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Research and development progress of New bone plate materials
Carbon fiber polyetheretherketone (CFR-PEEK) bone plate
Material properties: It has excellent fatigue strength, an elastic modulus close to that of cortical bone, is radiation-permeable without artifacts, and has good biocompatibility. Its fatigue resistance is remarkable. Through the efficient combination of polymers and carbon fibers, a long carbon fiber laminated structure is formed, which demonstrates outstanding durability under dynamic loads. The implants tested did not fail after four million fatigue cycles. The elastic modulus is very close to that of human cortical bone, which can more naturally bear bone stress and effectively avoid the common stress shielding effect of traditional metal steel plates. It does not produce artifacts in imaging techniques such as MRI, CT and X-rays, providing great convenience for intraoperative and postoperative assessment. It has passed extensive biocompatibility tests, including studies on systemic and intradermal toxicity as well as intramuscular implantation, and no adverse side effects have been shown. It can also promote the regeneration and repair of bone tissue.
Clinical application: There have been successful cases of its application in the treatment of distal fibular fractures in China. For intra-articular fractures, its light transmission enables doctors to clearly observe the reduction of the posterior ankle after fixing the lateral malleolus, making it easier to assess and operate. This achieves true “visual fixation”, upgrading the crucial step of articular surface reduction from empirical operation to precise visualization. Postoperative images showed that the patient’s fracture was well aligned and the internal fixation position was ideal.
Degradable magnesium bone internal fixation screws
Material properties: Made of high-purity medical magnesium metal, it can be automatically degraded and absorbed in the human body, avoiding secondary surgery. It has good biocompatibility and a density and elastic modulus close to that of human bone, effectively avoiding the “stress shielding effect”. Magnesium is one of the essential metal elements for the human body. After an implant is placed in the human body, the magnesium element naturally degraded and released not only does no harm to the body, but also is absorbed by the body as a nutrient, which is beneficial to health.
Research and development progress: The clinical trial summary report of the degradable magnesium bone internal fixation screw independently developed by the relevant enterprise has been obtained. The results show that it is effective and safe in the treatment of avascular necrosis of the femoral head with vascular pedicle bone flap transplantation. We have received the notice of acceptance of the domestic medical device registration application for degradable magnesium bone internal fixation screws issued by the National Medical Products Administration. The registration application has been officially accepted.
Domestic AKSOPEEK LCF material
Material properties: As a continuous carbon fiber reinforced implantable PEEK composite material, it has outstanding fatigue resistance, which is 30% higher than that of traditional metal materials, significantly reducing the risk of secondary surgery caused by material fatigue. In terms of mechanical properties, the elastic modulus is highly matched with the human cortical bone, which can not only provide stable support but also avoid the “stress shielding” effect. The X-ray transmission feature enables doctors to clearly observe the growth of callus through routine imaging examinations, achieving precise medical monitoring. In terms of biocompatibility, it meets the medical implantable grade standards. The ISO10993 biosafety test shows no cytotoxicity, sensitization or genotoxicity. The incidence of inflammatory reactions after implantation is 60% lower than that of titanium alloy materials.
Clinical application: Clinical exploration has been carried out in fields such as orthopedic tumor resection and reconstruction, spinal internal fixation, knee joint replacement, and craniofacial repair, with excellent initial application results.
Bionic composite artificial bone material
Material properties: Taking self-curing calcium phosphate artificial bone as an example, it can self-cure in the human body environment, gradually fuse with the patient’s bone tissue, and eventually be absorbed and replaced by new bone. Its composition is highly similar to that of human bones, and it has excellent biocompatibility and degradability. It can be shaped freely according to the shape of bone defects, significantly shortening the healing time. There is also recombinant human gene bone morphogenetic protein (rhBMP-2), which is produced through genetic engineering technology. It can effectively induce undifferentiated mesenchymal cells to form new bone, significantly accelerating the fracture healing process. It also has a remarkable therapeutic effect on patients with large bone defects, shortening the healing time by 3 to 6 months.
Research and development progress: Relevant enterprises, relying on their independently developed bionic composite artificial bone technology, have overcome the pain point that it is difficult to balance the mechanical properties and biocompatibility of traditional materials, providing a precise medical solution for artificial bone repair to millions of patients.