Developing and Validating a Model of Humeral Stem Primary Stability, Intended for In Silico Clinical Trials.

In silico clinical trials (ISCT) can contribute to demonstrating a device's performance via credible computational models applied on virtual cohorts. Our purpose was to establish the credibility of a model for assessing the risk of humeral stem loosening in total shoulder arthroplasty, based on a twofold validation scheme involving both benchtop and clinical validation activities, for ISCT applications. A finite element model computing bone-implant micromotion (benchtop model) was quantitatively compared to a bone foam micromotion test (benchtop comparator) to ensure that the physics of the system was captured correctly.

[Enriching in vivo clinical trials with in silico models for orthopedic implants].

Clinical trials are used by the medical device industry to confirm products safety, performance, and clinical benefits. Traditional clinical studies typically follow a limited number of volunteers, which prevents capturing the full breath of patient demographics and implant use. New tools are required to overcome the limitations of traditional trials while fulfilling increasingly demanding regulatory requirements.

In Silico Clinical Trials in the Orthopedic Device Industry: From Fantasy to Reality?

The orthopedic device industry relies heavily on clinical evaluation to confirm the safety, performance, and clinical benefits of its implants. Limited sample size often prevents these studies from capturing the full spectrum of patient variability and real-life implant use. The device industry is accustomed to simulating benchtop tests with numerical methods and recent developments now enable virtual "in silico clinical trials" (ISCT).

Conventional finite element models estimate the strength of metastatic human vertebrae despite alterations of the bone's tissue and structure.

Introduction: Pathologic vertebral fractures are a major clinical concern in the management of cancer patients with metastatic spine disease. These fractures are a direct consequence of the effect of bone metastases on the anatomy and structure of the vertebral bone. The goals of this study were twofold.

Finite element models can reproduce the effect of nucleotomy on the multi-axial compliance of human intervertebral discs.

Finite element (FE) models can unravel the link between intervertebral disc (IVD) degeneration and its mechanical behaviour. Nucleotomy may provide the data required for model verification. Three human IVDs were scanned with MRI and tested in multiple loading scenarios, prior and post nucleotomy.

"Peroperative estimation of bone quality and primary dental implant stability".

Objectives: Dental implants are widely used to restore function and appearance. It may be essential to choose the appropriate drilling protocol and implant design in order to optimise primary stability. This could be achieved based on an assessment of the implantation site with respect to bone quality and objective biomechanical descriptors such as stiffness and strength of the bone-implant system.

Supervised learning for bone shape and cortical thickness estimation from CT images for finite element analysis.

Knowledge about the thickness of the cortical bone is of high interest for fracture risk assessment. Most finite element model solutions overlook this information because of the coarse resolution of the CT images. To circumvent this limitation, a three-steps approach is proposed.

Variogram-based evaluations of DXA correlate with vertebral strength, but do not enhance the prediction compared to aBMD alone.

Ancillary evaluation of spinal Dual-energy X-ray Absorptiometry (DXA) via variogram-based texture evaluation (e.g., Trabecular Bone Score) is used for improving the fracture risk assessment, despite no proven relationship with vertebral strength.

Integrating MRI-based geometry, composition and fiber architecture in a finite element model of the human intervertebral disc.

Intervertebral disc degeneration is a common disease that is often related to impaired mechanical function, herniations and chronic back pain. The degenerative process induces alterations of the disc's shape, composition and structure that can be visualized in vivo using magnetic resonance imaging (MRI). Numerical tools such as finite element analysis (FEA) have the potential to relate MRI-based information to the altered mechanical behavior of the disc.

Estimation of the effective yield properties of human trabecular bone using nonlinear micro-finite element analyses.

Micro-finite element ([Formula: see text]FE) analyses are often used to determine the apparent mechanical properties of trabecular bone volumes. Yet, these apparent properties depend strongly on the applied boundary conditions (BCs) for the limited size of volumes that can be obtained from human bones. To attenuate the influence of the BCs, we computed the yield properties of samples loaded via a surrounding layer of trabecular bone ("embedded configuration").

μCT-based trabecular anisotropy can be reproducibly computed from HR-pQCT scans using the triangulated bone surface.

The trabecular structure can be assessed at the wrist or tibia via high-resolution peripheral quantitative computed tomography (HR-pQCT). Yet on this modality, the performance of the existing methods, evaluating trabecular anisotropy is usually overlooked, especially in terms of reproducibility. We thus proposed to compare the TRI routine used by SCANCO Medical AG (Brüttisellen, Switzerland), the classical mean intercept length (MIL), and the grey-level structure tensor (GST) to the mean surface length (MSL), a new method for evaluating a second-order fabric tensor based on the triangulation of the bone surface.

Head-Neck Osteoplasty has Minor Effect on the Strength of an Ovine Cam-FAI Model: In Vitro and Finite Element Analyses.

Background: Osteochondroplasty of the head-neck region is performed on patients with cam femoroacetabular impingement (FAI) without fully understanding its repercussion on the integrity of the femur. Cam-type FAI can be surgically and reproducibly induced in the ovine femur, which makes it suitable for studying corrective surgery in a consistent way. Finite element models built on quantitative CT (QCT) are computer tools that can be used to predict femoral strength and evaluate the mechanical effect of surgical correction.

Not only stiffness, but also yield strength of the trabecular structure determined by non-linear µFE is best predicted by bone volume fraction and fabric tensor.

The micro-architecture of cancellous bone is considered a major determinant of the fracture risk. Yet, if morphometry tells about alterations of the trabecular network, its elastic behaviour is best described by bone volume fraction (BV/TV) and the fabric tensor, which gives the anisotropy of the trabecular structure. This remains to be proven for yield strength, the onset of bone failure.

The effective elastic properties of human trabecular bone may be approximated using micro-finite element analyses of embedded volume elements.

Boundary conditions (BCs) and sample size affect the measured elastic properties of cancellous bone. Samples too small to be representative appear stiffer under kinematic uniform BCs (KUBCs) than under periodicity-compatible mixed uniform BCs (PMUBCs). To avoid those effects, we propose to determine the effective properties of trabecular bone using an embedded configuration.

Identification of elastic properties of human patellae using micro-finite element analysis.

Current homogenized finite element (hFE) models of the patella lack a validated material law and mostly overlook trabecular anisotropy. The objective of this study was to identify the elastic constants of patellar trabecular bone. Using μCT scans of 20 fresh-frozen cadaveric patellae, we virtually extracted 200 trabecular cubes (5.

The Initial Slope of the Variogram, Foundation of the Trabecular Bone Score, Is Not or Is Poorly Associated With Vertebral Strength.

Trabecular bone score (TBS) rests on the textural analysis of dual-energy X-ray absorptiometry (DXA) to reflect the decay in trabecular structure characterizing osteoporosis. Yet, its discriminative power in fracture studies remains incomprehensible because prior biomechanical tests found no correlation with vertebral strength. To verify this result possibly owing to an unrealistic setup and to cover a wide range of loading scenarios, the data from three previous biomechanical studies using different experimental settings were used.

Finite element analysis predicts experimental failure patterns in vertebral bodies loaded via intervertebral discs up to large deformation.

Vertebral compression fractures are becoming increasingly common. Patient-specific nonlinear finite element (FE) models have shown promise in predicting yield strength and damage pattern but have not been experimentally validated for clinically relevant vertebral fractures, which involve loading through intervertebral discs with varying degrees of degeneration up to large compressive strains. Therefore, stepwise axial compression was applied in vitro on segments and performed in silico on their FE equivalents using a nonlocal damage-plastic model including densification at large compression for bone and a time-independent hyperelastic model for the disc.

Bone volume fraction and fabric anisotropy are better determinants of trabecular bone stiffness than other morphological variables.

As our population ages, more individuals suffer from osteoporosis. This disease leads to impaired trabecular architecture and increased fracture risk. It is essential to understand how morphological and mechanical properties of the cancellous bone are related.

Compressive strength of elderly vertebrae is reduced by disc degeneration and additional flexion.

Computer tomography (CT)-based finite element (FE) models assess vertebral strength better than dual energy X-ray absorptiometry. Osteoporotic vertebrae are usually loaded via degenerated intervertebral discs (IVD) and potentially at higher risk under forward bending, but the influences of the IVD and loading conditions are generally overlooked. Accordingly, magnetic resonance imaging was performed on 14 lumbar discs to generate FE models for the healthiest and most degenerated specimens.

Finite element analyses of human vertebral bodies embedded in polymethylmethalcrylate or loaded via the hyperelastic intervertebral disc models provide equivalent predictions of experimental strength.

Quantitative computer tomography (QCT)-based finite element (FE) models of vertebral body provide better prediction of vertebral strength than dual energy X-ray absorptiometry. However, most models were validated against compression of vertebral bodies with endplates embedded in polymethylmethalcrylate (PMMA). Yet, loading being as important as bone density, the absence of intervertebral disc (IVD) affects the strength.

Finite element based nonlinear normalization of human lumbar intervertebral disc stiffness to account for its morphology.

Disc degeneration, usually associated with low back pain and changes of intervertebral stiffness, represents a major health issue. As the intervertebral disc (IVD) morphology influences its stiffness, the link between mechanical properties and degenerative grade is partially lost without an efficient normalization of the stiffness with respect to the morphology. Moreover, although the behavior of soft tissues is highly nonlinear, only linear normalization protocols have been defined so far for the disc stiffness.

Human intervertebral disc stiffness correlates better with the Otsu threshold computed from axial T2 map of its posterior annulus fibrosus than with clinical classifications.

Degeneration of the intervertebral disc, sometimes associated with low back pain and abnormal spinal motions, represents a major health issue with high costs. A non-invasive degeneration assessment via qualitative or quantitative MRI (magnetic resonance imaging) is possible, yet, no relation between mechanical properties and T2 maps of the intervertebral disc (IVD) has been considered, albeit T2 relaxation time values quantify the degree of degeneration. Therefore, MRI scans and mechanical tests were performed on 14 human lumbar intervertebral segments freed from posterior elements and all soft tissues excluding the IVD.

Embedding of human vertebral bodies leads to higher ultimate load and altered damage localisation under axial compression.

Computer tomography (CT)-based finite element (FE) models of vertebral bodies assess fracture load in vitro better than dual energy X-ray absorptiometry, but boundary conditions affect stress distribution under the endplates that may influence ultimate load and damage localisation under post-yield strains. Therefore, HRpQCT-based homogenised FE models of 12 vertebral bodies were subjected to axial compression with two distinct boundary conditions: embedding in polymethylmethalcrylate (PMMA) and bonding to a healthy intervertebral disc (IVD) with distinct hyperelastic properties for nucleus and annulus. Bone volume fraction and fabric assessed from HRpQCT data were used to determine the elastic, plastic and damage behaviour of bone.

Removal of the cortical endplates has little effect on ultimate load and damage distribution in QCT-based voxel models of human lumbar vertebrae under axial compression.

Every year, 500,000 osteoporotic vertebral compression fractures occur in Europe. Quantitative computed tomography (QCT)-based finite element (FE) voxel models predict ultimate force whether they simulate vertebral bodies embedded in polymethylmethacrylate (PMMA) or vertebral sections with both endplates removed. To assess the effect of endplate removal in those predictions, non-linear FE analyses of QCT-based voxel models of human vertebral bodies were performed.