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Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 513 - 513
1 Dec 2013
Ruiter L Janssen D Briscoe A Verdonschot N
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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.

Materials and methods

An FEA model was created, consisting of a femoral component cemented onto a femur, and a polyethylene tibial component. A standard loading regime was applied mimicking an adapted gait cycle, according to ISO14243-1. The implant-cement interface was modelled as a zero-thickness layer connecting the implant to the cement layer. Femoral flexion/extension was prescribed for the femur in a displacement controlled manner, while the joint loads were applied to pivoting nodes attached to the tibial construct, consistent with the ISO standard. Implant-cement interface properties were adopted from a previous study on CoCr interface debonding[1].


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 239 - 239
1 Dec 2013
Berahmani S Janssen D Wolfson D De Waal Malefijt M Verdonschot N
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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.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 358 - 358
1 Mar 2013
Verdonschot N Van Der Ploeg B Tarala M Homminga J Janssen D
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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.

Methods

An FE model of a complete femur with a CLS Spotorno stem inserted was generated. An ideal fit between the implant and the bone was modeled proximally, whereas distally an interface gap of 100μm was created to simulate a more realistic interface condition obtained during surgery. Furthermore, a gait analysis was performed on a young subject and fed into the Anybody™ MS modeling system. The anatomical data set (muscle attachment points) used by the Anybody™ system was morphed to the shape of the femoral reconstruction. In this way a set of muscle attachment points was obtained which was consistent with the FE model. The predicted muscle and hip contact forces by the Anybody™ modeling system were dynamic and divided into 37 increments including two stance phases and a swing phase of the right leg.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 357 - 357
1 Mar 2013
van de Groes S De Waal Malefijt M Verdonschot N
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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.

Materials & methods

To achieve data for the cement-(cortical)bone interface strength and the effects of different preparation techniques on interfacial strength, human cadaver interface stress tests were performed for different preparation techniques of the bony surface and the results were implemented in a finite element (FE) model as described before. The FE model consisted of a proximal tibia and fibula, TKA components, a quadriceps and patella tendon and a non-resurfaced patella. For use in this study, the distal femur was integrated in the FE model including cohesive interface elements and a 1 mm bone cement layer. In the model, the cement-bone interface was divided into two areas, representing cortical and cancellous bone. The posterior-stabilised PFC Sigma RP-F (DePuy, J&J, USA) was incorporated in the FE knee model following the surgical procedure provided by the manufacturer. A full weight-bearing squatting cycle was simulated (ROM = 50°-155°). The interface failure index was calculated.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 25 - 25
1 Sep 2012
Biemond L Hannink G Verdonschot N Buma P
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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.

METHODS


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 199 - 199
1 Sep 2012
van de Groes S Ypma J Spierings P Verdonschot N
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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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 192 - 192
1 Sep 2012
Tomaszewski P Verdonschot N Bulstra S Verkerke G
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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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 211 - 211
1 Sep 2012
Waanders D Janssen D Mann K Verdonschot N
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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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 74 - 74
1 Sep 2012
Innocenti B van Jonbergen H Labey L Verdonschot N
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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.

METHODS

MRI images of a healthy knee were acquired, segmented and reconstructed into a 3D physiological model of the bony and cartilaginous geometries of distal femur and patella with patellar tendon and insertion of the quadriceps tendon. This model was modified to include PFJ replacements with either a Journey PFJ or a Richards II PFJ prosthesis, and a Genesis II TKA (Smith&Nephew, Memphis, TN). The prosthetic components were incorporated in the intact model based on the manufacturer's instructions or previously described surgical techniques (Figure 1).

Cortical bone was modeled with orthotropic properties, while homogeneous linear isotropic elasticity was assumed for trabecular bone, cartilage, cement and femoral components materials. The patellar tendon was given Neo-Hookean behavior. UHMWPE patellar buttons for all designs were assigned non-linear elasto-plastic material.

The simulated motion consisted of a 10 second loaded squat, starting from 0° until a flexion angle of 120° matching experimental kinematics tests performed in previous in-vitro analysis on physiological cadaveric legs [1-2]. The patella model was constrained fixing the distal part of the patellar ligament and applying a quadriceps force distributed on the quadriceps insertion on the proximal surface of the patella.

During the dynamic simulation the average Von Mises stress was calculated in two regions of interest (ROI) defined in the femoral bone: one anterior and one proximal. The location of the ROIs was defined to fit the same regions as used in a previous bone mineral density analysis following patellofemoral arthroplasty (height 1cm, length 1cm).


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 8 | Pages 1135 - 1142
1 Aug 2012
Derikx LC van Aken JB Janssen D Snyers A van der Linden YM Verdonschot N Tanck E

Previously, we showed that case-specific non-linear finite element (FE) models are better at predicting the load to failure of metastatic femora than experienced clinicians. In this study we improved our FE modelling and increased the number of femora and characteristics of the lesions. We retested the robustness of the FE predictions and assessed why clinicians have difficulty in estimating the load to failure of metastatic femora. A total of 20 femora with and without artificial metastases were mechanically loaded until failure. These experiments were simulated using case-specific FE models. Six clinicians ranked the femora on load to failure and reported their ranking strategies. The experimental load to failure for intact and metastatic femora was well predicted by the FE models (R2 = 0.90 and R2 = 0.93, respectively). Ranking metastatic femora on load to failure was well performed by the FE models (τ = 0.87), but not by the clinicians (0.11 < τ < 0.42). Both the FE models and the clinicians allowed for the characteristics of the lesions, but only the FE models incorporated the initial bone strength, which is essential for accurately predicting the risk of fracture. Accurate prediction of the risk of fracture should be made possible for clinicians by further developing FE models.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 255 - 255
1 Jun 2012
Zelle J Malefijt MDW Verdonschot N
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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.

Materials & methods

The FE knee model utilized in this study has been described previously [3] and consisted of a proximal tibia and fibula, TKA components, a quadriceps and patella tendon and a non-resurfaced patella. For use in this study, the distal femur was integrated in the FE model including cohesive interface elements and a 1 mm bone cement layer. High-flexion TKA components of the posterior-stabilised PFC Sigma RP-F (DePuy, J&J, USA) were incorporated in the FE knee model following the surgical procedure provided by the manufacturer. A full weight-bearing squatting cycle was simulated (ROM = 50°-155°). The interface stresses calculated by the FE knee model were decomposed into tension, compression and shear components. The strength of the femoral implant-cement interface was determined experimentally using interface specimens to predict whether a local interface stress-state calculated by the FE knee model would lead to interface debonding.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 145 - 145
1 Jun 2012
Meijerink H Loon CV Malefijt MDW Kampen AV Verdonschot N
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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.

Materials and Methods

Five synthetic distal femora with a bicondylar defect were reconstructed with impacted bone grafting (IBG) and this new knee revision design. A custom-made screw connection between the stem and the intercondylar box was designed to lock or initiate the sliding mechanism, another screw (dis)connected the stem. A cyclically axial load of 500 N was applied to the prosthetic condyles to assess the stability of the reconstruction. Radiostereometry was used to determine the migrations of the femoral component with a rigidly connected stem, a sliding stem and no stem extension.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 106 - 106
1 Jun 2012
Janssen D Srinivasan P Scheerlinck T Verdonschot N
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Introduction

Hip resurfacing arthroplasty has gained popularity as an alternative for total hip arthroplasty. Usually, cemented fixation is used for the femoral component. However, each type of resurfacing design has its own recommended cementing technique.

In a recent investigation the effect of various cementing techniques on cement mantle properties was studied. This study showed distinct differences in cement mantle volume, filling index and morphology.

In this study, we investigated the effect of these cement mantle variations on the heat generation during polymerization, and its consequences in terms of thermal bone necrosis.

Materials and methods

Two FEA models of resurfacing reconstructions were created based on CT-data of in vitroimplantations (Fig 1). The two models had distinct differences with respect to the amount of cement that was used for fixation. The first model was based on an implantation with low-viscosity cement, with anchoring holes drilled in the bone, and suction applied to maximize cement penetration. The second model was based on an implantation with medium viscosity cement smeared onto the bone, with no holes and no suction, leading to a thin cement layer.

Thermal analyses were performed of the polymerization process, simulating three different types of bone cement: Simplex P (Stryker), CMW3 (DePuy J&J) and Osteobond (Zimmer), with distinct differences in polymerization characteristics. The polymerization kinematics were based on data reported previously.

During the polymerization simulations the cement and bone temperature were monitored. Based on the local temperature and time of exposure, the occurrence of thermal bone necrosis was predicted. The total volume of necrotic bone was calculated for each case.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 425 - 426
1 Nov 2011
Janssen D Waanders D Mann K Verdonschot N
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The stability of cemented hip implants relies on the fixation of the cement mantle within the bone cavity. This fixation has been investigated in experiments with cement-bone interface specimens, which have shown that the cement-bone interface is much more compliant than is commonly assumed. Other studies demonstrated that the mechanical response of the interface is dependent on penetration of the cement into the bone. It is, however, unclear how cement penetration exactly affects the stiffness and strength of the cement-bone interface. We therefore used finite element (FE) models of cement-bone specimens to study the effect of cement penetration depth on the micromechanical behavior of the interface.

The FE models were created based on micro computed tomography (micro CT) data of two small cement-bone interface specimens (8x8x4 mm). The specimens had distinct differences with respect to interface morphology. In these models we varied the penetration depth, with six different penetration levels for each model. We then incrementally deformed each model in tension and in shear, until failure of the models. Failure was simulated to occur in the bone and cement when the local ultimate tensile stress was exceeded, by locally reducing the material stiffness to near zero. From the resulting force-displacement curves we established the apparent tensile stiffness and strength for each of the models.

Our results indicated that the strength and stiffness of the cement-bone interface increased with increasing cement penetration depth, both in tension and in shear. However, after reaching a certain penetration depth, both strength and stiffness did not further increase. This depth was dependent on the specific interface morphology. We furthermore found that the strength of the models was higher in shear than in tension. After failure of the models, damage was mainly found in the cement, rather than in the bone.

The FE-based techniques developed for the current study are suitable for exploration of a variety of aspects that may affect the cement-bone interface micromechanics, such as biological changes to the bone and variations of cement material properties.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 455 - 455
1 Nov 2011
Zelle J De Waal Malefijt M Verdonschot N
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High-flexion knee replacements have been developed to accommodate a large range of motion (ROM > 120°) after total knee arthroplasty (TKA). Femoral rollback or posterior translation of the femoral condyles during knee flexion is essential to maximise ROM and to avoid bone-implant impingement during deep knee flexion. The posterior cruciate ligament (PCL) has been described as the main contributor to femoral rollback. In posterior-stabilised TKA designs the PCL is substituted by a post-cam mechanism. The main objective of this study was to analyse the mechanical interaction between the PCL and a highflexion cruciate-retaining knee replacement during deep knee flexion. For this purpose, the mechanical performance of the high-flexion cruciate-retaining TKA design was evaluated and compared with two control designs including a highflexion posterior-stabilised design.

Materials & Methods: Prosthetic knee kinematics and kinetics were computed using a three-dimensional dynamic finite element (FE) model of the knee joint. The FE knee model consisted of a distal femur, a proximal tibia and fibula, a quadriceps and patella tendon, a non-resurfaced patella, TKA components and a posterior cruciate ligament in case cruciate-retaining designs were evaluated. Tibio-femoral and patello-femoral contact were defined in the FE knee model and the polyethylene insert was modelled as a non-linear elastic-plastic material. Three different rotating platform TKA systems were analysed in this study: the high-flexion cruciate-retaining PFC Sigma CR150, the high-flexion posterior-stabilised PFC Sigma RP-F and the conventional cruciate-retaining PFC Sigma RP (Depuy, J& J, UK). Both the polyethylene stress characteristics and the tibio-femoral contact locations were evaluated during a squatting movement (ROM = 50° – 150°).

Results: During deep knee flexion (ROM > 120°), the high-flexion cruciate-retaining TKA design showed a lower peak contact stress (74.7 MPa) than the conventional cruciate-retaining design (96.5 MPa). The posterior-stabilized high-flexion TKA design demonstrated the lowest peak contact stress at the condylar contact interface (54.2 MPa), although the post was loaded higher (77.4 MPa). All three TKA designs produced femoral rollback in the normal flexion range (ROM ≤ 120°), whereas the cruciate-retaining designs showed a paradoxical anterior movement of the femoral condyles during high-flexion.

Discussion: PCL retention is a challenging surgical aim and affects the prosthetic knee load and kinematics as shown in this study. In addition, for adequate functioning the PCL should not be too tight or too lax after surgery. Hence, we investigated the effect of PCL laxity on the prosthetic performance and the best-balanced PCL was used in our simulations. Although PCL balancing is not an issue for posterior-stabilized TKA, we found the tibial post to be loaded relatively high for this implant type.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 463 - 464
1 Nov 2011
Heesterbeek P Keijsers N Verdonschot N Wymenga A
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Instability is a major cause for revision surgery in total knee replacement (TKR). With a balanced gap technique, the ligaments are theoretically balanced. However, there is concern that ligament releases needed to align the leg may cause instability. Furthermore, no information is available about the relationship between the amount of varus-valgus laxity directly after implantation and at a later postoperative interval. This prospective clinical study investigated whether ligament releases necessary during total knee replacement (TKR) led to a higher varus-valgus laxity during peroperative examination and after 6 months.

In this prospective cohort study, in 49 patients a primary TKR was implanted using a balanced gap technique. Varus and valgus laxity of the knee was assessed in extension and flexion (70 degrees) per-operative (before and after implant) with a navigation system and post-operative with standardised stress radiographs (both methods 15 Nm stress applied).

Knees were catalogued according to ligament releases performed during surgery: no releases, lateral releases, medial releases with posteromedial condyle (PMC), and medial releases with superficial medial collateral ligament (SMCL). ANOVA was used to test between release groups.

At surgery, before and after implantation of the prosthesis, there was no difference in varus or valgus laxity in extension and flexion between knees that did not need a ligament release (n=22), knees with lateral release (n=5), knees with medial SMCL releases (n=15) and knees with medial PMC releases (n=7). Six months after TKR, varus or valgus laxity in extension and flexion was not significantly different between the release categories.

In conclusion, ligament releases of the SMCL, PMC, and lateral structures performed during a balanced gap technique in TKR do not lead to an increased varus-valgus laxity in extension and flexion at 6 months after surgery. Therefore, routine releases of these structures to achieve neutral leg alignment can safely be performed without causing increased varus-valgus laxity. The results of this study suggest that the reported high incidence of revisions for ligament instability after TKR is not likely to be caused by routine ligament releases when a balanced gap technique is used. Apparently, there is not a ligament instability problem as long as the gaps are properly filled with prosthesis components. We believe that the conclusion of this study would also be valid when bone referenced techniques are applied instead of tensors, as long as the gaps created are balanced.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 446 - 447
1 Nov 2011
Walschot L Aquarius R Schreurs B Verdonschot N Buma P
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Bone impaction grafting (BIG) is a surgical technique for the restoration of bone stock loss with impaction of autograft or allograft bone particles (BoP). The goal of a series in-vitro and in-vivo experiments was to assess the suitability of deformable pure Ti (titanium) particles (TiP, FONDEL MEDICAL BV, Rotterdam, The Netherlands) for application as a full bone graft substitute in cemented revision total hip arthroplasty. TiP are highly porous (interconnective porosity before impaction 85 to 90%). In-vitro acetabular reconstructions were made in Sawbones (SAWBONES EUROPE, Malmö, Sweden) to evaluate migration by roentgen stereo photogrammetric analysis and shear force resistance by a lever out experiment. In-vitro femoral TiP reconstructions (SAWBONES, Malmö, Sweden) were used to evaluate micro-particle release and subsidence. Mature Dutch milk goats were used for two in-vivo experiments.

A non-loaded femoral defect model was used to compare osteoconduction of bioceramic coated TiP with BoP and ceramic particles (CeP).

Acetabular defects (AAOS type 3) were reconstructed in 10 goats using a metal mesh with impacted TiP acting as a full bone graft substitute in combination with a cemented polyethylene cup and a downsized cemented Exeter femoral stem (STRYKER BENOIST, Girard, France).

Blood samples were taken for toxicological analysis.

In-vitro: TiP were as deformable as BoP and created an entangled graft layer (porosity after impaction 70 to 75%). Acetabular TiP reconstructions were more stable and resistant to subsidence and shear force than BoP reconstructions (lever-out moment 56 ± 12 Nm respectively 12 ± 4 Nm, p < 0.001). After initial setting, femoral subsidence rates were smaller than seen in femoral bone impaction grafting (0.45 ± 0.04 mm after 300 000 loading cycles). Impaction generated 1.3 mg particles/g TiP (particle Ø 0.7–2 000 μm, tri-modal size distribution). In-vivo: Bioceramic coated (10 −40 μm) TiP showed bone ingrowth rates comparable to BoP and CeP. Reconstructed acetabular defects showed rapid bone ingrowth into the layer of TiP. Serum titanium concentrations slowly increased from 0.60 ± 0.28 parts per billion (ppb) preoperatively to 1.06 ± 0.70 ppb at fifteen weeks postoperatively (p = 0.04).

Mechanical studies showed very good initial mechanical properties of TiP reconstructed defects. The in-vitro study showed micro-particle generation, but in the short-term goat studies, histology showed very few particles and no negative biological effects were found. The in-vivo acetabular study showed very favorable bone ingrowth characteristics into the TiP layer and a much thinner interface with the cement layer compared to similar defects reconstructed with BoP or mixtures of BoP with CeP. Further analysis in a human pilot study should proof that TiP is an attractive and safe alternative for allograft bone in impaction grafting revision arthroplasty.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 432 - 432
1 Nov 2011
Heesterbeek P Keijsers N Verdonschot N Wymenga A
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Balancing the PCL in a PCL-retaining total knee replacement (TKR) is important, but sometimes difficult to execute in an optimal manner. Due to the orientation of the PCL it is conceivable that flexion gap distraction will lead to anterior movement of the tibia relative to the femur. This tibio-femoral repositioning influences the tibio-femoral contact point, which on its turn affects the kinematics of the TKR. So far, the amount of tibiofemoral repositioning during flexion gap distraction is unknown which leads to uncertain kinematic effects after surgery. The goal of this study was to quantitatively describe the parameters of the flexion gap (gap height, anterior tibial translation and femoral rotation) and their relationship while the knee is distracted during implantation of a PCL-retaining TKR with the use of computer navigation. Furthermore, the effect of PCL elevation angle on the flexion gap parameters was determined.

In 50 knees, during a ligament-guided TKR procedure, the flexion gap was distracted with a double-spring tensor with 100 and 200 N after the tibia had been cut. The flexion gap height, anterior tibial translation and femoral rotation were measured intra-operatively using a CT-free navigation system. PCL elevation was calculated based on the femoral and tibial insertion sites as indicated by the surgeon with the pointer of the navigation system.

To identify a relationship between flexion gap height increase and anterior tibial translation, the ratio between anterior translation and gap height increase was determined for each patient between 100 and 200 N.

The mean gap height increased 2.2 mm (SD 0.96) and mean increase in anterior tibial translation was 4.2 mm (SD 1.6). Hence, on average, for each mm increase in gap height, the tibia moved 1.9 mm (SD 0.96) in anterior direction. Knees with a steep PCL showed significantly more AP translation for each mm gap height increase (gap/AP-ratio was 1 : 2.31 (SD 0.63)) compared to knees with a flat PCL (gap/AP-ratio was 1 : 1.73 (SD 0.50)).

The increase in femur (exo)rotation was on average 0.60° (SD 1.4).

With a tensioned PCL the tibia will move anteriorly on average 1.9 mm for every extra mm that the flexion gap is increased. The flexion gap dynamics can be explained in part by the orientation of the PCL: the greater the elevation angle, the more anterior tibial displacement during distraction of the flexion gap. The surgeon must be aware that distraction of the flexion gap influences the tibiofemoral contact point. The tibio-femoral contact point will move posteriorly and stresses in the PCL will rise and produce limited flexion and pain. In case of a conforming insert AP-movement will be limited but high PE stresses may be introduced that can lead to wear. This information may be helpful in selecting the optimal soft tissue balancing procedure and the optimal PE insert thickness in PCL retaining TKR.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 90 - 90
1 Mar 2010
Verdonschot N van Tienen T Buma P
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Meniscectomy, induces osteoarthritis. Options for repair of a damaged meniscus are an allograft meniscus, an implant made of natural scaffold materials (the collagen meniscus implant; CMI) or an implant made of polymers.

Allograft menisci and the CMI are already clinically used for a considerably number of years. In this educational lecture the focus is on a comparison between the three implant types and the status of a tissue-engineered meniscus.

The allograft meniscus is already used for at least ten years. It is intended for the younger patient with a previous total meniscectomy, with moderate cartilage degeneration and with a good alignment of the knee. The clinical outcome is based on function and pain scores. In this lecture the functional scores, the survival rate and the histology of allograft menisci will be highlighted.

The CMI meniscus implant is intended for a different patient group. To enable implantation of the CMI the rim of the native meniscus should be intact. Patient series that should demonstrate the efficacy of this type of implant are still small and are mainly of the inventors of the implant. In general patients tolerated the implant well. Tissue ingrowth and remodelling into a fibro-cartilaginous tissue was found in animals and patients.

Polymers may be a good alternative for the allograft and CMI implant. Previously they were used to guide vascularized new repair tissue through an ingrowth channel to the avascular lesion. We developed a porous polymer meniscus scaffold with properties to allow tissue infiltration and regeneration of a neomeniscus. It was implanted in dog knees and compared with total meniscectomy. The tissue infiltration and redifferentiation in the scaffold, the stiffness of the scaffold, and the articular cartilage degeneration were evaluated.

Three months after implantation, the implant was completely filled with fibrovascular tissue. After 6 months, the central areas of the implant contained cartilage-like tissue with abundant collagen type II and proteoglycans in their matrix. The foreign-body reaction remained limited to a few giant cells in the implant. The compression modulus of the implant-tissue construct still differed significantly from that of the native meniscus, even at 6 months. Cartilage degeneration was observed both in the meniscectomy group and in the implant group.

The improved properties of these polymer implants resulted in a faster tissue infiltration and in phenotypical differentiation into tissue resembling that of the native meniscus. However, the material characteristics of the implant need to be improved to prevent degeneration of the articular cartilage.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 124 - 124
1 Mar 2010
Zelle J Barink M Verdonschot N
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Introduction: Recently, high-flexion knee implants have been developed to provide for a large range of motion (ROM > 120°) after total knee arthroplasty (TKA). High-flexion knee implants are more likely subjected to large knee loads than conventional implants since knee joint forces increase with larger flexion angles. Highly conforming knee replacements are designed to minimise polyethylene peak stresses during (deep) knee flexion.

The Birmingham Knee Replacement (BKR, Jointmedica, UK) is a newly designed knee replacement which combines a high conformity during the complete ROM with the principles of rotating platform and high-flexion TKA. The main objective of this study was to analyze the mechanical performance of the BKR during its full ROM (0°–155°) and investigate whether its high conformity could be maintained during high-flexion. In addition, the BKR polyethylene loading computed in this study was compared with other mobile bearings.

Materials & methods: TKA performance was analyzed using a three-dimensional dynamic finite element (FE) model of the knee joint. The FE knee model consisted of a distal femur, a proximal tibia and fibula, a quadriceps and patella tendon, a non-resurfaced patella and TKA components. Tibio-femoral and patello-femoral contact were defined in the knee model. Three different posterior stabilised rotating platform TKAs were subsequently incorporated: the high-flexion BKR, the high-flexion PFC Sigma RP-F and the standard PFC Sigma RP (Depuy, J& J, USA). The polyethylene insert was modelled as a non-linear elastic-plastic material in each TKA system. Polyethylene loading parameters as well as the tibio-femoral contact point locations were computed during an entire flexion movement (0°–155°).

Results: In the normal flexion range (flexion ≤ 120°) the three knee implants behaved very similar except for the polyethylene loading at the post. At 120° of flexion, the contact stress at the dish was ±45 MPa for all implants whereas the maximal post-cam contact stress came down to 26.7 MPa for the BKR which was half the amount of contact stress experienced by both PFC Sigma implants. During high-flexion (flexion > 120°), the contact stress difference at the post between the BKR and the PFC Sigma RP-F became smaller and came down to 37.9 MPa and 60.7 MPa, respectively. The total amount of plastic deformation at maximal flexion (155°) was smaller for the BKR (577 mm3) in comparison with the Sigma RP-F (2256 mm3). Femoral rollback was negligible for the BKR in the high-flexion range in comparison with the Sigma RP-F (1.9 mm).

Discussion: A comparison between different geometrical models using finite element techniques is jeopardised by differences in element distribution within the various models. These differences may affect calculated parameters such as peak stress values. However, in this study the models were very similar which would indicate that the differences in stress patterns found are due to design differences rather than model artefacts.

The current study therefore indicates that the BKR benefits from its high conformity during the full ROM. Hence, the BKR demonstrated relatively low polyethylene stresses. The quadriceps efficiency during deep knee flexion may be lower in case of the BKR since the femoral rollback was negligible at these flexion angles. Whether this phenomenon is of any clinical relevance is unknown.