In severe cases of total knee arthroplasty which cannot be treated with off-the-shelf implants anymore custom-made knee implants may serve as one of the few remaining options to restore joint function or to prevent limb amputation. Custom-made implants are specifically designed and manufactured for one individual patient in a single-unit production, in which the surgeon is responsible for the implant design characteristics in consultation with the corresponding engineer. The mechanical performance of these custom-made implants is challenging to evaluate due to the unique design characteristics and the limited time until which the implant is needed. Nevertheless, the custom-made implant must comply with clinical and regulatory requirements. The design of custom-made implants is often based on a underlying reference implant with available biomechanical test results and well-known clinical performance. To support surgeons and engineers in their decision whether a specific implant design is suitable, a method is proposed to evaluate its mechanical performance. The method uses finite element analysis (FEA) and comprises six steps: (1) Identification of the main potential failure mechanism and its corresponding FEA quantity of interest. (2) Reproduction of the biomechanical test of the reference implant via FEA. (3) Identification of the maximum value of the corresponding FEA quantity of interest at the required load level. (4) Definition of this value as the acceptance criteria for the FEA of the custom-made implant. (5) Reproduction of the biomechanical test with the custom-made implant via FEA. (6) Conclusion whether the acceptance criteria is fulfilled or not. The method was applied to two exemplary cases of custom-made knee implants. The FEA acceptance criteria derived from the reference implants were fulfilled in both custom-made implants. Subsequent biomechanical tests verified the FEA results. This study suggests and applies a non-destructive and efficient method for pre-clinical testing of a single-unit custom-made knee implant to evaluate whether the design is mechanically suitable

Background. Children suffering from primary bone cancer necessitating resection of growth plates, may suffer progressive leg length discrepancy, which can be attenuated with extendable prostheses. A serious complication is catastrophic implant failure. Over time, bone will remodel, altering the stress pattern in the implant. By using finite element analysis we can model different bone remodeling conditions to ascertain the effect that this will have on stress distribution and magnitude. A finite element analysis was performed. Simplified computer generated models were designed of a cemented femoral Stanmore growing massive endoprosthesis. Three scenarios were designed, modelled on post-operative radiographs. Scenario 1 had a gap between the end of the femur and the implant collar, scenario 2 had no gap, but with no bone attachment into the collar, and scenario 3 had growth of the bone over the length of the collar with attachment. Physiological loading conditions were applied. The resultant stress in the implant for each scenario was measured, and compared to the strength of the material. Peak stresses were recorded at the stem-collar junction. The maximum stress recorded in the implant in scenario 1 was 3104.2Mpa, compared to 1054.4Mpa in scenario 2, and 321.2Mpa in scenario 3. Conclusions. Both accurate reduction and bone growth with attachment to the stem of a massive endoprosthesis will greatly reduce the resultant stress in the implant under loading conditions. The load is redistributed throughout the length of the bone. This may help to prevent catastrophic failure in the implant under loading conditions. Further investigations of patient findings are needed to ensure the model findings are verified. Level of Evidence. IIb (Theoretical)

Introduction and aims. Biomechanical testing has been a cornerstone of the development of surgical implants for fracture stabilisation. To date most fracture surgery implant design and testing has been dominated by the use of standard bench top biomechanical testing. Although such methods have been used to successfully reproduce certain clinical observations, there are very clear limitations. More recently however, computerised engineering technology using finite element analysis (FEA) has been used to research orthopaedic biomechanical testing. This study aims to use FEA technology to further understand proximal femoral fractures, simulating falls, recreating fracture patterns and analyse fracture fixation devices for such fractures. Study design and results. In a multi-disciplinary collaboration, novel clinically relevant models were developed at Swansea University using advanced computational engineering. In-house software (developed initially for commercial aerospace engineering), allowed accurate finite element analysis (FEA) models of the whole femur to be created, including the internal architecture of the bone, by means of linear interpolation of Greyscale images from multiaxial CT scans. This allowed for modeling the changing trabecular structure & bone mineral density in progressive osteoporosis. Falls from standing were modeled in a variety of directions, (with & without muscle action) using analysis programs which resulted in fractures consistent with those seen in clinical practice. By meshing implants into these models and repeating the mechanism of injury in simulation, periprosthetic fractures have been successfully recreated. Discussion. The results highlight significant progress in FEA simulation and biomechanical testing of fractures. Further development with simulated physiological activities (e.g. walking and rising from sitting) along with attrition in the bone (in the boundary zones where stress concentration occurs) will allow further known the modes of failure of tried and tested implants to be reproduced. Robust simulation of macro and micro-scale events will allow the testing of novel new designs in simulations far more complex than conventional biomechanical testing will allow

Abstract. Background. Proximal fibular osteotomy (PFO) was defined to provide a treatment option for knee pain caused by gonarthrosis(1). Minor surgical procedure, low complication rate and dramatic pain relief were the main reasons for popularization of this procedure(2, 3). However, changes at the knee and ankle joint after PFO were not clarified objectively in the literature. Questions/purposes. We asked: 1) Does PFO change the maximum and average pressures at the medial and lateral chondral surface of the tibia plateau? 2) Are chondral surface stresses redistributed at the knee and ankle joint after PFO? 3)Does PFO change the distribution of total load on the knee joint? 4) Can PFO lead to change in alignment of lower limb?. Methods. This study was conducted at Maltepe University Faculty of Medicine Hospital, Orthopedics and Traumatology Department and Yildiz Technical University Mechanical Engineering Department in Istanbul, Turkey, between September 2019 and February 2020. Finite element analysis (FEA) was used to evaluate effects of PFO(4). One 62 years old, female volunteer's X-ray, computer tomography and magnetic resonance imaging images were used for creating right lower limb model. Two different lower limb models were created. One of them was osteotomized model (OM) which was created according to definition of PFO and the other was non-osteotomized model (NOM). To obtain a stress distribution comparison between the two models, 350 N of axial force was applied to the femoral heads of the models. Results. After PFO, the maximum contact pressures at the medial and lateral tibial cartilages decreased 83.2% and 66.9%, respectively at the knee joint. The average contact pressure decreased 26.1% at the medial tibial cartilage and increased 42.4% at the lateral tibial cartilage. The Von Mises stresses decreased 57.1% at the femoral cartilage and decreased 79.1% at tibial cartilage. The stress on the tibial cartilage increased 44.6%, and stress on the talar cartilage increased 7.1% at the ankle joint. Under a 350 N axial force, distribution of the total load at the knee joint was changed and become more homogenous in OM compared to NOM. Change in lower extremity alignment after PFO could not be evaluated with FEA. Conclusion. FEA revealed that PFO causes some changes in knee and ankle joint kinematics. Main loading at the knee joint shifted from medial tibial cartilage to the lateral tibial cartilage after PFO. Additionally, the stresses on each cartilage were redistributed across a wider and more peripheral area. These changes could be the main reason for pain relief at the knee joint. FEA also demonstrated that the Von Mises stresses of the tibial and talar cartilages of the ankle joint increased after PFO. This stress increase may cause long-term arthritic changes in the ankle joint. Level IV; in silico study

Background. Comminuted fractures involving the tibia are associated with a high level of complications including delayed healing and non-union, in conjunction with dramatically increased healthcare costs. Certain clinicians utilise a Pixel Value Ratio (PRV) of 1 to indicate such fracture healing. The subjectivity of this method has led to mixed outcomes including regenerate fracture. The poor prognosis of complex load bearing fractures is accentuated by the fact that no quantitative gold standard currently exists to which clinicians can reference regarding the definition of a healed fracture. The aim of the current study is to use patient specific finite element analysis of complex tibial fractures treated with Ilizarov frames to demonstrate callus maturation and to determine the optimum frame removal time. Methods. 3 patients (2 males, 1 female) were analysed following presentation with complex tibial fractures treated with Ilizarov frames. Patient specific computational analysis was performed according to radiographic data, incorporating maturing material properties to analyse the callus response to weight bearing over the healing timeframe. Computational results were compared to the PVR method to evaluate its efficacy in determining the optimum Ilizarov frame removal time. Results. All fractures were observed to clinically heal at a mean of 25.4 (±2.404) weeks. Following computational analysis however, the mean optimum Ilizarov frame removal time was seen to be 23.5 (±2.323) weeks. When compared with the PVR method, the suggested removal time presented a mean PVR of 1.025 (±0.017). Conclusion. Computational models of patient specific tibial fractures has shown promising correlations with the PVR method and has shown efficacy in predicting callus strength and subsequent optimum frame removal time. Level of Evidence. Level 4

To date, the fixation of proximal humeral fractures with angular stable locking plates is still insufficient with mechanical failure rates of 18% to 35%. The PHILOS plate (DePuy Synthes, Switzerland) is one of the most used implants. However, this plate has not been demonstrated to be optimal; the closely symmetric plate design and the largely heterogeneous bone mineral density (BMD) distribution of the humeral head suggest that the primary implant stability may be improved by optimizing the screw orientations. Finite element (FE) analysis allows testing of various implant configurations repeatedly to find the optimal design. The aim of this study was to evaluate whether computational optimization of the orientation of the PHILOS plate locking screws using a validated FE methodology can improve the predicted primary implant stability. The FE models of nineteen low-density (humeral head BMD range: 73.5 – 139.5 mg/cm3) left proximal humeri of 10 male and 9 female elderly donors (mean ± SD age: 83 ± 8.8 years) were created from high-resolution peripheral computer tomography images (XtremeCT, Scanco Medical, Switzerland), using a previously developed and validated computational osteosynthesis framework. To simulate an unstable mal-reduced 3-part fracture (AO/OTA 11-B3.2), the samples were virtually osteotomized and fixed with the PHILOS plate, using six proximal screws (rows A, B and E) according to the surgical guide. Three physiological loading modes with forces taken from musculoskeletal models (AnyBody, AnyBody Technology A/S, Denmark) were applied. The FE analyses were performed with Abaqus/Standard (Simulia, USA). The average principal compressive strain was evaluated in cylindrical bone regions around the screw tips; since this parameter was shown to be correlated with the experimental number of cycles to screw cut-out failure (R2 = 0.90). In a parametric analysis, the orientation of each of the six proximal screws was varied by steps of 5 in a 5×5 grid, while keeping the screw head positions constant. Unfeasible configurations were discarded. 5280 simulations were performed by repeating the procedure for each sample and loading case. The best screw configuration was defined as the one achieving the largest overall reduction in peri-screw bone strain in comparison with the PHILOS plate. With the final optimized configuration, the angle of each screw could be improved, exhibiting significantly smaller average bone strain around the screw tips (range of reduction: 0.4% – 38.3%, mean ± SD: 18.49% ± 9.56%). The used simulation approach may help to improve the fixation of complex proximal humerus fractures, especially for the target populations of patients at high risk of failure

Summary Statement. An MRI-derived subject-specific finite element model of a knee joint was loaded with subject-specific kinetic data to investigate stress and strain distribution in knee cartilage during the stance phase of gait in-vivo. Introduction. Finite element analysis (FEA) has been widely used to predict the local stress and strain distribution at the tibiofemoral joint to study the effects of ligament injury, meniscus injury and cartilage defects on soft tissue loading under different loading conditions. Previous studies have focused on static FEA of the tibiofemoral joint, with few attempts to conduct subject-specific FEA on the knee during physical activity. In one FEA study utilising subject-specific loading during gait, the knee was simplified by using linear springs to represent ligaments. To address the gap that no studies have performed subject-specific FEA at the tibiofemoral joint with detailed structures, the present study aims to develop a highly detailed subject-specific FE model of knee joint to precisely simulate the stress distribution at knee cartilage during the stance phase of the gait cycle. Method. A detailed three-dimensional model of a healthy human knee was developed from MRI images of a living subject, including the main anatomical structures (bones, all principal ligaments, menisci and articular cartilages). The femur, tibia and fibula were considered as rigid bodies, while the menisci and articular cartilage were modelled as linearly elastic, isotropic and homogeneous while the ligaments were considered to be hyperelastic. Loading and boundary condition assignment was based on the kinematic and kinetic data recorded during gait analysis. Ten time intervals during the stance phase of gait were separately simulated to quantify the time–dependent stress distribution throughout the cycle from heel-strike to toe-off. Loading condition of the tibiofemoral joint varys during the gait cycle since the joint angle changes from extension to flextion, therefore different joint angles at relative time interval were determined to accurately simulate the varing loading condition. Results. The compressive stress and tensile strain distributions in the femoral cartilage, tibia cartilage and menisci of each selected time interval during the stance phase of gait cycle were quantified and corresponded to specific amount of varus/valgus knee moment obtained by inverse dynamics analysis of the kinematic and kinetic data from gait analysis. Therefore a correlation between stress/strain and the frontal movement was established and analysed. For example, at 10% of stance phase, the stress concentration was observed on the lateral compartment due to the valgus moment created at heel strike. At the next interval, the stress concentration shifted to the medial side as the frontal knee moment shifted to a varus orientation. Discussion. The results suggest that the stress distribution of tibiofemoral articular cartilage is qualitatively consistent with the valgus and varus moment observed during the stance phase of gait. The methods described could be applied to investigate the effects of injury and reconstruction on stress distribution within the tibiofemoral joint

Femoro-acetabular impingement involves a deformity of the hip joint and is associated with hip osteoarthritis. Although 15% of the asymptomatic population exhibits a deformity, it is not clear who will develop symptoms. Current diagnostic imaging measures have either low specificity or low sensitivity and do not consider the dynamic nature of impingement during daily activities. The goal of this study is to determine stresses in the cartilage, subchondral bone and labrum of normal and impinging hips during activities such as walking and sitting down.

Quantitative CT scans were obtained of a healthy Control and a participant with a symptomatic femoral cam deformity (‘Bump’). 3D models of the hip were created from automatic segmentation of CT scans. Cartilage layers were added so the articular surface was the mid-line of the joint. Finite element meshes were generated in each region. Bone elastic modulus was assigned element-by-element, calculated from CT intensity converted to bone mineral density using a calibration phantom. Cartilage was modelled as poroelastic, E=0.467 MPa, v=0.167, and permeability 3×10^-16 m⁴/N s. The pelvis was fixed while rotations and contact forces from Bergmann et al. (2001) were applied to the femur over one load cycle for walking and sitting in a chair. All analyses were performed in FEBio.

High shear stresses were seen near the acetabular cartilage-labrum junction in the Bump model, up to 0.12 MPa for walking and were much higher than in the Control.

Patient-specific modelling can be used to assess contact and tissue stresses during different activities to better understand the risk of degeneration in individuals, especially for activities that involve high hip flexion. The high stresses at the cartilage labrum interface could explain so-called bucket-handle tears of the labrum.

Biomechanical analysis is important to evaluate the effect of orthopaedic surgeries. CT-image based finite element method (CT-FEM) is one of the most important techniques in the computational biomechanics field. We have been applied CT-FEM to evaluate resorptive bone remodeling, secondary to stress shielding, after total hip arthroplasty (THA). We compared the equivalent stress and strain energy density to postoperative BMD (bone mineral density) change in the femur after THA, and a significant correlation was observed between the rate of changes in BMD after THA and equivalent stress. For periacetabular osteotomy cases, we investigated mechanical stress in the hip joint before and after surgery. Mechanical stress in the hip joint decreased significantly after osteotomy and correlated with the degree of the acetabular coverage. For arthroscopic osteochondroplasty cases, we examined mechanical strength of the proximal femur after cam resection using CT-FEM. The results suggested that both the depth and area of the resection at the distal part of femoral head-neck junction correlated strongly with fracture risk after osteochondroplasty. This talk consists of our results of clinical application studies using CT-FEM, and importance of application of CT-FEM to biomechanical studies to assess the effect of orthopaedic surgeries.

The annulus fibrosus (AF) of the intervertebral disc (IVD) has a unique, complex structure. If engineered tissues for the IVD are to be successfully developed, it is essential that the constituent level mechanics of the tissues in their natural form are fully understood (Nerurkar, J. Biomech. 2010).

Published finite element (FE) models of the IVD do not represent lamellae behaviour and are validated using bulk mechanics of the intervertebral joint. This study aims to develop models of the IVD that include representation of the lamellae structure of the AF and the behaviour of this tissue within the disc.

Background

Finite element (FE) models are frequently used in biomechanics to predict the behaviour of new implant designs. To increase the stability after severe bone loss tibial components with long stems are used in revision total knee replacements (TKR). A clinically reported complication after revision surgery is the occurrence of pain in the stem-end region. The aim of this analysis was the development of a validated FE-model of a fully cemented implant and to evaluate the effect of different tibial stem orientations.

Introduction

Stemless shoulder implants have recently gained increasing popularity. Advantages include an anatomic reconstruction of the humerus with preservation of bone stock for upcoming revisions. Several implant designs have been introduced over the last years. However, only few studies evaluated the impact of the varying designs on the load transfer and bone remodeling. The aim of this study was to compare the differences between two stemless shoulder implant designs using the micro finite element (µFE) method.

Osteochondral (OC) grafting is one available method currently used to repair full thickness cartilage lesions with good results clinically when grafting occurs in patients with specific positive prognostic factors. However, there is poor understanding of the effect of individual patient and surgical factors. With limited tissue availability, development of Finite Element (FE) models taking into account these variations is essential. The aim of this study was to evaluate the effect of altering the material properties of OC grafts and their host environment through computer simulation.

A generic FE model (ABAQUS CAE 2017) of a push-out test was developed as a press-fit bone cylinder (graft) sliding inside a bone ring (host tissue). Press-fit fixation was simulated using an interference fit. Overlap between host and graft (0.01mm–0.05mm) and coefficient of friction (0.3–0.7) were varied sequentially. Bone Young's moduli (YM) were varied individually between graft and host within the range of otherwise derived tissue moduli (46MPa, 82MPa, 123MPa).

Increasing both overlap and frictional coefficient increased peak dislodging force independently (overlap: 490% & frictional coefficient: 176% across range tested). Increasing bone modulus also increased dislodging force, with host bone modulus (107%, 128%, and 140% increase across range, when Graft YM = 123MPa, 82 MPa, and 46MPa, respectively) having a greater influence than graft modulus (28%, 19% and 10% increase across range, when Host YM = 123 MPa, 82MPa and 46MPa, respectively).

As anticipated increasing overlap and friction caused an increase in force necessary to dislodge the graft. Importantly, differentially changing the graft and host material properties changed the dislodging force indicating that difference between graft and host may be an important factor in the success or failure clinically of osteochondral grafting.

To analyse bone stresses in humerus-megaprosthesis construct in response to axial loading under varying implant lengths in proximal humeral replacement following tumour excision.

CT scans of 10 cadaveric humeri were processed in 3D Slicer to obtain three-dimensional (3D) models of the cortical and cancellous bone. Megaprostheses of varying body lengths (L) were modelled in FreeCAD to obtain the 3D geometry. Four FE models: group A consisting of intact bone; groups B (L=40mm), C (L=100mm) and D (L=120mm) comprising of humerus-megaprosthesis constructs were created. Isotropic linear elastic behaviour was assigned for all materials. A tensile load of 200N was applied to the elbow joint surface with the glenohumeral joint fixed with fully bonded contact interfaces. Static analysis was performed in Abaqus. The bone was divided at every 5% bone length beginning distally. Statistical analysis was performed on maximum von Mises stresses in cortical and cancellous bone across each slice using one-way ANOVA (0-45% bone length) and paired t-tests (45-70% bone length). To quantify extent of stress shielding, average percentage change in stress from intact bone was also computed.

Maximum stress was seen to occur distally and anteriorly above the coronoid fossa. Results indicated statistically significant differences between intact state and shorter megaprostheses relative to longer megaprostheses and proximally between intact and implanted bones. Varying levels of stress shielding were recorded across multiple slices for all megaprosthesis lengths. The degree of stress shielding increased with implant lengthening being 2-4 times in C and D compared to B.

Axial loading of the humerus can occur with direct loading on outstretched upper limbs or indirectly through the elbow. Resultant stress shielding effect predicted in longer megaprosthesis models may become clinically relevant in repetitive axial loading during activities of daily living. It is recommended to use shorter megaprosthesis to prevent failure.

Objectives

Preservation of both anterior and posterior cruciate ligaments in total knee arthroplasty (TKA) can lead to near-normal post-operative joint mechanics and improved knee function. We hypothesised that a patient-specific bicruciate-retaining prosthesis preserves near-normal kinematics better than standard off-the-shelf posterior cruciate-retaining and bicruciate-retaining prostheses in TKA.

Prophylactic treatment is advised for metastatic bone disease patients with a high risk of fracture. Clinicians face the task of identifying these patients with high fracture risk and determining the optimal surgical treatment method. Subject-specific finite element (FE) models can aid in this decision process by predicting the mechanical effect of surgical treatment. In this study, we specifically evaluated the potential of FE models to simulate femoroplasty, as uncertainty remains whether this prophylactic procedure provides sufficient mechanical strengthening to the weight-bearing femur.

In eight pairs of human cadaveric femurs artificial metastatic lesions were created. In each pair, an identical defect was milled in the left and right femur. Four pairs received a spherical lesion in the neck and the other four an ellipsoidal lesion in the intertrochanteric region, each at the medial, superior/lateral, anterior and posterior side, respectively. One femur of each pair was augmented with polymethylmethacrylate (5–10 ml), while the contralateral femur was left untreated. CT scans were made at three different time points: from the unaffected intact femurs, the defect femurs with lesion and the augmented femurs. Bone strength was measured by mechanical testing until failure in eight defect and eight augmented femurs. Nonlinear CT-based FE models were developed and validated against the experimentally measured bone strength. Subsequently, the validated FE model was applied to the available CT scans for the three different cases: intact (16 scans), defect (16) and augmented (8). The FE predicted strength was compared for the three different cases.

The FE models predicted the experimental bone strength with a strong correspondence, both for the defect (R² = 0.97, RMSE= 0.75 kN) and the augmented femurs (R² = 0.90, RMSE = 0.98 kN). Although all lesions had a “moderate” to “high” risk for fracture according to the Mirels’ scoring system (score 7 or 8), three defect femurs did not fracture through the lesion (intertrochanteric anterior, lateral and posterior), indicating that these lesions did not act as a critical weak spot. In accordance with the experimental findings, the FE models indicated almost no reduction in strength between the intact and defect state for these femurs (0.02 ± 0.1%). For the remaining “critical” lesions, bone strength was reduced with 15.7% (± 14.9%) on average. The largest reduction was observed for lesions on the medial side (up to 43.1%). For the femurs with critical lesions, augmentation increased bone strength with 29.5% (± 29.7%) as compared to the defect cases, reaching strength values that were 2.5% (± 3.7%) higher than the intact bone strength.

Our findings demonstrate that FE models can accurately predict the experimental bone strength before and after augmentation, thereby enabling to quantify the mechanical benefit of femoroplasty. This way FE models could aid in identifying suitable patients for whom femoroplasty provides sufficient increase in strength. For all lesions evaluated in this study, femoroplasty effectively restored the initial bone strength. Yet, additional studies on larger datasets with a wide variation of lesion types are required to confirm these results.

Aims

Metaphyseal tritanium cones can be used to manage the tibial bone loss commonly encountered at revision total knee arthroplasty (rTKA). Tibial stems provide additional fixation and are generally used in combination with cones. The aim of this study was to examine the role of the stems in the overall stability of tibial implants when metaphyseal cones are used for rTKA.

In severe cases of total knee & hip arthroplasty, where off-the-shelf implants are not suitable (i.e., in cases with extended bone defects or periprosthetic fractures), 3D-printed custom-made knee & hip revision implants out of titanium or cobalt-chromium alloy represent one of the few remaining clinical treatment options. Design verification and validation of such custom-made implants is very challenging. Therefore, a methodology was developed to support surgeons and engineers in their decision on whether a developed design is suitable for the specific case. A novel method for the pre-clinical testing of 3D-printed custom-made knee implants has been established, which relies on the biomechanical test and finite element analysis (FEA) of a comparable clinically established reference implant. The method comprises different steps, such as identification of the main potential failure mechanism, reproduction of the biomechanical test of the reference implant via FEA, identification of the maximum value of the corresponding FEA quantity of interest at the required load level, definition of this value as the acceptance criterion for the FEA of the custom-made implant, reproduction of the biomechanical test with the custom-made implant via FEA, decision making for realization or re-design based on the acceptance criterion is fulfilled or not. Exemplary cases of custom-made knee & hip implants were evaluated with this new methodology. The FEA acceptance criterion derived from the reference implants was fulfilled in both custom-made implants and subsequent biomechanical tests verified the FEA results. The suggested method allows a quantitative evaluation of the biomechanical properties of custom-made knee & hip implant without performing physical bench testing. This represents an important contribution to achieve a sustainable patient treatment in complex revision total knee & hip arthroplasty with custom-made 3D printed implants in a safe and timely manner

Implant manufacturers develop new products to improve existing fracture fixation methods or to approach new fracture challenges. New implants are commonly tested and approved with respect to their corresponding predecessor products, because the knowledge about the internal forces and moments acting on implants in the human body is unclear. The aim of this study was to evaluate and validate implant internal forces and moments of a complex physiological loading case and translate this to a standard medical device approval test. A finite elements model for a transverse femur shaft fracture (AO/OTA type 32-B2) treated with a locked plate system (AxSOS 3 Ti Waisted Compression Plate Broad, Stryker, Kalamazoo, USA) was developed and experimentally validated. The fractured construct was physiologically loaded by resulting forces on the hip joint from previously measured in-vivo loading experiments (Bergmann et. al). The forces were reduced to a level where the material response in the construct remained linear elastic. Resulting forces, moments and stresses in the implant of the fractured model were analysed and compared to the manufacturers’ approval data. The FE-model accurately predicted the behaviour of the whole construct and the micro motion of the working length of the osteosynthesis. The resulting moment reaction in the working length was 24 Nm at a load of 400 N on the hip. The maximum principle strains on the locking plate were predicted well and did not exceed 1 %. In this study we presented a protocol by the example of locked plated femur shaft fracture to calculate and validate implant internal loading using finite element analysis of a complex loading. This might be a first step to move the basis of development of new implants from experience from previous products to calculation of mechanical behaviour of the implants and therefore, promote further optimization of the implants’ design

Orthopaedic impaction-instruments are used to drive implants into the bone of the patient. Pre-clinical experimental testing protocols and computer models of those are used to assess robustness and functional efficiency of such instruments. This generally involves impaction of the instrument mounted on a substrate that should represent the mechanics of the patient. In this study, the effects of the substrate on stressing of the impaction-instruments were investigated using dynamic finite element analysis. Model results were compared with experimental data from lab protocols, which have been derived to recreate the mechanics of cadaveric implantations, which represent clinical conditions. FEA models of selected experimental protocols were created in which a simplified instrument was impacted on substrates with varying material properties and boundary conditions. After impaction, the instrument settled into a modal vibration which then decayed over time. The resulting axial strain data from the computational model was compared to strain-gauge data collected from experimental measurements. Strain signal amplitude, frequency and decay were compared. The damping-ratio was derived from the decay of the strain signal. The computational model slightly over-predicted the initial experimental strain amplitudes in all cases, but the frequency of the cyclic strain signals matched. However, the model underestimated the experimentally measured rate of signal decay. Inclusion of implant seating and soft-tissue conditions had little effect on decay. Clinical failures of impaction-instruments may be related to multiple fatigue cycles for each impaction and should be modelled accurately to allow failure prediction. Any soft substrate results in an impedance mismatch at the instrument interface, which reflects the pressure wave and causes vibration with a frequency related to the speed-of-sound in the instrument, and its geometry. While this could be accurately modelled computationally, signal decay was underestimated. Further experimental quantification of energy losses will be important to understand vibration decay