Experimental assessment of pelvis slipping during postless traction for orthopaedic applications.

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.

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.

Development and validation of cryopreserved or freeze-dried decellularized human dermis for transplantation.

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.

Bone Plates Runout Prediction Through Tensile Strength and Geometric Properties for Regulatory Mechanical Testing.

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 R2 coefficients above 0.95 in the runout condition, with potential impact in reducing the experimental tests needed for the CE marking of bone plates.

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.

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.

Novel Load Systems for In Vitro Testing of Biomaterials and Medical Devices.

In the mechanical characterization of materials or devices, the real load conditions to which they will be subjected in their operational environment must often be simulated by starting from the availability of universal testing machines [...].

Decellularized cryopreserved human pericardium: a validation study towards tissue bank practice.

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.

In Silico Meta-Analysis of Boundary Conditions for Experimental Tests on the Lumbar Spine.

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.

Multibody Computer Model of the Entire Equine Forelimb Simulates Forces Causing Catastrophic Fractures of the Carpus during a Traditional Race.

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.

Are the forearm muscles excited equally in different, professional piano players?

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.

Kinematics and kinetics comparison of ultra-congruent versus medial-pivot designs for total knee arthroplasty by multibody analysis.

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.

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.

Improving the Hip Fracture Risk Prediction with a Statistical Shape-and-Intensity Model of the Proximal Femur.

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.

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.

Corrigendum: Surgical Treatments for Canine Anterior Cruciate Ligament Rupture: Assessing Functional Recovery Through Multibody Comparative Analysis.

[This corrects the article DOI: 10.3389/fbioe.2019.00180.].

Design of a loading system for cyclic test on sutured organs.

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.