Weight %
SiO2+M20 (M20:Na20,K20 etc)
0.1
Fe203
0.1
Al203
0.5
Y203
4.8 ± 0.7
Zro2
Remainder
Fig. 3.1
(a) A zirconia made femoral head with an outer diameter of 22 mm. (b) A cementless hip prosthesis made of titanium alloy with a combination of zirconia head and polyethylene socket for the bearing component
Mechanical properties of PSZs are compared with those of new alumina ceramic with grain size of less than 2 μm in Table 3.2. PSZs have significantly higher bending strength, compressive strength, fracture toughness, and impact strength, but have a lower Vickers hardness and elastic modulus than the alumina ceramic, although they are slightly different depending on the grain size and kind of chemical stabilizers used. Among them, yttrium oxide PSZ (Y-PSZ) has the highest bending strength and fracture toughness followed by cerium oxide PSZ (Ce-PSZ). Breaking tests for Y-PSZ and alumina femoral heads, 22 mm in outer diameter, were performed by static loading over a polyethylene liner which was set against the ceramic head. The alumina heads were broken by loads of 2,400–3,400 kg (average 2,800 kg), while Y-PSZ heads were broken by loads of 2,770–4,480 kg (average 3,700 kg). Thus, Y-PSZ head was significantly stronger than the alumina head against breakage [7]. Fatigue test was performed on eight Y-PSZ femoral heads on a hip simulator in physiological saline at 37 °C, by applying 107 cycles of repeated loading with 450 kg. This loading is considered to correspond approximately to 20 years of a person walking. After the test, no breakage was observed in all the eight Y-PSZ heads.
Table 3.2
Mechanical properties of bioinert ceramics
Zirconia | Alumina | ||
---|---|---|---|
Bending strength | (kgf/mm2) | 170 | >40.8 |
Compressive strength | (kgf/mm2) | 500 | 408 |
Fracture toughness | (MPa,m1/2) | 5.2 | 3.4 |
Impact strength | (kg/mm2 or kJ/m2) | 14 | 4 |
Vickers hardness | (HV kg/mm2) | 1270 | 2300 |
Elastic modulus | (kgf/mm2) | 20500 | >38800 |
Density | (g/cm3) | 6.05 | >3.9 |
Crystal size | (μm) | 0.2 | <7 |
Wear tests for the polyethylene liner against the Y-PSZ, alumina and stainless steel head, all 22 mm in outer diameter, were performed using a hip simulator in physiological saline at 37 °C by applying a load of 450 kg at 1 Hz. After 5 × 105 cycles of loading, the polyethylene liner against the stainless steel head showed significant wear, while those against the Y-PSZ head and alumina head did not show any measurable wear, even after 2 × 106 loading [7].
Thus, alumina is chemically more stable than PSZ in vivo, while PSZ is mechanically stronger than alumina, and both of them exhibit much better wear-resistant character comparing the stainless steel or Co-Cr alloy as assessed in a form of bearing components of hip prosthesis. For these reasons, alumina is used to fabricate a ceramic-on-ceramic hip prosthesis where head size is not a key issue, while PSZ is used to fabricate a PE-on-ceramic hip prosthesis where the head size must be made reasonably small. One of reasons why the zirconia-on-zirconia or alumina-on-zirconia hip prosthesis is not yet brought to the market is that, even with the PSZ, its crystallographical stability in vivo in a long term has not been confirmed.
On the other hand, recently a combined ceramic (Zirconia 20 % and Alunina 80 %) is brought into clinical use as a XLPE-on-Ceramic hip prosthesis. This combination of Zirconia and Alumina is to aim at covering the weak points each other. It is said, however, when a proportion of Zirconia exceeds 6 %, effect of phase transformation can not be neglected in vivo. Therefore, clinical follow-up longer than 10 years is required to confirm the long term results in this combination as well.
A new technology developed by Smith and Nephew Co. in 1998 using Zirconium-Niobium alloy made it possible to solve the problem of phase transformation of zirconia ceramic in vivo. When a high temperature is applied on Zr-Nb alloy, its surface transforms to a monoclinic zirconia layer in about 5 μm thick. The layer is called Oxinium. Thus made surface monoclinic zirconia layer (Oxinium) is a gradient material made from Zr-Nb alloy. When a femoral head of hip prosthesis is made by the use of the above technique, its surface is not affected by phase transformation in vivo as it is made of monoclinic zirconia, and, in addition, the femoral head is not broken as it is made of Zr-Nb alloy, a metal. For these reasons, Oxinium-on Oxinium hip prosthesis is considered reasonable theoretically.
Bioactive Ceramics
Bioactive ceramics include glasses, glass-ceramics, and ceramics that elicit a specific biological response at the interface between the material and the bone tissue which results in the formation of a bond between them. The first evidence of direct bone bonding to a glass implant was discovered by Hench et al. in 1970 [8]. Since then, some other glasses, glass-ceramics, and ceramics had been proved to have a bone bonding capability. Among them, Bioglass®, apatite-and wollastonite-containing glass-ceramic (AW-GC) and synthetic hydroxyapatite (HA) are representative materials currently used for clinical application.
In 1970, Hench et al. [8] synthesized a bioactive glass by a chemical composition of SiO2 45, CaO 24.5, P2O5 6, Na2O 24.5 (wt%). This glass is called 45S5 Bioglass® and known to exhibit the strongest bioactivity among hitherto developed bioactive ceramics. Wilson et al. [9] proved that when the implant-tissue interface was immobilized, collagen fibers of the soft tissue became embedded and bonded within the growing silica-rich and hydroxy-carbonate apatite layer on the 45S5 Bioglass®. Such soft-tissue bonding has never been observed with other bioactive ceramics or glass-ceramics. However, as Bioglass® is mechanically much weaker than the human cortical bone, it cannot be used as a weight bearing bone prosthesis. In stead, it has been used as a bone void filler in a form of granule, coating material on metallic prostheses, and to fabricate a middle ear prosthesis.
Aoki et al. [10] in 1966 and Jarcho et al. [11] in 1976 separately developed a process for producing dense hydroxyapatite implants with considerably high mechanical strength. Synthetic hydroxyapatite (Ca10(PO4)6(OH)2) has a capability of chemical bonding with the living bone tissue, but it takes much longer time than Bioglass® for bone bonding. Its mechanical property is shown in Table 3.3 in comparison with that of the natural bone and AW-GC. The bending strength of HA is lower than that of the natural cortical bone, and hence HA cannot be used to fabricate a weight bearing bone prosthesis with absolute safety against breakage in vivo. It has been used as a bone void filler in a form of granule with various particle size (Fig. 3.2), coating material on metallic prostheses, and to fabricate an iliac crest prosthesis and a laminoplasty spacer in which high mechanical strength is not required. In 1987, Geesink et al. [12] developed a HA coated hip prosthesis and reported an excellent 10 year clinical result in a large number of patient (Fig. 3.3). At present, HA is the bioactive ceramic most widely used for clinical application as a bone void filler and a coating material for hip prostheses which are employed in cementless hip replacement.
Table 3.3
Mechanical property of natural bone and bioactive ceramics