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Work Packages
Work Packages
WP1 - Synthesis of Key Chemicals
A comprehensive library of monomers, oligomers and polymers will be synthesized for use in the three domains of BoneFix, i.e. i) function as a scaffold, ii) biodefradable, and iii) antibacterial. This library will be optimized to provide all of the properties required for BoneFix, from the biodegradation of the bone scaffold, to the high rigidity of the fixation patch, and the anti-bacterial action of the hydrogel coating. The incorporation of allyl and thiol functionalities throughout this library will allow for rapid, on-demand curing of the domains by the surgeon via high energy visible light initiated thiol-ene chemistry.
Lead Participant: Royal Institute of Technology
WP2 - Bone Scaffold Material
The material from WP1 will be mixed with nanohydroxyapatite and biological motifs, such as bone marrow mesenchymal cells (MSC), to create a water based solution or suspension of appropriate viscosity that can be injected into the fracture site, bind to the bone, and remain in place until it is cured with High-Energy Visible (HEV) light. The cured material will be optimized for biodegradability over the timespan of bone healing, its ability to accelerate the bone healing process, its adhesion to bone surfaces, and its mechanical properties, as it will need to provide initial support to the bone fracture site as the rest of the Bone Restoration Patch (BRP) is applied.
Lead Participant: University of Bergen
WP3 - Adhesive Fixation Patch and Hydrogel Coating
A bone fixation patch and a hydrogel coating will be developed. The fixation patch will be formulated from (i) an adhesive; (ii) a primer, and (iii) beyond-state-of-the-art biodegradable origami membranes. The fixation patches will be optimized for bone adhesion, mechanical strength and biodegradability, while the hydrogel coating will be optimized for antibacterial efficacy against various bacterial strains, including Meticillinresistent Staphylococcus Aureus (MRSA).
Lead Participant: Royal Institute of Technology
WP4 - Biological Evaluation
The project will assess the biological competences of the BoneFix domains, their components and degradation products. Standard ISO norm will be used to test the cytocompatibility and biocompatibility of the leach out and degradation products of the domains on eukaryotic cell viability. The lack of negative influence of the primer layer, adhesive and membrane on human mesenchymal cells attachment, proliferation and osteogenic differentiation will be assed in vitro. An in vitro study will assess the activation of macrophages towards more pro- and anti-inflammatory phenotype on contact with the primer, adhesive and membrane layers.
Lead Participant: MINES Saint-Étienne
WP5 - Biomechanical Testing on ex vivo Fracture Models
The three domains of BoneFix will be brought together and applied in a hierarchal fashion to a variety of ex vivo animal bone fracture models, starting with a simple transverse finger fracture model before expanding in complexity and location to multi-fragmented fractures in wrist, ankle, maxillofacial and cranial models. The mechanical properties and adhesion of BoneFix will be analysed in a customized bioreactor that allows for assessment under physiological conditions and under the time scales required for bone healing.
Lead Participant: AO Research Institute Davos
WP6 - In vivo Animal Studies and ex vivo Human Cadaver Testing
The surgical application and performance of BoneFix will be further analysed in human cadaver models of several fractures. BoneFix will also be applied and evaluated in vivo in sheep. Bones with importance to orthopaedic trauma surgery will be fractured and treated with BoneFix, followed by either 18 weeks or 12 months of observation and imaging, followed by histology and biomechanical analysis. Bone segment transport models will also be tested to study BoneFix’s efficiency at facilitating the healing of bone defects and voids.
Lead Participant: Region Hovedstaden
WP7 - Pain Evaluation of BoneFix
The project will assess if implantation of BoneFix affects sensory function and locomotor peformance in vivo by assessment of pain-related behaviors and gait using a battery of behavioral tests. Sensory and sympathetic nerve fiber growth and innervation will be examined in the periosteum underlying and surrounding the Bone Restoration Patch (BRP) with immunohistochemistry. These assessements will first be performed after implantation of Bonefix on intact bone. Building on the results of WP6 acute and long-term pain (and motor function) related behavioural changes will be carefully evaluated in vivo after stabilization of fractures with BRP. The results will be compared to metal plate fixation.
Lead Participant: Karolinska Institute
WP8 - Project Management
In this work package we will ensure smooth and seamless progress and cohesive communication and cooperation between the consortium partners through every stage of the work plan.
Lead Participant: Royal Institute of Technology
WP9 - Dissemination and Exploitation
We will perform exploitation of the data from the prior work packages in order to propel the BoneFix technology towards future clinical trials and commercial exploitation. The surgical application of BoneFix will be refined with consultation from eventual end users in the medical community, product kits will be designed and training materials for surgeons will be developed. Our consortium will have established key relationships with influential actors in the medical community and investment field in order to ensure that BoneFix is able to continue its journey towards revolutionizing the internal fixation field.
Lead Participant: Biomedical Bonding
WP10 - Ethical approval
The consortium will work with an independent ethics advisor to ensure the highest ethical standards are met during this project. Of particular concern will the ethical approval needed for the various studies involving animals and the isolation of mesenchymal/stromal cells from human bone marrow.
Lead Participant: Royal Institute of Technology
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