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Uinicul Biomechanics Vol. 11, No. 4, pp. 214-219.

1996
Copyright 0 1996 Elsevier Science Limited. All rights reserved
Printed in Great Britain
0268-0033196 $15.00 + 0.00
ELSEVIER

B A 0 McCormack MSC~, P J Prendergast PhD*, D G Gallagher MEngSc’

‘Bioengineering Research Centre, Department of Mechanical Engineering, University


College Dublin, and 2Department of Mechanical Engineering, Trinity College, Dublin 2,
Ireland

Abstract
Objective. To develop a methodology to characterize the pattern of crack initiation and
damage accumulation in intramedullary fixated cemented prostheses.
Design. An experimental physical model of intramedullary fixation was developed which
both represents the implant structure and permits monitoring of fatigue crack growth.
Background. Many joint replacement prostheses are fixed into the medullary cavity of
bones using a poly(methylmethacrylate) ‘bone cement’, which forms a mantle around the
prosthesis and locks it to the bone. The endurance of the replacement is, to a great extent,
determined by the mechanical durability of the cement and the implant interfaces under
cyclic stresses generated by dynamic loading. The cement mantle is subjected to complex
multiaxial stresses which vary in particular distribution depending on the prosthesis design.
Methods. Damage accumulation is reported in terms of the number of cracks, the location
of cracks, and the rate of crack growth.
Results. The results clearly show the nature of damage accumulation in the cement mantle,
and that many of the cracks which propagate within the cement mantle are related to
cement porosity.
Conclusion. This study gives experimental evidence to support the hypothesis of a damage
accumulation failure scenario in cemented hip reconstructions.

Relevance
Cementing is the most popular technique for the fixation of joint replacement prosthesis.
However, the sequence of events leading to the failure of cemented fixation is not fully
understood. In this paper it is shown that damage accumulation can be directly monitored
in an experimental model of cemented intramedullary fixation. Copyright @ 1996 Elsevier
Science Ltd.

Key words: Damage accumulation, prosthesis fixation, hip replacement, failure scenario

Clin. Biomech. Vol. 11, No. 4, 214-219, 1996

Introduction can be associated with failure of the cement mantle by


the process of ‘damage accumulation’. Damage
Most joint replacement prostheses have an intra-
accumulation is defined as the propagation of small
medullary component which is fixed into the bone
internal flaws and microcracks which eventually form
using a poly (methylmethacrylate) ‘bone cement’. For
critical defects’. Cracks have been reported in the
example, the femoral side of hip replacement, the tibia1
cement mantles of autopsy-retrieved hip prostheses
component of knee replacement and both the humeral
even though there were no signs of clinical failure at the
and radial components of elbow replacements can all
time of death4. These cracks were seen both within the
be fixed in this way’. Breakdown in the mechanical
cement mantle and on the interfaces, and were present
integrity of the cement layer is one route to clinical
in all retrievals (including those which had been
failure of these joint reconstructions2. This breakdown
implanted for only 3 years). Other retrieval studies
have shown that pores and voids are formed during the
.l---.--
insertion of the cernen$(j, an observation that has been
Received: 13 April 1995; Accepted: 23 November 1995
Correspondence and reprint requests to: B A 0 McCormack MSC,
made many times in bone cement specimens prepared
Bioengineering Research Centre, Department of Mechanical under laboratory conditions7s. Fatigue striations on
Engineering, Ilniversity College Dublin, Dublin 4, Iretand the fracture surfaces of retrieved mantles prove that, in
McCormack et al: Damage accumulation in cemented hip prosthesis 215

certain cases at least, not only do cracks occur in viva Methods


but that they also propagate to cause failure’.
The first part of this section describes the design of the
The objective of this investigation was to develop an
experimental model and the second part describes the
experimental methodology for the analysis of micro-
methods of crack observation and analysis.
crack growth in intramedullary-fixated implant struc-
tures. There are many studies reporting the particular
nature of the stress pattern in the cement mantle and on The experimental model
the interfaces of intramedullary prostheses”,“. These
The design concept for the model is a structure com-
stresses induce a complex failure mechanism in the
prising a tapered metal stem with a cement layer on
cement mantle’* that cannot be fully regenerated in a
either side and a layer of bone on the outside of the
simple test specimen. Therefore an experimental model
cement layers, held intact by a component which repli-
must be designed to reproduce the essential features of
cates the circumferential force transfer of the bone, see
this stress distribution whilst at the same time being
concept design of Figure 1. Hence the structure has five
simple enough to facilitate crack observation.
layers (bone/cement/prosthesis/cement/bone) and is
One of the common problems encountered when
open on one side to allow crack observation. To permit
attempting to study cracks in real structures is simply
the transmission of light through the cement layers,
one of crack observation and crack growth monitoring.
three ‘windows’ were machined into the back wall of
In a hip arthroplasty, the cement mantle is encased in
the model. To ensure internal visibility of the cracks
bone and, even if the mantle were exposed, it is usually
and flaws, a clear poly (methylmethacrylate) cement
difficult to see into the depth of the cement. Non-
was used. The experimental test model may be
destructive crack detection techniques such as acoustic
considered as a longitudinal slice taken from the centre
emission13 and ultrasound14 have been used, but the
of an idealized intramedullary fixation.
accurate location of new cracks, and accurate tracking
Dimensions were calculated to ensure that the
of crack growth is not possible using these techniques.
experimental model transferred the stress through the
Destructive testing such as sectioning or splitting the
cement mantle in a similar way to the real intra-
test specimen have been developedi5. However,
medullary system. Beams-on-elastic-foundation theory
destructive testing means that several different
is applied to calculate the loading in this system, as has
specimens must be used to determine what happens
been applied previously to the femoral component of
over time and an error due to inter-specimen variation
the artificial hip joint l&i’ The theory assumes that
is introduced. In addition, destructive techniques do
bone and prosthesis are stiff beams separated by an
not allow the distinction between pre-test cracks and
elastic layer, which is modelled as a set of springs.
cracks initiated during testing, and accurate tracking
Using this approach, Huiskes” resolved the joint
of damage accumulation under fatigue loading is
loading into axial and transverse components and
therefore difficult.
carried out separate analysis for each. He has shown
An experimental model which represents the implant
that the fundamental load transfer pattern of intra-
structure in respect of its material properties, interface
medullary fixation involves proximal stress transfer to
conditions, and geometry was developed. The design is
the bone, a central region where the structure behaves
achieved subject to the constraint that damage accumu-
as a composite beam, and a distal region of load
lation must be continuously visible during fatigue
transfer to the prosthesis. Using the beams-on-elastic-
loading. In this way we can successfully monitor crack
foundation approach (see Appendix), we evaluated
initiation sites and the growth characteristics of cracks.
many alternative designs of experimental model. The
The growth of many cracks is observed (as opposed to
dimensions given in Figure 2 were those of the final
just the rapid emergence of one dominant crack) and
design. For the final design of the experimental model
this supports the hypothesis of a damage accumulation
it was calculated that a peak load of 1 kN applied to the
failure scenario for cemented intramedullary recon-
stem develops stresses in the range O-6 MPa in the
structions, such as hip joint replacements.
cement layers.

Specimen manufacture and testing method


Six identical models were fabricated for the testing
programme. The details of manufacture are as follows.
BOW.2
An aluminium channel section component acted as a
Ph4MA ‘holder’ to replicate the bone. Lengths of bovine rib
Stem/Holder bone were cleaned, sectioned longitudinally, rough
ground to a thickness of approximately 2 mm, and
Channel Section
finally cut to fit the inside face of the aluminium
“holder” component. The cortical side of the bone was bonded
to the inside walls of the aluminium (using Araldite
epoxy resin); thus the cancellous bone remained
Figure 1. The experimental model is a five-layered structure held
together with a channel section.
exposed. Next, a mild steel tapered stem with a
216 Clin. Biomech. Vol. 11, No. 4, 1996

shorter than 0.2 mm were not recorded. Figure 2b


shows the location and reference numbers used for the
20 t viewing windows. The criterion for crack growth was
2s 0 that the final length must be greater than the initial
A
i length by 0.2 mm.
The models were dynamically loaded at 20 degrees to
the long axis, at room temperature in air. The
aluminium holder was clamped 60 mm from its distal
end. The fatigue loading followed a saw-tooth wave
.oi pattern, varying from zero to 1 kN at a frequency of
10 Hz, applied using a customized 4-station Instron
hydraulic testing machine (Instron Limited, UK). After
500000 cycles the test was interrupted and the location
and length of any new cracks recorded for each zone.
The growth of existing cracks was also measured. This
procedure was repeated every 500000 cycles up to five
million cycles (i.e. a total of 11 times for each experi-
mental model).

Results
! The results clearly show that damage accumulation
can occur in cemented intramedullary fixation. In the
final count (i.e. after 5 million cycles), 389 cracks
were observed altogether in the six specimens; 19.8%
(n = 77) of these were pre-existing cracks. The growth
of pre-existing cracks were studied as a subgroup. The
majority of pre-existing cracks were at the bone/cement
interface, see Figure 3. However, as Figure 3 also
shows, the majority of pre-existing cracks that grew
Figura 2. (a) Front and cross-sectional views showing layered structure. were from the group of cracks within the cement layers.
(b) Rear view showing crack-viewing windows (‘cut-outs’) and the zone Of the cracks that were initated during loading,
identification code for counting cracks. The code for the zones are as
follows: P (proximal); M (middle); D (distal); suffix 1 (lateral side); suffix 2 almost all initiated within the cement layers, and were
(medial side). Design features are (i) tapered stem; (ii) cement mantle of associated with pores in the cement. The distal tip of
Simplex Rapids cement; (iii) cement layers extend beyond the distal tip;
(iv) bone layer with cancellous bone inner surface; (v) aluminium holder
the cement in all cases broke away from the main body
with windows to facilitate crack observation; (vi) loading applied through of the cement after several thousand cycles; after this,
the stem. Dimensions are in mm. Note that the cement layers in the
axperimental model are 5-10 mm thickto facilitate observation of cracks,
whereas in clinical practice typical cement mantles are 2-5 mm thick.
50 -7

machined finish was located centrally between the two 45 --


bony walls using an alignment device fabricated for that
purpose. The remaining space between the stem and 40 -- 0 Growing ~
the cancellous bone was then packed with hand-mixed
Simplex Rapid@cement mixed in a 2: 1 powder to liquid
35 -- n Not Growing j
;-2
ratio at room temperature. This cement is transparent 30 --
when polished. No pressurization or specialized cement Number
insertion equipment were used. After 24 h the front of Pre-test 25 --
face of the specimen was polished, using a rotating Cracks
emery disc, to remove the cloudy surface on the cement 20 --
layers. Next the surface was treated with a red dye 15 --
penetrant (Johnson and Allen Ltd, UK) to highlight
the cracks, see Boyer and Carnesi*. Thirty minutes 10 --
were allowed for the dye to penetrate into the cracks
5 --
before removal from the surface with a standard
cleaner. o-
Before loading, each model was examined for cracks Cement/Bone In-Mantle cemenVYrosmes1s
in the cement layers using a 20 x magnification profile Interface Interface
projector (lvlitutoyo PJ300, Japan). The location and Figure 3. The numbers of pre-existing cracks (n = 77 for all six
specimens) which grew compared with the number which did not, for the
size of all pre-existing cracks were recorded, to 0.1 mm bulk cement In = 27) and the bone-cement (n = 49) and cement-stem
accuracy, in each of the viewing windows. Cracks interfaces (n = 1).
McCormack et al: Damage accumulation in cemented hip prosthesis 217

a crack type and zone. However, a much greater number


350 of specimens will need to be tested to obtain statistical
T significance.
300

250
I Discussion
Number 200-- Huiskes” addresses the issue of failure in load-bearing
of cracks
150’- Ccmcnt/5one interface implants in terms of failure scenarios and he identifies
damage accumulation as one failure scenario. Damage
accumulation alone can lead to loosening, or it can
CementIPmsthesis generate poly (methylmethacrylate) wear particles due
interface
to the abrasion of crack surfaces and hence lead on
0 1 2 3 4 5
to a wear particle reaction failure scenario*“. Lee21
NO.of Cycles (millions) emphasizes that the definition of failure initiation
must be considered in relation to the implant design
b principles. However, no matter how failure initiation is
140 defined, it would seem that damage accumulation
within the bulk cement is a critical phase in the
120 failure of cemented reconstructions. McCormack and
1
Prendergast** proposed that, rather than attempting
loo-- to prevent mechanical failure initiation, the design
objective should be to maximize the .time taken to
Number go-- progress through the failure train. The experimental
of Cracks quantification of the progress of failure scenarios (such

r \
0.9
0.8
0.7 In-mantle
I 0.6
0 1 2 3 4 5 Average
No. of Cycles (millions) 0.5
Changein
Length(mm) 0.4 Cement/Bone interface
Figure 4. The continuous initiation of new cracks in the cement layers of
the model throughout the testing for all six specimens added together. 0.3
Crack accumulation is plotted for (a) crack type and (b) crack zone. Cement/Prosthesis
0.2

the rate of stem subsidence increased to a maximum


subsidence of approximately 5 mm. Cracks initiated
continuously during fatigue loading. There is a steady 0 1 2 3 4 5
No. of Cycles (millions)
increase in the number of new cracks initiating within
the mantle from zero to five million cycles, as shown in b
Figure 4a. The number of new interfacial cracks was 0.7
small in comparison. In this experimental model, most
new cracks were generated in the middle zones and the
T
0.6 --
least number of cracks occurred in the proximal zones,
see Figure 4b.
Of importance for the longevity of cemented re- Average
constructions is the rate of damage accumulation. The Change in
rate of crack growth (which is a measure of the rate of f--en& (mm)
damage accumulation) is calculated as the average
change in crack length per cycle. Cracks from pores
within the mantle grew steadily during testing, whereas
cracks from the interfaces showed much smaller Ml
amounts of growth, see Figure 5a. The most rapid
crack growth occurs in the medial M2 zone, and the
distal zones, Dl and D2, whereas the cracks in the 0 1 2
proximal zones, Pl and P2, and the medial zone, Ml, No. of Cycles (millions)
grow very slowly, see Figure 5b. Figure 5. The rate of damage accumulation in terms of the continuous
increase in crack length throughout testing plotted for (a) cracktype and
Table 1 presents means and standard deviations of all (b) crack zone. The data is plotted as the average over six specimens of
the cracks in the six specimens tested, according to the 77 pre-existing cracks.
218 C/in. Biomech. Vol. 11, No. 4, 1996

Table 1. Means and standard deviations of numbers of cracks occurring are the ones that grow most rapidly. This observation
in all six specimens after 5 million cycles of loading
suggests that distributed cracking occurs continuously
Zme nt bone-cement Within the At metal-cement under fatigue loading, and that the rapid emergence of
interface cement mantle interface
(Mean (SD)) (Mean (SD))
a critical crack is not the failure mechanism of the
(Mean (SD)/
_~~. --- cement mantle. From Figure 5a, it can be read that the
Pl I.0 (1.1)
most rapid growth is about 0.9 mm in 5 million cycles.
P2 22 12.2) 1.2 (1.21
Ml 2.3 (2.6) 75.8 (14.2) At this rate of growth, a 3-mm mantle would develop
M2 2.8 (3.8) 16.7 112.5) 0.8 (1.2)
1.5 (1.9) 6.0 (7.5)
one or more cracks through the thickness in lo-15
D?
lx? 23 (2.1) 12.2 (11.0) - years of normal use. This timescale is not dissimilar to
rotai ll,i 52.9 0.8 revision times reported in the clinical literature*“.
The table shows the distribution of cracks in both cement layers wth respect to This result would support the clinical practice which
pfox~mal, middle and distal regions. For each zone the data has been subgrouped
rrack type P ‘--’ tndicated no crack observation
by goes to extreme effort to reduce air bubbles and cement
defects by, for example, vacuum*‘j or centrifugal
mixing” of the cement and by pressurization*s.
as damage accumulation presented in this paper) could Although it is surely impossible to eliminate every
facilitate this design objective. pore. a reduction should mean fewer crack initiation
Because of the technical approach to design of the sites, and this will reduce the rate of damage accumu-
experimental model. the difficulty that others have lation and should improve the endurance of the
reported regarding detection of mechanical failure was fixation.
avoided”. The frustration of not being able to see the In conclusion, an experimental model has been
failure process has been overcome and direct evidence developed that allows crack growth/damage accumu-
of damage accumulation has been provided. However, lation to be directly observed. The model has many of
the trade-off is that the complex stress distributions of the features of a intramedullary fixation. Additional
r~eal intramedullary fixation has not been completely experiments, and a thorough stress analysis of the
replicated in the model. Specifically, the three- experimental model in the form of a finite element
dimensional nature of the real cement mantle is analysis will allow a more complete interpretation of
represented hv an aluminium channel component the results. This experimental model may prove useful
which provides circumferential force transfer. Many to investigate the effect of specific design factors (e.g.
finite element analyses have shown this to be a satis- stem texture and roughness, stem taper, cement re-
factory approach for the calculation of the bending inforcement) on damage accumulation.
stresses so long as the bone and the model have the
same second moment of area. Nevertheless, circum-
ferential stresses are not generated in the cement layers Acknowledgements
of this experimental model and it is not possible to We are grateful to Luke Curley for his advice regarding
determine the effect of this simplification except by the manufacturing and testing of the models. Financial
testing a fully three-dimensional model. In addition, support was provided by the UCD President’s Research
the interfacial conditions occurring clinically are not Award to Brendan McCormack and by a Forbairt
replicated precisely in the model because the cement/ Applied Research Award to Donnachadha Gallagher.
bone interface in the experimental model is for bovine
rib cancellous bone. which obviously differs somewhat
in roughness from human femoral cancellous bone.
When pail; (methylmethacrylate) samples are tested
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and acoustic emission. Clin Orthop Rel Res 1989; 249: The load (denoted P) arises at each point in the cement layer along the
122-8 length of the stem (i.e. in the z-direction). It is given by
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18 Boyer HE, Carnes WJ. (Eds.) Metals handbook; Vol. 11; d2
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Non-Destructive Inspection and Quality Control; Liquid
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19 Huiskes R. Stresspatterns, failure modes and bone pectively. These equations were solved to produce equations for u\(z), ~~(2).
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20 Horowitz SM. Dotv SB. Lane JM. Burstein AH. Studies Q(z) = G(z)x (A41
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21 Lee AJC. Rough or polished surface on femoral gives the final stress distribution in the cement layer. We note that this analysis
anchorage stems? In: Buchhorn GH, Willert H-G ed. is only approximate for two main reasons. Firstly, the experimental model is
Technical Principles, Design and Safety of Joint Implants. not symmetric in the plane of bending (and therefore the shear centre and the
centroid do not coincide) and this gives rise to some torsional stresses which
Hogrefe and Huber, Gottingen, 1994; 209- 11 the beams-on-elastic foundation mode1does not calculate. Secondly, soon after
22 McCormack BA, Prendergast PJ. Interface failure in loading, the metal debonds from the cement and this causesa redistribution of
implants cemented with different bone cements: a fracture stress in the cement mantle. The beams-on-elastic foundations stress analysis
mechanics analysis. In: Middleton J, Pande G, Jones M. was used as a guide in the design of the physical model. During the design
process, Perspex (Plexiglas) and aluminium were considered as possible
ed. Second Znternational Symposium on Computer materials for the circumferential component, the latter being the final choice as
Methods in Biomechanics and Biomedical Engineering. it produced the closest fit with the stress distributions reported for the cement
Gordon and Breach, Amsterdam, 1996; 35-45 layer of a hip prosthesis.

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