Conventional proximal tibial osteotomy is a widely successful joint-preserving treatment for osteoarthritis; however, conventional procedures do not adequately control the posterior tibial slope (PTS). Alterations to PTS can affect knee instability, ligament tensioning, knee kinematics, muscle and joint contact forces as well as range of motion. This study primarily aimed to provide a comprehensive investigation of the variables influencing PTS during high tibial osteotomy using a 3D surgical simulation approach. Secondly, it aimed to provide a simple means of implementing the findings in future 3D pre-operative planning and /or clinically. The influence of two key variables: the gap opening angle and the hinge axis orientation on PTS was investigated using three independent approaches: (1) 3D computational simulation using CAD software to perform virtual osteotomy surgery and simulate the post-operative outcome. (2) Derivation of a closed-form mathematical solution using a generalised vector rotation approach (3) Clinical assessment of synthetically generated x-rays of osteoarthritis patients (n=28; REC reference: 17/HRA/0033, RD&E NHS, UK) for comparison against the theoretical/computational approaches. The results from the computational and analytical assessments agreed precisely. For three different opening angles (6°, 9° and 12°) and 7 different hinge axis orientations (from −30° to 30°), the results obtained were identical. A simple analytical solution for the change in PTS, ΔPs, based on the hinge axis angle, α, and the osteotomy opening angle, θ, was derived: ΔPs=sin-1(sin α sin θ) The clinical assessment demonstrated that the absolute values of PTS, and changes resulting from various osteotomies, matched the results from the two relative prediction methods. This study has demonstrated that PTS is impacted by the hinge axis angle and the extent of the osteotomy opening angle and provided computational evidence and analytical formula for general use.
High tibial osteotomy (HTO) is an effective surgical treatment for isolated medial compartment knee osteoarthritis; however, widespread adoption is limited due to difficulty in achieving the planned correction, and patient dissatisfaction due to soft tissue irritation. A new HTO system – Tailored Osteotomy Knee Alignment (TOKA®, 3D Metal Printing Ltd, Bath, UK) could potentially address these barriers having a custom titanium plate and titanium surgical guides featuring a unique mechanism for precise osteotomy opening as well as saw cutting and drilling guides. The aim of this study was to assess the accuracy of this novel HTO system using cadaveric specimens; a preclinical testing stage ahead of first-in-human surgery according to the ‘IDEAL-D’ framework for device innovation. Local ethics committee approval was obtained. The novel opening wedge HTO procedure was performed on eight cadaver leg specimens. Whole lower limb CT scans pre- and post-operatively provided geometrical assessment quantifying the discrepancy between pre-planned and post-operative measurements for key variables: the gap opening angle and the patient specific surgical instrumentation positioning and rotation - assessed using the implanted plate. The average discrepancy between the pre-operative plan and the post-operative osteotomy correction angle was: 0.0 ± 0.2°. The R2 value for the regression correlation was 0.95. The average error in implant positioning was −0.4 ± 4.3 mm, −2.6 ± 3.4 mm and 3.1 ± 1.7° vertically, horizontally, and rotationally respectively. This novel HTO surgery has greater accuracy and smaller variability in correction angle achieved compared to that reported for conventional or other patient specific methods with published data available. This system could potentially improve the accuracy and reliability of osteotomy correction angles achieved surgically.
High tibial osteotomy for knee realignment is effective at relieving symptoms of knee osteoarthritis but the operation is surgically challenging. A new personalised treatment with simpler surgery using pre-operatively planned measurements from computed tomography (CT) imaging and 3D-printed implants and instrumentation has been designed and is undergoing clinical trial. The aim of this study was to evaluate the early clinical results of a preliminary pilot study evaluating the safety of this new personalised treatment. The single-centre prospective clinical trial is ongoing (IRCCS Istituto Ortopedico Rizzoli; IRB-0013355; ClinicalTrials.gov NCT04574570), with recruitment completed and all patients having received the novel custom surgical treatment. To preserve the completeness of the trial reporting, only surgical aspects were evaluated in the present study. Specifically, the length of the implanted osteosynthesis screws was considered, being determined pre-operatively eliminating intraoperative measurements, and examined post-operatively (n=7) using CT image processing (ScanIP, Synopsys) and surface distance mapping. The surgical time, patient discharge date and ease of wound closure were recorded for all patients (n=25).Abstract
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Methods
Additive manufacturing has led to numerous innovations in orthopaedic surgery: surgical guides; surface coatings/textures; and custom implants. Most contemporary implants are made from titanium alloy (Ti-6Al-4V). Despite being widely available industrially and clinically, there is little published information on the performance of this 3D printed material for orthopaedic devices with respect to regulatory approval. The aim of this study was to document the mechanical, chemical and biological properties of selective laser sintering (SLS) manufactured specimens following medical device (TOKA®, 3D Metal Printing LTD, UK) submission and review by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). All specimens were additively manufactured in Ti-6Al-4V ELI (Renishaw plc, UK). Mechanical tests were performed according to ISO6892-1, ISO9585 and ISO12107 for tensile (n=10), bending (n=3) and fatigue (n=16) respectively (University of Bath, UK). Appropriate chemical characterisation and biological tests were selected according to recommendations in ISO10993 and conducted by external laboratories (Wickham Labs, UK; Lucideon, UK; Edwards Analytical, UK) in adherence with Good Lab Practise guidelines. A toxicological review was conducted on the findings (Bibra, UK).Abstract
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Ultra-High Molecular Weight Polyethylene (UHMWPE) can be made radiopaque through the diffusion of an oil-based contrast agent (Lipiodol Ultra-fluid). A similar process is used for Vitamin E incorporated polyethylene, which has a well-established clinical history. This study aimed to quantify the leaching of Lipiodol and compare to vitamin E polyethylene. GUR 1050 polyethylene (4 mm thickness) was cut into squares, 10 mm2. Samples (n=5) were immersed in 25 ml Lipiodol (Guerbet, France), or 15 ml Vitamin E (L-atocopherol, Sigma-Aldrich, UK). To facilitate diffusion, samples were held at 105°C for 18 hours. After treatment, all samples were immersed in DMEM (Sigma-Aldrich, UK) with Penicillin Streptomycin (Sigma-Aldrich, Kent, UK) at 4%v/v and held at 37°C in an incubator. Untreated polyethylene samples were included as controls. Leaching was quantified gravimetrically at weeks 2, 4 and 8. The radiopacity of the Lipiodol-diffused samples was investigated from µCT images (162kV, resolution 0.2 mm, X Tec, XT H 225 ST, Nikon Metrology, UK).Abstract
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Oil-based fluids can be used to enhance the properties of polyethylene materials. For example, vitamin E infused polyethylene has a superior oxidation resistance and Lipiodol infused polyethylene has an enhanced X-ray attenuation. The aim of this study was to evaluate the long-term influence of oily fluid on the chemical, physical and tensile properties of polyethylene. An accelerated ageing procedure (an elevated temperature (80°C) for four weeks in air1) was used to investigate the oxidative stability (ASTM F2012-17)2, tensile (ISO 527)3 and thermal properties4 of oil treated polyethylene (n=5, GUR 1050, Celanese, Germany)and compared with clinically used polyethylene controls (oil-free standard and thermally treated polyethylene). All the experiments were performed on aged and unaged specimens in accordance to international standards and compared to currently available literature. A Kruskal-Wallis test was performed using a custom MATLAB code (R2017a, USA); with p < 0.05 considered statistically significant.Abstract
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Cervical spine fractures are frequent in impact sports, such as rugby union. The consequences of these fractures can be devastating as they can lead to paraplegia, tetraplegia and death. Many studies have been conducted to understand the injury mechanisms but the relationship between player cervical spine posture and fracture pattern is still unclear. The aim of this study was to evaluate the influence of player cervical spine posture on fracture pattern due to an impact load. Nineteen porcine cervical spines (C2 to C6) were dissected, potted in PMMA bone cement and mounted in a custom made rig. They were impacted with a mean load of 6 kN. Eight specimens were tested in an axial position, five in flexion and six in lateral bending. All specimens were micro-CT imaged (Nikon XT225 ST Scanner, Nikon Metrology, UK) before and after the tests, and the images were used to assess the fracture patterns. The injuries were classified according to Allen-Ferguson classification system by three independent observers. The preliminary results showed that the main fracture modalities were consistent with those seen clinically. The main fractures for the axial orientation were observed in C5-C6 level with fractures on the articular process and endplates. These findings support the concept that the fracture patterns are related to the spine position and give an insight for improvements on sports rules in order to reduce the risk of injury.
The screw fastening torque applied during bone fracture fixation has a decisive influence on subsequent bone healing. Insufficient screw tightness can result in device/construct instability; conversely, excessive torques risk damaging the bone causing premature fixation failure. This effect is even more prominent in osteoporotic bone, a condition associated annually with almost 9 million fractures worldwide. During fracture fixation, screw tightening torque is applied using subjective feel. This approach may not be optimal for patient”s recovery, increasing risk of fixation failure, particularly in osteoporotic bone, and potentially require revision surgical interventions. Besides bone density, various factors influence the performance of screw fixation. These factors include bone geometry, cortical thickness and time-dependant relaxation behaviour of the bone. If the influence of screw fastening torque on the bone and relationships between these factors was better understood, the surgical technique could be optimised to reduce the risk of complications. Within this study, we developed an axisymmetric finite element (FE) model of bone screw tightening incorporating viscoelastic behaviour of the cortical bone such as creep and stress relaxation. The model anticipated time-dependent behaviour of the bone for different bone thickness and density after a typical bone fixation screw had been inserted. The idealised model has been developed based on CT scans of bones with varying densities and inserted screws. The model was validated through a series of experiments involving bovine tibiae (4–5 months) to evaluate the evolution of surface strains with time (Ncorr v1.2). Stress distribution was assessed in photoelastic experiments using acrylic analogues. Relaxation tests have been performed in aqueous environment for up to 48 hours to ensure the relaxation would be complete. The creep behaviour (maximum principal strain) was compared against computational predictions. Our early simulations predicted relaxation strains on the surface of the bone to be 1.1% within 24 hours comparing favourably to 1.3% measured experimentally. Stress distribution patterns were in agreement with photoelastic results. Using experimentally derived viscoelastic properties, the model has the potential to predict creep and stress relaxation patterns after screw insertion with different fastening torques for bones with varying density and geometry. We aim to develop this into a planning tool providing guidance to surgeons for optimal tightening when using screw fixation, particularly in reduced quality bone.
A large proportion of the expense incurred due to hip fractures arises due to secondary factors such as duration of hospital stay and additional theatre time due to surgical complications. Studies have shown that the use of intramedullary (IM) nail fixation presents a statistically higher risk of re-fracture than plating, which has been attributed to the stress riser at the end of the nail. It is not clear, however, if this situation also applies to unstable fractures, for which plating has a higher fixation failure rate. Moreover, biomechanical studies to date have not considered newer designs of IM nails which have been specifically designed to better distribute weight-bearing loads. This aim of this experimental study was to evaluate the re-fracture risk produced by a newer type of nailing system compared to an equivalent plate. Experimental testing was conducted using fourth generation Sawbones composite femurs and X-Bolt IM hip nail (n=4) and fracture plate (n=4) implants. An unstable pertrochanteric fracture pattern was used (AO classification: 31-A1 / 31-A2). Loading was applied along the peak loading vector experienced during walking, up to a maximum load of 500N. The risk of re-fracture was evaluated from equivalent strains measured using four rosette strain gauges on the surface of the bone at known stress riser locations.Background
Methods
Numerical modelling using Finite Element (FE) Analysis has become ubiquitous in orthopaedic biomechanics, with both commercial and freely available packages widely used. Three FE packages in particular have gained popularity: Abaqus (Simulia); Ansys (ANSYS, Inc.) and FEBio (University of Utah). Although FEBio is now well established, its developers advise that comparisons should be made against more extensively tested software before trusting its results for specific problems. The aim of the study to conduct a comparison of mesh convergence and to provide validated open-source models of the femur for use all three FE packages. Three-dimensional FE models of the femur were created in Abaqus. To ensure that all aspects of the models were identical, custom scripts were developed to import the models into other packages. Mesh convergence studies were conducted for each solver using seven mesh densities for linear tetrahedral elements (up to 2 million). Experimental validation used fourth generation Sawbones composite femurs (n=8) with surface strains measured at four locations. The loading applied at the hip was the averaged peak joint reaction force during walking (Bergman et al); experimentally, this loading vector was used for a reduced load of 500N.Background
Methods
Understanding vertebral fracture is important in order to reduce fracture risk. Previous studies have used FE to investigate mechanical behaviour, typically using a linear material response. This study aimed to establish a novel model that could represent the plastic behaviour leading to fracture. Porcine vertebrae were mCT scanned and they were loaded to failure in a material test machine (Instron 5965). The specimens were then rescanned. From the first scan, specimen specific FE models were created (ScanIP, Simpleware, UK). Mesh convergence was studied and tetrahedral elements with an approximate element size of 0.7 were used for computational simulations. The relationship between greyscale values (GS) and Young's modulus (E) was optimised to match the experimental load displacement data using Ansys. Further, a plastic material response was modelled.Background
Method
Femoral head collapse is a possible complication after surgical treatment of femoral neck fractures. The purpose of this study was to examine whether implantation of a Sliding Hip Screw (SHS) or an X-Bolt could increase the risk of femoral head collapse. Similar to traditional hip screws, the X-Bolt is implanted through the femoral neck; however, it uses an expanding cross-shape to improve rotational stability. The risk of collapse was investigated alongside patient factors, such as osteonecrosis. This numerical study assessed the risk of femoral head collapse using linear eigenvalue buckling (an established method [1]), and also from the maximum von Mises stress within the cortical bone. The femoral head was loaded using the pressures reported by Yoshida
Osteonecrosis, modelled as a cone of bone of varying angle, and varying modulus values Cortical thinning Reduced cortical modulus Femoral head size Twenty-two finite element models were run for each implant condition (intact; implanted with the X-Bolt; implanted with a SHS), resulting in a total of 66 models. The finite element models were validated using experimental tests performed on five 4th generation composite Sawbones femurs (Malmö, Sweden), and verified against previously published results [1]. No significant difference was found between the X-Bolt and the SHS, for either critical buckling pressure ( The study by Volokh
Using Python scripting it is possible to automate the pre-processing, solving and post-processing stages of finite element analysis using ABAQUS software. This is particularly useful when running multiple models parametrically. When the model involves a bony part, it is necessary to assign material properties based on the CT scan to represent bone heterogeneity, and unfortunately this cannot currently be done from within ABAQUS using software such as Bonemat [1]. To address this issue a Python package was written called ‘py_bonemat_abaqus’ to assign material properties from within ABAQUS. The purpose of this study was to compare the material assignments of py_bonemat_abaqus and Bonemat, to compare the processing speed, and to describe the workflow. The software packages were compared using a CT scan of a half pelvis downloaded from the VAKHUM database, and the associated hexahedral finite element mesh of the left half pelvis. To examine different element types, the hexahedral mesh was converted to linear and quadratic tetrahedral elements by dividing each hexahedron into 5 tetrahedral elements. The equations used to convert the Hounsfield Unit ( Equation 1: Equation 2 The time taken to analyse the models by each software was assessed using a Windows 7 PC with a 64-bit operating system, 4 CPUS, 8 GB of RAM and an Intel Core I5-3470 processor. The mean difference between the moduulus assignment made by py_bonemat_abaqus and Bonemat was −0.05 kPa (range −10.19 to 4.50 kPa, standard deviation 0.62 kPa). The Python package took a similar time to run for all element types; this was between 109 and 126 s. Bonemat software was significantly faster, and took between 5 and 20 s. Finally, the Python package was successfully used from within a Python script to perform material assignment from within ABAQUS software in a fully automated manner. Material assignments were almost equivalent between the two software packages, with any differences explainable by rounding effects. To put the differences into context, a difference of −0.05 kPa is 0.00000002% of the typical modulus of cortical bone (20.7 GPa), and 0.00000003% of the modulus of trabecular bone (14.8 GPa) [3]. The Python package was slower to process the models, but was successfully able to assign material properties from within ABAQUS software as part of an automated script.
The mechanical properties of porcine tibial plateau (TP) cartilage are shown to vary topographically. Low Elastic moduli (Em) were found in the positions where unicompartimental knee osteoarthritis (OA) lesions are typically expected to develop. These results suggest that there is a different response to load in these areas. OA is one of the ten most disabling diseases in developed countries. OA of the knee, in particular, is a major cause of mobility impairment; up to 40% of the population over the age of 70 suffers from OA of the knee. It has been observed that unicompartmental knee OA occurs with very distinct and repeatable lesion patterns. It is hypothesised that these patterns are the result of differences in the material properties throughout articular cartilage. The aim of this study was to measure the mechanical properties of porcine cartilage in a whole undamaged TP.Summary
Introduction
The required torque leading to an abrasion of the passive layer in the stem-head interface positively correlates to the assembly force. In order to limit the risk of fretting and corrosion a strong hammer blow seems to be necessary. Modular hip prostheses are commonly used in orthopaedic surgery and offer a taper connection between stem and ball head. Taper connections are exposed to high bending loads and bear the risk of fretting and corrosion, as observed in clinical applications. This is particularly a problem for large diameter metal bearings as the negative effects may be enhanced due to the higher moments within the taper connection. Currently, it is not known how much torque is required to initiate a removal of the passive layer, which might lead to corrosion over a longer period and limits the lifetime of prostheses. Therefore, the purpose of this study was to identify the amount of torque required to start an abrasion of the passive layer within the interface dependent on the assembly force and the axial load.Summary
Introduction
Simulated increases in body weight led to increased displacement, von Mises stress, and contact pressure in finite element models of the extended and flexed knee. Contact shifted to locations of typical medial osteoarthritis lesions in the extended knee models. Obesity is commonly associated with increased risk of osteoarthritis (OA). The effects of increases in body weight and other loads on the stresses and strains within a joint can be calculated using finite element (FE) models. The specific effects for different individuals can be calculated using subject-specific FE models which take individual geometry and forces into account. Model results can then be used to propose mechanisms by which damage within the joint may initiate.Summary Statement
Introduction
Technical skill is an essential domain of surgical competency. Arthroscopic surgery forms a particularly challenging subset of these skills. The innate ability to acquire these skills is not fully understood. The aim of this study was to investigate the innate arthroscopic skills and learning curve patterns of medical students - our future surgeons. Two arthroscopic tasks (one shoulder and one knee) were set up in a bioskills laboratory to represent core skills required for arthroscopic training. Twenty medical students with no previous arthroscopic surgery experience were recruited and their performance assessed whilst undertaking each task on 30 occasions. The primary outcome variable was success or failure. Individuals were assessed as ‘competent’ if they stabilised their learning curve within 20 episodes. The secondary outcome measure was an objective assessment of technical dexterity using a validated Motion Analysis system (time taken to complete tasks, total path length of the subject's hands, and number of hand movements).Background
Methods
The ability to learn arthroscopic surgery is an important aspect of modern day orthopaedic surgery. Knowing that variation in innate ability exists amongst medical students, the aim of this study was to investigate the effect of training on the arthroscopic surgical performance of our future orthopaedic surgeons (medical students). Two arthroscopic tasks (one shoulder and one knee) were set up in a bioskills laboratory to represent core skills required for arthroscopic training. Thirty three medical students with no previous arthroscopic surgery experience were randomised to a ‘Trained’ (n=16) and ‘Non-trained’ (n=17) cohort. Both groups watched an instructional video. The Trained cohort also received specific training on the tasks prior to their first episode. Thirty episodes of each task were then undertaken. The primary outcome variable was success or failure. Individuals were assessed as ‘competent’ if they stabilised their learning curve within 20 episodes. The secondary outcome measure was an objective assessment of technical dexterity using a validated Motion Analysis system (time taken to complete tasks, total path length of the subject's hands, and number of hand movements).Background
Methods
In pre-operative planning for total hip arthroplasty (THA), femoral offset (FO) is frequently underestimated on AP pelvis radiographs as a result of inaccurate patient positioning, imprecise magnification, and radiographic beam divergence. The aim of the present study was to evaluate the reliability and accuracy of predicting three-dimensional (3-D) FO as measured on computed tomography (CT) from measurements performed on standardised AP pelvis radiographs. In a retrospective cohort study, pre-operative AP pelvis radiographs and corresponding CT scans of a consecutive series of 345 patients (345 hips, 146 males, 199 females, mean age 60 (range: 40-79) years, mean body-mass-index 27 (range: 29-57) kg/m2) with primary end-stage hip osteoarthritis were reviewed. Patients were positioned according to a standardised protocol and all images were calibrated. Using validated custom programmes, FO was measured on corresponding AP pelvis radiographs and CT scans. Inter- and intra-observer reliability of the measurement methods were evaluated using intra-class correlation coefficients (ICC). To predict 3-D FO from AP pelvis measurements, the entire cohort was randomly split in two groups and gender specific linear regression equations were derived from a subgroup of 250 patients (group A). The accuracy of the derived prediction equations was subsequently assessed in a second subgroup of 100 patients (group B). In the entire cohort, mean FO was 39.2mm (95%CI: 38.5-40.0mm) on AP pelvis radiographs and 44.6mm (95%CI: 44.0-45.2mm) on CT scans. FO was underestimated by 14% on AP pelvis radiographs compared to CT (5.4mm, 95%CI: 4.8-6.0mm, p<0.001) and both parameters demonstrated a linear correlation (r=0.642, p<0.001). In group B, we observed no significant difference between gender specific predicted FO (males: 48.0mm, 95%CI: 47.1-48.8mm; females: 42.0mm, 95%CI: 41.1-42.8mm) and FO as measured on CT (males: 47.7mm, 95%CI: 46.1-49.4mm, p=0.689; females: 41.6mm, 95%CI: 40.3-43.0mm, p=0.607). The results of the present study suggest that femoral offset can be accurately and reliably predicted from AP pelvis radiographs in patients with primary end-stage hip osteoarthritis. Our findings support the surgeon in pre-operative templating and may improve offset and limb length restoration in THA without the routine performance of CT.
In uncemented total hip arthroplasty (THA), the optimal femoral component should allow both maximum cortical contact with proximal load transfer and accurate restoration of individual joint biomechanics. This is often compromised due to a high variability in proximal femoral anatomy. The aim of this on-going study is to assess the variation in proximal femoral canal shape and its association with geometric and anthropometric parameters in primary hip OA. In a retrospective cohort study, AP-pelvis radiographs of 98 consecutive patients (42 males, 56 females, mean age 61 (range:45-74) years, BMI 27.4 (range:20.3-44.6) kg/m2) who underwent THA for primary hip OA were reviewed. All radiographs were calibrated and femoral offset (FO) and neck-shaft-angle (NSA) were measured using a validated custom programme. Point-based active shape modelling (ASM) was performed to assess the shape of the inner cortex of the proximal femoral meta- and diaphysis. Independent shape modes were identified using principal component analysis (PCA). Hierarchical cluster analysis of the shape modes was performed to identify natural groupings of patients. Differences in geometric measures of the proximal femur (FO, NSA) and demographic parameters (age, height, weight, BMI) between the clusters were evaluated using Kruskal-Wallis one-way-ANOVA or Chi-square tests, as appropriate. In the entire cohort, mean FO was 39.0 mm, mean NSA was 131 degrees. PCA identified 10 independent shape modes accounting for over 90% of variation in proximal femoral canal shape within the dataset. Cluster Analysis revealed 6 shape clusters for which all 10 shape modes demonstrated a significantly different distribution (p-range:0.000-0.015). We observed significant differences in age (p=0.032), FO (p<0.001) and NSA (p<0.001) between the clusters. No significant differences with regard to gender or BMI were seen. Our preliminary analysis has identified 6 different patterns of proximal femoral canal shape which are associated with significant differences in femoral offset, neck-shaft-angle and age at time of surgery. We are currently evaluating the entire dataset of 345 patients which will allow a comprehensive classification of variation in proximal femoral shape and joint geometry. The present data may optimise preoperative planning and improve future implant design in THA.
