The development history of ceramic materials for artificial hip joints
early stage
In 1891, Gluck was the first to implant a hip joint made of ivory into the human body, starting the exploration of artificial hip joint replacement, but ceramic materials were not involved at this time.
Metal material dominant stage
In 1937, Venable and Stuck developed cobalt-chromium-molybdenum alloy. Since then, metal materials have been widely used in the field of artificial hip joints and became the mainstream at that time. The bending strength of metal materials is ≥1500 MPa, the Vickers hardness is ≤1400 HV, and the fracture toughness is ≥10 MPa*m1/2.
Introduction stage of ceramic materials
In 1970, Boutin introduced ceramic hip joints, and ceramic materials began to be used in the field of artificial hip joints.
In 1972, Boutin reported on the production of human hip joints with alumina ceramics and its clinical application. In 1977, a hip prosthesis combining an alumina ceramic femoral head and a high molecular weight polyethylene acetabulum was developed. In 1982, the U.S. Food and Drug Administration approved artificial hip joints composed of alumina ceramic balls, sockets, and cobalt-chromium-molybdenum alloy stems for clinical use in the United States. With process improvements, the performance of alumina ceramics continues to improve, such as improving its toughness and fracture strength by doping additives and optimizing sintering parameters. The four-point bending strength of alumina ceramics is 500-700 MPA, the Vickers hardness is ≥1800 Hv, and the fracture toughness is 3-4 MPa*m1/2.
Around 1985, zirconia femoral ball heads began to be implanted into the human body. In 1988, Y2O3-doped tetragonal zirconia was first clinically used in artificial joints. The four-point bending strength of zirconia ceramics is ≥1000 MPA, the fracture toughness is ≥8 MPa*m1/2, and the Vickers hardness is 1400-1600 HV. However, due to a batch recall of zirconia ceramic ball heads in 2001, its application as a joint surface material was restricted. However, relevant research is still continuing to solve problems such as low-temperature aging.
Composite ceramic material stage
Based on the respective advantages and disadvantages of alumina and zirconia, the materials science community has developed alumina-zirconia composite ceramic materials, such as zirconia-toughened alumina, with a four-point bending strength of ≥1000 MPA and a fracture toughness of ≥5.0 MPa*m1/ 2. Vickers hardness ≥1700 HV. The Biolox delta ceramic joint prosthesis launched by Ceramtec uses this type of material, which combines the toughening ability of zirconia with the low degradation sensitivity of alumina, and has better strength and fracture toughness. At present, the global ceramics for artificial hip joints are mainly provided by Germany's CeramTec, which accounts for about 90% of the ball head market according to relevant data reports. Before 2024, the Chinese market is basically occupied by CeramTec of Germany.Currently, there is a ceramic company in China (Cericare Medical HeFei Co., Ltd.) that can independently carry out artificial ceramic hip joint manufacturing technology, involving full manufacturing capabilities from original powder modification and preparation, blank, and mechanical processing. It also has a group of products with many years of experience. High-level technical personnel engaged in ceramic manufacturing, medical device development, and medical device management are expected to be fully launched into the market in 2025. According to reports, the company has developed an artificial hip ceramic material that meets the same technical specifications and requirements as CeramTec, and has a greater advantage in overall manufacturing cost, which is expected to further reduce the burden on patients undergoing artificial hip replacement surgery.
