Introduction

Relative motion at the modular head-neck junction of hip prostheses can lead to severe surface damage through mechanically-assisted corrosion. One factor affecting the mechanical performance of modular junctions is the frictional resistance of the mating surfaces to relative motion. Low friction increasing forces normal to the head-neck interface, leading to a lower threshold for slipping during weight-bearing. Conversely, a high friction coefficient is expected to limit interface stresses but may also allow uncoupling of the interface in service. This study was performed to examine this trade-off using finite element models of the modular head-neck junction

Current implant designs and materials provide a high grade of quality and safety, but aseptic implant loosening is still the main reason for total hip revision. Highly cross-linked polyethylene (HX-PE) is used successfully in total hip replacements (THR) since several years. The good wear properties lead to a reduction of wear debris and may contribute to a longer survival time of the THRs. Furthermore, thin HX-PE liner allows the use of larger femoral heads associated with a decreased risk of dislocation and an improved range of motion. However, the cross-linking process is associated with a loss of mechanical properties of the polyethylene material which compromise the use of thin HX-PE liner in terms of high stress situations.

The aim of the present study was the experimental wear analysis of HX-PE liner under steep acetabular cup position. Furthermore, a finite element analysis (FEA) was performed in order to calculate the stress within the HX-PE material in case of steep cup position under physiological loading.

Experimental wear testing was performed for 5 Mio load cycles, using highly cross-linked polyethylene (HX-PE) acetabular liner combined with 44 mm ceramic femoral heads at a standard position of the acetabular cup (30° inclination) according to ISO 14242 as well as at 60° cup inclination. The wall thickness of the HX-PE liner was 3.8 mm. A hip wear simulator, according to ISO 14242 (EndoLab GmbH, Rosenheim, Germany), was used and wear was determined gravimetrically. Moreover, finite element models of the THR system at standard and steep cup position was created by Abaqus/CAE (Dessault Systemes Providence, USA). Using the finite element software Abaqus (Dessault Systemes Providence, USA) the total hip implants were physiologically loaded with maximum force of the gait cycle (3.0 kN). Thereby, the stresses within the HX-PE material were analysed.

The average gravimetrical wear rates of the HX-PE liners at standard implant position (30°) and 60° cup inclination showed small wear amounts of 3.15 ± 0.32 mg and 1.92 ± 1.00 mg per million cycles, respectively. The FEA revealed a clear increase of stresses at the HX-PE liner with respect to steep cup position (von Mises stress of 8.78 MPa) compared to ISO standard implant position (von Mises stress of 5.70 MPa).

The wear simulator tests could not demonstrate significant differences of gravimetrical wear amount of HX-PE liners under steep hip cup position compared to standard implant position. The small contact surface between the femoral head and the SX-PE liner during the wear testing may lead to the low wear rate of the misaligned acetabluar cup. Moreover, the FEA showed that the effect of a misaligned acetabular cup on the stresses within the polyethylene liner can be critical. Although an increase of wear could not be detected a steeper acetabular cup position using thin HX-PE liners should be avoided due to higher stresses preventing implant failure in clinical application.

Background. Surgical reconstruction of the anterior cruciate ligament is a common practice to treat the disability or chronic instability of the knee. Several factors associated with success or failure of the ACL reconstruction, including surgical technique and graft material and graft tension. We aimed to show how we can optimize the graft properties and achieve better post surgical outcomes during ACL reconstruction using 3-dimensional computational finite element simulation. Methods. In this paper, 3-dimensional model of the knee was constructed to investigate the effect of graft tensioning on the knee joint biomechanics. Four different grafts were compared: 1) bone-patellar tendon-bone graft (BPTB) 2) Hamstring tendon 3) BPTB and a band of gracilis 4) Hamstring and a band of gracilis. The initial graft tension was set as “0, 20, 40, or 60N”. The anterior loading was set to 134 N. Findings. Our study shows that the use of the discarded gracilis tendon, which usually excised after graft fixation, could be associated with a host of merits. Our results show that preserving this excess part of gracilis would decrease the required pretention load and, subsequently, could optimize biomechanical properties of the knee. Conclusion. Required pretension during surgery will have decreased significantly by adding a band of gracilis to the proper graft. Therefore, in addition to achieving normal stability of the knee, we can have lower risk of degradation

Experimental knee simulators for component evaluation or in vitro testing provide valuable insight into the mechanics of the implanted joint. The Kansas knee simulator (KKS) is an electro-hydraulic whole joint knee simulator, with five actuators at the hip, ankle and quadriceps muscle used to simulate a variety of dynamic activities in cadaveric specimens. However, the number and type of experimental tests which can feasibly be performed is limited by the need to make physical component parts, obtain cadaveric specimens and the substantial time required to carry out each test. Computational simulations provide a complementary toolset to experimental testing; experimental data can be used to validate the computational model which can subsequently be used for early evaluation and ranking of component designs. The objective of this study was to explore potential improvements to loading and boundary conditions in current computational/experimental models, specifically the KKS, in order to develop representations of several activities of daily living (ADLs) which reproduce in vivo knee joint loading measurements.

An existing finite element model of the KKS was modified to extend the capability, and improve the fidelity, of the computational model beyond the experimental setup. An actuator to allow anterior-posterior (A-P) motion of the hip was included and used to prescribe relative hip-ankle A-P kinematics during the simulations. The quadriceps muscle, which in the experimental simulator consisted of a single quadriceps bundle with a point-to-point line of action, was divided into four heads of the quadriceps with physiological muscle paths. The hamstrings muscle, which was not present in the experiment, was represented by point-to-point actuators in four bundles. A flexible control system was developed which allowed control of the quadriceps and hamstrings actuators to match a knee flexion profile, similar to actuation of the experimental KKS, but also allowed control of the compressive tibiofemoral (TF) joint force, medial-lateral (M-L) load distribution, internal-external (I-E) torque and A-P load at the joint. A series of sensors, measuring all six load components on the medial and lateral compartments of the tibial insert, as well as knee flexion angle, were incorporated into the simulation. Instantaneous measurements from the sensors were fed to a control system, implemented within an Abaqus/Explicit user subroutine (Figure 1). The controller was used to drive actuators in the FE model to match target in vivo joint loading profiles, measured from telemetric patient data. The control system was applied to recreate in vivo loading conditions at the knee joint during three ADLs for three different subjects (Figure 2), with excellent agreement between simulation joint loading conditions and the target profiles; RMS differences were less than 1°, 80N, 2.5%, and 0.8Nm for knee flexion angle, compressive joint load, M-L load split and I-E torque, respectively, throughout the cycle for all three activities (Figure 3). The flexible nature of the control system ensures that it can be used to evaluate an expansive variety of ‘effect of’ studies, as well as to determine advanced loading profiles for the experimental simulator.

The wear particles released from the polyethylene (PE) tibial insert of modular total knee replacements (TKRs) have been shown to cause wear particle induced osteolysis, which may necessitate revision surgery [1]. Wear occurs at the backside surface of the PE insert of modular TKRs, resulting from the relative movement between the PE insert and the tibial tray [2]. Wear particles generated from the backside surface of the PE insert have been shown to be smaller in size than those originating from the articular surface [1], and may therefore have increased biological activity and osteolytic potential [3-4]. The ability to predict backside micromotion and contact pressure by finite element simulation has previously been demonstrated by O'Brien et al. [6-7]. Although the effect of insert thickness on articular surface contact pressure has been investigated [5], the effects of insert thickness on backside contact pressures, backside micromotion, and wear has not received adequate attention. Brandt et al. [2] has suggested that increased insert thickness was associated with increased backside damage (Fig. 1). In the present study, finite element simulations were conducted using the Sigma - Press Fit Condylar TKR (Sigma-PFC®, DePuy Orthopedics Inc., Warsaw, IN) with inserts of different insert thickness ranging between 5, 10, 15, 20 and 25 mm. The TKRs were simulated under ISO 14343-2 [8]. A non-linear PE material model was implemented by means of the J2-plasticity theory [6] and the effects of insert thickness on backside micromotion and contact pressure were analyzed. At the peak loading of the simulated gait cycle (time=13%), the 5 mm thick PE insert showed a greater backside peak contact pressure than the 25 mm thickness PE insert. Increasing insert thickness from 5 mm to 25 mm lead to approximately 15% greater peak micromotion at the modular interface (Fig. 2). This effect may be attributed to the ability of the PE material to distribute the load more evenly through deformation at the modular interface and reduce micromotion for thinner inserts. It is suggested that increased insert thickness results in increased moments at the modular interface that could lead to increased backside wear in silico. Although an increase in PE insert thickness was only associated with a moderate increase in backside micromotion in the present study, it was deemed likely that backside micromotion could be accelerated for thicker inserts in vivo as the PE locking mechanism has been shown to degrade after extended implantation periods

Surgical education of fracture fixation biomechanics relies mainly on simplified illustrations to distill the essence of the underlying principles. These mostly consist of textbook drawings or hands-on exercises during courses, both with unique advantages such as broad availability and haptics, respectively. Computer simulations are suited to bridge these two approaches; however, the validity of such simulations must be guaranteed to teach the correct aspects. Therefore, the aim of this study was to validate finite element (FE) simulations of bone-plate constructs to be used in surgical education in terms of fracture gap movement and implant surface strain. The validation procedure was conducted in a systematic and hierarchical manner with increasing complexity. First, the material properties of the isolated implant components were determined via four-point bending of the plate and three-point bending of the screw. Second, stiffness of the screw-plate interface was evaluated by means of cantilever bending to determine the properties of the locking mechanism. Third, implant surface strain and fracture gap motion were measured by testing various configurations of entire fixation constructs on artificial bone (Canevasit) in axial compression. The determined properties of the materials and interfaces assessed in these experiments were then implemented into FE models of entire fixation constructs with different fracture width and screw configurations. The FE-predicted implant surface strains and fracture gap motions were compared with the experimental results. The simulated results of the different construct configurations correlated strongly with the experimentally measured fracture gap motions (R. 2. >0.99) and plate surface strains (R. 2. >0.95). In a systematic approach, FE model validation was achieved successfully in terms of fracture gap motion and implant deformation, confirming trustworthiness for surgical education. These validated models are used in a novel online education tool OSapp (. https://osapp.ch/. ) to illustrate and explain the biomechanical principles of fracture fixations in an interactive manner

Osteosynthesis aims to maintain fracture reduction until bone healing occurs, which is not achieved in case of mechanical fixation failure. One form of failure is plastic plate bending due to overloading, occurring in up to 17% of midshaft fracture cases and often necessitating reoperation. This study aimed to replicate in-vivo conditions in a cadaveric experiment and to validate a finite element (FE) simulation to predict plastic plate bending. Six cadaveric bones were used to replicate an established ovine tibial osteotomy model with locking plates in-vitro with two implant materials (titanium, steel) and three fracture gap sizes (30, 60, 80 mm). The constructs were tested monotonically until plastic plate deformation under axial compression. Specimen-specific FE models were created from CT images. Implant material properties were determined using uniaxial tensile testing of dog bone shaped samples. The experimental tests were replicated in the simulations. Stiffness, yield, and maximum loads were compared between the experiment and FE models. Implant material properties (Young's modulus and yield stress) for steel and titanium were 184 GPa and 875 MPa, and 105 GPa and 761 MPa, respectively. Yield and maximum loads of constructs ranged between 469–491 N and 652–683 N, and 759–995 N and 1252–1600 N for steel and titanium fixations, respectively. FE models accurately and quantitatively correctly predicted experimental results for stiffness (R2=0.96), yield (R2=0.97), and ultimate load (R2=0.97). FE simulations accurately predicted plastic plate bending in osteosynthesis constructs. Construct behavior was predominantly driven by the implant itself, highlighting the importance of modelling correct material properties of metal. The validated FE models could predict subject-specific load bearing capacity of osteosyntheses in vivo in preclinical or clinical studies. Acknowledgements: This study was supported by the AO Foundation via the AOTRAUMA Network (Grant No.: AR2021_03)

Introduction. Achieving an appropriate primary stability after implantation is a prerequisite for the long-term viability of a dental implant. Virtual testing of the bone-implant construct can be performed with finite element (FE) simulation to predict primary stability prior to implantation. In order to be translated to clinical practice, such FE modeling must be based on clinically available imaging methods. The aim of this study was to validate an FE model of dental implant primary stability using cone beam computed tomography (CBCT) with ex vivo mechanical testing. Method. Three cadaveric mandibles (male donors, 87-97 years old) were scanned by CBCT. Twenty-three bone samples were extracted from the bones and conventional dental implants (Ø4.0mm, 9.5mm length) were inserted in each. The implanted specimens were tested under quasi-static bending-compression load (cf. ISO 14801). Sample-specific homogenized FE (hFE) models were created from the CBCT images and meshed with hexahedral elements. A non-linear constitutive model with element-wise density-based material properties was used to simulate bone and the implant was considered rigid. The experimental loading conditions were replicated in the FE model and the ultimate force was evaluated. Result. The experimental ultimate force ranged between 67 N and 789 N. The simulated ultimate force correlated better with the experimental ultimate force (R. 2. =0.71) than the peri-implant bone density (R. 2. =0.30). Conclusion. The developed hFE model was demonstrated to provide stronger prediction of primary stability than peri-implant bone density. Therefore, hFE Simulations based on this clinically available low-radiation imaging modality, is a promising technology that could be used in future as a surgery planning tool to assist the clinician in evaluating the load-bearing capacity of an implantation site. Acknowledgements. Funding: EU's Horizon 2020 grant No: 953128 (I-SMarD). Dental implants: THOMMEN Medical AG

Despite past advances of implant technologies, complication rates of fixations remain high at challenging sites such as the proximal humerus [1]. These may not only be owed to the implant itself but also to dissatisfactory surgical execution of fracture reduction and implant positioning. Therefore, the aim of this study was to quantify the instrumentation accuracy of a highly standardised and guided procedure and its influence on the biomechanical outcome and predicted failure risk. Preoperative planning of osteotomies creating an unstable 3-part fracture and fixation with a locking plate was performed based on CT scans of eight pairs of low-density proximal humerus samples from elderly female donors (85.2±5.4 years). 3D-printed subject-specific guides were used to osteotomise and instrument the samples according to the pre-OP plan. Instrumentation accuracies in terms of screw lengths and orientations were evaluated by comparing post-OP CT scans with the pre-OP plan. The fixation constructs were biomechanically tested until cyclic cut-out failure [2]. Failure risks of the planned and the post-OP configurations were predicted using a validated sample-specific finite element (FE) simulation approach [2] and correlated with the experimental outcomes. Small deviations were found for the instrumented screw trajectories compared to the planned configuration in the proximal-distal (0.3±1.3º) and anterior-posterior directions (-1.7±1.8º), and for screw tip to joint distances (-0.3±1.1 mm). Significantly higher failure risk was predicted for the post-OP compared to the planned configurations (p<0.01) via FE. When incorporating the instrumentation inaccuracies, the biomechanical results could be predicted well with FE (R. 2. =0.70). Despite the high instrumentation accuracy achieved using sophisticated subject-specific 3D-printed guides, even minor deviations from the pre-OP plan significantly increased the FE-predicted risk of failure. This underlines the importance of intraoperative guiding technology [3] in tandem with careful pre-OP planning to assist surgeons to achieve optimal outcomes. Acknowledgements. This study was performed with the assistance of the AO Foundation via the AOTRAUMA Network

Introduction. Metallic resurfacing systems have been widely used until pseudotumors and ALTR have been clinically found and related to excessive wear of these metal-on-metal hip systems. Hence, surgeons widely abandoned the use of resurfacing systems. Meanwhile, there is a ceramic on ceramic (CoC) resurfacing system (Embody, London, UK) made of zirconia toughened alumina (BIOLOX. ®. delta, CeramTec, Plochingen, Germany) in a clinical safety study. Even though conventional CoC hip systems are known for their excellent wear behavior, it has to be ensured that intraoperative and in-vivo deformations of the ceramic acetabular cup do not infringe the proper functionality of the system. The method of determining the minimum clearance of such a system will be presented here. Materials and Methods. Combined experimental and numerical results were used to determine the deformation of the ceramic shell. In a cadaver lab, the resulting deformations after impaction of generic metal shells have been measured, see e.g. [1] for the method of measurement. The maximum deformation has been chosen for further calculation. Additionally, the stiffness of both generic metal and ceramic shells has been measured using ISO 7206–12. The deformation of the ceramic shells were then calculated by the equation. where u. c. and u. m. are the deformations of the ceramic and the metal shell, respectively, and K. m. and K. c. are the respective stiffnesses. Additionally, in a finite element simulation, the resulting deformation of the ceramic shell under in-vivo conditions was calculated and superposed with u. c. The resulting deformation was used as the minimum value of the clearance for the ceramic resurfacing system. Results. The average value of the maximum deformation of the 8 generic metal shells was 177 µm (StD. 68 µm). Using the stiffness values for the ceramic and the metal shells, a maximum deformation for the ceramic shells (with the smallest and the largest outer diameter) were calculated to 56 µm and 74 µm, respectively. The superposition with the results from the FE studies led to deformation values of 69 µm (smallest shell) and 87 µm (largest shell), respectively. These values were chosen as the minimum values for the realization of the minimum clearance. Discussion. The above described minimum clearance results from a worst-case scenario for the long-term deformation of the ceramic shells. The values from the experimental measurements were taken ten minutes after impaction in the cadaveric hips, when first relaxation already took place. Any other bone remodeling in the long-term, leading to further relaxation of the ceramic shell, has not been taken into account. The maximum deformations resulting from the numerical investigations have been superposed to the experimental values, assuming that both maximum deformations are acting in the same direction. In reality, this is most likely not the case because the line-of-action of the in-vivo forces acting on the hip are not collinear with the direction where the maximum deformation during intra-operative impaction takes place. Additionally, the experimentally chosen underreaming (1 mm) can also be considered as a worst-case. Hence, the calculated minimum clearances are representing the maximal deformation that in the long-term may take place in-vivo

Background. Osteoporotic fracture fixation in the proximal humerus remains a critical challenge. While the biomechanical benefits of screw augmentation with bone cement are established, minimising the cement volume may help control any risk of extravasation and reduce surgical procedure time. Previous experimental studies suggest that it may be sufficient to only augment the screws at the sites of the lowest bone quality. However, adequately testing this hypothesis in vitro is not feasible. Methods. This study systematically evaluated the 64 possible strategies for augmenting six screws in the humeral head through finite element simulations to determine the relative biomechanical benefits of each augmentation strategy. Two subjects with varying levels of local bone mineral density were each modeled with a 2-part and 3-part fracture that was stabilised with a PHILOS plate. The biomechanical fixation was evaluated under physiological loads (muscle and joint reaction forces) that correspond to three different motions: 45 degrees abduction, 45 degrees abduction with 45 degrees internal rotation, and 45 degrees flexion. Results. The higher risk cases (low bone quality or 3-part fracture) exhibited greater peri-implant bone strains and derived greater benefits from screw augmentation. When selecting four screws to augment, the biomechanical benefits ranged from a 25% reduction in bone strain to a 59% reduction in bone strain, depending on the choice of screws. Further, the relative benefits of each augmentation strategy varied between patients and under different loading conditions. Correlations between local bone mineral density and benefits of augmentation were not significant. Conclusions. An optimal augmentation strategy is likely patient-specific and a larger cohort, modeled under a variety of conditions, would be required to elucidate any patient-specific factors (e.g. morphology or bone quality) that may dictate the relative benefits of each augmentation strategy

Introduction. Pedicle screw loosening in posterior instrumentation of thoracolumbar spine occurs up to 60% in osteoporotic patients. These complications may be alleviated using more flexible implant materials and novel designs that could be optimized with reliable computational modeling. This study aimed to develop and validate non-linear homogenized finite element (hFE) simulations to predict pedicle screw toggling. Method. Ten cadaveric vertebral bodies (L1-L5) from two female and three male elderly donors were scanned with high-resolution peripheral quantitative computed tomography (HR-pQCT, Scanco Medical) and instrumented with pedicle screws made of carbon fiber-reinforced polyether-etherketone (CF/PEEK). Sample-specific 3D-printed guides ensured standardized instrumentation, embedding, and loading procedures. The samples were biomechanically tested to failure in a toggling setup using an electrodynamic testing machine (Acumen, MTS) applying a quasi-static cyclic testing protocol of three ramps with exponentially increasing peak (1, 2 and 4 mm) and constant valley displacements. Implant-bone kinematics were assessed with a stereographic 3D motion tracking camera system (Aramis SRX, GOM). hFE models with non-linear, homogenized bone material properties including a strain-based damage criterion were developed based on intact HR-pQCT and instrumented 3D C-arm scans. The experimental loading conditions were imposed, the maximum load per cycle was calculated and compared to the experimental results. HR-pQCT-based bone volume fraction (BV/TV) around the screws was correlated with the experimental peak forces at each displacement level. Result. The nonlinear hFE models accurately (slope = 1.07, intercept = 0.2 N) and precisely (R. 2. = 0.84) predicted the experimental peak forces at each displacement level. BV/TV alone was a weak predictor (R. 2. <0.31). Conclusion. The hFE models enable fast design iterations aiming to reduce the risk of screw loosening in low-density vertebrae. Improved flexible implant designs are expected to contribute to reduced complication rates in osteoporotic patients

Introduction. In total hip arthroplasty, press-fit anchorage is one of the most common fixation methods for acetabular cups and mostly ensures sufficient primary stability. Nevertheless, implants may fail due to aseptic loosening over time, especially when the surrounding bone is affected by stress-shielding. The use of acetabular cups made of isoelastic materials might help to avoid stress-shielding and osteolysis. The aim of the present numerical study was to determine whether a modular acetabular cup with a shell made of polyetheretherketone (PEEK) may be an alternative to conventional titanium shells (Ti6Al4V). For this purpose, a 3D finite element analysis was performed, in which the implantation of modular acetabular cups into an artificial bone stock using shells made of either PEEK or Ti6Al4V, was simulated with respect to stresses and deformations within the implants. Methods. The implantation of a modular cup, consisting of a shell made of PEEK or Ti6Al4V and an insert made of either ceramic or polyethylene (PE), into a bone cavity made of polyurethane foam (20 pcf), was analysed by 3D finite element simulation. A two-point clamping cavity was chosen to represent a worst-case situation in terms of shell deformation. Five materials were considered; with Ti6Al4V and ceramic being defined as linear elastic and PE and PEEK as plastic materials. The artificial bone stock was simulated as a crushable foam. Contacts were generated between the cavity and shell (μ = 0.5) and between the shell and insert (μ = 0.16). In total, the FE models consisted of 45,282 linear hexahedron elements and the implantation process was simulated in four steps: 1. Displacement driven insertion of the cup; 2. Relief of the cup; 3. Displacement driven placement of the insert; 4. Load driven insertion of the insert (maximum push-in force of 500 N). The FE model was evaluated with respect to the radial deformations of the shell and insert as well as the principal stresses in case of the ceramic inserts. The model was experimentally validated via comparison of nominal strains of the titanium shells. Results. The maximum radial deformation of the shell made of PEEK was 581 μm (insertion) and 470 μm (relief) and therefore multiple times higher compared to the Ti6Al4V shell (42 μm and 21 μm). As a result, larger deformations occurred at the PE and ceramic inserts in combination with the PEEK shell. Partially, the deformations were above an usual clearance of 100 μm. When the ceramic insert was combined with the shell made of PEEK, maximum principal stresses in the ceramic insert amounted to 30 MPa and were clearly lower than approved bending strength of the ceramic material (948 MPa). Conclusion. The examined acetabular shell made of PEEK was intensively deformed during insertion compared to the geometrically identical Ti6Al4V shell and is therefore not suitable for modular acetabular cups. In future studies it should be clarified to what extent acetabular cups with shells made of carbon fiber reinforced PEEK materials with higher stiffness lead to reduced deformations during the insertion procedure

Morsellised cortico-cancellous bone (MCB) is used extensively in impaction grafting procedures, such as the filling of cavitory defects on the femoral and acetabular sides during hip arthroplasty. Several experimental studies have attempted to describe the mechanical behaviour of MCB in compression and shear, and it has been found that it’s properties can be improved by washing and rigorous impaction at the time of surgery. However their focus has not been on the development of constitutive models that can be used in computational simulation. The results of serial confined compaction tests are presented and used to develop constitutive models describing the non-linear elasto-plastic behaviour of MCB, as well as its time dependent visco-elastic behaviour. It is found that the elastic modulus, E of MCB increases linearly with applied pressure, p, with E achieving a value of around 30 MPa at a pressure of around 1 MPa. The plastic behaviour of MCB can be described using a Drucker Prager Cap yield criterion, capable of describing yielding of the graft in shear and compression. The time dependent visco-elastic behaviour of MCB can be accurately modelled using a spring and dashpot model that can be numerically expressed using a fourth order Prony series. The role of impaction in reducing subsequent plastic deformation was also investigated. The developed relationships allow the constitutive modelling of MCB in finite element simulations, for example of the acetabular construct following impaction grafting. The relationships also act as a gold standard against which to compare synthetic graft and graft extender materials

There is a critical need for safe innovation in total joint replacements to address the demands of an ageing yet increasingly active population. The development of robust implant designs requires consideration of uncertainties including patient related factors such as bone morphology but also activity related loads and the variability in the surgical procedure itself. Here we present an integrated framework considering these sources of variability and its application to assess the performance of the femoral component of a total hip replacement (THR). The framework offers four key features. To consider variability in bone properties, an automated workflow for establishing statistical shape and intensity models (SSIM) was developed. Here, the inherent relationship between shape and bone density is captured and new meshes of the target bone structures are generated with specific morphology and density distributions. The second key feature is a virtual implantation capability including implant positioning, and bone resection. Implant positioning is performed using automatically identified bone features and flexibly defined rules reflecting surgical variability. Bone resection is performed according to manufacturer guidelines. Virtual implantation then occurs through Boolean operations to remove bone elements contained within the implant's volume. The third feature is the automatic application of loads at muscle attachment points or on the joint contact surfaces defined on the SSIM. The magnitude and orientation of the forces are derived from models of similar morphology for a range of activities from a database of musculoskeletal (MS) loads. The connection to this MS loading model allows the intricate link between morphology and muscle forces to be captured. Importantly, this model of the internal forces provides access to the spectrum of loading conditions across a patient population rather than just typical or average values. The final feature is an environment that allows finite element simulations to be run to assess the mechanics of the bone-implant construct and extract results for e.g. bone strains, interface mechanics and implant stresses. Results are automatically processed and mapped in an anatomically consistent manner and can be further exploited to establish surrogate models for efficient subsequent design optimization. To demonstrate the capability of the framework, it has been applied to the femoral component of a THR. An SSIM was created from 102 segmented femurs capturing the heterogeneous bone density distributions. Cementless femoral stems were positioned such that for the optimal implantation the proximal shaft axis of the femurs coincided with the distal stem axis and the position of the native femoral head centre was restored. Here, the resection did not affect the greater trochanter and the implantations were clinically acceptable for 10000 virtual implantations performed to simulate variability in patient morphology and surgical variation. The MS database was established from musculoskeletal analyses run for a cohort of 17 THR subjects obtaining over 100,000 individual samples of 3D muscle and joint forces. An initial analysis of the mechanical performance in 7 bone-implant constructs showed levels of bone strains and implant stresses in general agreement with the literature

Total Hip Replacement (THR) is one of the most successful operations in all of medicine, however surgeons just rely on their experience and expertise when choosing between cemented or cementless stem, without having any quantitative guidelines. The aim of this project is to provide clinicians with some tools to support in their decision making. A novel method based on bone mineral density (BMD) measurements and assessments was developed 1) to estimate the periprosthetic fracture risk (FR) while press-fitting cementless stem; 2) to evaluate post-operative bone remodeling in terms of BMD changes after primary THR. Data for 5 out of over 70 patients (already involved in a previous study. 1. ) that underwent primary THA in Iceland were selected for developing novel methods to assess intra-operative FR and bone mineral density (BMD) changes after the operation. For each patient three CT images were acquired (Philips Brilliance 64 Spiral-CT, 120 kVp, slice thickness: 1 mm, slice increment: 0.5 mm): pre-op, 24 hours and 1 year post-operative. Pre-op CT scan was used to create 3D finite element model (Materialise Mimics) of the proximal femur. The material properties were assigned based on Hounsfield Units. Different strategies were analyzed for simulating the press-fitting operation, developing what has already been done in prior study. 1. In the finite element simulation (Ansys Workbench), a pressure (related to the implant hammering force of 9.25 kN. 2. ) was applied around the femur's hollow for the stem and the distribution of maximum principal elastic strain over the bone was calculated. Assuming a critical failure value. 3. of 7300 με, the percentage of fractured elements was calculated (i.e. FR). Post 24 hours and Post 1 year CT images were co-registrated and compared (Materialise Mimics) in order to assess BMD changes. Successively, volumes of bone lost and bone gained were calculated and represented in a 3D model. Age and gender should not be taken as unique indicators to choose between implants typologies, since also three dimensional BMD distribution along with volume of cortical bone influence the risk of periprosthetic fractures. Highest FR values were experienced in the calcar-femorale zone and in similar location on the posterior side. BMD loss volume fractions after 1 year were usually higher than BMD gain ones. Consistently with prior studies. 4. , BMD loss was mainly concentrated around the proximal end (lesser trochanter area, outer bone). If present, BMD gain occurred at the distal end (below stem's tip) or proximally (lesser trochanter area, interface contact with the stem). The use of clinical data for BMD assessments serves as an important tool to develop a quantitative method which will support surgeons in their decisions, guiding them to the optimal implant for the patient. Knowing the risk of fracture if choosing a cementless stem and being aware of how the bone will remodel around the stem in one year's time can eventually lead to reduction in revisions and increased quality of life for the patient. Further work will target analysis of a larger cohort of patients and validate FE models

Introduction: Mechanical complications following lumbar fixation are due to the combination of various factors related to morphology, pathology, and surgery. The aim of this study was to provide a patient-specific Finite Element Model of the lumbar spine for the simulation of surgical strategies, and to use it as a predictive tool aiming to detect and reduce preoperatively the risks of mechanical complications. Materials & Methods: A pre-existing 3D personalized FEM of the lumbar spine was used. Posterior implants and main degenerative pathologies were also modelled. After in vitro validation based on 24 specimens and 4 different instrumentations, the model was used to simulate real cases. Applied loads were based on patient characteristics (weight, imbalance). Simulation results included mechanical stresses in the discs and within the implants. Clinical consistency of the simulations was tested through the gathering of clinical data for 66 patients instrumented with lumbo-sacral rigid screw-rod systems. Two subsets were considered: “mechanical successes” (53), and “mechanical failures” (13, including 11 screw breakage and 2 screw loosening). Blind comparison was then performed between these observed clinical outcomes and numerical simulations results. Results & Discussion: Among the 66 patients, simulation results highlighted specific behaviours for 9 patients for which mechanical loads on implants were significantly higher. All of these 9 patients were actual “mechanical failures”. None of the actual “mechanical successes” were associated with “abnormal” simulation results. Conclusion: This is the first time finite element simulations helped predicting 9 failures out of 13 observed among a total of 66 patients. This is a promising step towards the possibility to use FEM as a clinically relevant simulation tool for surgery planning

Introduction. As population grows older, and patients receive primary joint replacements at younger age, more and more patients receive a total hip prosthesis nowadays. Ten-year failure rates of revision hip replacements are estimated at 25.6%. The acetabular component is involved in over 58% of those failures. From the second revision on, the pelvic bone stock is significantly reduced and any standard device proves inadequate in the long term [Villanueva et al. 2008]. To deal with these challenges, a custom approach could prove valuable [Deboer et al. 2007]. Materials and methods. A new and innovative CT-based methodology allows creating a biomechanically justified and defect-filling personalized implant for acetabular revision surgery [Figure 1]. Bone defects are filled with patient-specific porous structures, while thin porous layers at the implant-bone interface facilitate long-term fixation. Pre-operative planning of screw positions and lengths according to patient-specific bone quality allow for optimal fixation and accurate transfer to surgery using jigs. Implant cup orientation is anatomically analyzed for required inclination and anteversion angles. The implant is patient-specifically analyzed for mechanical integrity and interaction with the bone based upon fully individualized muscle modeling and finite element simulation. Results. Ten clinical severe pelvic bone defects, classified Parosky IIIb, have benefited from this methodology so far. Implant outline, thickness, fixation and cup orientation was adapted to the anatomical situation. Stress shielding of the bone was eliminated by taking into account personalized muscle anatomy, bone quality and patient weight while evaluating the design performance. All implants were applied smoothly intra-operatively because of personalized case documentation provided and jig technology for accurate pre-drilling of screw holes. Postoperative imaging showed excellent results. Short term follow-up indicates good outcome for the patients treated, restoring mobility and functionality, and showing solid anchorage to the bone. Conclusion. Complex acetabular bone defects can be treated adequately and efficiently, using a personalized solution which addresses both patient's and surgeon's needs

In recent years 3D preoperative planning has become increasingly popular with orthopaedic surgeons. One technique that has shown to be successful in transferring this preoperative plan to the operating room is based on surgical templates that guide various surgical instruments. Such a patient-specific template is designed using both the 3D reconstructed anatomy and the preoperative plan and is then typically produced via additive manufacturing technology. The combination of a preoperative plan and a surgical template has the potential to result in a more accurate procedure than an unguided one, when the following three criteria are met: the template needs to achieve a stable fit on the surgical field, it needs to fit in a unique position, and the surgeon needs to be able to determine the correct, planned position during the surgery. When the template fails one of these conditions, it can be used incorrectly. Consequently the process could result in an inaccurate outcome. This research focuses on modelling the stability of a surgical template on bone. The relationship between the contact surface of the template and the resulting stability is investigated with a focus on methods to quantify the template stability. The model calculates a quality score on the designed contact surface, which reflects the likelihood of positioning the template on the bone in a stable position. The model used in this study has been experimentally validated to verify its ability to provide a reliable indication of the template stability. This was analysed using finite element analysis where multiple templates and support models with different contact surface shapes were created. The application of forces and moments in varying directions was simulated. Stability is then defined as the ability of a template to resist an applied force or moment. The displacements of the templates were computed and analysed. The results show a minimal displacement of less than 0.01 mm and a maximal displacement larger than 10 mm. The former is considered to be a very stable template design; the latter to be very unstable and hence, would result in an insecure contact. The geometry of the contact surface had a clear influence on the template stability. Overall, the coverage of curvature variations improved the stability of the template. The displacements of the different finite element simulations were used as criterion for ranking the tested template designs according to their stability on their corresponding model surface. This ranking is then compared to that resulting from the quality score of the stability model. Both rankings showed a similar trend. This evaluation phase thus indicates that the developed stability model can be used to predict the stability of a surgical template during the preoperative design process

In biomechanical finite element (FE) simulations, the mechanical nonlinear behaviors must be considered frequently and depend on several properties, such as structural, material, and contact situation. The hexahedral meshes were widely applied to the modeling with the mechanical nonlinearities and can decrease the computer resources and improve the accuracy of the simulations. However, it is quite difficult to construct the three-dimensional hexahedral meshes of complicated shapes such as human joints. This study proposes the development of the semi-automatic meshing technique which consists of only hexahedral elements, thereby reducing the number of elements without spoiling the shape fidelities. In order to create the three-dimensional models of the tibial plateau and femoral condyle, the simply-shaped ‘seed’ models consisting of only hexahedral elements were prepared. The seed meshes were located into the surface of the target bone and expanded until they fitted the target surface. When the seed meshes expanded and intersected with the target surface, the contact condition was detected and the seed surface slide on the target one. These procedures are repeated until the seed meshes filled up inside the complicated target surface. Figure 1 shows the transformed and filled seed meshes inside the surface. The boundary between the cortical and cancellous bone was kept clearly. In the finite element meshes, there was no concentration of elements, and each hexahedral element had the good aspect ratio. Figure 2 shows the impact FE simulation of the TKR joint model, which was constructed by hexahedral elements using this technique. The impact stress propagated cleary through the TKR joint. The number of elements were reduced by a sixth, compared with that of the tetrahedral ones. Because the number of nodes and elements of the model can be defined beforehand, it is easy to predict the scale of the final model. Therefore, this technique is very effective in creating the huge skeltal models which build the complicated biomaterial shapes by the hexahedral elements