Mixed oxides prosthetic ceramic ball heads. Part 3: effect of the ZrO2 fraction on the wear of ceramic on ceramic hip joint prostheses. A long-term in vitro wear study

Using ceramic materials it is possible to obtain a number of beneficial mechanical properties such as considerable hardness, good chemical resistance, high tensile strength, and a good fracture toughness. The use of ceramic-on-ceramic as bearing surfaces for hip joint prostheses has been reported to produce a lower wear rate than other combinations (i.e. metal-on-polyethylene and ceramic-on-polyethylene) in total hip artroplasty. These advantages may increase the life expectancy of hip implants and improve the life of patients. Two new types of mixed-oxide ceramics (alumina and yttria-stabilised zirconia) femoral heads and acetabular cups containing different ratios of alumina and zirconia were compared with pure commercial alumina in terms of wear behaviour in a hip joint simulator. Hip joint wear simulator studies were carried out with a full-peak load of 2030 N and a frequency of 1 Hz in bovine calf serum. After 10 million cycles the measured weight loss of all specimens was very low. However, the experimental results did not show any significant difference between the new experimental mixed-oxide ceramics prototype and the commercial ceramic material couplings.     

Wear properties of alumina/zirconia composite ceramics for joint prostheses measured with an end-face apparatus

While only alumina is applied to all-ceramic joint prostheses at present, a stronger ceramic is required to prevent fracture and chipping due to impingement and stress concentration. Zirconia could be a potential substitute for alumina because it has high strength and fracture toughness. However, the wear of zirconia/zirconia combination is too high for clinical use. Although some investigations on composite ceramics revealed that mixing of different ceramics was able to improve the mechanical properties of ceramics, there are few reports about wear properties of composite ceramics for joint prosthesis. Since acetabular cup and femoral head of artificial hip joint are finished precisely, they indicate high geometric conformity. Therefore, wear test under flat contact was carried out with an end-face wear testing apparatus for four kinds of ceramics: alumina monolith, zirconia monolith, alumina-based composite ceramic, and zirconia based composite ceramic. Mean contact pressure was 10 MPa and sliding velocity was 40 mm/s. The wear test continued for 72 hours and total sliding distance was 10 km. After the test, the wear factor was calculated. Worn surfaces were observed with a scanning electron micrograph (SEM). The results of this wear test show that the wear factors of the both composite ceramics are similarly low and their mechanical properties are much better than those of the alumina monolith and the zirconia monolith. According to these results, it is predicted that joint prostheses of the composite ceramics are safer against break down and have longer lifetime compared with alumina/alumina joint prostheses.     

Mixed oxides prosthetic ceramic ball heads. Part 1: effect of the ZrO2 fraction on the wear of ceramic on polythylene joints.

Although mixed oxides ceramics have been indicated in the literature as a promising compromise between strength and wear, to the authors' knowledge no reports are available on the influence of the percentage of zirconia in ceramic femoral heads when sliding against polyethylene cups. Two types of mixed oxides ceramic ball heads (alumina plus, respectively, 60 and 80% of zirconia) were compared to pure zirconia and pure alumina heads in terms of wear behaviour against UHMWPE in a hip joint simulator. Polyethylene cups and ceramic femoral heads were fixed on a simulator apparatus with a sinusoidal movement and load in presence of bovine calf serum. The experimental results did not show significant difference between the two experimental ceramic materials or in comparison with pure materials. Considering that all specimens, regardless of the material, had the same level of surface roughness, this roughness factor seems to have a more relevant role than the mix of oxides used to manufacture the ceramic head. Wear tests are conducted on materials used in prosthetic hip implants in order to obtain quality control and to acquire further knowledge of the tribological processes that involve joint prostheses, therefore reducing the risk of implant failure of innovative prostheses.     

Crack growth resistance of alumina, zirconia and zirconia toughened alumina ceramics for joint prostheses.

Mono-phase bio-ceramics (alumina and zirconia) are widely used as femoral heads in total hip replacements (THR) as an alternative to metal devices. Unfortunately, the orthopaedic community reports significant in-vivo failures. Material scientists are already familiar with composites like alumina zirconia. Since both are biocompatible, this could prove to be a new approach to implants. This paper deals with a new generation of alumina-zirconia nano-composites having a high resistance to crack propagation, and as a consequence may offer the option to improve lifetime and reliability of ceramic joint prostheses. The reliability of the above mentioned three bio-ceramics (alumina, zirconia and zirconia toughened alumina) for THR components is analysed based on the study of their slow crack-growth behaviour. The influence of the processing conditions on the microstructure development, of the zirconia toughened alumina composites and the effect of these microstructures, on its mechanical properties, are discussed.     

Combining ageing and wear to assess the durability of zirconia-based ceramic heads for total hip arthroplasty

The degradation of zirconia-based ceramic components for total hip arthroplasty (head and cup) has been the topic of many works. However, the correlation between what is measured in vivo and what is expected from in vitro simulations on hip simulators may be sometimes feeble, especially where zirconia component are concerned, mainly due to a lack of representativeness of in vitro experiments. The present study seeks to explore the combined effects of hydrothermal ageing and wear on zirconia components. It shows that hydrothermal ageing increases the roughness of zirconia components, which in turn might increase the wear rate of the polyethylene counterparts. Moreover, the friction during hip simulation increases the ageing rate of the zirconia components. This auto-accelerating degradation may explain some of the poor long-term in vivo results of zirconia hip prostheses reported in the literature. Finally, it is shown that zirconia-toughened alumina components may be free from this combined degradation.     

Ce-TZP/Al2O3 nanocomposite as a bearing material in total joint replacement

The objectives of this study were to investigate the biocompatibility, phase stability, and wear properties of a newly developed Ce-TZP/Al(2)O(3) nanocomposite, as compared to conventional ceramics, and to determine whether the new composite could be used as a bearing material in total joint prostheses. In tests of mechanical properties, this composite showed significantly higher toughness than conventional Y-TZP. For biocompatibility tests, cylindrical specimens of both the Ce-TZP/Al(2)O(3) nanocomposite and monolithic alumina were implanted into the paraspinal muscles of male Wistar rats. The tissue reactions were almost the same, and at 24 weeks after implantation, thin fibrous capsules with almost no inflammation were observed around both of them. There were no significant differences in membrane thickness between the two ceramics. After hydrothermal treatment in 121 degrees C vapor for 18 h, the new composite showed complete resistance to aging degradation, whereas Y-TZP showed a phase transformation of 25.3 vol% (initial 0.4%) to the monoclinic form. According to the results of pin-on-disk tests, the wear rates of Ce-TZP/Al(2)O(3) nanocomposite and alumina were 0.55 +/- 0.04 x 10(-7) and 2.12 +/- 0.37 x 10(-7)mm(3)/Nm, respectively. The results of this study suggest that the Ce-TZP/Al(2)O(3) nanocomposite is a promising alternative ceramic component for total joint replacement.     

Phase stability after aging and its influence on pin-on-disk wear properties of Ce-TZP/Al2O3 nanocomposite and conventional Y-TZP

Recently zirconia/alumina composites have been examined by many researchers as the new generation of bearing materials in total joint replacements. In this study, the phase stability of a Ce-TZP/Al(2)O(3) nanocomposite and conventional Y-TZP after aging, and its influence on wear resistance, were investigated. Very slight phase transformation was observed in both types of ceramics 18 months after the implantation of Ce-TZP/Al(2)O(3) or Y-TZP samples into rabbit tibiae. However, Y-TZP showed marked phase transformation (approximately 80%) after aging in an autoclave (121 degrees C) for 190 h or in physiological saline at 62 degrees C for 18 months, whereas the new composite remained almost resistant to degradation. According to the results of self-pairing pin-on-disk wear tests using ceramic specimens with or without autoclave aging, the wear factor was almost the same between Ce-TZP/Al(2)O(3) samples with and without aging (6.74 +/- 0.36 x 10(-8) and 6.04 +/- 0.95 x 10(-8) mm(3)/Nm, respectively). In contrast, although non-aged Y-TZP had the lowest wear factor (4.88 +/- 0.51 x 10(-8) mm(3)/Nm) of all specimens tested, aged Y-TZP showed 10-fold greater wear than nonaged Y-TZP. The present study suggests that Ce-TZP/Al(2)O(3) nanocomposite has much greater phase stability than Y-TZP, and that its wear properties are not influenced by aging.     

Mechanical behaviour of zirconia and zirconia-toughened alumina in a simulated body environment

The mechanical properties of a zirconia-toughened alumina (ZTA) and three tetragonal zirconia polycrystal ceramics (TZPs), together with a biograde alumina, have been assessed in a simulated body solution (Ringer's solution). The hardness and fracture toughness of these materials were unchanged from the values in air when the tests were carried out in Ringer's solution; there was an instantaneous fall in strength in Ringer's solution but this was considered acceptable. However, ageing for long periods in Ringer's solution promoted a surface layer of monoclinic zirconia. This was accompanied by a strength decrement and it is concluded that these yttria-stabilized ZTA and TZP materials are unsuitable as implant materials.     

Isolation and morphological characterisation of UHMWPE wear debris generated in vitro

Wear tests are generally carried out on materials used in prosthetic hip implants, in order to obtain a better understanding of the tribological processes involved and improve the quality control of joint prostheses, directed towards reducing the risk of implant failure of innovative prostheses. Ceramic femoral heads of mixed alumina-zirconia oxides as well as zirconia and alumina single oxide heads were tested against UHMWPE acetabular cups in a hip joint simulator. Polyethylene cups and ceramic femoral heads were mounted in a simulator apparatus moving according to a sinusoidal function, under load and in the presence of bovine calf serum as lubricant. Wear particles were isolated from the bovine calf serum collected during the wear tests. An easy to follow method was used to separate the wear particles from the lubricant. Chemical digestive methods were used to separate the wear particles from the lubricant and the isolated particles were studied using scanning electron microscopy. The morphologies of the polyethylene debris showed considerable differences, both in size and shape of the particles, as a function of the coupled head material.     

Alumina-alumina artificial hip joints. Part II: characterisation of the wear debris from in vitro hip joint simulations

Until recently it was not possible to reproduce clinically relevant wear rates and wear patterns in in vitro hip joint simulators for alumina ceramic-on-ceramic hip prostheses. The introduction of microseparation of the prosthesis components into in vitro wear simulations produced clinically relevant wear rates and wear patterns for the first time. The aim of this study was to characterise the wear particles generated from standard simulator testing and microseparation simulator testing of hot isostatically pressed (HIPed) and non-HIPed alumina ceramic-on-ceramic hip prostheses, and compare these particles to those generated in vivo. Standard simulation conditions produced wear rates of approximately 0.1 mm3 per million cycles for both material types. No change in surface roughness was detected and very few wear features were observed. In contrast, when microseparation was introduced into the wear simulation, wear rates of between 1.24 (HIPed) and 1.74 mm3 per million cycles (non-HIPed) were produced. Surface roughness increased and a wear stripe often observed clinically on retrieved femoral heads was also reproduced. Under standard simulation conditions only nanometre-sized wear particles (2-27.5 nm) were observed by TEM, and it was thought likely that these particles resulted from relief polishing of the alumina ceramic. However, when microseparation of the prosthesis components was introduced into the simulation, a bi-modal distribution of particle sizes was observed. The nanometre-sized particles produced by relief polishing were present (1-35nm). however, larger micrometre-sized particles were also observed by both transmission electron microscopy (TEM) (0.021 microm) and scanning electron microscopy (SEM) (0.05-->10 microm). These larger particles were thought to originate from the wear stripe and were produced by trans-granular fracture of the alumina ceramic. In Part I of this study, alumina ceramic wear particles were isolated from the periprosthetic tissues from around Mittelmeier ceramic-on-ceramic hip prostheses. Characterisation of the particles by TEM and SEM revealed a bi-modal size distribution. SEM analysis revealed particles in the 0.05-3.2 microm size range. and TEM revealed particles in the 5-90 nm size range, indicating that microseparation of the prosthesis components may be a common event in vivo. This study (Part II) has revealed that the introduction of microseparation of the prosthesis components during the swing phase of the wear simulation reproduced clinically relevant wear rates, wear patterns and wear particles in in vitro hip joint simulators.     

The relative effects of radiation crosslinking and type of counterface on the wear resistance of ultrahigh-molecular-weight polyethylene

The lifetime of total joint replacement prostheses utilizing ultrahigh-molecular-weight polyethylene (UHMWPE) components has historically been determined by their wear resistance. It has been discovered that radiation crosslinking of UHMWPE can substantially increase its wear resistance. However, it is also well recognized that there is a radiation-dose-dependent decrease in several important mechanical properties of UHMWPE, such as fracture toughness and resistance to fatigue crack propagation. In this study, the effect of radiation crosslinking (followed by remelting) on the morphology, tensile properties and wear resistance of UHMWPE was investigated. Wear tests were conducted against both the commonly used cobalt-chromium counterface polished to implant grade smoothness as well as a smoother ceramic (alumina) counterface. The results showed that 50kGy dose radiation crosslinking increased the wear resistance of UHMWPE against the cobalt-chromium counterface 7-fold, but the coupling of remelted, crosslinked UHMWPE against the smoother alumina counterface led to a 20-fold increase in wear resistance. This study shows that the use of an alumina counterface would circumvent the need to use a high radiation dose in crosslinking UHMWPE, associated with poor mechanical properties, without compromising wear resistance.     

On the kinetics and impact of tetragonal to monoclinic transformation in an alumina/zirconia composite for arthroplasty applications

Latest trends in load-bearing materials for arthroplastic applications involve the development of highly fracture resistant alumina/zirconia composites, as an alternative choice to alumina and zirconia monolithic ceramics. Composite materials are designed from both chemical and microstructural viewpoints in order to prevent environmental degradation and fracture events in vivo, whose shadow yet hampers the full exploitation of ceramic materials in the field of arthroplasty. The aim of this paper is to evaluate the resistance to environmental degradation in an alumina/zirconia composite (Biolox Delta^®), which represents a primary candidate for hip and knee joint applications. Our approach consists first in the experimental determination of an activation energy value for environmentally driven tetragonal to monoclinic (t–m, henceforth) polymorphic transformation in the zirconia phase of the material; then, based on such an experimental value, a prediction is given for the long-term in vivo environmental resistance of prostheses made of the composite material. The present evaluation clarifies the in vivo performance of this new composite for orthopedic applications.     

Wear evaluation of cobalt-chromium alloy for use in a metal-on-metal hip prosthesis

Wear of the polyethylene in total joint prostheses has been a source of morbidity and early device failure, which has been extensively reported in the last 20 years. Although research continues to attempt to reduce the wear of polyethylene joint-bearing surfaces by modifications in polymer processing, there is a renewed interest in the use of metal-on-metal bearing couples for hip prostheses. Wear testing of total hip replacement systems involving the couple of metal or ceramic heads on polymeric acetabular components has been performed and reported, but, until recently, there has been little data published for pin-on-disk or hip-simulator wear studies involving the combination of a metallic femoral head component with an acetabular cup composed of the same or a dissimilar metal. This study investigated the in vitro wear resistance of two cobalt/chromium/molybdenum alloys, which differed primarily in the carbon content, as potential alloys for use in a metal-on-metal hip-bearing couple. The results of pin-on-disk testing showed that the alloy with the higher (0.25%) carbon content was more wear resistant, and this alloy was therefore chosen for testing in a hip-simulator system, which modeled the loads and motions that might be exerted clinically. Comparison of the results of metal-on-polyethylene samples to metal-on-metal samples showed that the volumetric wear of the metal-on-polyethylene bearing couple after 5,000,000 cycles was 110-180 times that for the metal-bearing couple. Polyethylene and metal particles retrieved from either the lubricant for pin-on-disk testing or hip simulator testing were characterized and compared with particles retrieved from periprosthetic tissues by other researchers, and found to be similar. Based upon the results of this study, metal-on-metal hip prostheses manufactured from the high carbon cobalt/chromium alloy that was investigated hold sufficient promise to justify human clinical trials.     

An in vitro investigation of diamond-like carbon as a femoral head coating

Wear of polyethylene acetabular components of hip implants is a significant clinical problem. In prosthetic hip surgery, polyethylene wear is identified as a factor that limits the life of the implant; it is known that the production of debris can cause adverse tissue reactions that may lead to extensive bone loss around the implant, and consequently loosening of the fixation. A new class of so-called Diamond-Like Carbon coatings, applied to titanium femoral heads was compared to ceramic and metallic heads in terms of wear behavior against UHMWPE using a hip joint simulator with a bovine calf serum lubricant. A thin film of Diamond-Like Carbon was deposited directly onto titanium (Ti6Al4V) head using chemical vapor deposition. The wear of polyethylene coupled with Diamond-Like Carbon coated femoral heads was comparable to that obtained with the polyethylene coupled with commercial alumina femoral heads.     

Volumetric determination of the wear of ceramics for hip joints.

Osteolysis relating to the reaction cascade to wear debris is the main cause of the failure of arthroprostheses. New materials are still under development to minimise the wear of joints and to improve in this way the performance of total joint replacements. Testing the wear performance of very low wear materials is a rather sophisticated technique. Currently, the worn volume is calculated from the weight variations of the sample, observed from wear testing. This method may be limited especially when very low weight differences are to be evaluated on high hardness, high-density materials like CoCr alloys or ceramics like alumina or zirconia. In the present work, the tribological behaviour of ceramic biomaterials like alumina, Y-TZP and alumina-zirconia composites was evaluated by a pin-on-disc apparatus under different testing conditions. The worn volume was calculated by the use of 3-D (three-dimensional) optical profilometry data. Comparison between 3-D optical profilometry and gravimetric wear data shows the better accuracy of the profilometric method in the determination of wear rate in the range of 10(-7) mm3 (mN(-1)) or lower.     

Effects of clinically relevant alumina ceramic wear particles on TNF-alpha production by human peripheral blood mononuclear phagocytes

The recent introduction of microseparation of the components of ceramic-on-ceramic hip prostheses during hip simulations has produced clinically relevant wear rates, wear patterns and wear particles. This provided an opportunity to determine the response of primary human peripheral blood mononuclear cells to clinically relevant alumina ceramic wear particles in vitro. Alumina ceramic wear particles were generated in a hip joint simulator under microseparation conditions. The particles showed a bi-modal size distribution with nanometer sized (5-20nm) and larger particles (0.2->10 micrometer). The particles were cultured with human peripheral blood mononuclear cells obtained from six different donors at particle volume to cell number ratios of 1, 10, 100 and 500 micrometer(3). After 24h incubation the viability of the cells and the levels of TNF-alpha were determined. The response to the microseparation wear particles was compared to that of commercially available alumina powder with a uniform morphology and mean size of 0.5 micrometer. All six Donors PBMNC produced significantly elevated levels of TNF-alpha when stimulated with 100 micrometer(3) of the alumina powder per cell. Volumetric concentrations of 10 and 1.0 micrometer(3) per cell failed to stimulate a significant response by the cells from any of the six donors. Three of the six Donors PBMNC secreted significantly elevated levels of TNF-alpha when stimulated with 100 micrometer(3) of the microseparation wear particles, whereas the other three failed to respond to the wear debris at this concentration. All of the Donors PBMNC produced significantly elevated levels of TNF-alpha when stimulated with 500 micrometer(3) of the microseparation wear particles per cell. Thus, a greater volume of the microseparation wear particles was required to activate the PBMNC than the alumina powder. This was probably due to the microseparation wear particles having fewer particles in the critical size range (0.1-1 micrometer) for macrophage activation compared to the alumina powder. It can be concluded that alumina ceramic wear particles generated under microseparation conditions are capable of inducing osteolytic cytokine production by human mononuclear phagocytes. However, the volumetric concentration of the particles needed to generate this response is extremely high and given the low wear rates (<4mm(3) per million cycles) of ceramic-on-ceramic bearings, even under severe microseparation conditions, it is unlikely that this concentration threshold will be achieved in vivo.     

Long-term wear of ceramic matrix composite materials for hip prostheses under severe swing phase microseparation

The purpose of this study was to evaluate the long-term wear performance of alumina matrix composite (AMC) heads against alumina matrix composite inserts and alumina matrix composite heads against alumina (Al) inserts with the use of a hip-joint simulator incorporating severe swing phase joint microseparation. The wear of AMC on Al produced an average wear rate of 0.61 mm3/million cycles over the 5-million-cycle test duration. The wear of AMC on AMC produced an average wear rate of 0.16 mm3/million cycles over the 5-million-cycle test duration. Both the AMC on alumina and AMC on AMC produced significantly lower wear than previously tested HIPed alumina, where an average wear rate of 1.84 mm3/million cycles was reported over 5 million cycles. The wear mechanisms and wear debris of AMC on AMC and AMC on Al were similar to those observed in previous alumina retrieval studies with stripe wear caused by intragranular fracture and wear debris consisting of predominantly uniform 10-20-nm-sized particles and a few irregular particles up to 3 microm in size.     

陶瓷对陶瓷人工髋关节的磨擦界面特征

背景：陶瓷对陶瓷人工髋关节假体在临床上已有一定的应用,在表面磨擦、磨损和润滑方面占有优势,具有很大的研发潜力。 目的：评价陶瓷对陶瓷人工髋关节表面磨擦、磨损和润滑特性。 方法：将金属对超高分子量聚乙烯、金属对金属以及陶瓷对陶瓷人工髋关节假体的磨损界面研究进行分析,了解氧化铝陶瓷材料的结构特点、制备工艺以及磨损参数,并分析陶瓷对陶瓷人工髋关节置换治疗的效果,与其它假体材料进行对比。 结果与结论：①金属对超高分子量聚乙烯人工髋关节抗磨损性能差,使磨损颗粒进入关节和周围组织,造成骨溶解和松动。②金属对金属人工髋关节的磨损性能较金属对超高分子量聚乙烯假体有很大改善,骨溶解的发生率非常少,但由于磨损颗粒可散布于体内各脏器和体液中,使用时要注意避免发生过敏反应和毒性。③体外试验和体内试验证明陶瓷对陶瓷人工髋关节具有良好的摩擦、磨损、润滑性能,临床治疗长期随访结果显示陶瓷对陶瓷人工髋关节假体置换后无磨损颗粒,不会发生骨溶解。对于年龄较小,并且对髋关节活动度有较高要求的患者,陶瓷对陶瓷人工髋关节是治疗的首选。随着陶瓷对陶瓷人工髋关节假体设计和材料学的发展,通过改进假体的机械学特性,提高摩擦界面的耐磨性能和润滑机制,陶瓷对陶瓷人工髋关节假体的远期临床疗效将更加满意。     

Isolation and characterization of UHMWPE wear particles down to ten nanometers in size from in vitro hip and knee joint simulators

There is currently considerable interest in the wear debris and osteolytic potential of different types of bearings used in total joint replacements. The biological activity of the wear debris is dependent on the size and volume of the particles produced. Wear volume also plays an important role in the functional biological activity of a joint replacement. In vitro studies have shown that crosslinking of ultra high molecular weight polyethylene (UHMWPE) acetabular cups and tibial trays produces a reduction in wear volume, and crosslinking has now been introduced clinically for both types of prostheses. Previous studies have identified both micron and submicron-sized polyethylene wear particles. The aim of this study was to characterize the wear and wear particles generated from moderately crosslinked GUR 1,020 GVF UHMWPE acetabular cups and tibial trays in hip and knee joint wear simulators down to 10 nanometers in size. The wear rates of the two prosthesis types were very similar at 25.6 +/- 5.3 mm(3) per million cycles for the hip prostheses and 22.75 +/- 5.95 mm(3) per million cycles for the knee prostheses. Nanometer-sized wear particles were isolated and characterized from both hip and knee simulator lubricants for the first time. Significantly higher numbers (p < 0.05) of particles in the nanometer (<0.1 microm) size range were produced by the hip prostheses compared to the knee prostheses. The knee prostheses produced larger particles, with the mode of particle size in the 0.1-1.0 microm size range, compared to <0.1 microm size range for the hip prostheses. In addition, the knee prostheses produced a greater volumetric concentration of wear particles in the 1.0-10 microm size range, and consequently lower specific biological activity and functional biological activity indices. These results indicated that the knee prostheses had a lower osteolytic potential compared to the hip prostheses.