Background: In clinical practice, specific customization is needed to address foot pathology, which must be disease and patient-specific. To date, the traditional methods for manufacturing custom functional Foot Orthoses (FO) are based on plaster casting and manual manufacturing, hence orthotic therapy depends entirely on the skills and expertise of individual practitioners. This makes the procedures difficult to standardize and replicate, as well as expensive, time-consuming and material-wasting, as well as difficult to standardize and replicate. 3D printing offers new perspectives in the development of patient-specific orthoses, as it permits addressing all the limitations of currently available technologies, but has been so far scarcely explored for the podiatric field, so many aspects remain unmet, especially for what regards customization, which requires the definition of a protocol that entails all stages from patient scanning to manufacturing.
Methods: A feasibility study was carried out involving interdisciplinary cooperation between industrial engineers and podiatrists. To that end: (i) For patient-specific data acquisition, 3D scanning of the foot is compared to traditional casting. (ii) a modelling GD workflow is first created to design a process permitting easy creations of customized shapes, enabling the end user (the podiatrist) to interactively customize the orthoses. Then, (iii) a comparison is made between different printing materials, in order to reproduce the same mechanical behavior shown by standard orthoses. To do this, the mechanical properties of standard materials (Polycarbonate sheets), cut and hand-shaped, are compared with four groups of 3D printed samples: poly(ethylene glycol) (PETG), poly(acrylonitrile-butadiene.styrene) (ABS), polycarbonate (PC) and poly(lactic acid) (PLA) obtained by Fused Filament Fabrication (FFF).
Results: Differences found between the foot plaster model obtained with the plaster slipper cast in a neutral position and the model of the real foot obtained with 3D scanning in the same position can be ascribed to the non-stationarity of the patient during the acquisition process, and were limited by a locking system with which no substantial differences in the almost entire sole of the foot scan were observed.
Conclusions: Using the designed GD workflow, podiatrists with limited CAD skills can easily design and interactively customize foot orthoses to adapt them to the patients' clinical needs. 3D printing enables the complex shape of the orthoses to be reproduced easily and quickly. Compared to Polycarbonate sheets (gold standard), all the printed materials were less deformable and reached lower yield stress for comparable deformation. No modifications in any of the materials as a result of printing process were observed.
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