Stage 1

Financial data on stage one

279.600 lei National Budget

31.455 Partner contribution

Ojectives for the first stage 2019

- Settlement of required characteristics and properties for fixation staples and manufacturing material;

- Settlement of required methods for material/surface characterization and testing;

- Definition of the manufacturing process requirements.

- Composition establishment of new superelastic Gum alloy for fixation staples; O2.2 - Obtaining the synthesis technologies of new superelastic alloy;

- Obtaining the SPD- HSHPT technologies for coned blanks manufacturing;

- Obtaining the methodology to effectively apply antibacterial nano-coatings onto the implants.

- To evaluate the behaviour of alloy coatings in simulated fluids conditions;

- To evaluate the biocide and bioactive features and cell compatibility of the novel antibacterial coatings.

Work package	Results/Deliverables/Progress Evaluation
T.1.1. Settlement of the technical and medical requirements for manufacturing and characterization of the temporary orthopaedic implants	- Technical study for defining the models and types of the temporary orthopaedic implants / Scientific and technical report / STR / 100%; - Technical study for defining the manufacturing chains and methods for characterization and testing of the fixation staples (STR) / 100%; - Study on the requirements for the new alloy, and its processing process / STR / 100%.
T.1.2 Gum alloy composition design for temporary orthopaedic implants	- The chemical composition for the new Gum- alloy (Ti31,50Nb3,10Zr3,10Ta0,90Fe0,16O, %wt / STR / 100%).
T.1.3 Design and experiment the technology of the superelastic alloy synthesis	- Experimental model for alloy synthesis technology in cold crucible melting furnace (technological chain, working method, technological parameters) / STR / 100%; - Laboratory model for the synthesis and characterization of the cast TiNbZrTaFeO alloy / STR / 100% .
T.1.4 Synthesis of the first test lot of the superelastic alloy	- Test lot 1 from cast alloy (12 ingots TiNbZrTaFeO alloy, 18.5 mm in diameter and 37-45 mm in length) / STR / 100%.
T.1.5 Chemical, mechanical and structural characterization of the cast alloy	- Chemical, mechanical and structural characterization of the TiNbZrTaFeO alloy in cast state / STR / 100%.
T.1.6 The biocompatibility testing of the as cast alloy	- Study regarding the corrosion resistance of the alloy in cast state / STR / 100%; - In vitro characterization of the biocompatibility on as cast alloy and on nanostructured coating / STR / 100%.
T.1.7 Design of the blanks for the manufacturing fixation staples	- Shapes and dimensions of the blanks / STR / 100%.
T.1.8 Design of HSHPT technology for the blanks fabrication	- HSHPT laboratory technology for the blanks fabrication (technological parameters) / STR / 100%; - Cold rolling laboratory technology for processing of the blanks (technological parameters) / STR / 100%.
T.1.9 Designing and fabrication of the SPD tools	- Execution drawings for severe plastic deformation tools / STR / 100%; - Tools for HSHPT processing of the blanks and for functionalization of the fixation staples. / STR / 100%.
T.1.10 Obtaining of the first test batch by means HSHPT and cold rolling on experimental alloy	- First run of the alloy processed via HSHPT (Severe plastic deformed discs 27.5 mm in diameter and 4 mm height) / STR / 100%; - First run of the alloy processed by cold rolling (long strips 0.8 mm in high) / STR / 100%
T.1.11 Characterization of the severe plastic deformed alloy	- Report of mechanical characteristics on cold rolled TiNbZrTaFeO / STR / 100% - Structural characterization of severe plastic deformed alloy /TSR/ 100%
Dissemination	-Dissemination / Project webpage http://www.bonefix.ugal.ro/ (100%)

Stage two / 2020

Financial data on stage two:

Budget allocations - 302.900 lei;

Partners' own contributions - 29.125 lei.

Objectives for stage two:

- Demonstration of the alloy laboratory synthesis technology;

- Demonstration of the implants (fixation staples) laboratory manufacturing process;

- Assessing of the cell compatibility of the novel alloy and coatings;

- Evaluation of the industrial implementation efficiency of the research results;

- Dissemination of the innovative results.

The activities carried out in stage two and the obtained results

Tasks	Results
T.2.1. Demonstration of the alloy laboratory synthesis technology	- Demonstrated laboratory technology for the synthesis of the novel Gum type alloy (TiNbZrTaFeO) - Test lot 2 from as-cast alloy
T.2.2 Chemical and structural characterization of the test lot 2	- Chemical and structural characteristics of the TiNbZrTaFeO alloy in as-cast state.
T.2.3 Design of the multidirectional compression staples	- Virtual models and design for multiaxial compression staples
T.2.4 Obtaining of the deformed blanks for implants manufacturing by means Severe Plastic Deformation - HSPT technology	- Demonstrated laboratory HSHPT technology for deformed blanks obtaining. - Lot test from SPD deformed blanks with ultrafine structure.
T.2.5 Structural characterization of severe plastic deformed blanks	- Structural characteristics of the TiNbZrTaFeO alloy SPD processed.
T.2.6 Design and experiment of the cutting, bending and deburring technology for implants with multidirectional compression.	- Laboratory technology for deformed blanks cutting, implants legs bending and implants deburring. - Lot test from unfunctionalized multidirectional compression staples.
T.2.7 Design and experiment of the functionalization (pretension) technology of multidirectional compression staples	- Demonstrated technology for implants functionalization. - Functionalized implants lot test.
T.2.8 Advanced bio-interface biological response analysis	- Standardized in vitro evaluation of coated alloy biocompatibility according to ISO 10993-Part 5/2009. - Study regarding evaluation of the response of MC3T-E1 pre-osteoblasts to the biomaterials (alloy and coatings) developed in the project.
T.2.9 Evaluation of industrial implementation efficiency of the research results	- Technical-economic analysis of industrial implementation efficiency of the research results - Tools for HSHPT processing of the blanks and for functionalization of the fixation staples. / STR / 100%..
T.2.10 Evaluation the Project’s innovative results. IPRs allocation.	- One patent application to the Romanian State Office for Inventions and Trademarks / 2020 00046 - “Compression staple with multidirectional fastening for orthopaedic surgery with nanometric structure “. - A published paper / “The Influence of Severe Plastic Deformation on Microstructure and In Vitro Biocompatibility of the New Ti-Nb-Zr-Ta-Fe-O Alloy Composition”, Materials, 2020.
Dissemination	- Project webpage.