OSTEOFUSE: WUT in a Polish–Turkish research project

The OSTEOFUSE project aims to combine the knowledge and experience of interdisciplinary research teams from Turkey and Poland in a science–industry partnership. The acronym itself refers to the development of a modern coating for bone implants printed from PEEK material to improve their bio-integration with the surrounding bone tissue.

"Currently available and used are PEEK materials adapted for 3D printing. The first implant made using this technology was applied clinically in 2021. The use of 3D printing technology allows for much more accurate reproduction of the implant's shape, and thus personalisation of the manufactured implant, which will contribute to faster patient recovery," says Jakub W. Trzciński, PhD, from the Centre for Advanced Materials and Technologies (CEZAMAT), the project manager on behalf of WUT. "Although PEEK exhibits biocompatibility and has been successfully used in orthopaedics and dentistry, further research and development work is still necessary to achieve better functional outcomes."

This is particularly important in cases where integration of the implant with the bone is required, as this material currently lacks this property. One of the most important strategies for improving the properties of medical devices in contact with human tissues is the modification of their surface through appropriately designed coatings. As Trzciński, PhD, notes, OSTEOFUSE is strictly a Polish innovation, and the idea itself originated in the minds of scientists from WUT and experts from the company Stenocoat – a partner in the consortium. The company Stenocoat sp. z o.o. specialises in developing methods for coating the surfaces of medical devices to give them the desired clinical properties. Hence the close cooperation between industry and the scientific unit, which will allow for the development of biocompatible coatings in the context of PEEK implants.

"The idea for the project originated at the Warsaw University of Technology and at Stenocoat sp. z o.o., represented by Kamil Kopeć, PhD, the company's president. After the idea was born, we began searching for a potential supplier and leader in PEEK polymer implants. Following this lead, we came across the company Trabtech. After several discussions with this company, we established that for them, too, this is a very pressing issue - meaning the lack of bio-compatibility of PEEK implants is still an open topic. So we decided to combine our competences, and that's how this bilateral project was created,” explains Jakub Trzciński, PhD.

WUT in an international consortium

The Warsaw University of Technology, and in particular CEZAMAT, Jakub Trzciński, PhD, and Prof. Tomasz Ciach’s group, is actively involved in product innovation in the fields of medicine, nano-medicine, as well as in the areas of pharmaceuticals and medical devices. The manager of the Polish consortium in the OSTEOFUSE project is Jakub Trzciński, PhD, and participating in it – besides the already mentioned Prof. Ciach – are also researchers from the Faculty of Chemical and Process Engineering: Michał Wojasiński, PhD, and Rafał Podgórski, PhD.

Trzciński, PhD, is responsible for planning, organising, and coordinating the entire project lifecycle, from concept to completion, and for ensuring the research and development goals are met. He is also directly engaged in research, including electron microscopy and zeta-potential studies to determine whether the engineered surfaces are suitable candidates for osseointegration.

“Michał Wojasiński, PhD, is the head of the Laboratory for the Preparation and Functionalisation of Nano-Hydroxyapatite (LabOFn), hence his involvement and invaluable knowledge and support regarding the production of hydroxyapatite and its impact on osteoinductivity. Wojasiński, PhD,  will be engaged in the synthesis of precisely defined hydroxyapatite, which will be used in the process. Rafał Podgórski, PhD, as an excellent expert in the field of cell studies, will support us in assessing the biocompatibility and cytotoxicity of the produced implants. His research will directly answer fundamental questions about the safety of implants in contact with human cells and components of human blood," explains Trzciński, PhD. "Furthermore, the involvement of Prof. Tomasz Ciach – an outstanding scientist, inventor, and founder of numerous biomedical businesses – will allow the young research team to draw on knowledge and experience. His direct involvement in the work on coating design and validation of the obtained prototypes will enable fast and efficient transfer of samples to our partners from Turkey, responsible, among other things, for the validation of safety and behaviour of the implants in an animal model."

The company Stenocoat sp. z o.o. is responsible for producing the coating containing materials developed at the Warsaw University of Technology. Our University will also conduct in-depth analyses – physicochemical and biocompatibility. The company Trabtech, in turn, is the supplier of PEEK implants produced using 3D printing technology, and the University of Ankara will be responsible for the safety validation of the coated PEEK implants developed in Poland on an animal model.

Ambitious plans of the researchers

The greatest challenge, according to our scientist, will be adapting the coating in such a way that it is safe for the end user. The answer to this question will be obtained after tests on an animal model conducted by the partners from the University of Ankara. One of the biggest challenges will also be the so-called post-project life of this solution. The overarching goal of the team of scientists is to achieve full commercialisation of the developed solution, so that it has a real impact on improving the quality of life of people who desperately need this type of solution. The greatest challenge will be conducting clinical trials after the completion of this project.

"The entire project, considering its specificity, is very ambitious. Hence, during the project, scientists will have to answer many scientific questions. Each stage of the project carries many unknowns, so it will be necessary to conduct many stages of research, validation, and optimisation of the final product. Due to the implant's purpose, one of the key elements, and one requiring very significant work input, will be the assessment of their biocompatibility and biosafety, to rule out potential adverse effects on living organisms during work on the animal model," predicts Trzciński, PhD. "Of course, the optimisation of the coating manufacturing processes will also be a lengthy process, nevertheless, due to the people involved in this project, the work should proceed at a very high level without unnecessary delays."

The project's results will be used primarily in the medical industry: regenerative medicine, orthopaedics, and traumatology, to improve the quality of life of patients after accidents and with chronic diseases (including bone cancer diseases), i.e., wherever bone reconstruction is needed. Furthermore, the use of 3D printing along with a new osteoinductive coating will shorten patient recovery, improve their quality of life, and enable the treatment of very difficult clinical cases where standard methods of surgical treatment and implantology cannot help the patient.

The project has 5 stages, including 4 research stages. The OSTEOFUSE project is a project with medium work advancement (starting at TRL4), meaning that the used implant coating technology is validated, and the associated intellectual property is protected by the Warsaw University of Technology and the company Stenocoat sp. z o.o. The achievement of TRL level 6 is planned by the end of the project, and further development of the technology towards TRL 9. The OSTEOFUSE project is a 2-year project, with completion scheduled for the end of May 2027.