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For decades, dermal tissue grafts have been used in various regenerative, reconstructive, and augmentative procedures across the body. To eliminate antigenicity and immunogenic response while still preserving the individual components and collective structural integrity of the extracellular matrix (ECM), dermis can be decellularized. Acellular dermal matrix (ADM) products like such are produced to accurately serve diverse clinical purposes. The aim of the present study is to evaluate the efficacy of a novel decellularization protocol of the human dermis, which eliminates residual human genetic material without compromising the biomechanical integrity and collagenous content of the tissue. Moreover, a freeze-drying protocol was validated. The results showed that though our decellularization protocol, human dermis can be decellularized obtaining a biocompatible matrix. The procedure is completely realized in GMP aseptic condition, avoiding tissue terminal sterilization., (© 2024. The Author(s).)

Pericardial patches are currently used as reconstructive material in cardiac surgery for surgical treatment of cardiac septal defects. Autologous pericardial patches, either treated with glutaraldehyde or not, can be used as an alternative to synthetic materials or xenograft in congenital septal defects repair. The availability of an allogenic decellularized pericardium could reduce complication during and after surgery and could be a valid alternative. Decellularization of allogenic tissues aims at reducing the immunogenic reaction that might trigger inflammation and tissue calcification over time. The ideal graft for congenital heart disease repair should be biocompatible, mechanically resistant, non-immunogenic, and should have the ability to growth with the patients. The aim of the present study is the evaluation of the efficacy of a new decellularization protocol of homologous pericardium, even after cryopreservation. The technique has proven to be suitable as a tissue bank procedure and highly successful in the removal of cells and nucleic acids content, but also in the preservation of collagen and biomechanical properties of the human pericardium., (© 2023. The Author(s).)

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., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The application of lower limb traction during hip arthroscopy and femur fractures osteosynthesis is commonplace in orthopaedic surgeries. Traditional methods utilize a perineal post on a traction table, leading to soft tissue damage and nerve neuropraxia. A postless technique, using high-friction pads, has been considered as a potential damage-free alternative. However, whether these pads sufficiently prevent patient displacement remains unknown. Thus, this study systematically assesses the efficacy of commercial high-friction pads (PinkPad and CarePad) in restraining subject displacement, for progressively increasing traction loads and different Trendelenburg angles., Methods: Three healthy male subjects were recruited and tested in supine and Trendelenburg positions (5° and 10°), using a customized boot-pulley system. Ten load disks (5 kg) were dropped at 15s intervals, increasing gradually the traction load up to 50 kg. Pelvis displacement along the traction direction was measured with a motion capture system. The displacement at 50 kg of traction load was analyzed and compared across various pads and bed inclinations. Response to varying traction loads was statistically assessed with a quadratic function model., Results: Pelvis displacement at 50 kg traction load was below 60 mm for all conditions. Comparing PinkPad and CarePad, no significant differences in displacement were observed. Finally, similar displacements were observed for the supine and Trendelenburg positions., Conclusions: Both PinkPad and CarePad exhibited nearly linear behavior under increasing traction loads, limiting displacement to 60 mm at most for 50 kg loads. Contrary to expectations, placing subjects in the Trendelenburg position did not increase adhesion., (© 2024. The Author(s).)

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., (© 2024. The Author(s).)

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., (© 2023. The Author(s) under exclusive licence to Biomedical Engineering Society.)

Mechanical tests on bone plates are mandatory for regulatory purposes and, typically, the ASTM F382 standard is used, which involves a four-point bending test setup to evaluate the cyclic bending fatigue performance of the bone plate. These test campaigns require a considerable financial outlay and long execution times; therefore, an accurate prediction of experimental outcomes can reduce test runtime with beneficial cost cuts for manufacturers. Hence, an analytical framework is here proposed for the direct estimation of the maximum bending moment of a bone plate under fatigue loading, to guide the identification of the runout load for regulatory testing. Eleven bone plates awaiting certification were subjected to a comprehensive testing campaign following ASTM F382 protocols to evaluate their static and fatigue bending properties. An analytical prediction of the maximum bending moment was subsequently implemented based on ultimate strength and plate geometry. The experimental loads obtained from fatigue testing were then used to verify the prediction accuracy of the analytical approach. Results showed promising predictive ability, with R 2 coefficients above 0.95 in the runout condition, with potential impact in reducing the experimental tests needed for the CE marking of bone plates., (© 2023. The Author(s).)

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., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier B.V.)

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., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Borrelli, Putame, Audenino, Bignardi, Ferro, Marone and Terzini.)

The study of the spine range of motion under given external load has been the object of many studies in literature, finalised to a better understanding of the spine biomechanics, its physiology, eventual pathologic conditions and possible rehabilitation strategies. However, the huge amount of experimental work performed so far cannot be straightforwardly analysed due to significant differences among loading set-ups. This work performs a meta-analysis of various boundary conditions in literature, focusing on the flexion/extension behaviour of the lumbar spine. The comparison among range of motions is performed virtually through a validated multibody model. Results clearly illustrated the effect of various boundary conditions which can be met in literature, so justifying differences of biomechanical behaviours reported by authors implementing different set-up: for example, a higher value of the follower load can indeed result in a stiffer behaviour; the application of force producing spurious moments results in an apparently more deformable behaviour, however the respective effects change at various segments along the spine due to its natural curvature. These outcomes are reported not only in qualitative, but also in quantitative terms. The numerical approach here followed to perform the meta-analysis is original and it proved to be effective thanks to the bypass of the natural variability among specimens which might completely or partially hinder the effect of some boundary conditions. In addition, it can provide very complete information since the behaviour of each functional spinal unit can be recorded. On the whole, the work provided an extensive review of lumbar spine loading in flexion/extension., (© 2022. The Author(s).)

Background and Objectives: Professional pianists tend to develop playing-related musculoskeletal disorders mostly in the forearm. These injuries are often due to overuse, suggesting the existence of a common forearm region where muscles are often excited during piano playing across subjects. Here we use a grid of electrodes to test this hypothesis, assessing where EMGs with greatest amplitude are more likely to be detected when expert pianists perform different excerpts., Methods: Tasks were separated into two groups: classical excerpts and octaves, performed by eight, healthy, professional pianists. Monopolar electromyograms (EMGs) were sampled with a grid of 96 electrodes, covering the forearm region where hand and wrist muscles reside. Regions providing consistently high EMG amplitude across subjects were assessed with a non-parametric permutation test, designed for the statistical analysis of neuroimaging experiments. Spatial consistency across trials was assessed with the Binomial test., Results: Spatial consistency of muscle excitation was found across subjects but not across tasks, confining at most 20% of the electrodes in the grid. These local groups of electrodes providing high EMG amplitude were found at the ventral forearm region during classical excerpts and at the dorsal region during octaves, when performed both at preferred and at high, playing speeds., Discussion: Our results revealed that professional pianists consistently load a specific forearm region, depending on whether performing octaves or classical excerpts. This spatial consistency may help furthering our understanding on the incidence of playing-related muscular disorders and provide an anatomical reference for the study of active muscle loading in piano players using surface EMG., Competing Interests: The authors have declared that no competing interests exist.

A catastrophic fracture of the radial carpal bone experienced by a racehorse during a Palio race was analyzed. Computational modelling of the carpal joint at the point of failure informed by live data was generated using a multibody code for dynamics simulation. The circuit design in a turn, the speed of the animal and the surface characteristics were considered in the model. A macroscopic examination of the cartilage, micro-CT and histology were performed on the radio-carpal joint of the limb that sustained the fracture. The model predicted the points of contact forces generated at the level of the radio-carpal joint where the fracture occurred. Articular surfaces of the distal radius, together with the proximal articular surface of small carpal bones, exhibited diffuse wear lines, erosions of the articular cartilage and subchondral bone exposure. Even though the data in this study originated from a single fracture and further work will be required to validate this approach, this study highlights the potential correlation between elevated impact forces generated at the level of contact surfaces of the carpal joint during a turn and cartilage breakdown in the absence of pre-existing pathology. Computer modelling resulted in a useful tool to inversely calculate internal forces generated during specific conditions that cannot be reproduced in-vivo because of ethical concerns.

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., (© 2022. The Author(s).)

Nowadays, several configurations of total knee arthroplasty (TKA) implants are commercially available whose designs resulted from clinical and biomechanical considerations. Previous research activities led to the development of the so-called medial-pivot (MP) design. However, the actual benefits of the MP, with respect to other prosthesis designs, are still not well understood. The present work compares the impact of two insert geometries, namely the ultra-congruent (UC) and medial-pivot (MP), on the biomechanical behaviour of a bicondylar total knee endoprosthesis. For this purpose, a multibody model of a lower limb was created alternatively integrating the two implants having the insert geometry discretized. Joint dynamics and contact pressure distributions were evaluated by simulating a squat motion. Results showed a similar tibial internal rotation range of about 3.5°, but an early rotation occurs for the MP design. Furthermore, the discretization of the insert geometry allowed to efficiently derive the contact pressure distributions, directly within the multibody simulation framework, reporting peak pressure values of 33 MPa and 20 MPa for the UC and MP, respectively. Clinically, the presented findings confirm the possibility, through a MP design, to achieve a more natural joint kinematics, consequently improving the post-operative patient satisfaction and potentially reducing the occurrence of phenomena leading to the insert loosening., (© 2022. The Author(s).)

Severe predictions have been made regarding osteoporotic fracture incidence for the next years, with major economic and social impacts in a worldwide greying society. However, the performance of the currently adopted gold standard for fracture risk prediction, the areal Bone Mineral Density (aBMD), remains moderate. To overcome current limitations, the construction of statistical models of the proximal femur, based on three-dimensional shape and intensity (a hallmark of bone density), is here proposed for predicting hip fracture in a Caucasian postmenopausal cohort. Partial Least Square (PLS)-based statistical models of the shape, intensity and their combination were developed, and the corresponding modes and components were identified. Logistic regression models using the first two shape, intensity and shape-intensity PLS components were implemented and tested within a 10-fold cross-validation procedure as predictors of hip fracture. It emerged that (1) intensity components were superior to shape components in stratifying patients according to their fracture status, and that (2) a combination of intensity and shape improved patients risk stratification. The area under the ROC curve was 0.64, 0.85 and 0.92 for the models based on shape, intensity and shape-intensity combination respectively, against a 0.72 value for the aBMD standard approach. Based on these findings, the presented methodology turns out to be promising in tackling the need for an enhanced fracture risk assessment., (© 2022. The Author(s).)

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., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

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., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

The design of loading systems to test biologic samples is often challenging, due to shape variability and non-conventional loading set-ups. In addition to this, large economic investments would not be justified since the loading set up is usually designed for one single or for a limited range of applications. The object of this work is the development of a loading set-up finalised to on-site testing of sutures whose main function is applying a localised tensile load. The main challenges of this design process can be so summarized:•Applying cyclic tensile loads on the suture wire, mimicking the physiologic condition where both suture anchorage points have a certain compliance;•Designing a loading system as versatile as possible, in order to be able to accommodate organs with different geometries and sizes;•Keeping low both the complexity and costs of realization.All these considerations and the design calculi are here reported in detail, discussing the novelty of the system, and its main advantages., (© 2020 The Authors.)

The incidence of periprosthetic fractures has rapidly increased in the last two decades and has been the cause of a large number of revision surgeries and permanent physical disability for many patients, as well as a significant socioeconomic burden for many nations. This research deals with a periprosthetic femur fracture real event, occurred following a total hip arthroplasty and treated with one of the most widespread internal fixation methods: the implant of a periprosthetic femur plate system. A Finite Element analysis was performed to investigate the implanted femur plate break after a short follow-up and to understand the plate break causes. Such events are currently object of forensic debate as more and more often hospitals, surgeons, and medical device manufacturers are denounced by patients to whom similar events occur. In this work, different load situations acting on the femur during daily and incidental activities were simulated, in order to validate the correct behavior of the plate, according to the intended use recommended by the manufacturer. The analysis demonstrates that the plate failure can occur in situations of unconventional loading such as that caused by stumbling and in presence of incomplete bone healing., (Copyright © 2020 Terzini, Aldieri, Nurisso, De Nisco and Bignardi.)

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.

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 (MV 1 ), (2) a revised concept of this device (MV 2 ), and (3) a new Terzini-Putame's nail (TP) concept. Firstly, the mechanical behavior of the MV 1 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 MV 2 and TP concepts were implemented and compared with the MV 1 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 MV 1 vs. 380 N for TP) and a greater stiffening action (up to a stiffness difference for bending load that ranges from 370 Nmm/° for MV 1 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., (Copyright © 2020 Putame, Pascoletti, Terzini, Zanetti and Audenino.)

A number of applications in the surgical practice are based on tensile sutures aimed to keep soft tissues in place and compensate the exit of neuropathies, prolapses or general tissue relaxation. Long-term behaviour of these constructs need to be carefully examined in order to define tensile forces to be applied and to compare different suture anchors. Data here reported refer to equine laryngoplasties, where a suitable loading system has been designed in order to be able to test sutures in-sito, applying known forces ("On-site testing of sutured organs: an experimental set up to cyclically tighten sutures" (Pascoletti et al., 2020 [1])). The loading protocol was made of two steps: in the first step, 3000 loading cycles have been performed; in the following step, a tensile test up to rupture was performed. Cyclic load/displacement curves allow evaluating suture distraction, as a consequence of suture migration and/or soft tissues creep. Tensile curves allow evaluating the residual thread strength and its ultimate displacement. These data can provide a detailed insight of long-term suture behaviour and can be a reference to compare different threads and/or suture anchors., (© 2020 The Authors.)

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.

The complex and highly organized environment in which cells reside consists primarily of the extracellular matrix (ECM) that delivers biological signals and physical stimuli to resident cells. In the native myocardium, the ECM contributes to both heart compliance and cardiomyocyte maturation and function. Thus, myocardium regeneration cannot be accomplished if cardiac ECM is not restored. We hypothesize that decellularized human skin might make an easily accessible and viable alternate biological scaffold for cardiac tissue engineering (CTE). To test our hypothesis, we decellularized specimens of both human skin and human myocardium and analyzed and compared their composition by histological methods and quantitative assays. Decellularized dermal matrix was then cut into 600-μm-thick sections and either tested by uniaxial tensile stretching to characterize its mechanical behavior or used as three-dimensional scaffold to assess its capability to support regeneration by resident cardiac progenitor cells (hCPCs) in vitro . Histological and quantitative analyses of the dermal matrix provided evidence of both effective decellularization with preserved tissue architecture and retention of ECM proteins and growth factors typical of cardiac matrix. Further, the elastic modulus of the dermal matrix resulted comparable with that reported in literature for the human myocardium and, when tested in vitro , dermal matrix resulted a comfortable and protective substrate promoting and supporting hCPC engraftment, survival and cardiomyogenic potential. Our study provides compelling evidence that dermal matrix holds promise as a fully autologous and cost-effective biological scaffold for CTE., (Copyright © 2020 Belviso, Romano, Sacco, Ricci, Massai, Cammarota, Catizone, Schiraldi, Nurzynska, Terzini, Aldieri, Serino, Schonauer, Sirico, D’Andrea, Montagnani, Di Meglio and Castaldo.)

Extracorporeal membrane oxygenation (ECMO) in blood-outside devices equipped with hydrophobic membranes has become routine treatment of respiratory or cardiac failure. In spite of membrane hydrophobicity, significant amounts of plasma water may form in the gas compartment during treatment, an event termed plasma water breakthrough. When this occurs, plasma water occludes some gas pathways and ultimately cripples the oxygenator gas exchange capacity requiring its substitution. This causes patient hemodilution and increases the activation of the patient's immune system. On these grounds, the resistance to plasma water breakthrough is regarded as an important feature of ECMO devices. Many possible events may explain the occurrence of plasma breakthrough. In spite of this, the resistance to plasma breakthrough of ECMO devices is commercially characterized only with respect to the membrane maximal pore size, evaluated by the bubble pressure method or by SEM analysis of membrane surfaces. The discrepancy between the complexity of the events causing plasma breakthrough in ECMO devices (hence determining their resistance to plasma breakthrough), and that claimed commercially has caused legal suits on the occasion of the purchase of large stocks of ECMO devices by large hospitals or regional institutions. The main aim of this study was to identify some factors that contribute to determining the resistance to plasma breakthrough of ECMO devices, as a means to minimize litigations triggered by an improper definition of the requirements of a clinically efficient ECMO device. The results obtained show that: membrane resistance to breakthrough should be related to the size of the pores inside the membrane wall rather than at its surface; membranes with similar nominal maximal pore size may exhibit pores with significantly different size distribution; membrane pore size distribution rather than the maximal pore size determines membrane resistance to breakthrough; the presence of surfactants in the patient's blood (e.g., lipids, alcohol, etc.) may significantly modify the intrinsic membrane resistance to breakthrough, more so the higher the surfactant concentration. We conclude that the requirements of ECMO devices in terms of resistance to plasma breakthrough ought to account for all these factors and not rely only on membrane maximal pore size., (Copyright © 2020 Fragomeni, Terzini, Comite and Catapano.)

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.

In flexion-extension motion, the interaction of several ligaments and bones characterizes the elbow joint stability. The aim of this preliminary study was to quantify the relative motion of the ulna with respect to the humerus in two human upper limbs specimens and to investigate the constraints role for maintaining the elbow joint stability in different section conditions. Two clusters of four markers were fixed respectively to the ulna and humerus, and their trajectory was recorded by a motion capture system during functional orthopedic maneuver. Considering the posterior bundle of medial collateral complex (pMUCL) and the coronoid, two section sequences were executed. The orthopedic maneuver of compression, pronation and varus force was repeated at 30°, 60° and 90° flexion for the functional investigation of constraints. Ulna deflection was compared to a baseline elbow flexion condition. With respect to the intact elbow, the coronoid osteotomy influences the elbow stability at 90° (deflection = 11.49 ± 17.39 mm), while small differences occur at 30° and 60°, due to ligaments constraint. The contemporary pMUCL section and coronoid osteotomy causes elbow instability, with large deflection at 30° (deflection = 34.40 ± 9.10 mm), 60° (deflection = 45.41 ± 18.47 mm) and 90° (deflection = 52.16 ± 21.92 mm). Surgeons may consider the pMUCL reconstruction in case of unfixable coronoid fracture.

Anterior cruciate ligament (ACL) deficiency can result in serious degenerative stifle injuries. Although tibial plateau leveling osteotomy (TPLO) is a common method for the surgical treatment of ACL deficiency, alternative osteotomies, such as a leveling osteotomy based on the center of rotation of angulation (CBLO) are described in the literature. However, whether a CBLO could represent a viable alternative to a TPLO remains to be established. The aim of this study is to compare TPLO and CBLO effectiveness in treating ACL rupture. First, a computational multibody model of a physiological stifle was created using three-dimensional surfaces of a medium-sized canine femur, tibia, fibula and patella. Articular contacts were modeled by means of a formulation describing the contact force as function of the interpenetration between surfaces. Moreover, ligaments were represented by vector forces connecting origin and insertion points. The lengths of the ligaments at rest were optimized simulating the drawer test. The ACL-deficient model was obtained by deactivating the ACL related forces in the optimized physiological one. Then, TPLO and CBLO treatments were virtually performed on the pathological stifle. Finally, the drawer test and a weight-bearing squat movement were performed to compare the treatments effectiveness in terms of tibial anteroposterior translation, patellar ligament force, intra-articular compressive force and quadriceps force. Results from drawer test simulations showed that ACL-deficiency causes an increase of the anterior tibial translation by up to 5.2 mm, while no remarkable differences between CBLO and TPLO were recorded. Overall, squat simulations have demonstrated that both treatments lead to an increase of all considered forces compared to the physiological model. Specifically, CBLO and TPLO produce an increase in compressive forces of 54% and 37%, respectively, at 90° flexion. However, TPLO produces higher compressive forces (up to 16%) with respect to CBLO for wider flexion angles ranging from 135° to 117°. Conversely, TPLO generates lower forces in patellar ligament and quadriceps muscle, compared to CBLO. In light of the higher intra-articular compressive force over the physiological walking range of flexion, which was observed to result from TPLO in the current study, the use of this technique should be carefully considered.

The pre-operative planning of a hip arthroplasty entails the choice of the prosthetic hip model and of the position of both joint components with reference to bone. Assessing the impact of geometrical factors on the final hip range of motion (ROM) is not trivial, since it requires performing 3D evaluations. Nonetheless, it deserves to be studied since hip impingement and dislocation are still relevant complications in hip arthroplasty. This work pertains a numerical model for the assessment of the hip ROM in relation to cotyle position. External/internal rotation is considered as a benchmark, and multiple combinations of acetabular anteversion/inclination are considered. According to results, over two hundred different geometric configurations can be examined in few minutes, and the cotyle position can be so optimized with relevant benefits in term of hip ROM.

Three-dimensional (3D) printing represents a key technology for rapid prototyping, allowing easy, rapid, and low-cost fabrication. In this work, 3D printing was applied for the in-house production of customized components of a mechanical stretching bioreactor with potential application for cardiac tissue engineering and mechanobiology studies. The culture chamber housing and the motor housing were developed as functional permanent parts, aimed at fixing the culture chamber position and at guaranteeing motor watertightness, respectively. Innovative sample holder prototypes were specifically designed and 3D-printed for holding thin and soft biological samples during cyclic stretch culture. The manufactured components were tested in-house and in a cell biology laboratory. Moreover, tensile tests and finite element analysis were performed to investigate the gripping performance of the sample holder prototypes. All the components showed suitable performances in terms of design, ease of use, and functionality. Based on 3D printing, the bioreactor optimization was completely performed in-house, from design to fabrication, enabling customization freedom, strict design-to-prototype timing, and cost and time effective testing, finally boosting the bioreactor development process.

The Marchetti-Vicenzi's nail is an intramedullary device where six curved nails are kept straight by a closing ring in order to allow their insertion into the medullary canal of a long bone; in a following step, these nails stabilize the fracture due to the ring withdrawal and to the consequent elastic expansion of the nails. Pre-clinical testing of this sort of device is strongly advocated in order to be able to foresee their stability inside the medullary canal and to quantify their stiffening action on a broken bone. In this numerical work, an MB (Multi Body) model of the device has been developed, with the dual purpose of evaluating forces between the bone and the system components during its progressive opening and verifying the behavior of the stabilized bone when it undergoes external loading. Different solutions, for flexible body modeling (discretization with lumped parameters, "flexible body," "FE Part"), have been analyzed and compared in terms of accuracy of results and required computational resources. Contact parameters have been identified and criteria to simplify geometries and therefore to reduce simulation times have been given. Results have allowed to demonstrate how a moderate lateral force is able to dislocate the fracture and how the final position of the retention nut can be optimized. On the whole, a tool for the pre-clinical testing of elastic intramedullary nails has been given.

Purpose: This preliminary case series report sought to evaluate the efficacy of an immediate loading protocol for mandibular overdentures retained by two mini-implants with the outcome measures patient satisfaction, masticatory cycles, and masticatory efficiency at 1 year., Materials and Methods: A convenience sample of 11 patients was recruited, and the clinical protocol consisted of immediately loading two mini-implants (10 mm long and 2.4 mm or 2.9 mm in diameter) via a mandibular overdenture connection with Locator attachments. Each patient completed a satisfaction questionnaire and underwent masticatory cycle recordings and masticatory efficiency tests. Implant-related evaluations were carried out by assessing probing depth (PD), Plaque Index (PI), bleeding on probing (BOP), mobility, and pain. All tests and evaluations were carried out six times: before implant surgery (T 0 ), just before implant surgery with patient under anesthesia (T 1 ), following implant insertion with patient still under anesthesia (T 2 ), and at 3 months (T 3 ), 6 months (T 6 ), and 1 year (T 12 ) after implant insertion., Results: Implant survival rate was 95%, and statistically significant increases (P < .05) in masticatory cycle patterns, masticatory efficiency, comfort, stability, and phonetics were also recorded., Conclusion: The employed treatment protocol suggests promise as a viable treatment option that in the short term provides improved prosthesis stability, comfort, and function while decreasing surgical invasiveness. Long-term follow-up outcomes in larger patient sample studies will be required to confirm and validate the merits of this preliminary report.

At present, the current gold-standard for osteoporosis diagnosis is based on bone mineral density (BMD) measurement, which, however, has been demonstrated to poorly estimate fracture risk. Further parameters in the hands of the clinicians are represented by the hip structural analysis (HSA) variables, which include geometric information of the proximal femur cross section. The purpose of this study was to investigate the suitability of HSA parameters as additional hip fracture risk predictors. With this aim, twenty-eight three-dimensional patient-specific models of the proximal femur were built from computed tomography (CT) images and a sideways fall condition was reproduced by finite element (FE) analyses. A tensile or compressive predominance based on minimum and maximum principal strains was determined at each volume element and a risk factor (RF) was calculated. The power of HSA variables combinations to predict the maximum superficial RF values was assessed by multivariate linear regression analysis. The optimal regression model, identified through the Akaike information criterion (AIC), only comprises two variables: the buckling ratio (BR) and the neck-shaft angle (NSA). In order to validate the study, the model was tested on two additional patients who suffered a hip fracture after a fall. The results classified the patients in the high risk level, confirming the prediction power of the adopted model., (Copyright © 2018 by ASME.)

Finite element models in conjunction with adequate constitutive relations are pivotal in several physiological and medical applications related to both native and engineered tissues, allowing to predict the tissue response under various loading states. In order to get reliable results, however, the validation of the constitutive models is crucial. Therefore, the main purpose of this work is to provide an experimental-computational approach to the biomechanical investigation of soft tissues such as the dermis. This is accomplished by implementing and validating three widely adopted hyperelastic constitutive models (the Ogden, the Holzapfel, and the Gasser-Ogden-Holzapfel laws) supposed to be adequate to reproduce human reticular dermis mechanical behavior. Biaxial experimental data have represented the basis for the determination of the respective material parameters identified thanks to the definition of a cost function accounting for the discrepancy between experimental and predicted data. Afterwards, the experimental tests have been reproduced through finite element simulations. Hence, the constitutive laws have been validated comparing experimental and numerical outcomes in terms of displacements of four reference points and stress-strain relations. Hence, an experimental-numerical framework is proposed for the investigation of collagenous tissues, which could become more accurate with larger and independent experimental datasets. Graphical abstract ᅟ.