Abstract
Alumina and zirconia are known for their general chemical inertness and hardness. These properties are exploited for implant purposes, where they are used as an articulating surface in hip and knee joints. Their ability to be polished to a high surface finish make them an ideal candidate for such wear applications, where they compete against materials such as ultra-high-molecular-weight polyethylene.
Alumina is a highly inert material and resistant to most corrosive environments. The term high alumina ceramics refersr to materials that have a minimal content of 97% of alumina. If there is a 99% minimal percentage of alumina it is called high purity alumina ceramics. In its _ phase (more famous than corundum), characterised by its particular structure and stability, high purity alumina has been being used in orthopaedics since 1970, in the articulations of the hip prostheses.
BIOLOX®forte (commercially available since 1994) is high purity alumina (ca 99.7 %) with a small percentage of magnesium oxide (MgO). Approximately 50 years ago, MgO was introduced during the sintering phase of alumina because it was discovered that a small amount of this additive prevented the increase in grains of alumina during the sintering process. It was therefore possible to have a more homogenous and dense microstructure; both characteristics directly correlated with the mechanical resistance. The suffix forte derives from the increased mechanical characteristic and continuous optimisation of the fabrication technology.
One of the main factors involved in wear reduction is the characteristic molecular structure of alumina. Its superficial layer is composed of oxygen atoms that create a residual electric power which interacts with polarized molecules of the lubricant, tying it to the surface by strong Van der Waals ties. Therefore the presence of a fluid film that reduces the coefficient of clutch between the two surfaces involved during the articulation is guaranteed.
The colour of alumina components varies. Originally it is ivory, but it can easily become brown after sterilization with gamma beams that interact with the free valences introduced by the MgO. This change in colour does not change the mechanical characteristics. Currently the systems are completely modular and allow a wide choice of couplings. In 1984 and subsequently in 1995, the introduction of ISO norms for the production of ceramics ball-heads and inserts and the concept of conical fixation has provided higher reliability.
Today, the alumina BIOLOX®forte components are prepared in clean-rooms, sintered with high quality control processes, laser marked and accurately inspected and tested. The tolerances between ceramics (ball-heads and inserts) and metallic parts (taper and metal shell) are fundamental for increasing implant reliability. It is important to control and validate the stems and cups which the ceramic parts are applied on. Correct assembly and the respect of the compatibilities between parts (angle, material, producer) guarantee the longevity of the implants.
Actually, in the orthopaedic field, alumina is mainly used in standard applications of hip prostheses. Ball-heads of 22 mm in diameter, lengths of neck type XL, and the knee prostheses are not possible because the mechanical characteristics of alumina do not allow for the elevated stress values requested for these special applications.
Between 1975 and 1977, it was discovered that the strength and toughness of alumina could endure a remarkable increment by developing composites with oxide of zirconium (zirconia). In zirconia, during the phase of cooling from temperatures over 1170°C, the grains go through a change of phase (from tetragonal to monoclica), with an increase of 3% of volume. At ambient temperatures the monoclica phase is stable. This transformation is martensitic, with energy absorption, and involves a heat-proof change of the symmetry of the structure. In the case of dispersed grains of zirconia in the alumina matrix, the transformation absorbs the energy of the crack and the strength of the ceramics increases. With the use of yttria (Y2O3) to stabilise the zirconia the problem of the structure defects can be resolved.
A percentage of zirconia stabilized with yttria (Y-TZP) was introduced in the alumina matrix and other mixed oxides to counterbalance the reduction of the hardness caused by particles of zirconia and to create lengthened particles during the sintering.
All these studies have been used to create the new ceramic BIOLOX®delta. Tests of biocompatibility in agreement with norms EN 30993 have been carried out, so that implants can be made of these new composite ceramics.
Since 1970, more than 3,500,000 ball-heads and 350,000 inserts of alumina BIOLOX® have been implanted. Owing to the grain size, currently reduced to values under 2 μm, the value of the mechanical resistance has been raised to about 580 MPa. The increase in the mechanical characteristics, the new shapes and the conical fixation have reduced the risk of fracture of the BIOLOX®forte ball-heads and inserts to around 0.01% (Ø28 mm), maintaining the excellent tribology and wear characteristics. Many laboratory tests and clinical cases have shown that the wear rate of the alumina-alumina bearing complex is extremely low (0.001 mm/year). If compared with metal-polyethylene (0.2 mm/year) it shows a drastic reduction of particles of debris and therefore of the osteolysis problem
BIOLOX®delta has a bending strength of around 1000 MPa, which is more than double that of the alumina ISO (400 MPa). In the minimum fracture load test, ball-heads of 28 mm Ø millimeter (neck L) have achieved values of around 100 KN, well beyond the 46 KN requested by the FDA. Multiple cycles of sterilisation in autoclaves have demonstrated that the the mechanical and tribological characteristics of BIOLOX®delta are not altered.
On the basis of these results, BIOLOX®forte can be considered a reliable alternative to other materials in standard applications and the new alumina composite BIOLOX®delta will allow the realization of medical ceramics devices, already in the study phase, such as knee prosthesis, 22-mm ball-heads and thinner wall-thickness of inserts, which could not be developed up to now with the available ceramic materials.
