Vertebral body replacement is still a challenge for spine surgeons, burdened by 45 % complication rate, and posing a huge healthcare, societal, and also, economic impact. Among the complications, surgical site infections are particularly critical and difficult to treat. Poor bone regeneration and mechanical instability are further issues, also correlated with infections.
NANO-VERTEBRA project proposes a breakthrough approach to realize customized vertebral prosthesis to replace vertebral bodies affected by bone tumours or major traumatic events, specifically engineered to prevent infections and to promote fast and effective bone regeneration.
The approach will start from the nano-scale, but will encompass micro- and macro- scales, as geometrical structures and overall shape of the implants will also be customized to boost integration and to be patient specific.
Antibacterial efficacy will be maximized by nano-thick and nanostructured silver coatings, potentially capable of assuring a tailored ion-release, also engineered to prevent cytotoxicity and the development of resistant bacterial strains. To mitigate possible negative effects of silver onto bone cells, combinations with hydroxyapatite and bone apatite will be investigated as well, to release, in the peri-implant environment, ions capable of triggering host cells response. Surfaces nanostructuration will allow boosting adhesion, spreading and proliferation of cells onto the implants.
Optimization, customization and manufacturing of the implants will be achieved by a full value-chain including high resolution medical imaging, computer-assisted modeling and 3D printing with metal powders.
The new implants will be validated in-vitro and in-vivo, allowing developments from TRL3 to TRL5 and paving the way for clinical applications.
Objectives
The objective of NANO-VERTEBRA project is to design and develop a breakthrough innovation in vertebral replacement surgery, preventing the rise of infections while favoring integration of the implant in the host site by taking advantage also of the additive manufacturing technology. This will be achieved by developing a new, 3D-printed Ti6Al4V vertebral prosthesis, with tailored porosity, properly designed to be coated by a nanostructured silver thin film, preventing infection and simultaneously favoring bone reconstruction. NANO-VERTEBRA design will be patient-specific, based on medical imaging and 3D imaging reconstruction, thus ensuring a perfect fit into bone defect, mechanical stabilization under loading, and an enhanced bone growth. NANO-VERTEBRA prosthesis will be developed and manufactured within the project and its efficacy will be validated by in vitro and in vivo tests, paving the way for clinical applications.
To reduce infections and increase patients’ surgical options after spine resection, NANO-VERTEBRA proposes to implement a personalized vertebra prosthesis, by combining nanostructured antibacterial coatings and simultaneous optimization of implant architecture by 3D modeling and additive manufacturing technologies.