In this study, we report on a group of complementary human osteoblast in vitro test methods for the preclinical evaluation of 3D porous titanium surfaces. The surfaces were prepared by additive manufacturing (electron beam melting [EBM]) and plasma spraying, allowing the creation of complex lattice surface geometries. Physical properties of the surfaces were characterized by SEM and profilometry and 3D in vitro cell culture using human osteoblasts. Primary human osteoblast cells were found to elicit greater differences between titanium sample surfaces than an MG63 osteoblast‐like cell line, particularly in terms of cell survival. Surface morphology was associated with higher osteoblast metabolic activity and mineralization on rougher titanium plasma spray coated surfaces than smoother surfaces. Differences in osteoblast survival and metabolic activity on titanium lattice structures were also found, despite analogous surface morphology at the cellular level. 3D confocal microscopy identified osteoblast organization within complex titanium surface geometries, adhesion, spreading, and alignment to the biomaterial strut geometries. Mineralized nodule formation throughout the lattice structures was also observed, and indicative of early markers of bone in‐growth on such materials. Testing methods such as those presented are not traditionally considered by medical device manufacturers, but we suggest have value as an increasingly vital tool in efficiently translating pre‐clinical studies, especially in balance with current regulatory practice, commercial demands, the 3Rs, and the relative merits of in vitro and in vivo studies. Biotechnol. Bioeng. 2016;113: 1586–1599. © 2015 The Authors. Biotechnology and Bioengineering Published by Wiley Periodicals, Inc.

The model of PVP is considered suitable for preclinical in vivo studies, mimicking clinical application. All sheep recovered and completed a 6-month implantation period. There was no evidence of cement leakage into the vertebral foramen in the postmortem examination.

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IntroductionModifying the surface of load-bearing biomedical implants and inserts with patterned deposits of bioactive materials can support cell proliferation and orientation, improving direct biological fixation.1,2 Practically this results in increased functional service life of implants, and fewer revision surgeries for patients. Our patented template-assisted electrohydrodynamic atomisation (TAEA) spraying is a novel ambient temperature process that can be exploited to apply non-continuous deposits in a wide range of materials 3,4 and potentially incorporate biological agents and drugs during manufacture. In TAEA patterning, topography can be controlled by way of template choice. The biological benefit of such patterns, in particular preferential cellular response, over continuous coatings has also been established. 4 The development of TAEA for application on curved substrates is a natural progression of research, which has been exclusively on flat surfaces to date since its invention, 5,6 and is a key milestone towards commercial viability. This work aims to further develop TAEA for the application of bioceramic patterns onto curved titanium (Ti) substrates for the first time.TAEA processing uses ground electrode configurations and templates with electrohydrodynamic atomisation spraying 7 to deposit well-defined patterns onto a substrate surface (see Figure 1). The process consists of a nozzle (needle) that is connected to a high-voltage power supply and a ground electrode. A suspension Bioinspired electrohydrodynamic ceramic patterning of curved metallic substrates Nithyanandan et al.

Add to CartThe testing of novel biomaterials for percutaneous vertebroplasty depends on suitable animal models. The aim of this study was to develop ex vivo a reproducible and feasible model of percutaneous vertebroplasty, for ulterior application in vivo. A large animal model was used (Merino sheep), due to its translational properties. Vertebroplasty was performed under tactile and fluoroscopic control, through a bilateral modified parapedicular access in lumbar vertebrae (n=12). Care was taken in order to avoid disruption of the vertebral foramen. The average defect volume was 1234±240 mm 3