Multiple acoustic wave mode method has been proposed as a new modality in axial bone QUS. The new method is based on measurement of ultrasound velocity at different ratio of wavelength to the bone thickness, and taking into account both bulk and guided waves. It allows assessment of changes in both the material properties related to porosity and mineralization as well as the cortical thickness influenced by resorption from inner layers, which are equally important in diagnostics of osteoporosis and other bone osteopenia. Developed method was validated in model studies using a dual-frequency (100 and 500 kHz) ultrasound device. Three types of bone phantoms for long bones were developed and tested: (1) tubular specimens from polymer materials to model combined changes of material stiffness and cortical wall thickness; (2) layered specimens to model porosity in compact bone progressing from endosteum towards periosteum; (3) animal bone specimens with both cortical and trabecular components. Observed changes of the ultrasound velocity of guided waves at 100 kHz followed gradual changes in the thickness of the intact cortical layer. On the other hand, the bulk velocity at 500 kHz remained nearly constant at the different cortical layer thickness but was affected by the material stiffness. Similar trends were observed in phantoms and in fragments of animal bones.

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The last decade has seen a surge in the development of axial transmission QUS (Quantitative UltraSound) technologies for the assessment of long bones using various modes of acoustic waves. The condition of cortical bones and the development of osteoporosis are determined by numerous mechanical, micro-structural, and geometrical or macro-structural bone properties like hardness, porosity and cortical thickness. Such complex manifestations of osteoporosis require the evaluation of multiple parameters with different sensitivities to the various properties of bone that are affected by the disease. This objective may be achieved by using a multi-frequency ultrasonic examination The ratio of the acoustic wavelength to the cortical thickness can be changed by varying the frequency of the ultrasonic pulse propagating through the long bone that results in the change in composition of the induced wave comprised of a set of numerous modes of guided, longitudinal, and surface acoustic waves. The multi-frequency axial transmission QUS method developed at Artann Laboratories (Trenton, NJ) is implemented in the Bone Ultrasonic Scanner (BUSS). In the current version of the BUSS, a train of ultrasonic pulses with 60, 100, 400, 800, and 1200 kHz frequencies is used. The developed technology was tested on a variety of bone phantoms simulating normal, osteopenic, and osteoporotic bones. The results of this study confirm the feasibility of the multi-frequency approach for the assessment of the processes leading to osteoporosis.

The paper presents results of a clinical validation study of Bone UltraSonic Scanner (BUSS), a novel dual-frequency axial transmission ultrasonometer, developed by Artann Laboratories. Assessment of bone conditions is based on evaluating relative changes of the axial profiles of ultrasonic characteristics in long bones and utilizes bulk and guided acoustic waves. The objective of this study was to determine the ability of BUSS to discriminate osteoporosis development stages. A total of 93 menopausal and post-menopausal women divided into five groups from normal to advanced osteoporosis according to their DXA hip t-score were enrolled in the study. The 2D waveform profiles at low (0.1 MHz) and high (1 MHz) frequencies were obtained by scanning 15 cm along the proximal tibia.A multi-parametric linear classifier based on a set of the parameters derived from 2D acoustic waveform profiles has been developed. The efficiency of this classifier in differentiating osteoporosis from a normal sample was assessed using a Receiver Operating Characteristic (ROC) curve analysis. Based on the ROC analysis, BUSS demonstrated 76% sensitivity and 70% specificity to DXAidentified osteoporosis. The area under the ROC curve, which is a measure of how well a parameter can distinguish between the two diagnostic groups (diseased/normal) was 79.3%. The study confirmed BUSS's capability to discriminate between stages of bone atrophy and in particular to distinguish early changes induced by osteoporosis.

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