Introduction. Functional outcomes of mechanically aligned (MA) total knee arthroplasty have plateaued. The aim of this study is to find an alternative technique for implant positioning that improves functional outcomes of TKA. Methods. We prospectively randomized 100 consecutive patients undergoing TKA into two groups: in the group A an intramedullary femoral guide and an extramedullary tibial guide were used with aim to obtain a neutral traditional mechanical alignment; in the group B an extramedullary femoral guide set on distal femoral condyles and an extramedullary tibial guide neutrally aligned were used to obtain an adaptation of the conventional MA technique. Patients were followed-up clinically with the Short Form Health Survey (SF-12), Oxford Knee Score (OKS) and Visual Analogue Score (VAS) questionnaires pre-operatively and then at 1 year post-operatively. Mechanical alignment was calculated on standing weight bearing Xray pre- and post-operatively. T-test was used to compare the results between groups. Results. Both groups showed an improvement of clinical scores. At 1 year of follow-up OKS and SF-12 were significantly higher in group B: 47,6 ±0.75 and 46.5 ±0.76 respectively; VAS was similar in both groups. Values of mechanical alignment changed from 6.45 ±8.45 to 0.25 ±0.91 for group A and from 6.8 ±7.94 to 2.5 ±4.7 for group B. Conclusion. This study shows that adjusted mechanical alignment (AMA) with a small under-correction of frontal deformity lead to improved functional scores following total knee replacement compared to conventional technique of neutral alignment. These results are satisfactory at short follow-up but long-term studies are needed to evaluate the difference in the rate of wear of the prosthetic components

Introduction. Low dose technology of an EOS scanner allows mechanical axis radiographs to be produced using a continuously moving x-ray emitting a thin beam to form a single image which includes all three joints, without the need for stitching. The aim of this study was to identify necessary improvements to enable effective interpretation of the radiographs, and to assess whether the quality of the radiographs varied by production method compared to a previous audit of CR and DR radiographs. Materials and Methods. 8 domains were identified based on a previous audit using the acronym MECHANIC each defining the qualities required for a radiograph to meet the criteria. 100 mechanical axis radiographs produced using conventional and digital methods were analysed in the original study to assess how many radiographs met the described criteria. The same criteria were amended and used to assess 123 different mechanical axis radiographs in the follow up study following the introduction of the EOS scanner, in which 77 were produced using EOS and 46 were produced using conventional and digital methods. Results. The second study showed improvement in 2 of the 6 domains being assessed and the result remained the same in 1 domain, with a mean change of +2%. There was a large increase in the number of radiographs with impeccable stitching in the second study due to the use of the EOS scanner. When comparing the methods of production, there were a greater percentage of EOS radiographs meeting the criteria for each domain compared to conventional and digital radiographs. Those produced using the EOS scanner had a mean 0.83% more radiographs meeting the criteria per domain. Conclusions. The overall quality of mechanical axis radiographs being produced has increased, but varies largely between the 6 domains. The EOS produced radiographs overall were of a greater quality than those produced using conventional and digital methods, but still had areas which required significant improvement

Introduction. According to American Joint Replacement Registry, particle mediated osteolysis represents 13 % of the knee revision surgeries performed in the United States. The comprehension of mechanical and wear properties of materials envisioned for TJR is a key step in product development. Furthermore, the maintenance of UHMWPE mechanical properties after material modification is an important aspect of material success. Initial studies conducted by our research group demonstrated that the incorporation of ibuprofen in UHMWPE had a minor impact on UHMWPE physicochemical and mechanical properties. Drug release was also evaluated and resulted in an interesting profile as a material to be used as an anti-inflammatory system. Therefore, the present study investigated the effect of drug release on the mechanical and biological properties of ibuprofen-loaded UHMWPE. Experimental. UHMWPE resin GUR 1020 from Ticona was for sample preparation. Samples with drug concentrations of 3% and 5% wt were consolidated as well as samples without anti-inflammatory addition through compression molding at 150 °C and 5 MPa for 15 minutes. Mechanical properties were evaluated via the tensile strength experiment (ASTM D638) and dynamic mechanic tests. Wear resistance was measured using the pin on disc (POD) apparatus. Finally, cytotoxicity analysis was conducted based on ISO 10993–5. Results. Dynamic-mechanic analysis demonstrated no difference in flexion modulus and stress for all materials (Table 1). No difference was also verified during cyclical loading experiments (Table 1), which indicates that the drug concentration added to material composition did not affect these properties. POD experiments were proposed to evaluate wear resistance of ibuprofen-loaded UHMWPE samples considering the combination of materials similar to those employed in TJR. Results from POD tests are presented in Table 1. Volumetric wear was close to zero for all samples after 200 thousand cycles. Comprehension of the effect of drug release on mechanical properties is essential to estimate how the material will behave after implantation. Therefore, mechanical properties were assessed after 30 days of ibuprofen release and the results were compared with those obtained in samples as prepared (Table 2). Initial results demonstrated a decrease in elastic modulus in samples prepared with ibuprofen. However, no difference was verified between UHMWPE, UHMWPE 3% IBU and UHMWPE 5% IBU after ibuprofen release. Finally, cell viability of UHMWPE 3% IBU and UHMWPE 5% was found to be superior to 100% (Figure 1). Therefore, both materials can be considered nontoxic. Conclusions. Ibuprofen-loaded UHMWPE did not demonstrate a significant influence on the mechanical and biological behavior of UHMWPE. Dynamic-mechanical tests demonstrated constancy for all samples under analysis. Wear testing resulted in gravimetric wear close to zero, for all tested materials. Mechanical properties conducted after 30 days of ibuprofen release also had a positive outcome. Although presenting a difference in modulus prior and after release tests, modulus and tensile yield stress remained inside acceptable range indicated to UHMWPE used in orthopedic implants. Furthermore, after drug elution UHMWPE 3% IBU and UHMWPE 5% IBU recovered original UHMWPE properties. Cytotoxicity assessment was performed and both ibuprofen-based formulations were considered nontoxic according to ISO 10993–5. For any figures or tables, please contact the authors directly

Introduction. Knee dislocations, vascular injuries and floating knee injuries can be initially managed by a external fixator. Fixator design constructs include the AO pattern and the Diamond pattern. However, these traditional constructs do not adhere to basic principles of external fixation. The Manchester pattern knee-spanning external fixator is a new construct pattern, which uses beam loading and multiplanar fixation. There is no data on any construct pattern. This study compares the stability of these designs. Materials & Methods. Hoffman III (Stryker, USA) external fixation constructs were applied to articulated models of the lower limb, spanning the knee with a diamond pattern and a Manchester pattern. The stiffness was loaded both statically and cyclically with a Bose 3510 Electroforce mechanical testing jig (TA Instruments). A ramp to load test was performed initially and cyclical loading for measurement of stiffness over the test period. The results were analysed with a paired t-test and ANOVA. Results. The mean stiffness with the diamond pattern fixator was significantly less stiff than the Manchester pattern fixator – by a factor of 3 (40N/mm vs 115N/mm). Displacement increased in all patterns over simulated loading equating to six weeks. The diamond pattern demonstrated a 50%% increase in displacement over time. The Manchester pattern demonstrated only 20% increase in displacement over time. These are all statistically significant (p<0.01). Conclusions. The aim of an external fixator in knee dislocations and vascular injuries is to provide stability, prevent displacement and protect repairs. Vascular injuries often require fixation for several weeks to protect a repair. The Manchester pattern, applying the principles of external fixation, provides a stiffer construct and also confers greater stability over the time a fixator may be required. We commend this more informed design for the management of knee dislocations and vascular injuries

Intervertebral disc (IVD) degeneration plays a major role in low back pain which is the leading cause of disability. Current treatments in severe cases require surgical intervention often leading to adjacent segment degeneration. Injectable hydrogels have received much attention in recent years as scaffolds for seeding cells to replenish disc cellularity and restore disc properties and function. However, they generally present poor mechanical properties. In this study, we investigated several novel thermosensitive chitosan hydrogels for their ability to mimic the mechanical properties of the nucleus pulposus (NP) while being able to sustain the viability of NP cells, and retain proteoglycans. CH hydrogels were prepared by mixing the acidic chitosan solution (2% w/v) with various combinations of three gelling agents: sodium hydrogen carbonate (SHC) and/or beta-glycerophosphate (BGP) and/or phosphate buffer (PB) (either BGP0.4M, SHC0.075M-BGP0.1M, SHC0.075M-PB0.02M or SHC0.075M-PB0.04M). The gelation speed was assessed by following rheological properties within 1h at 37°C (strain 5% and 1Hz). The mechanical properties were characterized and compared with that of human NP tissues. Elastic properties of the hydrogels were studied by evaluating the secant modulus in unconfined compression. Equilibrium modulus was also measured, using an incremental stress-relaxation test 24h after gelation in unconfined compression (5% strain at 5%/s followed by 5min relaxation, five steps). Cells from bovine IVD were encapsulated in CH-based gels and maintained in culture for 14 days. Cytocompatibility was assessed by measuring cell viability, metabolism and DNA content. Glycosaminoglycan (GAG) synthesis (retained in the gel and released) was determined using DMMB assay. Finally injectability was tested using human cadaveric discs. Unconfined compression confirmed drastically enhanced mechanical properties compared to conventional CH-BGP hydrogels (secant Young modulus of 105 kPa for SHC0.075PB0.02 versus 3–6 kPa for BGP0.04). More importantly, SHC0.075PB0.02 and SHC0.075BGP0.1 hydrogels exhibited mechanical properties very similar to NP tissue. For instance, equilibrium modulus was 5.2±0.6 KPa for SHC0.075PB0.02 and 8±0.8 KPa for SHC0.075BGP0.1 compared to 6.1±1.7 KPa for human NP tissue. Rheological properties and gelation time (G′=G″ after less than 15 s at 37°C, and rapid increase of G') of these hydrogels also appear to be adapted to this application. Cell survival was greater than 80% in SHC0.075BGP0.1 and SHC0.075PB0.02 hydrogels. Cells encapsulated in the new formulations also showed significantly higher metabolic activity and DNA content after 14 days of incubation compared to cells encapsulated in BGP0.4 hydrogel. Cells encapsulated in SHC0.075BGP0.1 and SHC0.075PB0.02 produced significantly higher amounts of glycosaminoglycans (GAG) compared to cells encapsulated in SHC0.075PB0.04 and BGP0.4 hydrogels. The total amount of GAG was higher in SHC0.075BGP0.1 hydrogel compared to SHC0.075PB0.02. Interestingly, both the SHC0.075BGP0.1 and SHC0.075PB0.02 hydrogels retained similar amounts of GAG. Injectability through a 25G syringe, filling of nuclear clefts and good retention in human degenerated discs was demonstrated for SHC0.075PB0.02 hydrogel. SHC0.075BGP0.1 appears to be a particularly promising injectable scaffold for IVD repair by providing suitable structural environment for cell survival, ECM production and mechanical properties very similar to that of NP tissue

The meniscus is comprised largely of type I collagen, as well as fibrochondrocytes and proteoglycans. In articular cartilage and intervertebral disc, proteoglycans make a significant contribution to mechanical stiffness of the tissue via negatively charged moieties which generate Donnan osmotic pressures. To date, such a role for proteoglycans in meniscal tissue has not been established. This study aimed to investigate whether meniscal proteoglycans contribute to mechanical stiffness of the tissue via electrostatic effects. Following local University Ethics Committee approval, discs of meniscal tissue two millimetres thick and of five millimetres diameter were obtained from 12 paired fresh frozen human menisci, from donors < 6 5 years of age, with no history of osteoarthritis or meniscal injury. Samples were taken from anterior, middle and posterior meniscal regions. Each disc was placed within a custom confined compression chamber, permeable at the top and bottom only and then bathed in one of three solutions − 0.14M PBS (mimics cellular environment), deionised water (negates effect of mobile ions) or 3M PBS (negates all ionic effects). The apparatus was mounted within a Bose Electroforce 3100 materials testing machine and a 0.3N preload was applied. The sample was allowed to reach equilibrium, before being subjected to a 10% ramp compressive strain followed by a 7200 second hold phase. Equal numbers of samples from each meniscus and meniscal region were tested in each solution. Resultant stress relaxation curves were fitted to a nonlinear poroviscoelastic model with strain dependent permeability using FEBio finite element modelling software. Goodness of fit (R2) was assessed using a coefficient of determination. All samples were assayed for proteoglycan content. Comparison of resultant mechanical parameters was undertaken using multivariate ANOVA with Bonferroni adjustment for multiple comparisons. 36 samples were tested. A significant difference (p < 0 .05) was observed in the value of the Young's modulus (E) between samples tested in deionised water compared to 0.14M/3M PBS, with the meniscus found to be stiffest in deionised water (E = 1.15 MPa) and least stiff in 3M PBS (E = 0.43 MPa), with the value of E in 0.14M PBS falling in between (0.68 MPa). No differences were observed in the zero strain permeability or the exponential strain dependent/stiffening coefficients. The viscoelastic coefficient and relaxation time values were not found to improve model fit and were thus held at zero. The mean R2 value was 0.78, indicating a good fit and did not differ significantly between solutions. Proteoglycan content was not found to differ with solution, but was found to be significantly increased in the middle region of both menisci. Proteoglycans make a significant electrostatic contribution to mechanical stiffness of the meniscus, increasing it by 58% in the physiological condition, and are hence integral to its function. It is important to include the influence of ionic effects when modelling meniscus, particularly where fluid flow or localised strain is modelled. From a clinical perspective, it is critical that meniscal regeneration strategies such as scaffolds or allografts attempt to preserve, or compensate for, the function of proteoglycans to ensure normal meniscal function

Tendinopathy is one of the most common orthopaedic pathological conditions characterized by tendon degenerative changes. Excessive mechanical loading is considered as a major causative factor in the development of tendinopathy, but the mechanisms of pathogenesis remain unclear. High mobility group box-1 (HMGB1), a potent inflammatory mediator when released into the matrix, has been identified in the early stage tendinopathy patients. Since the release and contribution of HMGB1 in tendinopathy development due to mechanical overloading is unknown, we investigated the role of HMGB1 in tendinopathy using a mouse intensive treadmill running (ITR) model and injection of glycyrrhizin (GL), a specific inhibitor of HMGB1. A total of 48 mice were divided into four groups, Cage Control group: The animals were allowed to move freely in their cage, GL group: The animals were received daily IP injection of GL (50 mg/kg body weight) for 24 weeks, ITR group: The animals ran on treadmill at 15 meters/min for three h/ day, five days a week for 12 or 24 weeks, GL+ITR group: The animals ran the same protocol as that of ITR group plus daily IP injection of GL for 12 or 24 weeks. Six mice/group were sacrificed at 12 or 24 weeks and the Achilles and patellar tendon tissues were harvested and used for histochemical staining and immunostaining. Mechanical overloading induced HMGB1 released from the cell nuclei to the matrix (Fig. 1a, b) caused tendon inflammation (Fig. 1c, d) and led to tendon degenerative changes (Fig. 1e-j). After 12 weeks of ITR, the tendon tissue near the bone insertion site showed typical tendinopathic changes in cell shape, accumulation of glycosaminoglycans (GAG) (Fig. 1e, f), and increase in SOX-9 staining (Fig. 1g-j). After 24 weeks ITR, the distal site of Achilles tendon showed considerable changes in cell shape (Fig. 2A, g, arrows), which is round compared to more elongated in the control and GL groups (Fig. 2A, e, f). However, daily treatment with GL prior to ITR blocked the cell shape change (Fig. 2A, h) and, ITR induced extensive GAG accumulation in ITR group (Fig. 2B, bottom panel). Furthermore, GL inhibited ITR-induced expression of chondrogenic markers (SOX-9 and collagen II) in the tendons (Fig. 3). Our results showed that mechanical overloading-induced HMGB1 plays a critical role in the development of tendinopathy by initiating tendon inflammation and eventual degeneration characterized by the presence of chondrocyte-like cells, accumulation of proteoglycans, high levels of collagen type II production, and chondrogenic marker SOX-9 expression. These results provide the first evidence for the role of HMGB1 as a therapeutic target to prevent tendinopathy before its onset and block further development at its early inflammation stages. The inhibition of tendinopathy development by GL administration in this study also suggests the putative therapeutic potential of this natural triterpene that is already in clinical use to treat other inflammation-related diseases. For any figures or tables, please contact authors directly

A common location for radius fracture is the proximal radial head. With the arm in neutral position, the fracture usually happens in the anterolateral quadrant (Lacheta et al., 2019). If traditional surgeries are not enough to induce bone stabilization and vascularization, or the fracture can be defined grade III or grade IV (Mason classification), a radial head prosthesis can be the optimal compromise between bone saving and recovering the “terrible triad”. A commercially available design of radial head prosthesis such as Antea (Adler Ortho, Milan, Italy) is characterized by flexibility in selecting the best matching size for patients and induced osteointegration thanks to the Ti-Por. ®. radial stem realized by 3D printing with laser technique (Figure 1). As demonstrated, Ti-Por. ®. push-out resistance increased 45% between 8 −12 weeks after implantation, hence confirming the ideal bone-osteointegration. Additional features of Antea are: bipolarity, modularity, TiN coating, radiolucency, hypoallergenic, 10° self-aligning. The osteointegration is of paramount importance for radius, in fact the literature is unfortunately reporting several clinical cases for which the fracture of the prosthesis happened after bone-resorption. Even if related to an uncommon activity, the combination of mechanical resistance provided by the prosthesis and the stabilization due to the osteointegration should cover also accidental movements. Based upon Lacheta et al. (2019), after axial compression-load until radii failure, all native specimens survived a compression-load of 500N, while the failure happened for a mean compression force of 2560N. The aim of this research study was to test the mechanical resistance of a radial head prosthesis obtained by 3D printing. In detail, a finite element analysis (FEA) was used to understand the mechanical resistance of the core of the prosthesis and the potential bone fracture induced in the radius with simulated bone- resorption (Figure 2a). The critical level was estimated at the height for which the thickness of the core is the minimum (Figure 2b). Considered boundary conditions:. - Full-length prosthesis plus radius out of the cement block equal to 60mm (Figure 2a);. - Bone inside the cement equal to 60mm (Figure 2b);. - Load inclined 10° epiphysiary component (Figure 2c);. - Radius with physiological or osteoporotic bone conditions;. - Load (concentrated in the sphere simulating full transmission from the articulation) of 500N or 1300N or 2560N. Figure 3 shows the results in terms of maximum stress on the core of the prosthesis and the risk of fracture (Schileo et al., 2008). According to the obtained results, the radial head prosthesis shows promising mechanical resistance despite of the simulated bone-resorption for all applied loads except for 2560N. The estimated mechanical limit for the material in use is 200MPa. The risk of fracture is in agreement with the experimental findings (Lacheta et al. (2019)), in fact bone starts to fail for the minimum reported failure load, but only for osteoporotic conditions. The presented FEA aimed at investigating the behavior of a femoral head prostheses made by 3D printing with simulated bone-resorption. The prosthesis shows to be a skilled solution even during accidental loads. For any figures or tables, please contact the authors directly

INTRODUCTION. Avascular necrosis (AVN) of the femoral head (FH) initiates from biological disruptions in the bone and may progress to mechanical failure of the hip. Mechanical and structural properties of AVN bone have not been widely reported, however such understanding is important when designing therapies for AVN. Brown et al.[1] assessed mechanical properties of different regions of AVN FH bone and reported 52% reduction in yield strength and 72% reduction in elastic modulus of necrotic regions when compared to non-necrotic bone. This study aimed to characterise structural and mechanical properties of FH bone with AVN and understand the relationship between lesion volume and associated mechanical properties. METHODS. Twenty FH specimens from patients undergoing hip arthroplasty for AVN and six non-pathological cadaveric FH controls were collected. Samples were computed tomography scanned and images analysed for percentage lesion volume with respect to FH volume. Samples were further divided for structural and mechanical testing. The mechanical property group were further processed to remove 9mm cylindrical bone plugs from the load bearing and non-load-bearing regions of the FHs. FH and bone plug samples were tested in compression (1mm/min); elastic modulus and yield stress were calculated. RESULTS. Imaging. Individual lesion size within AVN FHs varied: multiple small lesions or small numbers of large lesions were present in all FHs. Mean lesion volume percentage for AVN FHs was significantly greater than control FHs (p30% total FH volume. Structural Properties: The mean elastic modulus for AVN FHs was 15% lower than that of control FHs and mean yield stress was 4% lower than that of control FHs, however this difference was not significant. Mechanical Properties. The mean elastic modulus and yield stress of bone plugs from the load-bearing regions of AVN FHs were significantly lower than those of control samples (79% and 77% respectively; p<0.05, Kruskal-Wallis), however, for non-load-bearing samples, mean elastic modulus and yield stress of AVN FHs were significantly higher than control samples (by 153% and 123% respectively; p<0.05, Kruskal-Wallis). DISCUSSION. Although mechanical properties of bone in load-bearing regions of AVN FHs were significantly less than those of control FHs, replicating previous findings by Brown et al. (1981, CORR. 156, 240-7), mechanical properties in the non-load bearing regions were increased. This may be due to adaptation of the non-load bearing region to support loads following AVN in normally load bearing regions, or due to the presence of denser sclerotic tissue. In this study, necrotic bone samples demonstrated smaller changes in mechanical properties in the load-bearing region with respect to those regions in the control samples than previously reported by Brown et al.. This may be due to differences in experimental methods (e.g. patient demographics, quality of control bone samples, loading rate, and location of samples) or due to the disease stage of the AVN FHs from which tissues were taken. In addition, this study has demonstrated that necrotic lesions are not consistent in quantity, size and location

INTRODUCTION. Mechanical loosening of total hip replacement (THR) is primarily diagnosed using radiographs, which are diagnostically challenging and require review by experienced radiologists and orthopaedic surgeons. Automated tools that assist less-experienced clinicians and mitigate human error can reduce the risk of missed or delayed diagnosis. Thus the purposes of this study were to: 1) develop an automated tool to detect mechanical loosening of THR by training a deep convolutional neural network (CNN) using THR x-rays, and 2) visualize the CNN training process to interpret how it functions. METHODS. A retrospective study was conducted using previously collected imaging data at a single institution with IRB approval. Twenty-three patients with cementless primary THR who underwent revision surgery due to mechanical loosening (either with a loose stem and/or a loose acetabular component) had their hip x-rays evaluated immediately prior to their revision surgery (32 “loose” x-rays). A comparison group was comprised of 23 patients who underwent primary cementless THR surgery with x-rays immediately after their primary surgery (31 “not loose” x-rays). Fig. 1 shows examples of “not loose” and “loose” THR x-ray. DenseNet201-CNN was utilized by swapping the top layer with a binary classifier using 90:10 split-validation [1]. Pre-trained CNN on ImageNet [2] and not pre-trained CNN (initial zero weights) were implemented to compare the results. Saliency maps were implemented to indicate the importance of each pixel of a given x-ray on the CNN's performance [3]. RESULTS. Fig. 2 shows the saliency maps for an example x-ray and the corresponding accuracy of the CNN on the entire validation dataset at different stages of the training for both pre-trained (Fig. 2a) and not pre-trained (Fig. 2b) CNNs. Colored regions in the saliency maps, where red denotes higher relative influence than blue, indicate the most influential regions on the CNN's performance. Pre-trained CNN achieved higher accuracy (87%) on the validation set x-rays than not pre-trained CNN (62%) after 10 epochs. The pre-trained CNN's saliency map at 10 epochs identified significant influence of bone-implant interaction regions on the CNN's performance. This indicates that the CNN is ‘looking’ at the clinically relevant features in the x-rays. The saliency maps also demonstrated that the pre-trained CNN quickly learned where to ‘look’, while the not pre-trained CNN struggles. DISCUSSION. An automated tool to detect mechanical loosening of THR was developed that can potentially assist clinicians with accurate diagnosis. By visualizing the influential regions of the x-ray on the CNN performance, this study shed light into CNN learning process and demonstrated that CNN is ‘looking’ at the clinically relevant features to classify the x-rays. This visualization is crucial to build trust in the automated system by interpreting how it functions to increase the confidence in the application of artificial intelligence to the field of orthopaedics. This study also demonstrated that pre-training CNN can accelerate the learning process and achieve high accuracy even on a small dataset. For any figures or tables, please contact the authors directly

Aseptic loosening is the most common cause of failure in load bearing orthopaedic implants. This is most often attributed to stress shielding, which is caused by a mismatch in mechanical properties between the implant and bone, predominantly stiffness. The implant causes a redistribution of the forces through the bone leading to localised tissue resorption in low stress areas and over time loosening of the implant. To address this, the implant design may be modified to introduce porous structures that reduced overall stiffness. Conventional methods of creating porous structures include the space holder method and gas foaming, although these allow control of the pore size and volume fraction, the position of the voids is random and potentially non-uniform, creating unpredictable mechanical properties. Using additive manufacture predictable porous lattice structures can be built. Two methods for creating lattice structure are explored here: controlled stochastic lattices, and layers of repeating unit cells. Due to the predictable nature of these design methods the mechanical properties can be tailored to suit the needs of the implants. In addition to mechanical optimisation the porous lattice structures can be optimised for osseointegration properties. The ability of the tissue to grow into the implant are affected by; the size of the pores, how interconnected the pores are, the overall void fraction (porosity), the shape and roughness of the pores, and whether the structure is coated. Although additive manufacture allows great design freedoms, there are also some manufacturing constraints to consider including resolution which is determined by powder and laser spot size, and strut angle since these cannot be too close to horizontal or they will collapse during the build unless supported. This preliminary work uses Finite Element Analysis to model the compressive properties of lattice structures with different design parameters, with the intention to optimise for mechanical, osseointegration and manufacturability properties. Cylinders of the lattice structures were generated in Simpleware ScanIP (Synopsys, Exeter, UK) and their compression was modelled in Ansys Workbench 18.2 (Canonsburg, PA, USA) in accordance with ISO 13314. Stress distributions for each lattice structure were produced which showed the stochastic lattice did not undergo banded deformation unlike the repeating unit cell based lattices. Future work will physically test the lattices and feed that data back into the model for further optimisation. Other relevant mechanical testing will be modelled and performed in order to choose the optimal lattice design for future implants

No, Neutral mechanical axis has never been regarded as “necessary” to the success of TKA. In fact it has never been established as “ideal” with published data. Tibial femoral alignment after TKA is important, but it is also an issue that we do not understand completely. Neutral mechanical alignment refers to the relationship between the mechanical axes of the femur and tibia as shown on full length radiographs. “Neutral” means that these axes are collinear, i.e. that a line may be drawn from the center of the hip to the center of the ankle and it will intersect the center of the knee joint. The allure of the “straight line” has led many surgeons to regard a neutral mechanical axis as “perfection” for TKA surgery, but indeed, it is not the usual “normal” alignment for most human knees, nor is it the target for many conventional knee replacements. The “neutral mechanical axis” represents OVERCORRECTION for most knees. Moreland demonstrated in 1987 that few human knee joints are naturally aligned “in neutral”, but with the line from center of hip to center of ankle passing through the medial compartment. This tendency to relative varus mechanical axis in most human knees was corroborated by Bellemans et al in 2012. They substituted the word “constitutional varus” for what would otherwise be known as “normal alignment”. In general, patients with pathologic or significant varus alignment, whose arthroplasties have been performed competently, are at greatest risk for failure by wear, osteolysis and loosening. This is the prototypical failure mechanism that pre-occupied the surgeons responsible for making knee arthroplasty successful in the 1970s. The first paper to identify varus TKA alignment and failure due to loosening was Lotke and Ecker in 1977. They worked from short radiographs and ushered in an era of careful attention to valgus TKA alignment-not neutral alignment. Correction of varus deformity combined with ligament balancing was probably responsible for making condylar type knee arthroplasties work durably in the early days. Full length radiographs, used by Kennedy and White in 1987 to study alignment in unicompartmental arthroplasties, provide a more sophisticated method of evaluating knee alignment. These studies must be aligned with correct rotation to be valid. Computerised navigation was probably responsible for some surgeon's dedication to the neutral mechanical axis. The study of Parratte et al from Mayo has received much attention and argued that a neutral mechanical axis did NOT improve success rates at 15 years. It should be noted that these TKA's were expertly performed and even the less well-aligned cases were not “excessively” malaligned. This study does not state that alignment is irrelevant to the success of TKA, but rather that a range of alignments (with stability) might be expected to produce a durable arthroplasty. Concurrent with these developments has been an interest in “under-correcting” knee deformity or allowing osseous anatomy (with compensation for cartilage loss) guide component position. In truth, it is inaccurate to describe conventional “align and balance” techniques as necessarily seeking a neutral mechanical axis. Most classical alignment techniques do, however, alter the angle of component position from the original articular surface angles and theoretically may not function as well with the native soft tissue environment. Surgeons who would align the TKA identically to the arthritic knee may credit previous generations with improving the technology such that this is a possibility. If every patient is to be aligned with this technique, however, this suggests that soft tissue pathology does not exist. As with all complex issues, glib answers are to be avoided and deep analysis is appropriate

Abstract. Background. Conventional TKR aims for neutral mechanical alignment which may result in a smaller lateral distal femoral condyle resection than the implant thickness. We aim to explore the mismatch between implant thickness and bone resection using 3D planning software used for Patient Specific Instrumentation (PSI) TKR. Methods. This is a retrospective anatomical study from pre-operative MRI 3D models for PSI TKR. Cartilage mapping allowed us to recreate the native anatomy, enabling us to quantify the mismatch between the distal lateral femoral condyle resection and the implant thickness. Results. We modelled 292 knees from PSI TKR performed between 2012 and 2015. There were 225 varus knees and 67 valgus knees, with mean supine hip-knee-angle of 5.6±3.1 degrees and 3.6±4.6 degrees, respectively. In varus knees, the mean cartilage loss from medial and lateral femoral condyle was 2.3±0.7mm and 1.1±0.8mm respectively; the mean overstuffing of the lateral condyle 1.9±2.2mm. In valgus knees, the mean cartilage loss from medial and lateral condyle was 1.4±0.8mm and 1.5±0.9mm respectively; the mean overstuffing of the lateral condyle was 4.1±1.9mm. Conclusions. Neutral alignment TKR often results in overstuffing of the lateral condyle. This may increase the patello-femoral pressure at the lateral facet in flexion. Anterior knee pain may be persistent even after patellar resurfacing due to tight lateral retinacular structures. An alternative method of alignment such as anatomic alignment may minimise this problem

Introduction. Mechanical property relationships used in the computational modeling of bones are most often derived using mechanical testing of normal cadaveric bone. However, a significant percentage of patients undergoing joint arthroplasties exhibit some form of pathologic bone disease, such as osteoarthritis. As such, the objective of this study was to compare the micro-architecture and apparent modulus (E. app. ) of humeral trabecular bone in normal cadaveric specimens and bone extracted from patients undergoing total shoulder arthroplasty. Methods. Micro-CT scans were acquired at 20 µm spatial resolution for humeral heads from non-pathologic cadavers (n=12) and patients undergoing total shoulder arthroplasty (n=10). Virtual cylindrical cores were extracted along the medial-lateral direction. Custom-code was used to generate micro finite element models (µFEMs) with hexahedral elements. Each µFEM was assigned either a homogeneous tissue modulus of 20 GPa or a heterogeneous tissue modulus scaled by CT- intensity. Simulated compression to 0.5% apparent strain was performed in the medial-lateral direction. Morphometric parameters and apparent modulus-bone volume fraction relationships were compared between groups. Results. Comparing morphometric parameters, arthroplasty patients had significantly larger bone volume fractions (p = .023) and mean trabecular separation (p = .031), but no significant differences in mean trabecular thickness (p = .060) or trabecular number (p = .178). Variations were observed in the fit curves between normal and arthroplasty cases, with normal bone being best fit by power relationships, and arthroplasty bone exhibiting a more linear relationship. There was no significant difference in mean apparent modulus for homogeneous tissue moduli (p = .060) but was a significant difference for heterogeneous tissue moduli (p = .038). DISCUSSION. Consistent with previously developed relationships that map apparent mechanical properties, normal cadaveric bone was best fit by a power relationship with an exponential coefficient over 2. However, the apparent modulus- volume fraction relationship in the arthroplasty patient bone exhibited a more linear relationship. These results suggest that the architectural and mechanical properties of normal cadaveric and arthroplasty patient trabecular bone are not equal. Since these relationships are used to map apparent mechanical properties to computational models, these preliminary results suggest that relationships derived from cadaveric normal bone may map the apparent mechanical properties differently than patients who undergo arthroplasty. Additional samples added to this dataset will allow for mechanical property relationships to be developed that account for these bone mechanical property variations. This has the potential to greatly improve the computational modeling of patients undergoing arthroplasty procedures and computational models that are used to design and improve shoulder arthroplasty components

Pre-operative knowledge. Knowledge-based total hip arthroplasty is becoming increasingly recognised for improved safety, efficiency, and accuracy. Pre-operative knowledge of native and planned femoral anteversion, the exact size of implants, neck length and offset, and head lengths can serve to safely accelerate surgery and reduce the need for intra-operative imaging. Pre-operative knowledge of the effect on change in leg length and offset effected by specific implant combinations can serve to minimise undesired changes. The use of a smart mechanical navigation tool superimposed on this knowledge, can serve to easily and swiftly achieve optimal component position. Cost savings. Economic data from Q1 2013 to Q2 2016 demonstrate that CMS-insured patients treated by knowledge-based surgery using the HipXpert mechanical navigation system combined with the superior hip approach have the lowest cost of all patients treated in Massachusetts by an average of more than $7,000 over 90 days for Medicare Part A expenditure (HipXpert System, Surgical Planning Associates, Boston, MA). The data show that these combined techniques outpace all other technology/technique combinations including robotics. Accuracy. The system has been proven to be robust, with repeated studies showing accurate cup placement in 100% of cases including an independent study. This compares to a recent study of robotic methods that showed only 88% accuracy in inclination and 84% for anteversion. Summary. Knowledge-based surgery with smart mechanical navigation has shown the potential to accelerate surgery, improve safety, lower cost and facilitate recovery

Purpose. Recently, kinematic aligned total knee arthroplasty (TKA) has gained interest for achieving better clinical outcomes over mechanical aligned TKA. The primary goal of kinematic aligned TKA is to position the femoral and tibial components so that the angles and levels of the distal and posterior femoral joint lines and the tibial joint line are each restored to the patient's natural alignment, and not to a neutral limb alignment that is unnatural for most patients. Despite good clinical outcomes reported at short to mid-term follow-up, surgeons should know reasons why this method is useful and safe surgery and carefully assess the long-term outcomes until this new technique is settled as standardized procedure for TKA. The main purpose of the present study was to compare postoperative radiography and clinical scores following kinematic and mechanical aligned TKA. Methods. Sixty TKAs—30 kinematic and 30 mechanical aligned—were performed in patients with varus-type osteoarthritis using a navigation system. Using postoperative double-leg and single-leg standing long leg radiographs, joint line orientation angle to the floor, conventional mechanical axis (cMA), and true mechanical axis (tMA; line from hip center to the lowest point of calcaneus) were compared between the two groups. One-year after surgeries, range of motion and the patient-derived score of the 2011 Knee Society Score (2011 KSS), which includes four categories: symptoms, patient satisfaction, patient expectations, and functional activities, e.g., walking/standing, standard activities, advanced activities, and discretionary activities, were compared between the two groups. Results. Joint line orientation angles were 1.3 ±1.8 ° varus in the kinematic and 3.2 ± 2.7° valgus in the mechanical group with double-leg standing condition (p<0.05), which were shifted to 0.7 ± 1.7° valgus and 4.3 ± 1.9° valgus with single-leg standing condition, respectively. In double-leg standing condition, cMAs passed through 43.8 ± 10.2 % in the kinematic and 48.7 ± 7.6 % in the mechanical group (p<0.05), which were shifted to 49.2 ± 12.2 % and 53.7 ± 7.5 % in tMA assessment, respectively. Postoperative flexion angle was significantly better in kinematic aligned TKA compared with mechanical aligned TKA (121.7±9.1 vs. 117.3±14.8, p<0.05). Among 4 contents of 2011 KSS, only functional activity score showed better results in the kinematic group compared with the mechanical group (p<0.05). Conclusions. Kinematic aligned TKA exhibited parallel joint line to the floor during single and double-leg standing and neutral weight-bearing in tMA when compared with mechanical aligned TKA, which might result in better functional score

Restoring the overall mechanical alignment to neutral has been the gold standard since the 1970s and remains the current standard of knee arthroplasty today. Recently, there has been renewed interest in alternative alignment goals that place implants in a more “physiologic” position with the hope of improving clinical outcomes. Anywhere from 10 – 20% of patients are dissatisfied after knee replacement surgery and while the cause is multifactorial, some believe that it is related to changing native alignment and an oblique joint line (the concept of constitutional varus) to a single target of mechanical neutral alignment. In addition, recent studies have challenged the long held belief that total knee placed outside the classic “safe zone” of +/− 3 degrees increases the risk of mechanical failure which theoretically supports investigating alternative, more patient specific, alignment targets. From a biomechanical, implant retrieval, and clinical outcomes perspective, mechanical alignment should remain the gold standard for TKA. Varus tibias regardless of overall alignment pattern show increased polyethylene wear and varus loading increases the risk of posteromedial collapse. While recently questioned, the evidence states that alignment does matter. When you combine contemporary knee designs placed in varus with an overweight population (which is the majority of TKA patients) the failure rate increases exponentially when compared to neutral alignment. A recent meta-analysis on mechanical alignment and survivorship clearly demonstrated reduced survivorship for varus-aligned total knees. The only way to justify the biomechanical risks associated with placing components in an alternative alignment target is a significant clinical outcome benefit but the evidence is lacking. A randomised control trial comparing mechanical alignment (MA) and kinematic alignment (KA) found a significant improvement in clinical outcomes and knee function in KA patients at 2 year follow-up. In contrast, Young et al. recently published a randomised control trial comparing PSI KA and computer assisted mechanical TKA and found no difference in any clinical outcome measure. Why were the clinical outcomes scores in the MA patients so different: One potential explanation is that different surgical techniques were used. In the Dosset study, the femur was cut at 5 degrees valgus in all patients and femoral component rotation was always set at 3 degrees externally rotated to the posterior condylar axis. We know from several studies that this method leads to inaccuracies in both coronal plane and axial plane in some patients. Young et al. used computer assisted navigation to align his distal femur cut with the mechanical axis and adjusted femoral component rotation to the transepicondylar axis. The results suggest that a well performed mechanical aligned total knee replacement has excellent clinical performance equal to that of kinematic alignment without any of the long term risks of implant failure. Most contemporary TKA implants are designed to be loaded perpendicular to the polyethylene surface and placing them in shear without extensive biomechanical testing to support this alignment target may put patients at long term risk for an unproven benefit. Have we not learned our lesson?

Background. Defining optimal coronal alignment in Total Knee Replacement (TKR) is a controversial and poorly understood subject. Tibial bone density may affect implant stability and functional outcomes following TKR. Our aim was to compare the bone density profile at the implant-tibia interface following TKR in mechanical versus kinematic alignment. Methods. Pre-operative CT scans for 10 patients undergoing medial unicompartmental knee arthroplasty were obtained. Using surgical planning software, tibial cuts were made for TKR with 7 degrees posterior slope and either neutral (mechanical) or 3 degrees varus (kinematic) alignment. Signal intensity, in Hounsfield Units (HU), was measured at 25,600 points throughout an axial slice at the implant-tibia interface and density profiles compared along defined radial axes from the centre of the tibia towards the cortices (Hotelling's t-squared and paired t-test). Results. From the tibial centre towards the lateral cortex, trabecular bone density for kinematic and mechanical TKR are similar in the inner 50% but differ significantly beyond this (p= 0.012). There were two distinct density peaks, with peak trabecular bone density being higher in kinematic TKR (p<0.001) and peak cortical bone density being higher in mechanical TKR (p<0.01). The difference in peak cortical to peak trabecular signal was 43 HU and 185 HU respectively (p<0.001). On the medial side there was no significant difference in density profile and a linear increase from centre to cortex. Conclusions. In the lateral proximal tibia, there is significantly less difference between peak cortical and peak trabecular bone densities in kinematic TKR compared to mechanical TKR. Laterally, mechanical TKR may be more dependent upon cortical bone for support compared to kinematic TKR, where trabecular bone density is higher. This may have implications for surgical planning and implant design

Low back pain is more common in women than men, yet most studies of intervertebral disc (IVD) degeneration do not address sex differences. In humans, there are sex differences in spinal anatomy and degenerative changes in biomechanics, and animal models of chronic pain have demonstrated sex differences in pain transduction. However, there are few studies investigating sex differences in annular puncture IVD degeneration models. IVD puncture is known to result in progressive biomechanical alterations, but whether these IVD changes correlate with pain is unknown. This study used a rat IVD injury model to determine if sex differences exist in mechanical allodynia, biomechanics, and the relationship between them, six weeks after IVD injury. Procedures were IACUC approved. 24 male & 24 female four-month-old Sprague-Dawley rats underwent a sham or annular puncture injury surgery (n=12 male, 12 female). In injury groups, three lumbar IVDs were each punctured three times with a needle, and injected with tumor necrosis factor-alpha. Mechanical allodynia was tested biweekly using von Frey filaments. Six weeks after IVD injury, rats were euthanized and motion segments were dissected for non-destructive axial tension-compression and torsional rotation biomechanical testing. Two-way ANOVA with Bonferroni corrections identified statistically significant differences (p < 0 .05) and correlations used Pearson's coefficient. Annular puncture injury induced a significant increase in mechanical allodynia compared to sham in male but not female rats up to six weeks after injury. There was a significant sex effect on both torque range and torsional stiffness, with males exhibiting greater stiffness and torque range than females. Tensile stiffness, compressive stiffness, and axial range of motion showed no sex difference. Males and females showed similar patterns of correlation between variables when sham and injury groups were analyzed together, but correlations were stronger in males. Most correlations were clustered within testing approach: axial biomechanics negatively correlated, torsional biomechanics positively correlated, and von Frey thresholds positively correlated. Surprisingly, mechanical allodynia did not correlate with any biomechanics after injury, and the axial and torsional biomechanics showed little correlation. This study demonstrates that males and females respond to IVD injury differently. Given the absence of correlation between pain and biomechanics, pain cannot be attributed completely to biomechanical changes. This may explain why spinal fusion surgery, an intervention limited to the spine, has produced inconsistent results and is controversial for patients with low back pain. Thus, in addressing low back pain, we must consider both spinal tissues and the nervous system. Further, the limited correlation between axial and torsional biomechanics indicates that IVD injury may have distinct effects on nucleus pulposus and annulus fibrosus. Biomechanics did not differ between sham and injury at week six, suggesting healing after injury. It remains possible that acute biomechanical changes may initiate chronic pain pathogenesis. We conclude that the observed sex differences demonstrate the need for inclusion of both males and females in IVD injury and pain studies, and suggest that males and females may require different treatments for conditions that appear similar

Background. Tigecycline, the first member of glycylcycline family, has effective antimicrobial activity against resistant and implant associated infectious organisms. The objectives of this study are to assess the compressive and tensile mechanical strength characteristics of tigecycline loaded bone cement and to compare them with vancomycin and daptomycin loaded bone cements which are used in prosthetic joint infections with resistant microorganisms. Methods. A control group without antibiotics and three antibiotic loaded bone cement groups with varying concentrations (1g, 2g and 3g vancomycin, 0.5g, 1g and 1.5g daptomycin and 50mg, 100mg and 150mg tigecycline) were prepared and tested according to ASTM F451 and ISO 5833 standards. Statistical analysis of the obtained data done by using LSD (least significant difference) and Bonferroni corrected Mann Whitney tests. Results. Both compression and tension tests showed that all determined antibiotic concentrations resulted in significant decrease when compared to the control group. Despite heterogenous statistical results, it was seen that the mechanical strength of tigecycline loaded bone cement was not significantly lower (even higher in some comparisons) when compared to vancomycin and daptomycin loaded bone cements. Conclusion. When used at defined concentrations, tigecycline loaded bone cement does not have mechanical disadvantage compared to vancomycin and daptomycin loaded bone cements. Thus, it should be kept in mind as an option in appropriate clinical situations