Recently, the international orthopedic clinical translation journal "Journal of Orthopaedic Translation" published an online publication by the team of Professor Dai Kerong and Professor Hao Yongqiang of the Institute of Bone and Joint Institute of Shanghai Jiaotong University School of Medicine and Ding Wenjiang and Yuan Guangyin, Directors of the National Engineering Research Center for Light Alloy Precision Forming, Shanghai Jiaotong University The results of clinical trials of biodegradable magnesium alloy bone nails completed by the professor's team for 1 to 2 years showed that all patients had healing of the medial malleolus fractures and functional recovery. Studies have confirmed the clinical efficacy and biological safety of biodegradable magnesium alloy screws in the treatment of medial malleolus fractures, laying a solid foundation for the further clinical promotion and application of high-end medical devices such as fully degradable magnesium alloy implants. This is the first public report of clinical trials of biodegradable medical magnesium alloys in China, and also the first public report of the results of clinical trials of biodegradable magnesium alloy bone nails with functional coatings in the world. It is a milestone.
At present, most of the fracture internal fixation devices that are widely used clinically are made of non-degradable metals such as stainless steel or titanium alloys. The elastic modulus is too high, and clinically it is easy to cause stress shielding effect, which affects bone healing. Disadvantages such as a second operation to take out after degraded implantation. Magnesium alloy material has the same elastic modulus and cortical bone, which can eliminate the stress shielding effect. At the same time, it can be degraded in the body and is safely absorbed and metabolized by the human body. It avoids the advantages of secondary operations. It is known as "a new generation of revolutionary metal biomaterials."
Since 2007, under the guidance of Ding Wenjiang, Yuan Guangyin led the research team from the perspective of clinical application needs, cleverly through the "phase potential control" and microstructure design of magnesium alloy materials, successfully developed "uniform controllable degradation, strong "Toughness matching, good biocompatibility" patented medical magnesium alloy JDBM (Jiaotong University Biomagnesium) (Nanoscale 2013, Biomaterials 2015, Biomaterials 2019, Acta Biomater 2020). The unique uniform degradation characteristics of the patented medical magnesium alloy have been verified and highly evaluated by international partner laboratories in the United States, Germany, Italy, Japan and other international partners. Among the existing publicly reported medical magnesium alloy materials, its excellent biological The three-in-one performance of compatibility, toughness, and degradation controllability is unique in the world.
In response to the degradation of magnesium alloy materials to release hydrogen, Yuan Guangyin led the research team to develop a patented coating technology that is biologically active, degradable, and can inhibit the rapid degradation of the substrate after several years of research, successfully solving the problem of magnesium alloy materials. Degradation in the body is too fast to produce a bad phenomenon of hydrogen accumulation (ACS Applied Materials Interfaces 2014, Mater Sci Eng C 2018, Biomaterials 2020). By synergistically regulating the degradation behavior of the material matrix and functional coating, it is the first to realize the uniform and controllable degradation of medical magnesium alloy intraosseous implant devices in the world.
In the research and development for more than 10 years, this research direction has successively won the Shanghai Jiaotong University Medical-Industry Intersection Project, Shanghai Basic Key, Major Project and Natural Science Foundation, Key Project and National 863 Project, Science and Technology Support Project and National Key Research and Development Special funding. It has formed a patent group (including two US invention patents) consisting of core patents related to medical magnesium alloy materials and their preparation processes, implant device design, and functional coatings. It is believed that the relevant results will benefit more and more fracture patients, and at the same time will contribute to the improvement of the technical level of orthopedic implant devices in my country.