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The use of external fixation devices is considered a valuable approach for the treatment of bone fractures, providing proper alignment to fractured fragments and maintaining fracture stability during the healing process. The need for external fixation devices has increased due to an aging population and increased trauma incidents. The design and fabrication of external fixations are major challenges since the shape and size of the defect vary, as well as the geometry of the human limb. This requires fully personalized external fixators to improve its fit and functionality. This paper presents a methodology to design personalized lightweight external fixator devices for additive manufacturing. This methodology comprises data acquisition, Computer tomography (CT) imaging analysis and processing, Computer Aided Design (CAD) modelling and two methods (imposed predefined patterns and topology optimization) to reduce the weight of the device. Finite element analysis with full factorial design of experiments were used to determine the optimal combination of designs (topology optimization and predefined patterns), materials (polylactic acid, acrylonitrile butadiene styrene, and polyamide) and thickness (3, 4, 5 and 6 mm) to maximize the strength and stiffness of the fixator, while minimizing its weight. The optimal parameters were found to correspond to an external fixator device optimized by topology optimization, made in polylactic acid with 4 mm thickness.

Metallic bone plates are commonly used as a medical implant to treat bone fractures. The gold standard materials for these implants are biocompatible 316L stainless steel, cobalt chromium, titanium and its alloys (e.g. CoCrMo and Ti6Al4V). However, the main disadvantage of these implants is the material stiffness mismatch between the implant and bone. This mismatch may negatively affect the biological processes in bone healing. This paper investigates topology optimization to produce plates with reduced equivalent stiffness and the fabrication of optimised plate designs using an electron beam melting (EBM) system. Nonpost-processed EBM plates were assessed against commercially available bone fixation plates in terms of mechanical and biological characteristics. Results show that some redesigned produced plates present mechanical properties similar to the cortical bone and that there is no need to post-process the produced plates in order to establish a good biological bonding with the surrounding tissue.

Orthoses (exoskeletons and fracture fixation devices) enhance users' ability to function and improve their quality of life by supporting alignment correction, restoring mobility, providing protection, immobilisation and stabilisation. Ideally, these devices should be personalised to each patient to improve comfort and performance. Production costs have been one of the main constraints for the production of personalised orthoses. However, customisation and personalisation of orthoses are now possible through the use of additive manufacturing. This paper presents the current state of the art of additive manufacturing for the fabrication of orthoses, providing several examples, and discusses key research challenges to be addressed to further develop this field.

The design of commercially available fixation plates and the materials used for their fabrication lead to the plates being stiffer than bone. Consequently, commercial plates are prone to induce bone stress shielding. In this study, three-dimensional fixation plates are designed using topology optimisation aiming to reduce the risk of bone stress shielding. Fixation plate designs were optimised by minimising the strain energy for three levels of volume reduction (i.e. 25%, 45% and 75%). To evaluate stress shielding, changes in bone stress due to the different fixation plate designs were determined on the fracture plane of an idealised shaft of a long bone under a four-point bending load considering the effect of a patient walking with crutches of a transverse fractured tibia. Topology optimisation is a viable approach to design less stiff plates with adequate mechanical strength considering high volume reductions, which consequently increased the stress transferred to the bone fracture plane minimising bone stress shielding. 4 Manchester University NHS Foundation Trust, Manchester, UK Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Commercially available fixation plates are built using metallic biocompatible materials such as titanium and its alloys and stainless steel. However, these plates show a stiffness mismatch comparing to bone, leading to stress shielding and bone loss. In this paper, we investigate the combined use of topology optimisation and additive manufacturing to print fixation plates with reduced stiffness and improved biological performance. Ti-6Al-4 V plates were topology optimised considering different loading conditions and volume reductions and printed using electron beam melting and selective laser melting. The effect of processing conditions on the mechanical properties, microhardness, wear resistance and surface roughness was analysed. Results show acceptable wear resistance values for a medical device and a reduction of stress shielding by increasing volume reduction. It is also shown that no polishing is required as 3D printed plates are able to support cell attachment and proliferation. In comparison to commercial plates, 3D printed ones show significantly better biological performance. For the same design, SLM plates present higher mechanical properties, while EBM plates present better cell attachment and proliferation.

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