Additive manufacturing played a keyrole in investigating the precision of a recently-developed device that measures the elastic characteristics of the trabecular bone by simulating the application of loads on a virtual biopsy obtained from radiographic images of the proximal epiphyses in the patient’s hand fingers. The simulation results are combined in a Bone Structure Index (BSI), which has shown to be able to detect trabecular bone alterations due to osteoporosis or other pathological situations. In order to obtain a large number of measurements without having voluntary patients undergo unnecessary radiations, the precision assessment tests were carried out on a 3D-printed phantom hand, in which different mimicked trabecular structures (chips) were inserted. Each mimicked bone had a unique internal structure and density and was 3D-printed using radiopaque composite materials. Fifteen different chips were additively manufactured; 20 measurements were performed on each chip. BSI and BSI_T-score precision values were computed according to ISO 5725 and ISCD standards. For all the chips, no relationship was found between the mean [Formula: see text] and standard deviation [Formula: see text] of the measurements in each chip. The range of the 95% confidence interval ([Formula: see text]) was computed assuming the repeatability standard deviation [Formula: see text] as the known standard deviation of the measurement method (average of [Formula: see text] values): [Formula: see text], corresponding to [Formula: see text]. Least Significant Change was evaluated as well: [Formula: see text], corresponding to [Formula: see text]. The 95% confidence intervals are small when compared to the commonly-accepted diagnostic values, where a patient is classified as osteoporotic if T-score < −2.5, non-osteoporotic if T-score > -1 and osteopoenic if -2.5 < T-score < -1. The LSC results are in line with the requirements for the gold-standard osteoporosis diagnostic systems. Additive manufacturing made it possible to avoid irradiation of humans in this precision assessment.
Devices for training of healthcare specialists are widespread applications of 3D printing. BES TEST™ is an innovative test for the diagnosis of osteoporosis and similar bone diseases, based on mechanical simulations performed on a virtual biopsy of the patient’s fingers, obtained by radiograms. Operator training is performed on a phantom hand, which is held in place by a specifically-designed support, which was 3D printed using stereolithography (SLA) with Formlabs Tough V5™ resin. Our aim is twofold: (1) perform a mechanical characterization of the resin and (2) verify that the obtained material characteristics can be used for the design of 3D-printed parts, in particular the phantom hand support. Tensile tests were performed following ISO-527. FEM analyses were carried out on the support CAD model adopting the experimentally-obtained material properties. The calculated displacements were compared with those measured experimentally on the prototype, which was manufactured using the same 3D printing and post-curing parameters as the tensile samples. FEM and experimental results were in very good agreement (error < 5.5%): this confirms that, when studying the mechanical performance of SLA 3D-printed parts, it is good practice to characterize the resin using the same printing and post-curing parameters as the final part.
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