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Description
Currently, in the case of significant damage to ligaments and tendons, the standard treatment approach is to use autografts. In some cases, autografts are replaced by decellularised allografts or xenografts. All of those methods indicates disadvandages. Long-term scientific studies show that 7 to 10 years after primary ACL reconstruction, 20-25% of the patients require revision surgery.
The project aims to develop a prototype of the implant for ACL reconstruction and regeneration and verify its biological and mechanical performance in preclinical conditions.
Research on innovative implants is a part of Programme'' Applied Research'' combines fundamental knowledge from materials sciences, chemistry, biology, and medicine to develop applicable implants. These works are essential for implementing the National Research Program, particularly in areas 2 "Civilization diseases, new drugs and regenerative medicine" and area 4, "Modern material technologies". They also fit into the National Smart Specializations, including KIS 1. Healthy society (Section 1. New products and technologies - including research and development of medicinal products). Additionally, the conducted works contribute to the implementation of the First Speed Programs, indicated in the national "Strategy for Responsible Development until 2020 (with a perspective until 2030)".
This grant would allow Principal Investigator to broaden knowledge, management skills, and medical device commercialisation skills, and finally, it would contribute support to career advancement (habilitation defence). Our team would develop a scientific career, each on a different level of scientific position (PhD, post-doc, diploma). Ortopedika Clinic PL will have the opportunity to broaden knowledge from material engineering and gain commercialization skills. There will be an exchange of knowledge and experience between the partners
Summary of project results
The project was initiated to address significant limitations in current ACL repair methods. Existing techniques leads to long-term complications and the need for further surgical interventions. An innovative solution was needed to offer better healing outcomes and durability.
Created a biomimetic implant with surface modifications using ceramics for bone reconstruction and proteins for ligament regeneration; Optimized polymers for mechanical properties and longevity, refining the Fused Deposition modeling (FDM) process for high-quality production; Fine-tuned implantation methodology in ex-vivo conditions for enhanced surgical precision; Extensive in-vitro and in-vivo testing demonstrated biocompatibility, safety, and efficacy, with preclinical studies on a large animal model validating performance.
Developed a biomimetic implant that promotes better bone regeneration; Advanced design and material composition support superior healing and integration compared to existing solutions; Comprehensive testing confirmed biocompatibility, paving the way for future clinical trials. Patients can expect enhanced bone healig leading to fewer complications and improved recovery times. The project expands the range of effective therapies, potentially reducing the need for reoperations and improving the overall quality of life for patients. It provides a more reliable and effective solution for ACL repair, addressing critical issues in current methods and offering a promising alternative that enhances patient outcomes and long-term success rates. The project advances knowledge in biodegradable polymers and implants, fostering interdisciplinary and international collaboration,The commercialization of the innovative ACL graft, anticipated after achieving Technology Readiness Level 9 (TRL9), promises significant economic benefits. The knee arthroscopy market is projected to grow substantially, highlighting the commercial potential; Emphasizes sustainability by using bio-based materials and minimizing environmental harm, aligning with goals of reducing pollution and promoting sustainable industries; The ACL graft can revolutionize treatment, improving public health and well-being, addressing crucial societal needs, and supporting the competitiveness of European industries.