Objectives. Bioresorbable orthopaedic devices with calcium phosphate (CaP) fillers are commercially available on the assumption that increased calcium (Ca) locally drives new bone formation, but the clinical benefits are unknown. Electron beam (EB) irradiation of polymer devices has been shown to enhance the release of Ca. The aims of this study were to: 1) establish the biological safety of EB surface-modified bioresorbable devices; 2) test the release kinetics of CaP from a polymer device; and 3) establish any subsequent beneficial effects on bone repair in vivo. Methods. ActivaScrew Interference (Bioretec Ltd, Tampere, Finland) and poly(L-lactide-co-glycolide) (PLGA) orthopaedic screws containing 10 wt% β-tricalcium phosphate (β-TCP) underwent EB treatment. In vitro degradation over 36 weeks was investigated by recording mass loss, pH change, and Ca release. Implant performance was investigated in vivo over 36 weeks using a lapine femoral condyle model. Bone growth and osteoclast activity were assessed by histology and enzyme histochemistry. Results. Calcium release doubled in the EB-treated group before returning to a level seen in untreated samples at 28 weeks. Extensive bone growth was observed around the perimeter of all implant types, along with limited osteoclastic activity. No statistically significant differences between comparative groups was identified. Conclusion. The higher than normal dose of EB used for surface modification did not adversely affect tissue response around implants in vivo. Surprisingly, incorporation of β-TCP and the subsequent accelerated release of Ca had no significant effect on in vivo implant performance, calling into question the clinical evidence base for these commercially available devices. Cite this article: I. Palmer, S. A. Clarke, F. J Buchanan. Enhanced release of calcium phosphate additives from bioresorbable orthopaedic devices using irradiation technology is non-beneficial in a rabbit model: An animal study. Bone Joint Res 2019;8:266–274. DOI: 10.1302/2046-3758.86.BJR-2018-0224.R2

Background. Medical applications of nanotechnology are promising because it allows the surface of biomaterial to be tailored to optimise the interfacial interaction between the biomaterial and its biological environment. Such interfaces are of interest in the domain of orthopaedic surgery as they could have anti-bacterial functions or could be used as drug delivery systems. The development of orthopaedics is moving towards better integration of biology in implants and surgical techniques, but the mechanical properties of implanted materials are still important for orthopaedic applications. During clinical implantation, implants are subjected to large mechanical stresses. In order to obtain the best performance during clinical use, mechanical properties of implants need to be investigated and understood. Method. We modified the topography of commercial titanium orthopaedic screws using electrochemical anodization in a 0.4 wt% hydrofluoric acid solution to produce titanium dioxide nanotube layers. The morphology of the nanotube layers were characterised using scanning electron microscopy. The mechanical properties of the nanotube layers were investigated by screwing and unscrewing an anodized screw into several different types of human bone while the torsional force applied to the screwdriver was measured using a torque screwdriver. The range of torsional force applied to the screwdriver was between 5 and 80 cN·m. Independent assessment of the mechanical properties of the same surfaces was performed on simple anodized titanium foils using a triboindenter. Results. The fabricated nanotube layers can resist mechanical stresses close to those found in clinical situations. Conclusion. The mechanical characteristics of this surface treatment appear to be sufficiently robust to withstand realistic clinical operating conditions that our in vitro experiments were designed to simulate. These results show that the nanotube layers remain intact after the implantation process. This may allow for the exciting possibility of nanotubes being loaded with molecules. Level of Evidence. II

Currently available fracture fixation devices that were originally developed for healthy bone are often not effective for patients with osteoporosis. Resulting outcomes are unsatisfactory, with longer recovery times, often requiring re-surgery for failed cases. One major issue is the design of bone screws, which can loosen or pull-out from osteoporotic bone. Design improvements are possible, but the development of new screws is a lengthy and expensive process due to the manufacture of the complex geometry involved. The aim of this research was to validate our currently available 3D printing technology in the design, manufacture and testing of screws. Three standard wood screw designs were reverse-engineered using computational modelling and then fabricated in polymeric resin using 3D rapid prototyping on a Stereolithography (SLA) machine. The original metal screws and the 3D screws (n=5 of each) were then inserted into a synthetic bone block (Sawbones, PCF5) representing the mechanical properties of severely osteoporotic cancellous bone. Pull-out tests were conducted in accordance with ASTM 543-13. The three metal screws exhibited pull-out strengths of 125, 74 and 118 N respectively. The 3D printed screws by comparison showed pull-out strengths approximately 15–20 % lower than their metal counterparts. However, when the results were normalised to the material tested, showing the relative changes to the first design, the pattern of results in the metal and 3D printed groups were almost identical (within 3 % of each other), showing excellent correlation. This study is the first to show that 3D Rapid Prototyping can be used in the pre-clinical testing of orthopaedic screws. The methodology provides a cheaper, faster development process for screws, allowing huge scope for development and improvement. Future work will include expanding the study to include more screw configurations as well as testing in higher density foams to compare performance in healthier bone

Purpose: The purpose of this study was to quantify cortical bone screw pullout force and extraction shear stress in synthetic femurs. The use of commercially available synthetic bone analogues has grown increasingly in the literature. They are commonly employed as human femur surrogates for use in biomechanical assessment of orthopaedic fracture fixation devices. However, whether screw purchase is the same in synthetic products as in human bone has not been addressed previously in the literature. Methods: Three large left adult Third Generation Composite Femurs or 3GCF’s (Model #3306, Pacific Research Labs, Vashon, Washington, USA) were mounted in a test jig that allowed exposure of their cortical mid-shaft area. Standard 3.5 mm (40 mm length) orthopaedic bicortical screws (Synthes, Paoli, PA, USA) were inserted at 5 locations in each specimen along their diaphyseal length and extracted using an Instron test machine. The pullout strengths were recorded and extraction shear stresses were calculated. The tests were repeated on 3 other synthetic femurs using 4.5 mm (40 mm length) bicortical screws. The results were compared to existing adult human cadaveric and animal data from the literature. Results: For 3.5 mm screws, pullout forces were measured (3.88 to 4.97 kN) and the effective extraction shear stresses calculated (23.70 to 33.99 MPa). The extraction shear stresses were in the range of that found in the literature on human cadaveric femurs and tibias (24.4 to 38.8 MPa). Similarly, for 4.5 mm screws, pullout forces were obtained (5.21 to 7.47 kN) and the extraction shear stresses computed (26.04 to 34.76 MPa). This overlapped with previously published extraction shear stress results for human femurs and tibias (15.9 to 38.9 MPa). Conclusions: The commercially available 3GCF femurs provide a satisfactory biomechanical analogue to human femurs and tibias at the screw-bone interface during axial screw pullout