PLATFORM PROJECT: materials, processes and advanced technologies for the implementation, monitoring and functional validation of osteotomy interventions

Project objectives

The project, taking advantage of the inclusion of different levels of expertise, specifically aims to validate at an industrial level an innovative platform that allows the creation of a patient-specific path, which includes the different phases (assessment, treatment and rehabilitation) in which the execution of an optimized surgical procedure for osteotomy (in this specific case, tibial osteotomy) is articulated. This platform will prove capable of quantifying functional needs, minimizing the invasiveness of the operation and monitoring the rehabilitation process, thus drastically reducing recovery times and complications associated with the operation itself.

The results that will be achieved through the implementation of the diagnostic-therapeutic path proposed by the PLATFORM project will concern:

1. Creation of a Surgery Planning Software (SPC) platform to support the
   surgeon who, starting from the available pre-operative images such as RX (2D), and/or MRI, CT (3D) allows optimization of the choice, positioning and type of implant. The SPC platform will also allow a simulation of the surgical procedure with indication of the clinical and biomechanical output for the subsequent phase of creation of the bioactive graft and information output for the active guidance system.
2. Creation of the personalized medical titanium graft to be used in the surgical procedure using electron beam fusion (EBM) technology. The internal trabeculation will be derived from the patient's anatomical and biometric data. The algorithms used for trabecular reconstruction will involve advanced mathematical methods such as non-Euclidean fractal geometry and stochastic differential calculus.
3. Synthesis of ceramic and glass-ceramic nanomaterials to be used as coatings to increase the
   bioactivity of titanium grafts. Using sol-gel techniques, bioactive nanoparticles will be produced,
   osteoconductive and antimicrobial for the surface decoration of the constructs manufactured using EBM technology referred to in point 2. The nanoparticles will be composed of bioactive glasses modified by the addition of appropriately selected doping elements to provide osteoconductive and antimicrobial properties, stimulating rapid regeneration and neo- formation of bone tissue at the interface with the graft and minimizing the risk of infections.
4. Creation of the intraoperative guide system to ensure compliance with the pre-operative planning by optimizing the instruments and implantable components (screws-plates) together with the intraoperative guides all obtained with EBM technology and/or with additive manufacturing on biopolymeric materials.
   5. Definition of a protocol for functional evaluation to be applied during postoperative follow-up. The protocol will make use of a kinematics evaluation system controlled via dedicated and optimized software for the evaluation of the recovery of patients undergoing tibial osteotomy operations.
5. Optimization of a nutraceutical route through the use of bioactive molecules, such as spirulina extracts, polyphenols and limonene, which promotes osteointegration processes. This result will be verified in vitro on 2D and 3D cell cultures within microfluidic platforms (organ-on-a-chip), in which it will be possible to analyze the response of the cell culture to nutraceutical molecules in terms of tissue formation and maturation bone, even in the presence of mechanical stress, thus allowing specific therapies, including nutritional ones, to be programmed to optimize the patient's response to the surgical procedure.

Start and end date

Project Manager

Coordinating institution of the project

Other Institutions involved

• Department of Biomedicine and Public Health, University of Rome Tor Vergata

Funding source(s).