Understanding the role of head size and neck length in micromotion generation at the taper junction in total hip arthroplasty.

Modular hip implants allow intra-operative adjustments for patient-specific customization and targeted replacement of damaged elements without full implant extraction. However, challenges arise from relative micromotions between components, potentially leading to implant failure due to cytotoxic metal debris. In this study magnitude and directions of micromotions at the taper junction were estimated, aiming to understand the effect of variations in head size and neck length. Starting from a reference configuration adhering to the 12/14 taper standard, six additional implant configurations were generated by varying the head size and/or neck length. A musculoskeletal multibody model of a prothesized lower limb was developed to estimate hip contact force and location during a normal walking task. Following the implant assembly, the multibody-derived loads were imposed as boundary conditions in a finite element analysis to compute the taper junction micromotions as the relative slip between the contacting surfaces. Results highlighted the L-size head as the most critical configuration, indicating a 2.81 µm relative slip at the mid-stance phase. The proposed approach enables the investigation of geometric variations in implants under accurate load conditions, providing valuable insights for designing less risky prostheses and informing clinical decision-making processes.

DXA-based statistical models of shape and intensity outperform aBMD hip fracture prediction: A retrospective study.

Areal bone mineral density (aBMD) currently represents the clinical gold standard for hip fracture risk assessment. Nevertheless, it is characterised by a limited prediction accuracy, as about half of the people experiencing a fracture are not classified as at being at risk by aBMD. In the context of a progressively ageing population, the identification of accurate predictive tools would be pivotal to implement preventive actions. In this study, DXA-based statistical models of the proximal femur shape, intensity (i.e., density) and their combination were developed and employed to predict hip fracture on a retrospective cohort of post-menopausal women. Proximal femur shape and pixel-by-pixel aBMD values were extracted from DXA images and partial least square (PLS) algorithm adopted to extract corresponding modes and components. Subsequently, logistic regression models were built employing the first three shape, intensity and shape-intensity PLS components, and their ability to predict hip fracture tested according to a 10-fold cross-validation procedure. The area under the ROC curves (AUC) for the shape, intensity, and shape-intensity-based predictive models were 0.59 (95%CI 0.47-0.69), 0.80 (95%CI 0.70-0.90) and 0.83 (95%CI 0.73-0.90), with the first being significantly lower than the latter two. aBMD yielded an AUC of 0.72 (95%CI 0.59-0.82), found to be significantly lower than the shape-intensity-based predictive model. In conclusion, a methodology to assess hip fracture risk uniquely based on the clinically available imaging technique, DXA, is proposed. Our study results show that hip fracture risk prediction could be enhanced by taking advantage of the full set of information DXA contains.

Determining the Mechanical Properties of Super-Elastic Nitinol Bone Staples Through an Integrated Experimental and Computational Calibration Approach.

Super-elastic bone staples have emerged as a safe and effective alternative for internal fixation. Nevertheless, several biomechanical aspects of super-elastic staples are still unclear and require further exploration. Within this context, this study presents a combined experimental and computational approach to investigate the mechanical characteristics of super-elastic staples. Two commercially available staples with distinct geometry, characterized by two and four legs, respectively, were examined. Experimental four-point bending tests were conducted to evaluate staple performance in terms of generated forces. Subsequently, a finite element-based calibration procedure was developed to capture the unique super-elastic behavior of the staple materials. Finally, a virtual bench testing framework was implemented to separate the effect of geometry from that of the material characteristics on the mechanical properties of the devices, including generated force, strain distribution, and fatigue behavior. The experimental tests indicated differences in the force vs. displacement curves between staples. The material calibration procedure revealed marked differences in the super-elastic properties of the materials employed in staple 1 and staple 2. The results obtained from the virtual bench testing framework have showed that both geometric features and material characteristics had a substantial impact on the mechanical properties of the device, especially on the generated force, whereas their effect on strain distribution and fatigue behavior was comparatively less pronounced. To conclude, this study advances the biomechanical understanding of Nitinol super-elastic staples by separately investigating the impact of geometry and material characteristics on the mechanical properties of two commercially available devices.

Quantifying mesh textile and effective porosities: A straightforward image analysis procedure for morphological analysis of surgical meshes.

BACKGROUND AND OBJECTIVES: Surgical meshes have demonstrated greater reliability compared to suture repair for abdominal wall hernia treatment. However, questions remain regarding the properties of these devices and their influence on surgical outcomes. Morphological properties, including pore size and porosity, play a crucial role in mesh integration and encapsulation. In this study, we introduce a straightforward image analysis procedure for accurately calculating both textile porosity and effective porosity. The latter specifically considers pores that prevent bridging, providing valuable insights into mesh performance. METHODS: A photographic setup was established to capture high-quality images of the meshes, accompanied by calibration images necessary for computing the effective porosity. The developed image analysis procedure comprises seven steps focused on improving the binarization process's quality, followed by the computation of textile and effective porosities. To facilitate usability, an app called "poreScanner" was designed using MATLAB app designer, guiding users through the algorithm described herein. The app was used to compute both porosities on 24 meshes sourced from various manufacturers, by averaging seven measurements obtained from as many images. The app's measurement stability was validated computing the coefficient of variation for both textile and effective porosity, for a total of 36 results (24 for the textile porosity and 12 for the effective one). Additionally, different operators independently tested one heavy and one light mesh, confirming the measurement's operator independence. RESULTS: The results on the coefficient of variation indicated values below 5 % in 34 out of 36 cases, regardless of the mesh density. Similarly, the same parameter was computed to assess the independence of the procedure from different operators, yielding a maximum value of 1.84 %. These findings confirm the robustness and user-independence of the measurement procedure. CONCLUSIONS: The procedure presented in this study is straightforward to replicate and yields dependable results. Its adoption has the potential to standardize the computation of surgical mesh porosity, enabling consistent determination of this crucial morphological parameter.

Multi-objective design optimization of bioresorbable braided stents.

BACKGROUND AND OBJECTIVES: Bioresorbable braided stents, typically made of bioresorbable polymers such as poly-l-lactide (PLLA), have great potential in the treatment of critical limb ischemia, particularly in cases of long-segment occlusions and lesions with high angulation. However, the successful adoption of these devices is limited by their low radial stiffness and reduced elastic modulus of bioresorbable polymers. This study proposes a computational optimization procedure to enhance the mechanical performance of bioresorbable braided stents and consequently improve the treatment of critical limb ischemia. METHODS: Finite element analyses were performed to replicate the radial crimping test and investigate the implantation procedure of PLLA braided stents. The stent geometry was characterized by four design parameters: number of wires, wire diameter, initial stent diameter, and braiding angle. Manufacturing constraints were considered to establish the design space. The mechanical performance of the stent was evaluated by defining the radial force, foreshortening, and peak maximum principal stress of the stent as objectives and constraint functions in the optimization problem. An approximate relationship between the objectives, constraint, and the design parameters was defined using design of experiment coupled with surrogate modelling. Surrogate models were then interrogated within the design space, and a multi-objective design optimization was conducted. RESULTS: The simulation of radial crimping was successfully validated against experimental data. The radial force was found to be primarily influenced by the number of wires, wire diameter, and braiding angle, with the wire diameter having the most significant impact. Foreshortening was predominantly affected by the braiding angle. The peak maximum principal stress exhibited contrasting behaviour compared to the radial force for all parameters, with the exception of the number of wires. Among the Pareto-optimal design candidates, feasible peak maximum principal stress values were observed, with the braiding angle identified as the differentiating factor among these candidates. CONCLUSIONS: The exploration of the design space enabled both the understanding of the impact of design parameters on the mechanical performance of bioresorbable braided stents and the successful identification of optimal design candidates. The optimization framework contributes to the advancement of innovative bioresorbable braided stents for the effective treatment of critical limb ischemia.

A reliable and replicable test protocol for the mechanical evaluation of synthetic meshes.

Despite the worldwide spread of surgical meshes in abdominal and inguinal surgery repair, the lack of specific standards for mechanical characterization of synthetic meshes, used in hernia repair and urogynecologic surgery, makes performance comparison between prostheses undoubtedly difficult. This consequently leads to the absence of acknowledged specifications about the mechanical requirements that synthetic meshes should achieve in order to avoid patient discomfort or hernia recurrences. The aim of this study is to provide a rigorous test protocol for the mechanical comparison between surgical meshes having the same intended use. The test protocol is composed of three quasi-static test methods: (1) ball burst test, (2) uniaxial tensile test, and (3) suture retention test. For each test, post-processing procedures are proposed to compute relevant mechanical parameters from the raw data. Some of the computed parameters, indeed, could be more suitable for comparison with physiological conditions (e.g., membrane strain and anisotropy), while others (e.g., uniaxial tension at rupture and suture retention strength) are reported as they provide useful mechanical information and could be convenient for comparisons between devices. The proposed test protocol was applied on 14 polypropylene meshes, 3 composite meshes, and 6 urogynecologic devices to verify its universal applicability towards meshes of different types and produced by various manufacturers, and its repeatability in terms of coefficient of variation. The test protocol resulted easily applicable to all the tested surgical meshes with intra-subject variability characterized by coefficient of variations settled around 0.05. Its use within other laboratories could allow the determination of the inter-subject variability assessing its repeatability among users of alternative universal testing machines.

Cross-link augmentation enhances CFR-PEEK short fixation in lumbar metastasis stabilization.

Introduction: Spinal stability plays a crucial role in the success of the surgical treatment of lumbar vertebral metastasis and, in current practice, less invasive approaches such as short constructs have been considered. Concurrently, carbon fiber-reinforced (CFR) poly-ether-ether-ketone (PEEK) fixation devices are expanding in oncologic spinal surgery thanks to their radiotransparency and valid mechanical properties. This study attempts to provide an exhaustive biomechanical comparison of different CFR-PEEK surgical stabilizations through a highly reproducible experimental setup. Methods: A Sawbones biomimetic phantom (T12-S1) was tested in flexion, extension, lateral bending, and axial rotation. An hemisome lesion on L3 vertebral body was mimicked and different pedicle screw posterior fixations were realized with implants from CarboFix Orthopedics Ltd: a long construct involving two spinal levels above and below the lesion, and a short construct involving only the levels adjacent to L3, with and without the addition of a transverse rod-rod cross-link; to provide additional insights on its long-term applicability, the event of a pedicle screw loosening was also accounted. Results: Short construct reduced the overloading onset caused by long stabilization. Particularly, the segmental motion contribution less deviated from the physiologic pattern and also the long-chain stiffness was reduced with respect to the prevalent long construct. The use of the cross-link enhanced the short stabilization by making it significantly stiffer in lateral bending and axial rotation, and by limiting mobiliza-tion in case of pedicle screw loosening. Discussion: The present study proved in vitro the biomechanical benefits of cross-link augmentation in short CFR-PEEK fixation, demonstrating it to be a potential alternative to standard long fixation in the surgical management of lumbar metastasis.

Impact of nickel-titanium super-elastic material properties on the mechanical performance of self-expandable transcatheter aortic valves.

Self-expandable transcatheter aortic valves (TAVs) elastically resume their initial shape when implanted without the need for balloon inflation by virtue of the nickel-titanium (NiTi) frame super-elastic properties. Experimental findings suggest that NiTi mechanical properties can vary markedly because of a strong dependence on the chemical composition and processing operations. In this context, this study presents a computational framework to investigate the impact of the NiTi super-elastic material properties on the TAV mechanical performance. Finite element (FE) analyses of TAV implantation were performed considering two different TAV frames and three idealized aortic root anatomies, evaluating the device mechanical response in terms of pullout force magnitude exerted by the TAV frame and peak maximum principal stress within the aortic root. The widely adopted NiTi constitute model by Auricchio and Taylor (1997) was used. A multi-parametric sensitivity analysis and a multi-objective optimization of the TAV mechanical performance were conducted in relation to the parameters of the NiTi constitutive model. The results highlighted that: five NiTi material model parameters (EA, σtLS, σtUS, σtUE and σcLS) are significantly correlated with the FE outputs; the TAV frame geometry and aortic root anatomy have a marginal effect on the level of influence of each NiTi material parameter; NiTi alloy candidates with pareto-optimal characteristics in terms of TAV mechanical performance can be successfully identified. In conclusion, the proposed computational framework supports the TAV design phase, providing information on the relationship between the super-elastic behavior of the supplied NiTi alloys and the device mechanical response.

Smartphone-based particle image velocimetry for cardiovascular flows applications: A focus on coronary arteries.

An experimental set-up is presented for the in vitro characterization of the fluid dynamics in personalized phantoms of healthy and stenosed coronary arteries. The proposed set-up was fine-tuned with the aim of obtaining a compact, flexible, low-cost test-bench for biomedical applications. Technically, velocity vector fields were measured adopting a so-called smart-PIV approach, consisting of a smartphone camera and a low-power continuous laser (30 mW). Experiments were conducted in realistic healthy and stenosed 3D-printed phantoms of left anterior descending coronary artery reconstructed from angiographic images. Time resolved image acquisition was made possible by the combination of the image acquisition frame rate of last generation commercial smartphones and the flow regimes characterizing coronary hemodynamics (velocities in the order of 10 cm/s). Different flow regimes (Reynolds numbers ranging from 20 to 200) were analyzed. The smart-PIV approach was able to provide both qualitative flow visualizations and quantitative results. A comparison between smart-PIV and conventional PIV (i.e., the gold-standard experimental technique for bioflows characterization) measurements showed a good agreement in the measured velocity vector fields for both the healthy and the stenosed coronary phantoms. Displacement errors and uncertainties, estimated by applying the particle disparity method, confirmed the soundness of the proposed smart-PIV approach, as their values fell within the same range for both smart and conventional PIV measured data (≈5% for the normalized estimated displacement error and below 1.2 pixels for displacement uncertainty). In conclusion, smart-PIV represents an easy-to-implement, low-cost methodology for obtaining an adequately robust experimental characterization of cardiovascular flows. The proposed approach, to be intended as a proof of concept, candidates to become an easy-to-handle test bench suitable for use also outside of research labs, e.g., for educational or industrial purposes, or as first-line investigation to direct and guide subsequent conventional PIV measurements.

Personalised 3D Assessment of Trochanteric Soft Tissues Improves HIP Fracture Classification Accuracy.

Passive soft tissues surrounding the trochanteric region attenuate fall impact forces and thereby control hip fracture risk. The degree of attenuation is related to Soft Tissue Thickness (STT). STT at the neutral hip impact orientation, estimated using a regression relation in body mass index (BMI), was previously shown to influence the current absolute risk of hip fracture (ARF0) and its fracture classification accuracy. The present study investigates whether fracture classification using ARF0 improves when STT is determined from the subject's Computed-Tomography (CT) scans (i.e. personalised) in an orientation-specific (i.e. 3D) manner. STT is calculated as the shortest distance along any impact orientation between a semi-automatically segmented femur surface and an automatically segmented soft tissue/air boundary. For any subject, STT along any of the 33 impact orientations analysed always exceeds the value estimated using BMI. Accuracy of fracture classification using ARF0 improves when using personalised 3D STT estimates (AUC = 0.87) instead of the BMI-based STT estimate (AUC = 0.85). The improvement is smaller (AUC = 0.86) when orientation-specificity of CT-based STT is suppressed and is nil when personalisation is suppressed instead. Thus, fracture classification using ARF0 improves when CT is used to personalise STT estimates and improves further when, in addition, the estimates are orientation specific.

Versatile electrical stimulator for cardiac tissue engineering-Investigation of charge-balanced monophasic and biphasic electrical stimulations.

The application of biomimetic physical stimuli replicating the in vivo dynamic microenvironment is crucial for the in vitro development of functional cardiac tissues. In particular, pulsed electrical stimulation (ES) has been shown to improve the functional properties of in vitro cultured cardiomyocytes. However, commercially available electrical stimulators are expensive and cumbersome devices while customized solutions often allow limited parameter tunability, constraining the investigation of different ES protocols. The goal of this study was to develop a versatile compact electrical stimulator (ELETTRA) for biomimetic cardiac tissue engineering approaches, designed for delivering controlled parallelizable ES at a competitive cost. ELETTRA is based on an open-source micro-controller running custom software and is combinable with different cell/tissue culture set-ups, allowing simultaneously testing different ES patterns on multiple samples. In particular, customized culture chambers were appositely designed and manufactured for investigating the influence of monophasic and biphasic pulsed ES on cardiac cell monolayers. Finite element analysis was performed for characterizing the spatial distributions of the electrical field and the current density within the culture chamber. Performance tests confirmed the accuracy, compliance, and reliability of the ES parameters delivered by ELETTRA. Biological tests were performed on neonatal rat cardiac cells, electrically stimulated for 4 days, by comparing, for the first time, the monophasic waveform (electric field = 5 V/cm) to biphasic waveforms by matching either the absolute value of the electric field variation (biphasic ES at ±2.5 V/cm) or the total delivered charge (biphasic ES at ±5 V/cm). Findings suggested that monophasic ES at 5 V/cm and, particularly, charge-balanced biphasic ES at ±5 V/cm were effective in enhancing electrical functionality of stimulated cardiac cells and in promoting synchronous contraction.

Combining shape and intensity dxa-based statistical approaches for osteoporotic HIP fracture risk assessment.

Aiming to improve osteoporotic hip fracture risk detection, factors other than the largely adopted Bone Mineral Density (BMD) have been investigated as potential risk predictors. In particular Hip Structural Analysis (HSA)-derived parameters accounting for femur geometry, extracted from Dual-energy X-ray Absorptiometry (DXA) images, have been largely considered as geometric risk factors. However, HSA-derived parameters represent discrete and cross-correlated quantities, unable to describe proximal femur geometry as a whole and tightly related to BMD. Focusing on a post-menopausal cohort (N = 28), in this study statistical models of bone shape and BMD distribution have been developed to investigate their possible role in fracture risk. Due to unavailable retrospective patient-specific fracture risk information, here a surrogate fracture risk based on 3D computer simulations has been employed for the statistical framework construction. When considered separately, BMD distribution performed better than shape in explaining the surrogate fracture risk variability for the analysed cohort. However, the combination of BMD and femur shape quantities in a unique statistical model yielded better results. In detail, the first shape-intensity combined mode identified using a Partial Least Square (PLS) algorithm was able to explain 70% of the surrogate fracture risk variability, thus suggesting that a more effective patients stratification can be obtained applying a shape-intensity combination approach, compared to T-score. The findings of this study strongly advocate future research on the role of a combined shape-BMD statistical framework in fracture risk determination.

A low-cost scalable 3D-printed sample-holder for agitation-based decellularization of biological tissues.

Decellularized extracellular matrix is one of the most promising biological scaffold supporting in vitro tissue growth and in vivo tissue regeneration in both preclinical research and clinical practice. In case of thick tissues or even organs, conventional static decellularization methods based on chemical or enzymatic treatments are not effective in removing the native cellular material without affecting the extracellular matrix. To overcome this limitation, dynamic decellularization methods, mostly based on perfusion and agitation, have been proposed. In this study, we developed a low-cost scalable 3D-printed sample-holder for agitation-based decellularization purposes, designed for treating multiple specimens simultaneously and for improving efficiency, homogeneity and reproducibility of the decellularization treatment with respect to conventional agitation-based approaches. In detail, the proposed sample-holder is able to house up to four specimens and, immersed in the decellularizing solution within a beaker placed on a magnetic stirrer, to expose them to convective flow, enhancing the solution transport through the specimens while protecting them. Computational fluid dynamics analyses were performed to investigate the fluid phenomena establishing within the beaker and to support the sample-holder design. Exploratory biological tests performed on human skin specimens demonstrated that the sample-holder reduces process duration and increases treatment homogeneity and reproducibility.

Bioreactor Platform for Biomimetic Culture and in situ Monitoring of the Mechanical Response of in vitro Engineered Models of Cardiac Tissue.

In the past two decades, relevant advances have been made in the generation of engineered cardiac constructs to be used as functional in vitro models for cardiac research or drug testing, and with the ultimate but still challenging goal of repairing the damaged myocardium. To support cardiac tissue generation and maturation in vitro, the application of biomimetic physical stimuli within dedicated bioreactors is crucial. In particular, cardiac-like mechanical stimulation has been demonstrated to promote development and maturation of cardiac tissue models. Here, we developed an automated bioreactor platform for tunable cyclic stretch and in situ monitoring of the mechanical response of in vitro engineered cardiac tissues. To demonstrate the bioreactor platform performance and to investigate the effects of cyclic stretch on construct maturation and contractility, we developed 3D annular cardiac tissue models based on neonatal rat cardiac cells embedded in fibrin hydrogel. The constructs were statically pre-cultured for 5 days and then exposed to 4 days of uniaxial cyclic stretch (sinusoidal waveform, 10% strain, 1 Hz) within the bioreactor. Explanatory biological tests showed that cyclic stretch promoted cardiomyocyte alignment, maintenance, and maturation, with enhanced expression of typical mature cardiac markers compared to static controls. Moreover, in situ monitoring showed increasing passive force of the constructs along the dynamic culture. Finally, only the stretched constructs were responsive to external electrical pacing with synchronous and regular contractile activity, further confirming that cyclic stretching was instrumental for their functional maturation. This study shows that the proposed bioreactor platform is a reliable device for cyclic stretch culture and in situ monitoring of the passive mechanical response of the cultured constructs. The innovative feature of acquiring passive force measurements in situ and along the culture allows monitoring the construct maturation trend without interrupting the culture, making the proposed device a powerful tool for in vitro investigation and ultimately production of functional engineered cardiac constructs.

Mechanical Behavior of Elastic Self-Locking Nails for Intramedullary Fracture Fixation: A Numerical Analysis of Innovative Nail Designs.

Intramedullary nails constitute a viable alternative to extramedullary fixation devices; their use is growing in recent years, especially with reference to self-locking nails. Different designs are available, and it is not trivial to foresee the respective in vivo performances and to provide clinical indications in relation to the type of bone and fracture. In this work a numerical methodology was set up and validated in order to compare the mechanical behavior of two new nailing device concepts with one already used in clinic. In detail, three different nails were studied: (1) the Marchetti-Vicenzi's nail (MV1), (2) a revised concept of this device (MV2), and (3) a new Terzini-Putame's nail (TP) concept. Firstly, the mechanical behavior of the MV1 device was assessed through experimental loading tests employing a 3D-printed component aimed at reproducing the bone geometry inside which the device is implanted. In the next step, the respective numerical model was created, based on a multibody approach including flexible parts, and this model was validated against the previously obtained experimental results. Finally, numerical models of the MV2 and TP concepts were implemented and compared with the MV1 nail, focusing the attention on the response of all devices to compression, tension, bending, and torsion. A stability index (SI) was defined to quantify the mechanical stability provided to the nail-bone assembly by the elastic self-locking mechanism for the various loading conditions. In addition, results in terms of nail-bone assembly stiffness, computed from force/moment vs. displacement/rotation curves, were presented and discussed. Findings revealed that numerical models were able to provide good estimates of load vs. displacement curves. The TP nail concept proved to be able to generate a significantly higher SI (27 N for MV1 vs. 380 N for TP) and a greater stiffening action (up to a stiffness difference for bending load that ranges from 370 Nmm/° for MV1 to 1,532 Nmm/° for TP) than the other two devices which showed similar performances. On the whole, a demonstration was given of information which can be obtained from numerical simulations of expandable fixation devices.

In Vitro Simulation of Dental Implant Bridges Removal: Influence of Luting Agent and Abutments Geometry on Retrievability.

Implant fixed dental prostheses are widely used for the treatment of edentulism, often preferred over the screw-retained ones. However, one of the main features of an implant-supported prosthesis is retrievability, which could be necessary in the case of implant complications. In this study, the retrievability of implant-fixed dental prostheses was investigated considering two of the main factors dental practitioners have to deal with: the abutments geometry and the luting agent. Impulsive forces were applied to dental bridge models to simulate crowns' retrievability in clinical conditions. The number of impulses and the impulsive force delivered during each test were recorded and used as retrievability indexes. One-hundred-and-five tests were conducted on 21 combinations of bridges and luting agents, and a Kruskal-Wallis test was performed on the results. The abutment geometry significantly influenced the number of impulses needed for retrieval (p < 0.05), and a cement-dependent trend was observed as well. On the other hand, the forces measured during tests showed no clear correlation with bridge retrievability. The best retrievability was obtained with long, slightly tapered abutments and a temporary luting agent.

On-site testing of sutured organs: An experimental set up to cyclically tighten sutures.

A number of surgical practices are aimed to compensate for tissue relaxation or weakened/atrophied muscles by means of suture prostheses/thread lifts. The success rate of these procedures is often very good in the short term, while it is quite variable among subjects and techniques in the middle-long term. Middle-long term failures are mostly related to suture distraction, loosening or wear, coming from repeated loading cycles. In this work, an experimental device to perform ex vivo tests on prosthetic sutures has been set up. An equine laryngoplasty has been used as a benchmark, being representative of sutures aimed to compensate for atrophied muscles. The peculiarity of this experimental set up is that the suture is on-site and it has been tightened with known, repeated loads, which do not depend on thread deformation at different load levels. Preliminary tests have been performed applying over 3000 load cycles and finally a tensile test up to rupture. Force/displacement curves obtained with this experimental set up have been reported and parameters useful to classify the biomechanical performance of sutures versus time (mainly its creep behaviour), have been outlined. Results have outlined that the organ-suture system undergoes significant creep over 3000 cycles, and this should be taken into account in order to foresee its long-term behaviour; in addition, the suture anchorage to cartilage should be improved. The experimental set up can be used to perform on-site testing of sutures, taking into account the compliance and creep response at both suture anchorage ends, in order to compare different surgeries and different kinds of thread.

In Vitro Impact Testing to Simulate Implant-Supported Prosthesis Retrievability in Clinical Practice: Influence of Cement and Abutment Geometry.

Cement-retained implant-supported prosthetics are gaining popularity compared to the alternative screw-retained type, a rise that serves to highlight the importance of retrievability. The aim of the present investigation is to determine the influence of luting agent, abutment height and taper angle on the retrievability of abutment-coping cementations. Abutments with different heights and tapers were screwed onto an implant and their cobalt-chrome copings were cemented on the abutments using three different luting agents. The removals were performed by means of Coronaflex®. The number of impulses and the forces were recorded and analyzed with a Kruskal-Wallis test. Harvard cement needed the highest number of impulses for retrieval, followed by Telio CS and Temp Bond. However, abutment height and taper showed a greater influence on the cap's retrievability (p < 0.05). Long and tapered abutments provided the highest percentage of good retrievability. The influence of the luting agent and the abutment geometry on the cap's retrieval performed by Coronaflex® reflects data from literature about the influence of the same factor on the maximum force reached during uniaxial tensile tests. The impulse force was slightly affected by the same factors.

Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing.

Medical devices are designed, tested, and placed on the market in a highly regulated environment. Wearable sensors are crucial components of various medical devices: design and validation of wearable sensors, if managed according to international standards, can foster innovation while respecting regulatory requirements. The purpose of this paper is to review the upcoming European Union (EU) Medical Device Regulations 2017/745 and 2017/746, the current and future International Electrotechnical Commission (IEC) and International Organization for Standardization (ISO) standards that set methods for design and validation of medical devices, with a focus on wearable sensors. Risk classification according to the regulation is described. The international standards IEC 62304, IEC 60601, ISO 14971, and ISO 13485 are reviewed to define regulatory restrictions during design, pre-clinical validation and clinical validation of devices that include wearable sensors as crucial components. This paper is not about any specific innovation but it is a toolbox for interpreting current and future regulatory restrictions; an integrated method for design planning, validation and clinical testing is proposed. Application of this method to design wearable sensors should be evaluated in the future in order to assess its potentially positive impact to fostering innovation and to ensure timely development.

Improving the Hip Fracture Risk Prediction Through 2D Finite Element Models From DXA Images: Validation Against 3D Models.

Osteoporotic fracture incidence represents a major social and economic concern in the modern society, where the progressive graying of the population involves an highly increased fracture occurrence. Although the gold standard to diagnose osteoporosis is represented by the T-score measurement, estimated from the Bone Mineral Density (BMD) using Dual-energy X-ray Absorptiometry (DXA), the identification of the subjects at high risk of fracture still remains an issue. From this perspective, the purpose of this work is to investigate the role that DXA-based two-dimensional patient-specific finite element (FE) models of the proximal femur, in combination with T-score, could play in enhancing the risk of fracture estimation. With this aim, 2D FE models were built from DXA images of the 28 post-menopausal female subjects involved. A sideways fall condition was reproduced and a Risk of Fracture ( RF ^ ) was computed on the basis of principal strains criteria. The identified RF ^ was then compared to that derived from the CT-based models developed in a previous study. The 2D and 3D RF ^ turned out to be significantly correlated (Spearman's ρ = 0.66, p < 0.001), highlighting the same patients as those at higher risk. Moreover, the 2D RF ^ resulted significantly correlated with the T-score (Spearman's ρ = -0.69, p < 0.001), and managed to better differentiate osteopenic patients, drawing the attention to some of them. The Hip Structural Analysis (HSA) variables explaining the majority of the variance of the 2D and 3D fracture risk were the same as well, i.e., neck-shaft angle and narrow neck buckling ratio. In conclusion, DXA-based FE models, developable from currently available clinical data, appear promising in supporting and integrating the present diagnostic procedure.