bone fractures and eventually aseptic loosening of the component. The introduction of a polyetheretherketone (PEEK) on UHMWPE bearing couple could address this problem. With mechanical properties more similar to distal (cortical) bone it could allow stresses to be distributed more naturally in the distal femur. A potential adverse effect, however, is that the femoral component and the underlying cement mantle may be at risk of fracturing. Therefore, we analyzed the effect of a PEEK-Optima® femoral component on stress shielding and the integrity of the component and cement mantle, compared to a conventional Cobalt-Chromium (CoCr) alloy implant.

Introduction

Recent reports implicate fretting corrosion at the head-stem taper junction as a potential cause of failure of some large diameter metal-on-metal (MOM) devices. Fretting observed at modular junctions is thought to be a type of ‘mechanically assisted’ corrosion phenomenon, initiated by mechanical factors that lead to an increase in contact stresses and micromotions at the taper interface. These may include: intra-operative taper assembly, taper contamination by debris or body fluids, patient weight and ‘toggling’ of the head or increased frictional torque in a poorly functioning bearing.

We adopted a finite element approach to model the head-taper junction, to analyze the contact mechanics at the taper interface. We investigated the effect of assembly force and angle on contact pressures and micromotions, during loads commonly used to test hip implants.

INTRODUCTION

The burden of Musculoskeletal (M-S) diseases and prosthetic revision operations is huge and increasing rapidly with the aging population. For patients that require a major surgical intervention, procedures are unsafe, uncertain in outcome and have a high complication rate. The goal of this project is to create an ICT-based patient-specific surgical navigation system that helps the surgeon safely reaching the optimal functional result for the patient and is a user friendly training facility for the surgeons. The purpose of this paper is to demonstrate the advancements in personalized musculoskeletal modeling for patients who require severe reconstructive surgery of the lower extremity.

Pegs are often used in cementless total knee replacement (TKR) to improve fixation strength. Studies have demonstrated that interference fit, surface properties, bone mineral density (BMD) and viscoelasticity affect the performance of press-fit designs. These parameters also affect the insertion force and the bone damage occurring during insertion. We aimed to quantify the effect of the aforementioned parameters on the short-term fixation strength of cementless pegs.

6 mm holes were drilled in twenty-four human femora. BMD was measured using calibrated CT-scans, and randomly assigned to samples. Pegs were produced to investigate the effect of interference fit (diameters 6.5 and 7.6 mm), surface treatment (smooth and rough- porous-coating [friction coefficient: 1.4]) and bone relaxation (relaxation time 0 and 30 min) and interactions were studied using a DOE method. Two additional rough surfaced peg designs (diameters 6.2 and 7.3 mm) were included to scrutinize interference. Further, a peg based on the LCS Porocoat® (DePuy Synthes Joint Reconstruction, Leeds, UK) was added as a clinical baseline. In total seven designs were used (n = 10 for all groups). Pegs were inserted and extracted using an MTS machine (Figure 1), while recording force and displacement. Bone damage was defined as the difference between the cross-sectional hole area prior to and after the test.

BMD and interference fit were significant factors for insertion force. BMD had a significant positive correlation with pull-out force and subsequent analyses were therefore normalised for BMD.

Pull-out force increased significantly with interference for both surface coatings at time 0 (p < 0.05). However, after 30 minutes the effect remained significant for rough pegs only (p < 0.05-Figure 2A).

Additionally, the pull-out force increased with diameter in a non-linear manner for the rough pegs (Figure 2B). The two surface treatments were not significantly different to the clinical comparator. Interference fit was the only significant factor for bone damage.

BMD was significant for insertion and pull-out forces, reinforcing the need to account for this factor in biomechanical studies and clinical practice. This study also highlights the importance of time in studying bone interactions, with surface treatment and interference showing different interaction effects with relaxation time. Although smooth pegs initially have a higher pull-out force, this effect reduces over time whereas the pullout force for rough pegs is maintained. Smooth pegs also show time sensitivity in relation to interference and the benefit of increased interference reduces over time, whereas it is maintained in rough pegs. This may be explained by different damage (compressive and abrasive) mechanisms associated with different surface treatments.

In conclusion, BMD and interference fit are significant factors for initial fixation. Bone relaxation plays an important role as it reduces the initial differences between groups. Therefore, these findings should be strongly considered in the design development of cementless TKR.

The effect of an advanced porous surface morphology on the mechanical performance of an uncemented femoral knee prosthesis was investigated. Eighteen implants were inserted and then pushed-off from nine paired femurs (Left legs: advanced surface coating; right legs: Porocoat® surface coating as baseline). Bone mineral density (BMD) and anteroposterior dimension were measured, which both were not significantly different between groups. The insertion force was not significantly different, but push-off force was significantly higher in the advanced surface coating group (P = 0.007). BMD had direct relationship with the insertion force and push-off force (p < 0.001). The effect of surface morphology on implant alignment was very small. We suggest that the surface properties create a higher frictional resistance thereby providing a better inherent stability of implants featuring the advanced surface coating.

Introduction

Recent reports have implicated fretting corrosion at the head-stem taper junction as a potential cause of failure of some large diameter metal-on-metal (MOM) devices. While it has been suggested that larger MOM heads, may induce greater frictional torques at the taper connection, the exact mechanisms underlying fretting corrosion remain poorly understood.

It is likely that the onset of the corrosion process is caused by mechanical factors, such as contact stresses and micromotions occurring at the interface. These stresses and micromotions depend on the fixation of the head onto the stem and may be affected by blood, fat, bone debris or other contaminations. The fixation of the head is achieved intraoperatively through impaction.

To further study this phenomenon, we adopted a finite element approach in which we modeled the head-taper junction fixation mechanics. In this model, we analyzed the effect of impaction force on the micromotions occurring at the head-stem interface.

Introduction

Current clinical practice in total knee arthroplasty (TKA) is largely based on metal on polyethylene bearing couples. A potential adverse effect of the stiff metal femoral component is stress shielding, leading to loss of bone stock, periprosthetic bone fractures and eventually aseptic loosening of the component. The use of a polymer femoral component may address this problem. However, a more flexible material may also have consequences for the fixation of the femoral component. Concerns are raised about its expected potential to introduce local stress peaks on the interface.

The objective of this study was to analyze the effect of using a polyether-etherketone (PEEK-Optima®) femoral component on the cement-implant interface. We analyzed the interface stress distribution occurring during normal gait, and compared this to results of a standard CoCr component.

To achieve desirable outcomes in cementless total knee replacement (TKR), sufficient primary stability is essential. The primary stability inhibits excessive motions at the bone-implant interface, hence providing the necessary condition for osseointegration [1]. Primary stability for cementless TKR is provided by press-fit forces between the bone and implant. The press-fit forces depend on several factors including interference fit, friction between bone and implant surface, and the bone material properties. It is expected that bone mineral density (BMD) will affect the stability of cementless TKR [2]. However, the effect of BMD on the primary stability of cementless femoral knee component has not been investigated in vitro.

Phantom calibrated CT-scans of 9 distal femora were obtained after the surgical cuts were made by an experienced surgeon. Since the press-fit forces of the femoral component mainly occur in the Anteroposterior (AP) direction, the BMD was measured in the anterior and posterior faces for a depth of 5 mm; this depth was based on stress distributions from a Finite Element Analysis of the same implant design. In addition, four strain gauges were connected to different locations on the implant's outer surface and implant strain measured throughout as an indication of underlying bone strain. A cementless Sigma CR femoral component (DePuy Synthes Joint Reconstruction, Leeds, UK) was then implanted using an MTS machine. In order to simulate a ‘normal’ bone condition, the implanted bone was preconditioned for one hour at a cyclic load of 250–1500 N, and a rate of 1 Hz. Finally, the implants were pushed-off from the bone in a high-flex position. Forces and displacements were recorded both during insertion and push-off tests.

Strong correlations were found for insertion and push-off forces with BMD, R² = 0.88 and R² = 0.88, respectively (p < 0.001), so although implantation may be harder in patients with higher BMD, initial stability is also improved. A correlation was also found between final strain and push-off forces (R² = 0.89, p < 0.01) and BMD also showed a strong reverse correlation with total bone relaxation (R² = 0.76, p = 0.023). These results indicate that higher BMD induces higher bone strain, which can lead to improved fixation strength.

There is no consensus on the best fixation method for the TKR but some surgeons prefer a cementless design for young and active patients. The results of our study showed that the primary stability of a cementless femoral knee component is directly correlated with the bone mineral density. Therefore, patient selection based on bone quality may increase the likelihood of good osseointegration and adequate long-term fixation for cementless femoral knee components.

Introduction

Many finite element (FE) studies have been performed in the past to assess the biomechanical performance of TKA and THA components. The boundary conditions have often been simplified to a few peak loads. With the availability of personalized musculoskeletal (MS) models we becomes possible to estimate dynamic muscle and prosthetic forces in a patient specific manner. By combining this knowledge with FE models, truly patient specific failure analyses can be performed.

In this study we applied this combined technique to the femoral part of a cementless THR and calculated the cyclic micro-motions of the stem relative to the bone in order to assess the potential for bone ingrowth.

Introduction

A few follow-up studies of high flexion total knee arthoplasties report disturbingly high incidences of femoral loosening. Finite element analysis showed a high risk for early loosening at the cement-implant interface at the anterior flange. However, femoral implant fixation is depending on two interfaces: cement-implant interface and the cement-bone interface. Due to the geometry of the distal femur, a part of the cement-bone interface consists of cement-cortical bone interface. The strength of the cement-bone interface is lower than the strength of the cement-implant interface.

The research questions addressed in this study were: 1) which interface is more prone to loosening and 2) what is the effect of different surgical preparation techniques on the risk for early loosening.

INTRODUCTION

Electron beam melting is a promising technique to produce surface structures for cementless implants. Biomimetic apatite coatings can be used to enhance bone ingrowth. The goal of this study was to evaluate bone ingrowth of an E-beam produced structure with biomimetic coating and compare this to an uncoated structure and a conventionally made implant surface.

In the present study we describe the clinical results of the Scientific Hip Prosthesis® (SHP). With the goal of smoothening cement-bone interface stress peaks, the SHP was developed using shape optimization algorithms together with finite element modelling techniques. The resulting shape and cement stresses are seen in Figure 1. The introduction of the SHP prosthesis was performed in a stepwise fashion including a RSA study performed by Nivbrant et al¹. RSA studies for prosthetic types that are in long-term use are of great value in predicting the survivorship related to the migration rate and pattern for that specific type of prosthesis. If a stem in a patient shows a much higher migration rate than the typical one, the stem may be identified as at high-risk for early loosening. The study of Nivbrant et al¹ revealed unexpectedly high migration values and it was stated that the SHP stem was not the preferred stem to use despite the good Harris Hip Score and Pain score at two years follow-up.

In the present study the clinical results of a single surgeon study consisting of 171 hips with a follow-up of 5–12 years were evaluated. The mean follow-up was 8.2 years (5.0–12.0). The survival rate was 98.8% at ten years follow-up for aseptic loosening of the stem. The mean Harris Hip Score at 10 year follow-up was 89.2 ± 7.5. This study therefore indicates that a new prosthetic design may function clinically rather well, despite the relatively high migration rates which have been reported.

In case of a RSA study with a new prosthesis it may not be so evident what the expected “typical” migration rate or pattern is. So in order to predict early loosening the typical migration rate has to be known. Perhaps typical migration rates can be established using standardized cadaver migration experiments or computer simulation models techniques. Since these standardized tools are currently not available, the prediction of clinical survival of new prosthetic components remains a challenging task and the interpretation of migration rates with new designs should be considered with much caution.

In cemented total hip arthroplasty, the cement-bone interface can be considerably degraded in less than one year in-vivo service (Figure 1). This makes the interface much weaker relative to the direct post-operative situation. Retrieval studies show that patients do, to a certain extent, not suffer from the degraded cement-bone interface itself. It is, however, unknown whether the degraded cement-bone interface affects other failure mechanisms in the cemented hip reconstruction. A good understanding of the mechanics of the cement-bone interface is therefore essential. The aim of this study was to investigate the mechanics of the cement-bone interface in the direct post-operative and degraded situation by the utilization of finite element analysis (FEA) and laboratory experiments. It was subsequently analyzed how the mechanics of the cement-bone interface affect failure of the cement mantle in terms of crack formation.

In order to investigate the mechanical response of the cement-bone interface, laboratory prepared (direct post-operative state) and postmortem (degraded state) specimens were loaded in various directions in the laboratory and FEA environment. From all specimens, multiple interface morphology parameters were documented, which were related to the interfacial response and subsequently converted to a numerical cohesive model. As a validation, this cohesive model was implemented into two FEA models of transverse sections of cemented hip reconstructions with distinct mechanical characteristics (Figure 2). Finally, the differences in fatigue crack formation in a complete hip reconstruction were determined by varying the cement-bone interface compliance (Figure 3).

When loaded in multiple directions, the interface compliance could not be related to the cement interdigitation depth (r²=0.08). However, compliance did correlate to the gap thickness between the bone and cement (r²=0.81) and the amount of interfacial contact (r²=0.50). Surprisingly, for the same amount of contact, the interface was more compliant in degraded state than in the direct post-operative state. The mechanical response of the experimental and FEA cement-bone interface tests could, independent on the direct post-operative or degraded state, successfully be described by a cohesive model. The cohesive model was even more confirmed by the successful reproduction of the mechanics of the retrieved transverse sections. When the cohesive model was implemented in a complete reconstruction, we found that a compliant cement-bone interface resulted in considerably more fatigue cracks in the cement mantle than a very stiff interface.

This study showed that an increased compliancy of the cement-bone interface results in an increase of cement cracks in the cement mantle. It is therefore crucial to minimize the interfacial gaps and, as a result, increase the amount of contact between the bone and cement to generate a stiff cement-bone interface. It is, unfortunately, unknown how this well fixed interface can be maintained. We finally conclude that the derived cohesive model of the cement-bone interface can be used for multiple applications in orthopaedics, including pre-clinical of implants and patient specific studies of failed cemented reconstructions.

For amputated patients, direct attachment of upper leg prosthesis to the skeletal system by a percutaneous implant is an alternative solution to the traditional socket fixation. Currently available implants, the OPRA system (Integrum AB, Göteborg, Sweden) and the ISP Endo/Exo prosthesis (ESKA Implants AG, Lübeck, Germany) [1-2] allow overcoming common soft tissue problems of conventional socket fixation and provide better control of the prosthetic limb [3], higher mobility and comfort [2, 4]. However, restraining issues such as soft-tissue infections, peri-prosthetic bone fractures [3, 5–8] and considerable bone loss around the stem [9], which might lead to implant's loosening, are present. Finally, a long a residual limb is required for implant fitting.

In order to overcome the limiting biomechanical issues of the current designs, a new concept of the direct intramedullary fixation was developed. The aim was to restore the natural load transfer in the femur and allow implantations in short femur remnants (Figure 1). We hypothesize that the new design will reduce the peri-prosthetic bone failure risk and adverse bone remodeling.

Generic CT-based finite element models of an intact femoral bone and amputated bones implanted with 3 analyzed implants were created for the study. Models were loaded with two loading cases from a normal walking obtained from the experimental measurements with the OPRA device [10-11]. Periprosthetic bone failure risk was evaluated by considering the von Mises stress criterion [12-14]. Subsequently the strain adaptive bone remodeling theory was used to predict long-term changes in bone mineral density (BMD) around the implants. The bone mineral content (BMC) change was measured around implants and the results were visualized in the form of DXA scans.

The OPRA and the ISP implants induced the high stress concentration in the proximal region decreasing in the distal direction to values below physiological levels as compared with the intact bone. The stresses around the new design were more uniformly distributed along the cortex and resembled better the intact case. Consequently, the bone failure risk was reduced as compared to the OPRA and the ISP implants. The adaptive bone remodeling simulations showed high bone resorption around distal parts of the OPRA and the ISP implants in the distal end of the femur (on average −75% ISP to −78% OPRA after 60 months). The bone remodeling simulation did not reveal any bone loss around the new design, but more bone densification was seen (Figure 2). In terms of total bone mineral content (BMC) the OPRA and the ISP implants induced only a short-term bone densification in contrast to the new design, which provoked a steady increase in the BMC over the whole analyzed period (Figure 3).

In conclusion, we have seen that the new design offers much better bone maintenance and lower failure probability than the current osseointegrated trans-femoral prostheses. This positive outcome should encourage further developments of the presented concept, which in our opinion has a potential to considerably improve safety of the rehabilitation with the direct fixation implants and allow treatment of patients with short stumps.

INTRODUCTION

Patellofemoral joint (PFJ) replacement is a successful treatment option for isolated patellofemoral osteoarthritis. With this approach only the involved joint compartment is replaced and the femoro-tibial joint remains intact. Minimizing periprosthetic bone loss, which may occur due to the stress shielding effect of the femoral component, is important to insure long-term outcomes. The objective of this study was to investigate, using finite element analyses, the effects of patellofemoral replacement on the expected stress distribution of the distal femur eventually leading to changes in bone density.

Introduction

High-flexion knee implants have been developed to accommodate a large range of motion (ROM > 120°) after total knee arthroplasty (TKA). In a recent follow-up study, Han et al. [1] reported a disturbingly high incidence of femoral loosening for high-flexion TKA. The femoral component loosened particularly at the implant-cement interface. Highly flexed knee implants may be more sensitive to femoral loosening as the knee load is high during deep knee flexion [2], which may result in increased tensile and/or shear stresses at the femoral implant fixation.

The objective of this study was to analyse the load-transfer mechanism at the femoral implant-cement interface during deep knee flexion (ROM = 155°). For this purpose, a three-dimensional finite element (FE) knee model was developed including high-flexion TKA components. Zero-thickness cohesive elements were used to model the femoral implant-cement interface. The research questions addressed in this study were whether high-flexion leads to an increased tensile and/or shear stress at the femoral implant-cement interface and whether this would lead to an increased risk of femoral loosening.

Introduction

Within the reconstruction of unicondylar femoral bone defects with morselized bone grafts in revision total knee arthroplasty (TKA), a stem extension appears to be critical to obtain adequate mechanical stability. Whether the stability is still secured by this reconstruction technique in bicondylar defects has not been assessed. Long, rigid stem extensions have been advocated to maximize the stability in revision TKAs. The disadvantage of relatively stiff stem extensions is that bone resorption is promoted due to stress shielding. Therefore, we developed a relatively thin intramedullary stem which allowed for axial sliding movements of the articulating part relative to the intramedullary stem. The hypothesis behind the design is that compressive contact forces are directly transmitted to the distal femoral bone, whereas adequate stability is provided by the sliding intramedullary stem. A prototype was made of this new knee revision design and applied to the reconstruction of uncontained bicondylar femoral bone defects.