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Materials Science and Technology

ISSN: 0267-0836 (Print) 1743-2847 (Online) Journal homepage: https://www.tandfonline.com/loi/ymst20

Biocompatible alumina ceramic for total hip


replacements

P. Zeng

To cite this article: P. Zeng (2008) Biocompatible alumina ceramic for total hip replacements,
Materials Science and Technology, 24:5, 505-516, DOI: 10.1179/174328408X287682

To link to this article: https://doi.org/10.1179/174328408X287682

Published online: 19 Jul 2013.

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LITERATURE REVIEW
Biocompatible alumina ceramic for total hip
replacements
P. Zeng*
Their resistance to wear and biocompatibility make ceramics ideal materials for medical
applications, such as implants. For over 30 years, pure alumina has been the dominant material
for ceramic hip prostheses. Interest in alumina hip prostheses continues to grow, due to the
relatively short life of polymer/metal prostheses, mainly resulting from osteolysis and aseptic
loosening caused by polymer wear debris. Since its introduction by Boutin in the 1970s,
substantial improvements have been achieved in the microstructure of medical grade alumina by
improving purity and processing to give complete densification and fine, uniform grain sizes. A
brief review is given of the types of alumina used in total hip replacement, the development of
medical grade alumina, and methods of in vivo and in vitro investigation of alumina prostheses,
with a focus on current knowledge of the damage observed on alumina prostheses. Particular
attention is paid to wear mechanisms and the influence of materials properties on wear behaviour.
A region of relatively severe wear, known as stripe wear, is widely observed on retrieved alumina
hip prostheses. This type of wear can now be replicated in vitro in joint simulators by the
introduction of a ‘microseparation’ motion during the test cycle. Finally, the future of ceramic hip
prostheses and development of the next generation of ceramics for hip prostheses is discussed.
Keywords: Microstructure, Alumina, Wear, Hip prostheses

This review is a revised version of a commended entry in polymer (Fig. 1d), ceramic on metal (Fig. 1e), and metal
the 2007 Literature Review Prize of the Institute of on ceramic. The first four combinations are already in
Materials, Minerals and Mining, set up to encourage the the market, the latter two being potential combinations
preparation of critical literature reviews by students as an that are still at the laboratory stage.6
essential part of study for a higher degree in the materials The first metal on polymer THR, also the first true
field, and to make the best of these available to a wider artificial hip joint, implanted by Charnley in 1959,7
readership. contained a stainless steel femoral head and a poly(-
tetrafluoroethylene) (PTFE) acetabular cup. Because of
the toxicity caused by PTFE wear debris, Charnley
Total hip replacements shortly afterwards changed the PTFE to ultrahigh
About 2% of people suffer hip problems that lead to the molecular weight polyethylene (UHMWPE).8 Almost
need to replace their natural hip joints. In the UK at at the same time, McKee and Watson 9 developed the
least 50 000 hip replacement surgeries are carried out metal on metal THR using a cobalt–chromium alloy
every year, and are highly successful in reducing the pain (Fig. 1b). The first ceramic on ceramic THR was
and disability of worn or damaged hip joints.1 Total hip introduced by Boutin in 1970 and developed by
replacement (THR) is one of the most successful Mittlemeier in 1974. Later in 1975, alumina on polymer
applications of biomaterials. THRs were implanted in Switzerland.10
The basic design of a THR involves a femoral head, The metal on UHMWPE THR, namely, the Charnley
an acetabular cup and a metallic stem (Fig. 1). The low friction arthroplasty (LFA), has dominated the
review by Dowson3 summarised six alternative existing THR markets for four decades and is widely referred to
or potential combinations, according to the materials as the ‘gold standard’.3 Nevertheless, the survival rate of
used for the femoral head and acetabular cup, as: metal- the Charnley LFA is not satisfactory in the long-term
on-polymer, such as the Charnley prosthesis (Fig. 1a), (.15 years), dropping from 94?2% at 10 years follow-up
metal on metal, such as the McKee–Farrar prosthesis to 88?7% at 15 years follow-up.11 It is estimated that
(Fig. 1b), ceramic on ceramic (Fig. 1c), ceramic on 15% of hip replacement surgeries are second replace-
ments,1 also known as revision surgeries, due to the
failure of the first THR. The revision operation always
Department of Engineering Materials, University of Sheffield, Mappin takes longer, and is harder, resulting in an even lower
Street, Sheffield S1 3JD, UK success rate. Therefore, some surgeons even reserve
*Corresponding author, email mtp03pz@sheffield.ac.uk THRs for patients aged over 60 years to reduce the rate

ß 2008 Institute of Materials, Minerals and Mining


Published by Maney on behalf of the Institute
Received 11 October 2007; accepted 11 October 2007
DOI 10.1179/174328408X287682 Materials Science and Technology 2008 VOL 24 NO 5 505
Zeng Biocompatible alumina ceramic for total hip replacements

a Charnley metal on polymer hip prosthesis;2 b McKee–Farrar metal on metal hip prosthesis;3 c alumina on alumina hip
prosthesis with metal shell;4 d ceramic on polymer hip prosthesis;3 e ceramic on metal hip prosthesis5
1 Existing or potential materials combinations for THRs classified by materials used for femoral head and acetabular
cup: a–d are already in market, whereas e is still in laboratory stage

of THR failure. However, with the increasing life such as metal on polymer and alumina on polymer,
expectancy of the population, there is a requirement alumina on alumina THRs show the lowest wear rate
for long-term (.15 years) performance THRs. In under laboratory conditions13,14 (Fig. 2). Additionally,
addition, there is a significant, and increasing, number alumina is a bioinert material that reduces the chance of
of patients younger than 50 years old who have hip osteolysis. However, the early clinical performance of
damage from severe sports injuries. It is important to alumina on alumina THRs was controversial. High
reduce the wear of THRs and improve the lifespan of the fracture rates of alumina femoral heads, from 6?9 to
artificial hip prostheses. 13?4%, were cited15–17 during the 1970s, although over a
The main causes of failure of THRs are loosening of
the joint due to wear, and inflammation caused by a
reaction to wear particles from the artificial joint
surfaces that have been absorbed by surrounding tissue.
Osteolysis (resorption of periprosthetic bone), which is
believed to be a result of polymer wear debris, has been
widely observed and has become a major problem
limiting the lifespan of polymer THRs.10,12 Therefore,
there is renewed interest in hard on hard THRs, such as
ceramic on ceramic and metal on metal.

Ceramic on ceramic total hip


replacements
Ceramics are regarded as favourable materials for THRs 2 Comparison of volumetric wear rates in pin on disc
due to their wear resistance and consequent reduction of wear test (mm3/million cycles) of different materials
wear particles. Alumina is the most widely used ceramic combinations:13 note that alumina on alumina pairs
for hip prostheses. Compared with other combinations, show lowest wear rates under laboratory conditions

506 Materials Science and Technology 2008 VOL 24 NO 5


Zeng Biocompatible alumina ceramic for total hip replacements

of alumina on alumina hip prostheses is a major


problem for surgeons and restricted the application of
alumina on alumina THRs in the early years (see below).
Interestingly, research on alumina on alumina hip
prostheses in the first 30 years was mainly a European
development, with some clinical research in Australia
and Japan, because the USA Food and Drug
Administration (FDA) banned the use of alumina hip
prostheses before 2003 due to the high fracture rates
encountered in the 1970s.
Early alumina on alumina THRs used aluminas
developed for industrial applications, the microstructure
of which is poor (Fig. 3a): insufficient purity, low
density and coarse grain size (compared with latest
alumina for hip prostheses, Fig. 3b and c). The
importance of developing alumina materials for medical
use was rapidly realised and the first standard for
alumina for hip prostheses, ISO 6474,22 was established
in 1984. ISO 6474 qualifies medical grade alumina and
decreases the risk of fracture in medical applications.
With the improvement of medical grade alumina
material and better hip design, alumina on alumina
THRs achieved great success in Europe. The work of
Sedel et al.23 showed increasing survival rates of alumina
on alumina THRs for patients younger than 50 years
and it is now well accepted by surgeons that alumina on
alumina THRs are the first choice for the patients
younger than 50 years. Based on the successes in Europe
and good results of trials on modern alumina-on-
alumina hip prostheses in the USA,24 the FDA withdrew
the ban on alumina on alumina hip prostheses in 2003.
Research on alumina on alumina hip prostheses is now a
global enterprise and the likelihood of widespread
adoption of ceramic on ceramic hip joints is high.

Development of medical grade alumina


As indicated above, the pioneering alumina materials for
hip joints were based on ceramics developed for
industrial applications, which had insufficient mechan-
ical strength for in vivo applications and hence poor
reliability and fracture rates.25 As a result, ISO 6474 was
set up to qualify ceramics used in hip prostheses. 22
Significant improvement of medical-grade alumina
was achieved in Germany in the early 1970s, as part of
the development of a range of modern engineering
ceramics.26,27 The development of medical grade alu-
a SEM image of early alumina for THRs after thermal mina has been rationalised in terms of three generations
etching (4 h, 1460uC, normal atmosphere);21 b SEM
of ceramics (Table 1). Developments have been concen-
image of third generation alumina for THRs after ther-
mal etching (15 min, 1470uC, normal atmosphere; c TEM
trated on purity, grain size and density in view of the
image of third generation alumina for THRs
3 Microstructures of alumina for THRs: note enrichment Table 1 Mechanical properties of medical grade
alumina27
of glass phases in grain boundaries and coarse grain
size in a 1970s 1980s 1990s
(first (second (third
generation) generation generation)
later period, fracture rates as low as 0?4% were
reported.18–20 It is worth noting that the aluminas with Strength (min.), MPa 400 500 580
high fracture rate were based on formulations developed Hardness (min.), HV 1800 1900 2000
for industrial applications,15–17 whereas the low fracture Bending strength, MPa .450 .500 .550
Wetting angle, u ,50 ,50 ,50
rates were observed from medical grade alumina.18–20 Average grain size, mm (4.5 (3.2 (2.0
Apart from the material itself, poor hip design and Density (min.), kg m23 3.86 3.94 3.96
operation skills were also responsible for the early Young’s modulus, GPa 380 380 380
failure of alumina on alumina hip prostheses. Unlike Laser making No Yes Yes
polymers, there is a high risk of fracture during an HIP No No Yes
Proof tested No No Yes
operation due to the low toughness of alumina. Fracture

Materials Science and Technology 2008 VOL 24 NO 5 507


Zeng Biocompatible alumina ceramic for total hip replacements

4 Wear rate–grain size dependence in wet erosive wear


test of pure polycrystalline alumina:28 note wear rate
decreases with decreasing grain size

close correlation between mechanical strength and these


characteristics.
Glassy phases are commonly found on the grain
boundaries of ceramic materials as a result of impurities
in the raw materials. The glassy phase tends to degrade
in the body and cause the material to age, i.e. to loose its
mechanical strength.28–30 For the latest, third generation
of alumina, purity is as high as 99?9%26 and glassy
phases are not observed even in TEM (Fig. 3c).
However, it is worth noting that some second phases
are useful, such as magnesium oxide (MgO). It is
believed that the grain size of alumina can be effectively
controlled by doping with MgO.26
Grain size control has been critical in the development 5 Schematic illustration of a development of intergranular
of medical-grade alumina. Apart from the favourable microcracking and b wear process as summation of
effect on mechanical strength, it is generally recognised crack growth and delay steps28
that the wear rate of alumina decreases with decreasing
grain size.28–33 Davidge and Riley28 reported a relation-
ship between wear rate and grain size for a set of high
purity polycrystalline aluminas of similar hardness and
fracture toughness (Fig. 4). They presented a simple
wear model, postulating that the critical wear process
involves the nucleation and propagation of grain
boundary microcracks (Fig. 5).28 The time t for the
crack to reach a critical length is given by
t~AzB=G (1)
where G is grain size, and A and B are constants. Thus,
the theoretical wear rate W is
W ~C½G=(AGzB) (2)
where C is a constant that can be incorporated into A
and B. Thus
W ~G=(MzNG) (3)
where M and N are the modified constants. 6 Wear data for nominally ‘pure’ alumina ceramics of
Therefore, a reduction in grain size is an essential three grain sizes: room temperature data for rotating
requirement in reducing wear. Reducing the grain size is silicon nitride sphere, 12 mm in diameter, 450 N load,
also believed to be beneficial in delaying the transition to on flat specimen, paraffin oil lubricant; note initial slow,
higher wear rates (Fig. 6),30,31 and this has been reflected steady increase in scar diameter with sliding time, fol-
in the development trends for medical-grade alumina lowed by abrupt transition to severe wear at critical
(Table 1). sliding time; sliding time for onset of transition
Porosity (i.e. density) also plays an important role in diminishes significantly for larger grain size materials;
wear of alumina.32,33 Pores, especially intergranular vertical dashed lines are theoretical predictions of tran-
pores, can act as sources of slip or twinning and promote sition times31

508 Materials Science and Technology 2008 VOL 24 NO 5


Zeng Biocompatible alumina ceramic for total hip replacements

7 Summarised fracture rates of alumina on alumina hip prostheses as function of ceramic brand and implantation per-
iod: note dramatic decrease of fracture rates in later 1970s and early 1980s15–18,24,27,34–46

wear.32,33 Third generation aluminas are hot isostatically observations have been made by surgeons who have
pressed (hipped) to give increased density of direct access to the retrieved prostheses.
3?96 kg m23 (Table 1). Since the temperatures used in
hipping are lower than those for sintering, grain growth Fracture rate
is limited, which also benefits grain size. The results of fracture analyses of the alumina hip
The colour of medical grade alumina is related to prostheses are summarised in Table 2 and Fig. 7.
its quality and chemical purity.26 Alumina ceramics Fracture rates as high as 13?4% were observed for first
with low impurity levels, but which have been generation alumina on alumina hip prostheses in the
doped with magnesium oxide (MgO) as specified by early years.16 After 1980, a dramatic decrease in fracture
ISO 6474, are not white, but ivory in the unsterilised rates occurred, with several authors reporting 0%
form. When the ceramic ball heads are sterilised using failure.34–37 No official data for third generation
gamma rays, the material turns brown, which can be alumina have been published; however, a lower fracture
explained in terms of the absorption due to the different rate is indicated. It can be concluded that fracture is no
valences of aluminium (3), oxygen (2) and magnesium longer the problem for surgeons that it was in the 1970s
(2).24 and modern alumina on alumina hip prostheses are
unlikely to fail during hip operations.
In vivo wear performance of alumina on Wear rate survival rate
alumina THRs The wear rate is the most direct way to evaluate wear
In vivo study of hip prostheses, involving clinical performance of prostheses. Alumina on alumina hip
evaluation of prostheses retrieved from bodies, is the prostheses exhibit lower wear rates, deduced from in vivo
most direct method to investigate the wear performance. investigation, than either metal on polymer or metal on
However, because of the limited supply of retrieved hip metal hip prostheses. Reported linear wear rates range
prostheses and the need to protect patients, it is extremely from ,161026 to .0?561023 m/year, with a mean
difficult for researchers to access in vivo materials. Most value of 5?661025 m/year.25 On this basis, ceramic on
prostheses in the work reviewed below are manufactured ceramic prostheses could function in vivo without
from first and second generation medical grade alumina, noticeable abrasion for nearly 10 years.47
with relatively limited information from retrieved third Although the wear rate is low, the published survival
generation prostheses. It is also worth noting that most rates of alumina on alumina hip prostheses are not

Materials Science and Technology 2008 VOL 24 NO 5 509


Zeng Biocompatible alumina ceramic for total hip replacements

Table 2 Reported fracture rates of alumina on alumina improved survival rates of 100% on 5 years follow-up
hip prostheses and 95?1 and 94?3% on 7 years follow-up for two
Implantation No. of Fracture different hip design.44 However, there is a lack of data
Authors period implantations rate, % for third generation prostheses as a result of their
restricted time in service.
Griss et al.16 1974–78 130 6.9 It is worth noting the work of Sedel et al.23 which
Trepte et al.18 1977–? 41 0 showed increasing survival rates of alumina hip pros-
Knahr et al.17 1976–79 67 13.4 theses for patients younger than 50 (87% for patients
Boutin et al.15 1977–85 560 0.54
O’Leary et al.35 1982–83 69 0 younger than 50 year on 15 year follow-up, against an
Higgs38 1980–87 337 0.29 overall survival rate of 70%). Although there is
Hoffinger et al.36 1983–84 119 0 uncertainty on the long term performance of alumina
Nizard et al.39 1977–79 187 1.6 on alumina hip prostheses due to the limited data,
Winter et al.40 1974–79 100 8 alumina hip prostheses show the best performance in the
Burckerd et al.41 1978–92 .1200 0.16 patient group younger than 50 years. It has been
Fritsch et al.42 1974–82 1069 0.4
Fritsch et al.42 1982–94 1763 0.06
suggested23 by surgeons that for young and more active
Boehler et al.43 1976–79 243 0 patients, alumina on alumina hip prostheses are good
Bizot et al.44 1990–92 234 0.002 choice; however, the standard Charnley LFA may still
Garino39 1997–98 333 0 be most appropriate for older patients.8
Willmann27 1974–82 – 0.026
Willmann27 1982–94 – 0.004 Reasons for revision
Hamadouche et al.34 1979–80 118 0 Table 4 summarises the published data on the reasons
D’Antonio et al.24 for revisions. It can be concluded that fracture of
1996–98 514 0.002
Bierbaum et al.45
alumina is no longer the main cause of failure; since the
Walter et al.46 ? 1588 0
introduction of medical grade alumina, aseptic loosen-
ing has become the main reason for revision surgeries.
satisfactory. These are summarised in Table 3 and However, the mechanism leading to this loosening is not
Fig. 8. It can be seen from Table 3 that the survival clear, i.e. it has not been established whether wear is a
rates of early alumina hip prostheses, before ISO 6474, factor in the loosening process. Therefore, there remains
are lower than those for the Charnley LFA.3 The limited a need for further studies on the wear mechanisms of
data for second generation alumina hip prostheses show alumina hip prostheses.

Table 3 Reported survival rates of alumina on alumina hip prostheses

Survival rate, %

Authors Implantation period 5 years 7 years 10 years 15 years 20 years

Nizard et al.39
1977–79 89.5 87.1 82.5 – –
Sedel et al.23 1977–? – – 83 70 (86 for patients younger than 50 year) –
Bizot et al.44 1978–94 97.3 94.1 90.4 78.9 –
94.7 88.8 88.8 – –
100 95.1 – – –
100 94.3 – – –
Hamadouche et al.34 1979–80 – – – – 61.2 for cup
87.3 for stem
– – – – 85.6 for cup
84.9 for stem
Nizard et al.48 1977–84 – – 88.6 – --

Table 4 Published data on revisions and causes

Implantation No. of
Authors period revisions Reasons for revision

Walter et al.21 1975–78 28 Loosening of stems and sockets (10), loosening of stems only (7), cup
loosening (5), loosening of sockets (3), ball fracture (2) and infection (1)
49
Nevelos et al. 1980–89 10 Displacement of acetabular cup (4), femoral stem perforation of cortex (2),
femoral stem too small (2), failure of bone in acetabulum (1) and dislocation
of prosthesis (1)
Fritsh et al.42 1974–94 6 Direct trauma (4), recurrent neck impingement (2) and fatigue failure (1)
Nevelos et al.50 1980–94 11 Aseptic loosening of acetabulum (2), loosening of femoral stem (4),
loosening of both components (4) and loosening but on inspection to be stable (1)
Bizot et al.44 1990–92 11 Aseptic loosening (6), recurrent dislocation (1), deep infection (2),
fracture of head (1) and persistent hip pain (1)
45
Bierbaum et al. 1996–98 4 A periprosthetic femur fracture (1) recurrent instability (1), sepsis (1)
D’Antonio et al.24 and suspected, but not confirmed sepsis (1)
Garino et al.51 4 Migration of cup (1), deep infection (1), dislocation (1) and liner
malplacement (1)
Walter et al.46 1997–2002 21 Periprosthetic fracture (6), psoas tendonitis (6), infection (3), aseptic
loosening (3), dislocation (2), and heterotopic ossification (1)

510 Materials Science and Technology 2008 VOL 24 NO 5


Zeng Biocompatible alumina ceramic for total hip replacements

8 Summary of survival rates of alumina on alumina hip


prostheses in literature as function of implantation
period23,34,39,44,48

Wear debris
Polymer wear debris is believed to be the main cause of
osteolysis as a result of biological reaction with
tissue.10,12 However, the role of ceramic wear debris
9 Wear debris in size range 5–90 nm in tissue from worn
remains unclear and only limited data involving ceramic
alumina on alumina hip prosthesis50
wear debris are published.
Numerous particles with a mean size of 5 mm were
observed in the pseudosynovial tissue obtained from materials for THRs. Pin on disc tests, reciprocating pin
revisions due to mechanical failure.52 In addition, wear on plate tests and joint simulators are the most widely
debris in the size range 5–90 nm (Fig. 9) was revealed in accepted in vitro methods for characterising the tribo-
the tissue from alumina on alumina hip prostheses, logical behaviour of hip prostheses.3 The first two tests
together with wear debris 0?5–3?2 mm in size.53 This was are widely applied in materials science to study the
the first description of nanometre sized alumina wear tribology of materials, e.g. to compare different material
particles in retrieval tissues. combinations or the effect of different lubricants. A
Two mechanisms were proposed to generate the two series of pin on disc tests indicated that the coefficient of
types of alumina wear debris:53 friction of alumina on alumina hip prostheses is affected
(i) relief polishing, producing nanometre sized alu- by the type of lubrication,55 being much smaller when a
mina wear debris under normal articulating 1 wt-% aqueous solution of carboxymethyl cellulose
conditions sodium salt was used as lubricant instead of distilled
(ii) intergranular and intragranular fracture due to water. Therefore, alumina on alumina hip joints might
edge loading under condition of microseparation benefit from full fluid film lubrication with appropriate
of the head and cup on rim contact, generating machining to produce a good surface finish, good fit and
larger wear particles. a proper lubricant.
Yoon et al.54 reported the only case of osteolysis caused In vitro studies are also used to analyse potential
by ceramic debris. However, some surgeons argued that materials used for hip prostheses, such as zirconia/
this was an exceptional case resulting from poor design alumina combinations. Although zirconia/zirconia pairs
of the THR.8 Therefore, clinical results concerning have shown poor wear performance,56 zirconia/alumina
osteolysis of alumina hip prostheses are required to and alumina/zirconia pairs exhibited similar wear
clarify the observation. performance to alumina/alumina. On this basis, combi-
nations of zirconia/alumina or alumna/zirconia were
proposed as potential materials for hip prostheses.56
In vitro wear performance of alumina on Although pin on disc studies have proven effective to
alumina THRs investigate the tribology of potential materials for hip
In vivo experience is the most direct and convincing prostheses, these conditions are not realistic in view of
means of obtaining data on long term hip prostheses the complex environment, configuration and stresses
performance; however, studies are based on failure experienced by human hip joints. This perception led in
analysis of retrieved prostheses, largely ignoring success- the 1970s to the development of a more sophisticated
ful implants. In addition, supply of in vivo samples is approach to joint tribology, based on joint simulators,3
limited and is not helpful to validate new materials. which are now used for most in vitro investigations.
Therefore, in vitro studies are often carried out as a In joint simulators, alumina on alumina bearings
complement to in vivo studies. show lower wear rates than metal on polymer or metal
In vitro tests performed outside a living organism, on metal bearings. However, the wear rates are
often in conditions designed to simulate in vivo service, significantly lower than those observed in vivo.34,50,57–61
are an effective way to investigate prospective new Fluoroscopy studies60 have suggested that the

Materials Science and Technology 2008 VOL 24 NO 5 511


Zeng Biocompatible alumina ceramic for total hip replacements

a separation during swing phase; b rim contact at heel strike; c relocation during stance phase
10 Schematic depiction of relative microseparation during gait cycle25

discrepancy is a result of differences in joint separation Wear of hipped alumina on alumina bearings for
between simulated and in vivo joints. Hip joint separa- THR under microseparation conditions has been
tion could be resolved in vivo if the amount of separation studied at the University of Leeds.62,63 During the first
was .0?75 mm. For gait, the maximum and minimum million cycles (bedding-in) of the microseparation tests,
separations were found to be 2?8 and 0?8 mm (average: characteristic stripe wear was observed on all femoral
1?2 mm); and for abduction/adduction leg lift, 3?0 and heads, with a matching area on the rim of the acetabular
1?7 mm (average: 2?4 mm). It was hypothesised that this inserts. Under mild microseparation conditions, pro-
micro separation could occur with any hip prosthesis duced by a swing phase load of 400 N, an average wear
and could be a factor in the initiation of fracture based rate of 5?5610210 m3/million cycles was observed
wear, leading to the characteristic ‘stripe’ observed on during the initial million cycles, which reduced to a
ceramic on ceramic hip prostheses.61 The small clear- steady state level of 1?0610210 m3/million cycles. Under
ances between the head and socket (typical radial more severe conditions, produced by a swing phase load
clearances are 30 mm) mean that the femoral head may of 50 N, an average wear rate of 4?061029 m3/million
translate inferiorly and laterally if micro-separation cycles was observed during bedding-in, which reduced to
occurs. These displacements would typically be a steady state level of 1?361029 m3/million cycles. In
,1 mm for a well positioned prosthesis. It was also contrast, a bedding-in wear rate of 1?1610210 m3/
postulated that after microseparation during the swing million cycles and steady state wear rate of
phase, on heel strike, the head would translate superiorly 5610211 m3/million cycles for the same material
and contact the rim before relocating in the cup.61 Rim (hipped alumina) were observed under normal simula-
contact would occur under high stresses and could tion with no microseparation.
initiate surface damage in the form of a wear stripe on It is clear that microseparation raises slightly the wear
the head, as shown in Fig. 10. A modification was made rate of alumina on alumina hip prostheses in simulated
to the hip simulator to replicate the microseparation, tests. Furthermore, under microseparation, the wear
which was achieved by applying a force of approxi- mechanisms and wear debris were similar to those
mately 400–50 N in the lateral direction using a spring observed in previous alumina retrieval studies with
(Fig. 11).61 debris ranging from 10nm to 1 mm in size. Replication of
the stripe wear, found on retrieved in vivo alumina hip
prostheses, was observed for the first time (Fig. 12). The

12 Stripe wear of hipped alumina components


(marked):63 left image shows pair of alumina hip
prostheses explanted after 1 year and right image
11 Schematic illustration of microseparation mechanism pair of alumina hip prostheses following in vitro
in in vitro simulation63 microseparation

512 Materials Science and Technology 2008 VOL 24 NO 5


Zeng Biocompatible alumina ceramic for total hip replacements

a pole zone wear; b equatorial zone wear21


13 Schematic depiction of wear on retrieved in vivo alumina hip prostheses

in vitro performance of hip joints with microseparation wear in the contact areas of the component associated
is much more similar to the in vivo performance than in with high stresses and poorer lubrication.50
previous simulations. It is worth noting that the equatorial zone has
subsequently been widely observed.46,50,62,65,66
Microstructure of worn alumina on However, no other reports of pole zone wear have been
found in the literature. Furthermore, some authors66
alumina THRs argue that wear always occurs on the rim of the socket
Plastic deformation, cracking and chemical reaction are and never on the apex (equivalent to pole zone wear).
the main wear mechanisms of alumina. It is well Although pole zone wear is feasible by a microsepara-
documented that wear behaviour is strongly affected tion mechanism, further observations are required to
by microstructural features, such as grain size and support the hypothesis.
pores.30–33,64 However, research to date on alumina on Walter and Plizt21 also observed little difference in the
alumina hip prostheses has concentrated on the wear microstructure corresponding to different wear patterns.
performance of the overall system rather than the wear Loss of intergranular cohesion led to severe wear in
mechanism of the material. Most observations were either the pole zone or equatorial zone. However,
made by surgeons, and there is a lack of quantitative outside the wear areas, the loss of one or more grains
data on either microstructure or mechanical properties. was observed in regions of the originally highly polished
Only limited work has been found in literature concern- bearing surfaces (caused by occasional grain pull-out in
ing microstructures of worn alumina on alumina hip the mild wear zone). They proposed that the severe wear
prostheses.21,46,49,50,62,65,66 While knowledge of wear rate might be explained not only by the ‘first point of
or survival rate may be sufficient for surgeons or contact’ mechanism but also by dry scratching of non-
patients wishing to choose between existing implants, polished bearing surfaces.21
it does not provide the fundamental understanding of Interestingly, energy dispersive microanalysis revealed
wear mechanisms crucial to the development of new a region of high alkaline earth and silicon concentra-
ceramic materials. tions in the grain boundaries after thermal etching21
Walter and Plizt21 investigated the wear surfaces of 29 (Fig. 3a). These regions were sensitive to corrosion,
retrieved in vivo first generation alumina hip prostheses. especially in zones where microcracks occurred, which
Wear was observed in two different zones (Fig. 13): a might be the initiation point for later fracture of the
‘pole’ zone (Fig. 13a), namely, at the top of the femoral component. Note, however, that this work21 investi-
heads or bottom of the acetabular cups, and an equatorial gated first generation alumina hip prostheses implanted
zone near the edges of the acetabular cups or correspond- between 1975 and 1978, and the higher purity third
ing zones of the femoral heads (Fig. 13b). The emergence generation materials would not be expected to show
of these two wear zones can be attributed to edge loading such impurity concentrations at grain boundaries.
due to microseparation, for example, Fig. 10c for the pole Further investigations were made on the worn surface
zone wear and Fig. 10b for the equatorial zone. It was of retrieved alumina on alumina hip prostheses, for
proposed that low level wear begins when the surfaces which clinical observations had given a range of reasons
first came into contact; this appears to progress to severe for failure.21 Although different wear patterns were

Materials Science and Technology 2008 VOL 24 NO 5 513


Zeng Biocompatible alumina ceramic for total hip replacements

(iii) severe wear: both head and cup showed large


areas of wear and loss of sphericity.
The unworn areas outside of the main contact area (low
wear area) had a mean roughness of 0?005 mm Ra. Wear
stripes had a typical roughness of 0?1–0?2 mm and severely
worn areas were usually in the range 0?2–0?4 mm Ra. It was
proposed, as above, that low level wear began on initial
surface contact, progressing to stripe wear in contact areas
of the component associated with high stresses and hence
poorer lubrication.51 In the low wear regime, the mechan-
ism appears to be polishing with occasional loss of surface
grains by a grain boundary fracture mechanism (Fig. 14a).
Stripe wear areas have sharply defined edges with a low
wear region outside the stripe and more severe surface
damage within (Fig. 14b and c). The spherical wear debris
(0?1–0?5 mm in diameter) seen in the pores left by grain
removal was believed to be a result of a third body wear
mechanism. The regions of severe wear were similar in
appearance to the areas of stripe wear but on a larger scale.
However, no transgranular fracture was observed in the
severe wear regime. Some boundary lubrication (provided
by adsorbed proteins), which gave the surfaces a degree of
protection, was also proposed: for short contact durations,
it is likely that the proteins could protect the surfaces; under
harsher conditions such as rising from a seated position
(squeeze lubrication effects), the boundary layer would not
have been sufficient to protect the surface.
Work on retrieved in vivo third generation alumina hip
prostheses has also been published.46 Stripe wear due to
edge loading was still visible and grain pull-out with fine
scale debris trapped in the pits was revealed in the wear
scar. In the centre of the scars, evidence of repolishing of
the surface was observed. Wider stripes were seen on the
femoral heads than on the acetabular cups.

Future of ceramic hip prostheses


Pure alumina hip prostheses have been used for more
than 30 years and have been the dominant ceramic hip
implant. The latest high performance alumina product
provides a competitive solution of high reliability and
excellent wear resistance. However, alumina is a brittle
material and subject to a small but persistent probability
a low wear area; b worn/ low wear boundary of wear of fracture.67 The challenge for ceramic engineering is to
stripe; c near edge of wear stripe61 develop an improved material which maintains the
14 Images (SEM) of ‘stripe’ wear advantageous properties of third generation alumina
but allows new applications that require high mechan-
observed on the retrieved prostheses, plastically ical load bearing capability.68
deformed, agglomerated alumina wear debris was One approach to this goal is a composite material
believed to play an active role in the enhancement of based on an alumina matrix with reinforcement phases
the avalanche effect, associated with exaggerated wear in to increase toughness and hardness, such as zirconia
certain alumina/alumina Autophor (Mitterlmeier) hip toughened alumina (ZTA). In 2000, CeramTec AG
joints.21 launched a mixed alumina–zirconia ceramic under the
The Leeds group50,61 made significant progress in trade name Biolox-delta which contained Al2O3
characterising the microstructures of worn alumina on (75 vol.-%), ZrO2 (24 vol.-%) and mixed oxides
alumina hip prostheses. They analysed retrieved in vivo (1 vol.-% CrO2zSrO).68 Compared with third genera-
first and second generation alumina prostheses tion alumina, this ZTA shows a potential doubling of
implanted between 1977 and 1994. Few differences were strength relative to unreinforced alumina, although the
observed between the worn surfaces of first and second hardness was slightly lower. Therefore, the door is open
generation aluminas. Three regions were distinguished, for new ceramics based on alumina.
according to the wear pattern:
(i) low wear: little visible wear, surface remained
polished
Conclusions
(ii) stripe wear: an elliptical wear stripe visible on On the basis of the critical review of research on alumina
head, with roughing of part of the cup surface hip prostheses presented above, the following conclu-
sometimes visible sions can be drawn:

514 Materials Science and Technology 2008 VOL 24 NO 5


Zeng Biocompatible alumina ceramic for total hip replacements

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