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2008 Alumina in THR
2008 Alumina in THR
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
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
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.
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
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.
Survival rate, %
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 – --
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)
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
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
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
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