Valentina Danesi

Digital volume correlation can be used to estimate local strains in natural and augmented vertebrae: an organ-level study

Digital Volume Correlation (DVC) has become popular for measuring the strain distribution inside bone structures. A number of methodological questions are still open: the reliability of DVC to investigate augmented bone tissue, the variability of the errors between different specimens of the same type, the distribution of measurement errors inside a bone, and the possible presence of preferential directions. To address these issues, five augmented and five natural porcine vertebrae were subjected to repeated zero-strain micro-CT scan (39μm voxel size). The acquired images were processed with two independent DVC approaches (a local and a global one), considering different computation sub-volume sizes, in order to assess the strain measurement uncertainties. The systematic errors generally ranged within ±100 microstrain and did not depend on the computational sub-volume. The random error was higher than 1000 microstrain for the smallest sub-volume and rapidly decreased: with a sub-volume of 48 voxels the random errors were typically within 200 microstrain for both DVC approaches. While these trends were rather consistent within the sample, two individual specimens had unpredictably larger errors. For this reason, a zero-strain check on each specimen should always be performed before any in-situ micro-CT testing campaign. This study clearly shows that, when sufficient care is dedicated to preliminary methodological work, different DVC computation approaches allow measuring the strain with a reduced overall error (approximately 200 microstrain). Therefore, DVC is a viable technique to investigate strain in the elastic regime in natural and augmented bones.

Reproducible reference frame for in vitro testing of the human vertebrae

Definition of an anatomical reference frame is necessary for in vitro biomechanical testing. Nevertheless, there is neither a clear recommendation, nor consensus in the literature concerning an anatomical reference frame for in vitro testing of the human vertebrae. The scope of this work is to define a reference frame for the human vertebrae for in vitro applications. The proposed anatomical reference frame relies on alignment of well-defined points on the endplates, and on two landmarks on the posterior wall. The repeatability of the proposed alignment procedure has been tested in vitro by 5 operators, on 7 specimens. Furthermore, the feasibility and repeatability of the proposed procedure was assessed in silico, using CT-scans of the same specimens. Variations between operators were slightly larger than between repetitions by the same operator. The intra-operator in vitro repeatability was better than 3° for all angles. The inter-operator in vitro repeatability was better than 9° for all angles. The lateral tilt was the most repeatable angle, while anterior-posterior tilt was least repeatable. The repeatability when alignment was performed in silico on CT-scans was comparable to that obtained in vitro, on the physical specimens. This is the first time than an anatomical reference frame is formally defined and validated for the human vertebrae. The adoption of this reference frame will provide more reproducible alignment of the specimens and of the test load. This will enable better in vitro biomechanical tests, and comparisons with numerical models.

Micro finite element models of the vertebral body: validation of local displacement predictions

The estimation of local and structural mechanical properties of bones with micro Finite Element (microFE) models based on Micro Computed Tomography images depends on the quality bone geometry is captured, reconstructed and modelled. The aim of this study was to validate microFE models predictions of local displacements for vertebral bodies and to evaluate the effect of the elastic tissue modulus on model’s predictions of axial forces. Four porcine thoracic vertebrae were axially compressed in situ, in a step-wise fashion and scanned at approximately 39μm resolution in preloaded and loaded conditions. A global digital volume correlation (DVC) approach was used to compute the full-field displacements. Homogeneous, isotropic and linear elastic microFE models were generated with boundary conditions assigned from the interpolated displacement field measured from the DVC. Measured and predicted local displacements were compared for the cortical and trabecular compartments in the middle of the specimens. Models were run with two different tissue moduli defined from microindentation data (12.0GPa) and a back-calculation procedure (4.6GPa). The predicted sum of axial reaction forces was compared to the experimental values for each specimen. MicroFE models predicted more than 87% of the variation in the displacement measurements (R2 = 0.87–0.99). However, model predictions of axial forces were largely overestimated (80–369%) for a tissue modulus of 12.0GPa, whereas differences in the range 10–80% were found for a back-calculated tissue modulus. The specimen with the lowest density showed a large number of elements strained beyond yield and the highest predictive errors. This study shows that the simplest microFE models can accurately predict quantitatively the local displacements and qualitatively the strain distribution within the vertebral body, independently from the considered bone types.

Application of digital volume correlation to study the efficacy of prophylactic vertebral augmentation

BACKGROUND Prophylactic augmentation is meant to reinforce the vertebral body, but in some cases it is suspected to actually weaken it. Past studies only investigated structural failure and the surface strain distribution. To elucidate the failure mechanism of the augmented vertebra, more information is needed about the internal strain distribution. This study aims to measure, for the first time, the full-field three-dimensional strain distribution inside augmented vertebrae in the elastic regime and to failure. METHODS Eight porcine vertebrae were prophylactically-augmented using two augmentation materials. They were scanned with a micro-computed tomography scanner (38.8μm voxel resolution) while undeformed, and loaded at 5%, 10%, and 15% compressions. Internal strains (axial, antero-posterior and lateral-lateral components) were computed using digital volume correlation. FINDINGS For both augmentation materials, the highest strains were measured in the regions adjacent to the injected cement mass, whereas the cement-interdigitated-bone was less strained. While this was already visible in the elastic regime (5%), it was a predictor of the localization of failure, which became visible at higher degrees of compression (10% and 15%), when failure propagated across the trabecular bone. Localization of high strains and failure was consistent between specimens, but different between the cement types. INTERPRETATION This study indicated the potential of digital volume correlation in measuring the internal strain (elastic regime) and failure in augmented vertebrae. While the cement-interdigitated region becomes stiffer (less strained), the adjacent non-augmented trabecular bone is affected by the stress concentration induced by the cement mass. This approach can help establish better criteria to improve vertebroplasty.

A PRELIMINARY IN VITRO BIOMECHANICAL EVALUATION OF PROPHYLACTIC CEMENT AUGMENTATION OF THE THORACOLUMBAR VERTEBRAE

In this paper, the biomechanical effectiveness of prophylactic augmentation in preventing fracture was investigated. In vitro biomechanical tests were performed to assess which factors make prophylactic augmentation effective/ineffective in reducing fracture risk. Nondestructive and destructive in vitro tests were performed on isolated osteoporotic vertebrae. Five sets of three-adjacent-vertebrae were tested. The central vertebra of each triplet was tested in the natural condition (control) non-destructively (axial-compression, torsion) and destructively (axial-compression). The two adjacent vertebrae were first tested nondestructively (axial-compression, torsion) pre-augmentation; prophylactic augmentation (uni- or bi-pedicular access) was then performed delivering 5.04mL to 8.44mL of acrylic cement by means of a customized device; quality of augmentation was CT-assessed; the augmented vertebrae were re-tested nondestructively (axial-compression, torsion), and eventually loaded to failure (axial-compression). Vertebral stiffness was correlated with the first-failure, but not with ultimate failure. The force and work to ultimate failure in prophylactic-augmented vertebrae was consistently larger than in the controls. However, in some cases the first-failure force and work in the augmented vertebrae were lower than for the controls. To investigate the reasons for such unpredictable results, the correlation with augmentation quality was analyzed. Some augmentation parameters seemed more correlated with mechanical outcome (statistically not-significant due to the limited sample size): uni-pedicular access resulted in a single cement mass, which tended to increase the force and work to first- and ultimate failure. The specimens with the highest strength and toughness also had: at least 25% cement filling, cement mass shifted anteriorly, and cement-endplate contact. These findings seem to confirm that prophylactic augmentation may aid reducing the risk of fracture. However, inadequate augmentation may have detrimental consequences. This study suggests that, to improve the strength of the augmented vertebrae, more attention should be dedicated to the quality of augmentation in terms of amount and position of the injected cement.

Effect of the In Vitro Boundary Conditions on the Surface Strain Experienced by the Vertebral Body in the Elastic Regime

The vertebral strength and strain can be assessed in vitro by both using isolated vertebrae and sets of three adjacent vertebrae (the central one is loaded through the disks). Our goal was to elucidate if testing single-vertebra-specimens in the elastic regime provides different surface strains to three-vertebrae-segments. Twelve three-vertebrae sets were extracted from thoracolumbar human spines. To measure the principal strains, the central vertebra of each segment was prepared with eight strain-gauges. The sets were tested mechanically, allowing comparison of the surface strains between the two boundary conditions: first when the same vertebra was loaded through the disks (three-vertebrae-segment) and then with the endplates embedded in cement (single-vertebra). They were all subjected to four nondestructive tests (compression, traction, torsion clockwise, and counterclockwise). The magnitude of principal strains differed significantly between the two boundary conditions. For axial loading, the largest principal strains (along vertebral axis) were significantly higher when the same vertebra was tested isolated compared to the three-vertebrae-segment. Conversely, circumferential strains decreased significantly in the single vertebrae compared to the three-vertebrae-segment, with some variations exceeding 100% of the strain magnitude, including changes from tension to compression. For torsion, the differences between boundary conditions were smaller. This study shows that, in the elastic regime, when the vertebra is loaded through a cement pot, the surface strains differ from when it is loaded through the disks. Therefore, when single vertebrae are tested, surface strain should be taken with caution.

MECHANICAL PROPERTIES OF THE HUMAN METATARSAL BONES

Despite the incidence of metatarsal fractures and the associated risk of significant disability, little is known about the biomechanical properties (strength and stiffness) of metatarsal bones. In most cases a single metatarsal bone (first, second and fifth) has been investigated. An extensive investigation of the biomechanical properties of the metatarsal bones is essential in the understanding and prevention of metatarsal injuries. Entire sets of metatarsal bones from four feet were tested. The first foot was used to fine-tune the testing set-ups. To measure the stiffness, each metatarsal bone was subjected to non-destructive four-point-bending in the sagittal and transverse planes, axial compression and torsion. Strain was measured at two locations. To measure the strength, each metatarsal bone was tested to failure in torsion. Significant differences (p < 0.0001) existed among the stiffness of the five metatarsal bones: (i) in torsion the first metatarsal bone was 2–3 times stiffer than the others; (ii) in four-point-bending and axial compression this difference was less pronounced than in torsion; (iii) differences were smaller among the other metatarsal bones; (iv) the second metatarsal bone was less stiff than the third and fourth in bending. The second, third and fourth metatarsal bones were stiffer in the sagittal than in the transverse plane (p < 0.0001). Conversely, there was no significant difference between the two planes of bending for the first and fifth bones. During destructive testing, all metatarsal bones exhibited a linear elastic behavior and brittle failure. The torsional strength at failure ranged between 1.9 Nm and 6.9 Nm. The first metatarsal bone was stronger than all the others. Stiffness in different loading conditions and failure were measured and compared for all metatarsal bones. These data corroborate previous biomechanical studies concerning the role and load sharing of the different metatarsal bones.

Re-use of explanted osteosynthesis devices: A reliable and inexpensive reprocessing protocol

INTRODUCTION Orthopaedic surgical treatments emphasizing immobilization using open reduction and internal fixation with osteosynthesis devices are widely accepted for their efficacy in treating complex fractures and reducing permanent musculoskeletal deformity. However, such treatments are profoundly underutilized in low- and middle-income countries (LMIC), partially due to inadequate availability of the costly osteosynthesis devices. Orthopaedic surgeons in some LMIC regularly re-use osteosynthesis devices in an effort to meet treatment demands, even though such devices typically are regulated for single-use only. The purpose of this study is to report a reprocessing protocol applied to explanted osteosynthesis devices obtained at a leading trauma care hospital. METHODS Explanted osteosynthesis devices were identified through a Register of Explanted Orthopaedic Prostheses. Guidelines to handle ethical issues were approved by the local Ethical Committee and informed patient consent was obtained at the time of explant surgery. Primary acceptance criteria were established and applied to osteosynthesis devices explanted between 2005 and 2008. A rigorous protocol for conducting decontamination and visual inspection based on specific screening criteria was implemented using simple equipment that is readily available in LMIC. RESULTS A total of 2050 osteosynthesis devices, including a large variety of plates, screws and staples, were reprocessed using the decontamination and inspection protocols. The acceptance rate was 66%. Estimated labour time and implementation time of the protocol to reprocess a typical osteosynthesis unit (1 plate and 5 screws) was 25 min, with an estimated fixed cost (in Italy) of €10 per unit for implementing the protocol, plus an additional €5 for final sterilization at the end-user hospital site. DISCUSSION This study was motivated by the treatment demands encountered by orthopaedic surgeons providing medical treatment in several different LMIC and their need for access to basic osteosynthesis devices. The rigorous decontamination protocol and generalized inspection criteria proved useful for efficiently screening a large volume of devices. Given that re-used osteosynthesis devices can yield satisfactory results, this study addresses potential complications of re-used devices and valid concerns that relate to patient safety. Implementing this defined reprocessing protocol into existing re-use practises in LMIC helps to limit the risks of inadequate sterilization and structural failure without adding additional risks to patients receiving re-used devices.

METHODS FOR THE CHARACTERIZATION OF THE LONG-TERM MECHANICAL PERFORMANCE OF CEMENTS FOR VERTEBROPLASTY AND KYPHOPLASTY: CRITICAL REVIEW AND SUGGESTIONS FOR TEST METHODS

There is a growing interest towards bone cements for use in vertebroplasty and kyphoplasty, as such spine procedures are becoming more and more common. Such cements feature different compositions, including both traditional acrylic cements and resorbable and bioactive materials. Due to the different compositions and intended use, the mechanical requirements of cements for spinal applications differ from those of traditional cements used in joint replacement. Because of the great clinical implications, it is very important to assess their long-term mechanical competence in terms of fatigue strength and creep. This paper aims at offering a critical overview of the methods currently adopted for such mechanical tests. The existing international standards and guidelines and the literature were searched for publications relevant to fatigue and creep of cements for vertebroplasty and kyphoplasty. While standard methods are available for traditional bone cements in general, no standard indicates specific methods ...