COMPOSITE BIOMATERIALS 44

Shalaby W. Shalaby and Robert A. Latour

44.1 COMPOSITES AS A FAMILY OF phosphate-based fiber showed large increases

BIOMATERIALS in both strength and stiffness (Casper et al.,
Although the use of high modulus metallic 1985; Lin, 1986). However, these families of
devices for internal bone fixation has been suc- composites lose a substantial fraction of their
cessful, there is a call to develop nonabsorbable, strength while retaining greater proportion of
their stiffness after short term exposure to an
polymeric, composite substitutes having elas-
aqueous physiological environment. Attempts
tic modulus approaching or slightly higher
to improve the strength retention have
than those of bones. This is to alleviate the
included coating the composite material to
problem of stress-shielding and consequent
bone resorption as well as any concerns related retard the transport of fluids to the
to toxicity of metallic ions as corrosion prod- polymer/fiber interface (Kelley et al., 1988;
Andriano, Daniels and Heller, 1991) and sur-
ucts. (Gillett et al., 1984; Tonino and Folmer,
face modification of the phosphate fibers with
1987). Furthermore, to avoid a second surgery
a siloxane film barrier (Andriano, Daniels, and
to remove a non-absorbable device and to
Heller, 1992).Growing interest in the inorganic
allow for gradual load transfer to healing
phosphate-based fillers led Andriano and
bones, completely absorbable composites were
coworkers to compare the biocompatibility of
proposed and evaluated by many investigators
several phosphate, fiber-reinforced polymers
(Casper et al., 1985; Daniels et al., 1990; Lin,
in a preliminary study (Andriano et al., 1993).
1986; Tormala et al., 1991; Vainionpaa, 1987).
Thus, phosphate fibers of calcium-sodium
Among the key types of totally absorbable
metaphosphate (CSM), sodium-calcium-alu-
composites are those based on polyesters or
minum-polyphosphate (NCAP) and
polyorthoesters, reinforced with organic fibers
potassium metaphosphate (PMS),with copoly-
(Tormala et al., 1991; Vainionpaa et al., 1987) or
mers of E-caprolactone and lactide or
calcium or sodium/calcium polymetaphos-
polyorthoesters have been used as organic
phates (Casper et al., 1985, Andriano et d.,
matrices. The CSM and NCAP fibers were
1993). A family of composites having organic
found to be acutely nontoxic in cellular tissue
polyester fibers as fillers (e.g. poly-L-lactide
and whole animal evaluation.
reinforced with polyglycolide fibers, displayed
large increases in strength and modest
increases in stiffness (Tormala et al., 1991; 44.2 COMPOSITE BIOMATERIALS: GENERAL
Vainionpaa et al., 1987). On the other hand,
polylactide reinforced with inorganic calcium Like the more traditional composites, those
classified as composite biomaterials contain
two or more distinct constituent materials or
Handbook of Composites. Edited by S.T. Peters. Published phases on a microscopic or macroscopic size
in 1998 by Chapman & Hall, London. ISBN 0 412 54020 7 scale but not on the atomic level. Thus, fiber-
958 Composite biomaterials
glass-reinforced polymeric composites and
other reinforced resins are composites while
metal alloys are not. Interest in the former sys-
tems was associated with the need to replace
or augment biological tissues which are com-
posites in their own rights. For instance bone,
skin and blood vessels are typical natural com-
posites. In both natural and man-made
composites (or composite biomaterials) the
strength and modulus of the matrix are depen-
dent on the shape, stiffness and orientation of
the reinforcing materials as well as their adhe-
sion to the matrix. High modulus fibers
uniaxially oriented in a low modulus matrix
can produce stiff solid composites with maxi-
mum strength and modulus along the fiber
direction as in carbon fiber-reinforced epoxy
resins. Complex high density natural compos-
ites include cortical bones, dentin, cartilage as
well as wood. Should air be a distinct phase of
the composite, a foam is produced, as in syn-
thetic sponges or lung tissues and cancellous
bone (Park and Lakes, 1992).
Early application of hard or dense synthetic
composites as biomaterials includes the use of
reinforced acrylics as dental fillings. The com-
posite resins consist of a polymer matrix such
as crosslinked methacrylate resin and a stiff,
inorganic filler including barium glass or silica.
The methacrylate resin can be based primarily
on the glycidyl methacrylate derivations of
bisphenol A. The choice of such components is
consistent with the repair site, i.e. dentin,
which in turn is a composite, made primarily
of collagen and microscopic inorganic crystals
of an apatite of calcium and phosphate. In gen-
eral, the primary tissue of the teeth such as
dentin is denoted as mineralized tissue where
the primary function is load-bearing. A closely
related tissue to dentin, both positionally and
functionally is bone, which is a complex min-
eralized collagen. The composition and
orientation of the bone components as load-
bearing composites vary in different bones.
Thus, in designing synthetic devices for repair-
ing bone, one has to take into account the
properties of the hard tissue in question. These
include strength, creep stiffness, and fatigue
characteristics. For example, for anchoring a
metallic hip prosthesis a high modulus
crosslinked, filled methacylate 'grouting' or
bone cement is usually sought. For cementless
hip prostheses, carbon-fiber reinforced high
performance thermoplastic polymers, such as
poly(ether-ether ketone), PEEK, or aromatic
poly sulfones (PS) are being explored.
Cartilage is a low-load bearing, natural
composite and its synthetic substitutes can be
made of reinforced elastomers. Elastomeric
tissues such as skin and blood vessels are
made primarily of collagen and other biopoly-
mers which impart compliance and elasticity.
Synthetic substitutes of these tissues are far
from being perfected. However, a key consid-
eration is the use of an elastomeric polymer or
design to provide inherent or engineering
elasticity, respectively.
Bioceramics and particularly hydroxyap-
atite (HA) have been used or proposed for use
in many orthopedic and dental applications
(Heimke, 1989, 1990). However, the mechani-
cal properties of HA were not sufficient for
demanding load bearing applications, such as
fracture fixation or spinal fusion, and this led
to its limited use in this area (Bostman et al.,
1989). To address this issue, Knowles and
Bonfield (1993) developed a glass-reinforced
HA with enhanced mechanical properties.
Utilizing glasses of the types xNa,O-(l-x)
P,O, and xCaO-(l-x) P,O, (where x = 0.2, 0.3
and 0.5), a systematic study was conducted on
the effect of increasing network-modifying
oxides in the glasses on the mechanical prop-
erties of composites containing 2.5 and 5 wt Yo
filler. The results indicate that HA reinforced
with CaO-P,O, glass at about 2.5 wt Yo is of
significant benefit to both the stabilization of
HA and production of high flexural bend
strength composites. This is illustrated in Fig.
44.1. for three types of CaO-P,O, glasses
where that mole ratio CaO/P,O, was 20/80,
30/70 and 50/50 for composites designated as
C,P, C,P and C,P, respectively.
 Orthopedic implant applications 959

160 nents for joint arthroplasty. Each of these

applications has a unique set of material and
140
-x-
. 2.5YOC3P
2.5YG5P mechanical requirements which are addressed
120

-
P
a
100
in this section.
FRP composite materials can be consid-
z 80
u)
ered to be composed of at least three, and
ftl 60 possibly four, distinct components: the fiber
which reinforces the matrix; the polymer
40
matrix which provides three-dimensional
20 support to the fiber; and the fiber/matrix
o i interface which serves as the agent of load
1150 1203 1250 1303 1350 1403 transfer between the fiber and polymer
Flrlng Temperature (C) matrix. In certain formulations, a fourth com-
ponent, the fiber/ matrix interphase, must
Fig. 44.1 Effect of glass composition on flexural
bend strength for three different glasses at 2.5% also be considered. The interphase represents
wt YO additions (from Knowles and Bonefield, the volume of matrix immediately adjacent to
1993). each fiber which is influenced by the fiber,
causing the matrix in this area to have mor-
phological differences (i.e. crystallinity)
44.3 ORTHOPEDIC IMPLANT APPLICATIONS
and/or compositional differences (i.e. mix-
The incentive for use of fiber reinforced poly- ture of matrix and sizing agent from fiber)
mer (FRP) composite materials in most compared to the bulk matrix material. The
nonmedical applications is provided by their site-specific biologic environment can poten-
superior specific mechanical properties (i.e. tially influence each of these components of
strength/weight, stiffness/weight ratios). the composite differently. Fortunately, experi-
However, this offers very little benefit for ence has shown that the in vivo environment
orthopedic implant applications. Implants are can often be suitably represented by simple
typically sufficiently small such that weight is physiologic saline solutions at 37°C (99°F)
not an important design requirement. and pH = 7.4 for in vitro biomaterials perfor-
However, there are other very important med- mance investigations. However, it must be
ically related incentives for the development recognized that exceptions to this are not
of these materials for the treatment of muscu- uncommon, and site-specific in vivo testing is
loskeletal problems. essential prior to clinical evaluation of new
While there are numerous potential ortho- composite material formulations; not only for
pedic applications for FPR composite implant biocompatibility assessment, but also to
materials, most work has been concentrated in ensure materials response to the biologic
four specific areas. FRP composite materials environment has been properly understood.
are being investigated for the design of FRP composites are uniquely different com-
femoral components for total hip arthroplasty pared to metals in that they are permeable to
and for pins, plates, screws, and nails for frac- moisture and salt ions. Therefore, if environ-
ture fixation as alternatives to metal alloys. mental durability is to be properly
Fiber reinforcement is also being investigated investigated, test samples ideally should be
as a means of improving the fatigue resistance fully saturated in their test environment prior
of polymethylmethacrylate (PMMA) bone to testing. The American Society for Testing
cement and the wear, creep, and fatigue resis- and Materials (ASTM) F04 Subcommittee on
tance of ultrahigh molecular weight Composite Materials is currently developing
polyethylene (UHMWPE)articulation compo- standards for environmental conditioning
960 Composite biomaterials
prior to materials performance evaluations to
address this issue.
The biologic response to an implant mater-
ial is as important as the material response to
the environment. Biologic response to an
implant material has been found to be strongly
dependent upon whether the material in ques-
tion can be internalized (phagocytosed)by the
cells of the body which regulate the body’s for-
eign body response. Thus, a material which is
very well tolerated in bulk form when
implanted in the body (i.e. too large to be
ingested by cells) may elicit a strong inflam-
matory response when in particulate form if
the material particles are sufficiently small (i.e.
< 10 mm (0.4 in)) to be phagocytosed by cells
which mediate inflammatory response
(Goldring, Clark and Wright, 1993; Black,
1992). Thus, in the development of composite
biomaterials, it is important to not only assess
the biocompatibility of the device in question,
but to also assess biologic response to wear
debris and degradation products of the fiber
and polymer matrix materials.
44.3.1 FEMORAL COMPONENTS FOR TOTAL
HIP ARTHROPLASTY
Femoral components are permanent implants
ideally intended to last the entire life time of
the patient. Current day metallic devices for
this application have reported life expectan-
cies of 90% survival out to 10-15 years in the
elderly patient population, lower survival
rates in younger patients (Callaghan, 1990).
While this is considered good performance for
an orthopaedic implant, certainly 90% sur-
vival at 30 years would be much preferred.
Metallic components have the draw-back of
being so stiff that much of the applied joint
load is bypassed around the normally highly
stressed proximal-medial region of the femur
(calcar). This condition has been documented
to lead to stress-shielding induced bone
resorption (Sumner et al., 1992). In severe
cases, this may not only contribute to compo-
nent failure through loosening, but may also
severely complicate revision surgery (Engh
and Bobyn, 1988).
Several theoretical and experimental
investigations have indicated that more com-
pliant femoral components result in higher
stress levels in the calcar area of the femur,
thereby reducing stress shielding and main-
taining greater levels of bone stock mass and
quality (Bobyn et aI., 1992; Huiskes, 1992).
While this is true, a widely reported miscon-
ception concerning this point is that an
optimal condition would be reached if a
femoral component could be designed to
match the longitudinal elastic modulus or
stiffness of cortical bone. This idea is com-
pletely erroneous and represents a failure to
understand the mechanics of femoral compo-
nent/femur load transfer. As long as a
femoral component relies on intramedullary
fixation, non-physiologic load transfer will
occur, leading to some degree of stress shield-
ing in the proximal femur. However, as a
general concept, the degree of stress shield-
ing should decrease proportionately to stem
bending compliance.
Three mechanical factors must be consid-
ered for the successful design of FRP
composite femoral components. These are: (1)
increased stem compliance to reduce calcar
stress shielding; (2) fixation to bone and main-
tenance of acceptably low stem/bone
interfacial stresses to prevent loosening; and
(3) maintenance of acceptable stress levels
within the femoral component to prevent
fatigue failure. These factors are not indepen-
dent; both interfacial stress level and
component fatigue strength will be influenced
by implant compliance. An optimal design
may exist which can satisfy all three mechani-
cal requirements and provide a superior hip
joint replacement over current day metallic
devices. Because of low bending stiffness, FRP
composite stems cannot be properly evaluated
by test methods developed for stiff metallic
stems. The ASTM is currently developing a
standard practice for fatigue testing of compli-
ant FRP composite stems.

Two FRP material systems are primarily
being considered for femoral component
development: carbon fiber-reinforced polysul-
fone (CF/PSF), and carbon fiber-reinforced
polyether etherketones (CF/PEEK) (Davidson,
1987; Skinner, 1988). Several studies have
addressed the effect of the biologic environ-
ment upon the mechanical material properties
of these two composite materials with mixed
results. CF/PEEK has been demonstrated to be
very durable in physiologic saline environ-
ments when PEEK was APC2 grade (ICI,
Tempe, AZ) (Strait et al., 1991; D’Ariano et al.,
1994;Zhang et al., 1994),while 380 grade PEEK
(IC1 Films Inc., Wilmington, DE) has been
found to be sensitive to hydrolytic degradation
of the fiber/matrix interface (Meyer and
Latour, 1993). CF/PSF strength has been
reported in separate studies to be both very
stable (Overland et al., 1993) and significantly
degraded by exposure to physiologic saline
and exudate environments (Strait et al., 1991;
Latour and Black, 1992,1993).Biocompatibility
studies of both CF/PSF and CF/PEEK com-
posite materials have suggested that, in bulk
form, these materials should provide accept-
able biocompatibility for use in femoral
component applications (Wen et al., 1990).
However, the generation of wear debris from
implant/bone abrasion, and subsequent
potential inflammatory reactions, is an impor-
tant concern.
44.3.2 FRACTURE FIXATION DEVICES
FRP composite material devices are being
developed for the replacement of metallic
plates, screws, pins, and nails for fracture fixa-
tion. In contrast to joint replacement, these
applications require only temporary implants.
The ideal fracture fixation device would be
sufficiently rigid initially to provide adequate
fracture stabilization, then gradually decrease
in stiffness over time to transfer stress to bone
after fracture union to avoid stress shielding,
and then eventually disappear to eliminate the
need for retrieval surgery.
Orthopedic implant applications 961
Two classes of FRP composite fracture fixa-
tion devices have been primarily considered:
nonabsorbable and fully absorbable. Compliant
nonabsorbable plates and nails have been
investigated as a means of avoiding stress
shielding associated with the use of stiff metal-
lic components (Woo et al., 1976).
Unfortunately, clinical results have indicated
that, in high load bearing applications such as
the tibia, compliant fracture fixation plates
allow excessive motion at the fracture site caus-
ing unacceptable levels of pain upon weight
bearing (Tayton et al., 1982; Tayton and Bradley
1983). This presents a ’Catch-22’ situation in
which compliant bone plates may only be able
to be utilized in very low load bearing applica-
tions, however, without high load bearing,
stress shielding is not a serious concern and
compliant plates are then no longer needed.
Whde the advantages of nonabsorbable com-
posite fracture fixation devices are therefore
questionable, fully absorbable composite frac-
ture fixation devices offer significant potential
advantages over currently used metallic
devices. These materials have the potential to
be developed into components with sufficient
initial stiffness and strength for load bearing
fixation, which are then slowly degraded and
absorbed by the body following healing such
that implant retrieval is unnecessary.
Two types of fully bioabsorbable compos-
ites have been investigated: (1) polymer fiber
reinforced polymer, and (2) ceramic reinforced
polymer. Bioabsorbable polymeric materials
for both fiber and/or matrix which have been
widely investigated are polyglycolic acid
(PGA), polylactic acid (PLA), polydioxanone
(PDS) (Tormala et al., 1991; Bostman et al.,
1991), poly-e-caprolactone (PCL) (in’t Veld,
1993), and polyhydroxybutyrate (PHB)
(Knowles et al., 1992). More recently, bioab-
sorbable polycarbonates and ’pseudo’-
polyamino acids have also been developed as
well (Pulapura and Kohn, 1992). Types of
ceramic fibers which have been investigated
are phosphate glasses and calcium phosphate
based ceramics (Andriano, Daniels and Heller,
962 Composite biomaterials

1992). Implant designs have utilized both con- devices typically occurs by loosening via com-
tinuous and discontinuous fiber reinforcement bined fatigue fracture of the cement and the
of the polymer. bone/cement or cement/implant interfaces.
The main obstacle to widespread applica- Fiber reinforcement is a potential means of
tion in these materials is their rapid loss of improving the fatigue strength of bone
strength and stiffness in vivo. This currently cement. Several investigations have
restricts their use to only low load bearing addressed this issue with the use of short
applications. This behavior has primarily been fiber reinforcements of carbon (Pilliar et al.,
attributed to rapid hydrolysis of the 1976), polyaramid (Wright and Trent, 1979),
fiber/matrix interface (Andriano, Daniels and ultrahigh molecular weight polyethylene
Heller, 1992). The development of more (Wagner and Cohn, 1989), titanium
durable fiber/matrix interfacial bonding in (Topoleski et al., 1992)) stainless steel
absorbable composites is essential if these (Fishbane and Pond, 1977), and PMMA
materials are to be successfully developed for (Buckley, 1991), to name a few. In general,
load bearing applications. these studies have demonstrated the
The biocompatibility of bioabsorbable poly- expected result that short fiber reinforcement
mers and fibers being developed for can increase both strength and toughness of
orthopaedic applications is considered to be bone cement. Problems with fiber wetting,
good, however, clinical use of self-reinforced fiber distribution, void content, and increased
PGA pins has demonstrated an 8% rate of viscosity are cited as the major problems
aseptic sinus tract development in patients which have prevented clinical implementa-
(Hofmann, 1992). While not compromising tion. Bulk bone cement is actually a
fracture union, this may require surgical inter- self-reinforced particulate filled composite
vention. Experience suggests this may occur material. The composite formulation with
when implant degradation product generation greatest potential may therefore be the
exceeds the local tissue clearance capability. replacement of the PMMA microspheres with
The balance between degradation product similar quantities of PMMA fibers. This may
release and tissue clearance ability raises a enable mechanical properties to be improved
concern for the development of larger while not causing significant increases in
implants of these materials. This problem may cement viscosity during cure.
potentially be overcome with the development
of more slowly degrading implants.
44.3.4 ARTICULATION COMPONENTS
Ultrahigh molecular weight polyethylene
44.3.3 BONE CEMENT
(UHMWPE) is extensively utilized in total
Polymethylmethacrylate (PMMA) is utilized joint replacement prostheses to provide a low
extensively in orthopedic surgery as a friction surface for articulation against a
method of prosthesis fixation in joint replace- matched metallic or ceramic component. Wear,
ment. Bone cement is prepared in the creep, and fatigue resistance are the major
operating room by the surgical team by mix- problems associated with the use of plain
ing methylmethacrylate monomer with UHMWPE in these application, especially for
polymethylmethacrylate microbeads. The knee joint prostheses (Connelly et al., 1984).
mixture is first allowed to partially polymer- Fiber reinforcement offers a mechanism of
ize, and then is placed in a prepared surgical potentially improving these properties.
site within a bone cavity. PMMA is a brittle Reinforcement with carbon fibers was ini-
polymer and can be considered the weak link tially considered for this application, and even
in joint replacement. The failure of cemented utilized clinically for both knee joint and hip

joint replacement (Wright et al., 1988). This,
however, proved to be a very poor choice of
reinforcement. Wear resistance studies with
this material provided mixed reports ranging
from significantly decreased to significantly
increased wear rates (McKellop et al., 1981),
while fatigue resistance was found to be actu-
ally decreased by an order of magnitude
compared to the unreinforced UHMWPE
(Connelly et al., 1984). This behavior can be
explained by the very brittle nature of carbon
fiber and the very low interfacial bond
strength between the fiber and matrix (Meyer
and Latour, 1991). This combination leads to
rapid crack initiation and propagation and
third body wear during articulation via fiber
fragment release. This incident in the history
of implant design provides a clear example of
the complexities of composite materials
behavior, and demonstrates the fact that fiber
reinforcement of a polymer does not necessar-
ily improve mechanical performance.
Although carbon fiber was not a good
choice for the reinforcement of UHMWPE, as
the old saying goes, ‘the baby should not be
thrown out with the bath water’. Potential
improvement of wear, creep, and fatigue resis-
tance of UHMWPE may still be achieved using
other types of reinforcement. In particular, a
reinforcement is required which has properties
of high strength, high strain to failure, high
bond strength to UHMWPE, high wear resis-
tance, and which is as biocompatible as
UHMWPE in both bulk and particulate form.
While UHMWPE is the most commonly
used polymer for articulation, other composite
systems have been investigated such as carbon
fiber reinforced triacine resin and polymer
fiber reinforced elastomeric composites
(Harms, 1984; Sutphin et al., 1993). Despite the
failure of CF/UHMWPE articulation compo-
nents, the reinforcement of polymeric
articulation surfaces is still an active area of
research for the development of improved
prostheses.
Composites for soft tissues 963
44.4 COMPOSITES FOR SOFT TISSUES
Composite biomaterials have been mostly
associated with their use in conjunction with
hard tissues. However, composites for repair-
ing or replacing soft tissues can potentially
become quite important due to the growing
interest in vascular and skin grafts, as well as
bioartifical organs. Simple devices such as
sutures for soft tissue repair have been
patented in composite forms. For instance,
composite silk sutures with compliant copoly-
ester matrix have been described as having
lower tissue reactivity, and higher strength
retention in the biologic environment as com-
pared with wax-coated silk sutures (Shalaby,
Stephenson and Schaap, 1984). Composite,
woven vascular prosthesis with absorbable
[10/90 poly(^-lactide-coglycolide)] and non-
absorbable (polyethylene terephthalate)
segments, were made and used as model sys-
tems for studying the derivation of neointima
in vascular grafts (Greisler et al., 1988).
Composite artificial blood vessels were pre-
pared by injecting water-soluble chitosan
derivatives (e.g. hydroxypropylchitosan) and
heparin into a microporous polytetrafluo-
roethylene tube followed by freeze-drying
(Yamamura et al., 1992).What may be consid-
ered as a bioartificial vascular graft is the one
prepared by endothelial cell seeding of a
woven synthetic graft using filtration tech-
nique (Idezuki, 1993). Thus, canine venous
endothelial cells which were seeded onto a
low porosity vascular prosthesis were
allowed to grow around the fibers in early
periods. They then formed a monolayer on
the internal surface of the tube at later periods
in vitro. Properties of polyester fiber blends
were evaluated as totally (Greisler, et al.,
1988a) or partially (Yu and Chu, 1993)
absorbable vascular grafts.
Melt-blended absorbable polymers made of
lactide and glycolide having the proper chem-
ical composition to provide controlled
miscibility in the liquid state were molded into
components of surgical staples having the
964 Composite biomaterials

desired in vivo strength retention profile Casper, R.A., Kelley, B.S., Dunn, R.L., Potter, A.G.
(Smith et al., 1988;Jamiolkowski et al., 1989).In and Ellis, D.N. 1985. Fiber-reinforced
the solid state the molded articles exhibited a absorbable composites for orthopedic surgery.
Polymer Mater. Sci. Eng. 53: 497-501.
two-phase morphology. The texture of the dis- Connelly, G.M., Rimnac, C.M., Wright, T.M.,
persed phase m a y allow one to denote these Hertszberg, R.W. and Manson, J.A. 1984.
systems a s microcomposites. Fatigue crack propagation behavior of ultrahigh
molecular weight polyethylene. J. Orthop. Res. 2:
119-125.
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