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Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 238 - 238
1 Dec 2013
Berahmani S Janssen D Wolfson D De Waal Malefijt M Verdonschot N
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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).

Pull-out force reduced significantly with roughness for both peg diameters at time 0 (p < 0.001). However, after 30 minutes the effect remained significant for small pegs only (p < 0.05-Figure 2A).

The time dependant interaction was only significant for smooth pegs in both diameters (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.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 15 - 15
1 Dec 2013
Berahmani S Janssen D Wolfson D De Waal Malefijt M Verdonschot N
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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.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 241 - 241
1 Dec 2013
Bitter T Janssen D Schreurs BW Khan I Verdonschot N
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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.

Materials and methods

We created a model of a BIOMET Type-1 taper and an adapter that is typically used for larger heads.

Titanium alloy material properties were assigned to both components, and frictional contact (μ = 0.5) was simulated between the adapter and the taper.

To ensure that the model accurately represented the contact mechanics, we first simulated experiments in which the head was assembled on the taper in a load-controlled manner, at different load (4 and 15 kN), after which it was disassembled axially. The disassembly loads predicted by the FEA simulations were then compared to the experimental values.

After ensuring a correct prediction of the disassembly loads, we used various impaction loads (2, 4, and 15 kN) to assemble the taper, after which a 2.3 kN load (ISO 7206-4) was applied to the adapter/taper assembly. This loading regime is commonly used to determine endurance properties of stemmed femoral components. Under these loading conditions, we then analyzed the contact stresses and micromotions, and the effect of impaction load on these quantities.


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_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_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. 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_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.