Novel 3D-printed foot orthoses with variable hardness: A comfort comparison to traditional orthoses

•A 3D-printed orthosis utilizing novel meta-structures is introduced.•Healthy subject comfort assessments of traditional and 3D-printed orthoses.•3D-printed and traditional orthoses achieved similar comfort levels. Custom foot orthoses are used to treat a variety of foot pathologies. However, orthotic production requires significant hands-on fabrication time and expertise to produce orthoses that are both comfortable and effective. This paper introduces a novel 3D printed orthosis and fabrication method that utilizes custom architectures to produce variable-hardness regions. These novel orthoses are compared to traditionally fabricated orthoses during a 2-week user comfort study. Twenty (n = 20) male volunteers underwent orthotic fitting for both traditional and 3D-printed foot orthoses prior to engaging in treadmill walking trials and 2 weeks of wear. Each participant undertook a regional comfort, acceptance, and comparison analysis of the orthoses at three time points throughout the study (0, 1, and 2 weeks). Both the 3D-printed and the traditionally fabricated foot orthoses demonstrated statistically significant increases in comfort when compared to the factory fabricated shoe insert. Additionally, the two orthosis groups were not significantly different from each other in comfort rankings both regionally and overall at any time point. The similar comfort achieved by the 3D-printed orthosis to the traditionally fabricated orthosis after 7 days and 14 days emphasizes the potential of the future use of the more reproducible and adaptable 3D-printed orthosis manufacturing methodology.