Materials Selection For Hip Prosthesis by The Method of Weighted Properties
Materials Selection For Hip Prosthesis by The Method of Weighted Properties
Materials Selection For Hip Prosthesis by The Method of Weighted Properties
Abstract – Process of materials selection for an artificial part, which is planted in vivo, has been
always a vital procedure. Production and construction requirements for implants would involve a
wide variety of considerations from mechanical specifications to medical limitations. From
mechanical point of view, it is desired the implant exhibits mechanical properties of the missing bone
as close as possible to reduce the risk of failure and provide a high level of comfort to the patient. The
most bolded medical trait that prostheses must possess is the quality of biocompatible being; meaning
that, they have to be accepted by the body’s living organisms. In this paper, five common
biocompatible materials as candidates for hip prostheses production namely, 316L St Steel (cold
worked, ASTM F138), Co–28Cr–6Mo (cast, ASTM F75), Ti–6Al–4V (hot forged, ASTM F620),
Zirconia (ceramic, 3Y-TZP) and Alumina (ceramic, ZTA) are selected and evaluated by the method of
weighted properties, in order to narrow down the search to find the candidate which best fit the real
bone’s mechanical traits. For the analysis, six attributes were considered and weighted against each
other namely, elastic modulus, yield strength, tensile strength, fatigue strength, corrosion rate and
density. From the results, alumina and stainless steel show highest performance indexes but as it is
discussed, due to the importance of biocompatibility required in practical, materials ranked on
position 4th and 5th which are respectively of cobalt and titanium alloys–although are less
mechanically similar to the real bone, are the most desirable choices in the industry. Indeed,
biocompatibility trait outweighs the highest mechanical similarity to real bone. It will be concluded
that in the process of materials selection for implants, WPM is not able to solely predict the best
candidate unless, the results are compared with experimental data concerning the body response to
candidate materials. Copyright © 2015 Penerbit Akademia Baru - All rights reserved.
Keywords: Materials Selection, Hip Prosthesis, Weighted Properties Method, Biocompatible Material,
Performance Index, Implant
1.0 INTRODUCTION
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and the dental industry [3]. Metals, such as 316L stainless steel, titanium alloys, and Cr-Co
alloys when suitably processed possess high tensile, fatigue and yield strengths, low
reactivity and good ductility for use as stems of hip implant devices. Composite materials are
another class of materials where the individual advantages of polymers, ceramics, and metals
combine in different applications. A typical example is hydroxyapatite coated Ti-C based
materials.
The most important characteristics that determine the feasibility of the use of metals as
implants are biocompatibility, strength including yield strength, tensile strength, fatigue
strength, and corrosion resistance. A biocompatible material may disrupt normal body
functions as little as possible. A biocompatible material causes no thrombogenic, toxic, or
allergic inflammatory response when the material is placed in vivo. The material must not
stimulate changes in plasma proteins and enzymes or cause an immunological reaction, nor
can instigate carcinogenic, mutagenic, or teratogenic (gross tissue change) effects.
2.0 BIOMATERIALS
There are many definitions for biomaterials. The most appropriate for current research is,
biomaterials are any materials which are used to make artificial devices to replace a part or a
function of the body in safe, reliable, economic and physiologically accepted manner [4]. A
biomaterial is synthetic material used to replace part of living system or to function in
intimate contact with living tissue [5]. Biomaterials have been formally defined as “a
systematically and pharmacologically inert substances designed for implantation within or
incorporation with living systems [6].
Successful design and development of biomaterials also requires characterization of physical
and chemical properties. As for instance, important physical and chemical properties include
porosity, protein adhesion, elastic modulus, yield stress, tensile strength, elongation, fracture
toughness, durability and in vivo stability [6]. Corrosion resistance in hip prosthesis should
be strong, durable and non-degradable in vivo.
The ultimate goal of biomaterials is to improve human health by replacing the function of
natural living tissue and organs in the body, it is necessary to understand their properties. The
success of any biomaterials depends on three factors: biocompatibility, health of recipient,
and skill of surgeon who performs the replacement surgery. Required characteristics of
biomaterials are: [6]
1. Biocompatibility,
2. Pharmacological acceptability (non toxic, non immunogenic, non carcinogenic),
3. Chemically inert and stable (no time dependent degradation),
4. Adequate mechanical strength (atomic bonding and elasticity, static load),
5. Sound engineering design,
6. Adequate fatigue life,
7. Proper weight and density.
Biocompatibility is one of the most important attributes which needs to be fulfilled by
biomaterials used in medical devices. Biocompatibility can be defined as the ability of the
material to perform with an appropriate host response in a specific application [7].
“Appropriate host response” implies identification and characterization of tissue reactions
and responses that could prove harmful to the host and/or lead to ultimate failure of the
biomaterial, medical device or prosthesis through biological mechanism.
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On the other side, appropriate host response does imply the success of biomaterial to tissue
reactions and response critical to use of biomaterial for particular implant. In selection of
biomaterials for making a medical device certain considerations are kept in practice. These
include chemical, toxicological, physical, electrical, morphological, and mechanical
properties.
In order to serve for longer period without rejection, an implant should possesses the
following attributes:
Mechanical Properties. Properties which are of prime interest for hip implants are hardness,
tensile strength, yield stress, modulus of elasticity and elongation. The response of the
material to repeated cyclic loads is determined by fatigue strength of the material. The
material replaced for bone is expected to have modulus equal to that of bone. The bone
modulus varies in the magnitude from 4 to 30 GPa depending on the type of the bone and
direction of measurement [8]. The current metallic and ceramic implant materials have higher
stiffness than bone, resulting in bone overloading and resorption around the implant and
consequently to implant loosening. Hence, biomaterial with excellent combination of high
strength and low modulus closer to bone has to be used for implantation to mitigate loosening
potential of implant and has potentially higher rate of success.
Biocompatibility. The materials used for implants should be non-toxic and should not cause
any inflammatory or allergic reactions in human body. The success of biomaterials is mainly
dependent on the reaction of human body to the implant, this reaction defines the level of
biocompatibility of material inside the human body environment [9]. Two main factors that
influence bio compatibility of material are the host response induced by the material and
materials degradation in the body environment. Types of the commonly used biomaterials are
listed in Table 1. When implants are exposed to human tissues and fluids, several reactions
take place between host and the implant material and these reactions dictate the success factor
of implant. Electrochemical reactions take place where metal ions interact with body fluids,
proteins and it may be cause allergic reactions like toxicity, carcinogenicity if metal degrades
inside the body environment it includes wear debris, free metallic ions, inorganic metal salts
or oxides. All metals in contact with biological systems corrode, and the released ions can
cause toxic reactions to immune system of body [10].
High Corrosion and Wear Resistance. The low wear and corrosion resistance of the
implants in the body fluid results in the release of non-compatible metal ions by the implants
into the body. The released ions are found to cause toxic and allergic reactions [11]. The low
wear resistance of biomaterial results in implant loosening and wear debris is found to cause
several reactions in tissues where they are deposited [12]. Thus development of implant with
high corrosion and wear resistance is of utmost importance for high success rate of implant.
The performance of a biomaterial used for implant after insertion can be considered in terms
of reliability. For example, there are four major factors contributing to the failure of hip joint
replacements. These are fracture, wear, infection, and loosening of implants. If the
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r =1− f (1)
Total reliability r can be expressed in terms of reliability of each contributing factor for
failures:
r = r1 , r2 , r3 ,... , rn (2)
Eq. 2 implies that even though if an implant has perfect reliability of one (i.e. r = 1 ), if an
infection occurs every time it is implanted then the total reliability of an operation is zero.
Failure of Implants. Orthopedic implants are artificial devices that are mounted into
skeleton system of the human body which help to give support to human joints, bones, or to
replace joint or bone. This replacement can fail for reasons as: failure of the bone to heal,
bone resorption, inflammation, wear/corrosion of implant, breakage of bone, loosening of
implants, bending of implants, and fracture disintegration of implants. Implants can undergo
fretting, corrosion, wear and may degrade inside the body. Major standards for orthopedic
implant materials have been developed for stainless steel, unalloyed Ti, Ti-6Al-4V (ASTM
F1108-97a), cast Co-Cr-Mo alloy, and wrought cobalt based alloy (ASTM F1537-11). Wear
of implants causes generation of debris inside the human body environment, debris as well as
metallic ions resulting from corrosion which are soluble are carried by blood and eventually
can be excreted through urine but the non-soluble debris may cause complex reactions in
human body like damage of cell tissue, and in long term, it may cause hypersensitivity,
chromosomal disorders like toxic reactions and carcinogenicity. Fractured implants fail
because of certain combination of alloys causing revision of surgery which has less rate of
success compared to first surgery.
Metals are by far the oldest biomaterials used in surgical implants. For metallic biomaterials
used in orthopedic implants, the functional requirements are optimal mechanical properties
including yield strength, ductility, stiffness, fatigue strength and fracture toughness. Metals
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used in orthopedic implants include surgical grade stainless steel, cobalt-chromium alloys,
titanium, and titanium alloys.
Stainless Steel. Stainless steel is not highly suitable for permanent implants because of its
poor fatigue strength and its ability to undergo plastic deformation which may cause failure
of implant in short term. Stainless steel is most commonly used for non-permanent implants
such as internal fixation devices for fractures. The type of stainless steel mainly used for
implants is 316L stainless steel. It contains C, Ni and Mo to improve the corrosion resistance
in body fluid. The maximum carbon content was reduced from 0.08 wt% to 0.03 wt% for
better corrosion [6]. The specifications of stainless steels for implants are as given in Table 2.
It was found that lowering carbon content of type 316L stainless steel makes them more
corrosion resistant to chloride solutions such as physiological saline in the human body.
Therefore, ASTM (American Society of Testing and Materials) recommends type 316L for
implants. Corrosion of stainless steel occurs via one or more reason as follows:
1) Incorrect composition or metallurgical conditions. Like for instance, the addition of
molybdenum increases the resistance of stainless steels to saline solution, too much of
it can result in brittleness.
2) Improper selection and handling of implant. This can arise by the intermixing of
components from variety of implants available. The problem with intermixing is, the
components may not fit together completely, resulting in corrosion and materials and
manufacturing process may not be identical, resulting in corrosion [6].
Cobalt-Chromium Alloys. Before the use of titanium, cobalt based alloys (Co-Cr-Ni, Co-
Cr-Mo) had often replaced stainless steel as biomaterials for permanent implants. These
alloys are generally more corrosion-resistant because of formation of a durable chromium
oxide (Cr2O3) surface layer, the so-called passivation layer.
Despite the good corrosion resistance ion release inside the body is major concern.
Chromium and nickel are known carcinogens, and cobalt is suspected carcinogen [6].
Chromium, nickel and cobalt are not only found in the tissues surrounding the implants, but
also found in blood and urine sample which is cause of concern [13].
The modulus of elasticity ranges from 220 to 234 GPa, which are higher that other materials
such as stainless steels. Modulus of elasticity is defined as substance tendency to deform
elastically when force is applied to it, which is one of important characteristic for biomaterial
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used in implant design. The mode of load transfer from the implant to the bone is affected by
the modulus of elasticity of the implants. Two types of alloys recommended by ASTM for
surgical implant applications are: cast CoCrMo alloy and wrought CoNiCrMo alloy (F562).
One of the most promising wrought Co-based alloys is the CoNiCrMo alloy, which contains
approximately 35 wt% Co and Ni each. The alloy was developed to have high degree of
corrosion resistance in seawater (chlorine), under stress [6]. Cold working is the process of
shaping up the metal below re-crystallization, at room temperature. It increases strength and
hardness. The wear properties of the wrought CoNiCrMo alloy are similar to the cast
CoCrMo alloy (0.14 mm/year) however the former is not recommended for bearing surfaces
of joint prostheses because of its poor frictional properties with itself or other materials. The
superior fatigue and ultimate tensile strength of the wrought CoNiCrMo alloy make it
suitable for applications that require long service life without fracture or stress fatigue.
Titanium Alloys. In recent years, titanium (Ti) and its alloys have proven as very good
biomaterials for medical application, especially for orthopedic applications. Titanium and its
alloys are used because of their excellent biocompatibility connected with good balance of
corrosion resistance and mechanical strength.
Titanium exists in two allotropic forms where at low temperatures it has a hexagonal closed
packed crystal structure (hcp), which is commonly known as α phase, whereas above 883 °C
it has a body centered cubic structure (bcc) termed as β phase. The α to β transformation
temperature of alloyed titanium either increases or decreases based on the nature of the
alloying elements. The elements which tend to stabilize the α phase and hence increases the
α-β TT, (Al, O, N) are α stabilizers while elements which stabilize β phase and hence
decreases α-β TT, (V, Mo, Nb, Fe, Cr) are β stabilizers. Alloys having only a stabilizers (Al,
O, N and C) and consisting entirely of α phase are known as α alloys. Alloys containing 1-2%
of β stabilizers and about 5-10% of β phase are termed as near-α alloys.
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Table 4 lists the typical properties for Ti-6Al-4V alloys with oxygen content and equiaxed or
lamellar microstructure. The mechanical properties of commercially pure titanium vary with
the presence of other elements, specifically with the changing concentration of interstitial
oxygen. By increasing oxygen level it will increase the ultimate tensile strength to decrease
both ductility and fatigue strength. Fatigue property becomes important because they are
exposed to relatively high repetitive load cycles.
Table 4: Mechanical properties of Ti-6Al-4V alloy with different oxygen content. [12]
Digital Logic Method. In the cases where numerous material properties are specified and the
relative importance of each property is not clear, determinations of the weighting factor α can
be largely intuitive, which reduces the reliability of selection. The digital logic approach can
be used as a systematic tool to determine α. In this procedure evaluations are arranged such
that only two properties are considered at a time. Every possible combination of properties or
goals is compared and no shades of choice are required, only a yes or no decision for each
evaluation. To determine the relative importance of each property or goal, a table is
constructed, the properties or goals are listed in the left-hand column, and comparisons are
made in the columns to the right.
In comparing two properties or goals, the more important goal is given the number 1 and the
less important is given as 0. The total number of possible decisions is N = n ( n − 1) / 2 ,
where n is the number of properties or goals under consideration. A relative emphasis
coefficient or weighting factor α for each goal is obtained by dividing the number of positive
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decisions for each goal (m) into the total number of possible decisions (N). In this case
Σα = 1 . To increase the accuracy of decisions based on the digital logic approach, the yes–
no evaluations can be modified by allocating gradation marks ranging from 0 (no difference
in importance) to 100 (large difference in importance). In this case, the total gradation marks
for each selection criterion are reached by adding up the individual gradation marks. The
weighting factors are then found by dividing these total gradation marks by their grand total
(Table 5). A simple interactive computer program can be written to help in determining the
weighting factors. A computer program will also make it easier to perform several runs of the
process in order to test the sensitivity of the final ranking to changes in some of the decisions
— sensitivity analysis.
Positive
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 α
Decision
Performance Index. In its simple form, the weighted-properties method has the drawback of
having to combine unlike units, which could yield irrational results. This is particularly true
when different mechanical, physical, and chemical properties with widely different numerical
values are combined. The property with higher numerical value will have more influence than
is warranted by its weighting factor. This drawback is overcome by introducing scaling
factors. Each property is so scaled that its highest numerical value does not exceed 100.
When evaluating a list of candidate materials, one property is considered at a time. The best
value in the list is rated as 100 and the others are scaled proportionally. By introducing a
scaling factor it will facilitate the conversion of normal material property values to scaled
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dimensionless values. For a given property, the scaled value β for a given candidate material
is equal to (refer to Table 7)
For material properties that can be represented by numerical values, application of the above
procedure is simple. However, with properties like corrosion, wear resistance, machinability,
and weldability, numerical values are rarely given and materials are usually rated as very
good, good, fair, poor, etc. In such cases, the rating can be converted to numerical values
using an arbitrary scale. For example, corrosion resistance ratings excellent, very good, good,
fair, and poor can be given numerical values of 5, 4, 3, 2, and 1, respectively. After scaling
the different properties, the material performance index γ can be calculated as (refer to table
8)
γ = ∑ βi α i (5)
i =1
Table 8: Evaluated performance indexes for the material candidates of this research.
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316L St Steel
M1 72.85 2
(cold worked, ASTM F138)
Co–28Cr–6Mo
M2 48.90 5
(cast, ASTM F75)
Ti–6Al–4V
M3 53.60 4
(hot forged, ASTM F620)
Zirconia
M4 68.70 3
(ceramic, 3Y-TZP)
Alumina
M5 75.60 1
(ceramic, ZTA)
Early prosthetic hip designs called for both the femoral stem and ball to be of the same
material e.g. a stainless steel. Subsequent improvements have been introduced, including the
utilization of materials other than stainless steel and, in addition, constructing the stem and
ball from different materials. Indeed, stainless steel is rarely used in current implant designs.
Fig. 1 shows an example of a hip replacement design. Currently, the femoral stem is
constructed from a metal alloy of which there are two primary types: cobalt–chromium–
molybdenum and titanium. Some models still use 316L stainless steel, which has a very low
sulfur content in its composition. The principal disadvantages of this alloy are its
susceptibility to crevice corrosion and pitting and its relatively low fatigue strength. As a
result the usage of this material has decreased.
Table 8 illustrates the performance index evaluated for each of the material candidates
studied within this research. As shown, Alumina appears to be the most suitable candidate
with regards to its performance index, which is the greatest, followed by 316L St Steel and
Zirconia respectively as the second and third. Various Co–Cr–Mo alloys are used for artificial
hip prostheses. One that has been found to be especially suitable, designated F75, is a cast
alloy that has a composition of 66 wt% Co, 28 wt% Cr, and 6 wt% Mo. The corrosion and
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fatigue characteristics of this alloy are excellent. Of those metal alloys that are implanted for
prosthetic hip joints, probably the most biocompatible is the titanium alloy Ti–6Al–4V; its
composition is 90 wt% Ti, 6 wt% Al, and 4 wt% V. The optimal properties for this material
are produced by hot forging; any subsequent deformation and/or heat treatment should be
avoided to prevent the formation of microstructures that are deleterious to its bioperformance.
Recent improvements for this prosthetic device to include using a ceramic material for the
ball component rather than any of the aforementioned metal alloys. The ceramics of choice
are a high-purity and polycrystalline aluminum oxide or zirconium oxide, which are harder
and more wear resistant than metals, and generate lower frictional stresses at the joint.
However, the elastic moduli of these ceramics are large and the fracture toughness of alumina
is relatively low. Hence, the femoral stem, is still fabricated from one of the above alloys, and
is then attached to the ceramic ball; this femoral stem–ball component thus becomes a two-
piece unit.
The materials selected for use in an orthopedic implant come after years of research into the
chemical and physical properties of a host of different candidate materials. Ideally, the
material(s) of choice will not only be biocompatible but will also have mechanical properties
that match the biomaterial being replaced—bone. However, no man-made material is both
biocompatible and possesses the property combination of bone and the natural hip joint—low
modulus of elasticity, relatively high strength and fracture toughness, low coefficient of
friction, and excellent wear resistance.
Consequently, material property compromises and trade-offs must be made. For example,
recall that the modulus of elasticity of bone and femoral stem materials should be closely
matched such that accelerated deterioration of the bone tissue adjacent to the implant is
avoided. Unfortunately, man-made materials that are both biocompatible and relatively strong
also have high modulus of elasticity. Thus, for this application, it was decided to trade off a
low modulus for biocompatibility and strength.
Some acetabular cups are made from one of the biocompatible alloys or aluminum oxide.
More commonly, however, ultra-high molecular weight polyethylene is used. This material is
virtually inert in the body environment and has excellent wear-resistance characteristics;
furthermore, it has a very low coefficient of friction when in contact with the materials used
for the ball component of the socket. A two-component cup assembly is shown for the total
hip implant in the chapter-opening photograph for this chapter. It consists of an ultrahigh
molecular weight polyethylene insert that fits within the cup; this cup is fabricated from one
of the metal alloys, which, after implantation, becomes bonded to the pelvis.
8.0 CONCLUSION
According to the nature of the problem studied here, the choices of materials suitable to build
a hip plant were reduced to a few options whose properties meet biocompatibility as the
major aim. Thus, five candidates as the most common biomaterials were adopted namely
316L St Steel (cold worked, ASTM F138), Co–28Cr–6Mo (cast, ASTM F75), Ti–6Al–4V
(hot forged, ASTM F620), Zirconia (ceramic, 3Y-TZP) and Alumina (ceramic, ZTA) to be
evaluated by the method of weighted properties (WPM) in order to narrow down the search
to distinguish the best suitable one. In this search, WPM was evaluated based on the
mechanical properties of the agents as highest mechanical similarity to that of the real bone is
of great interest, and quality of being biocompatible did not affect the process of evaluation.
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Contrary to other engineering problems which cost is considered as one of the main goals, in
medical procedures, due to the importance of health issues, focus on cost is considered as a
secondary objective and the challenge is a matter of biocompatibility.
Based on the analysis carried out, Alumina ceramic proved to be the best material for the
artificial hip with highest value of performance index. Ranked second appeared to be 316L St
Steel (cold worked) whereas this type of implant is not utilized any more due to its
susceptibility to crevice corrosion and pitting and its relatively low fatigue strength. In
contradistinction to the results obtained here currently, femoral stem is constructed from
materials on position 4 and 5 of our rankings, which are of cobalt and/or titanium alloys. The
reason is that, although they are not the best ones with regards to their mechanical properties
compared with other opponents but since they have experimentally proven to be more
biocompatible compared with the other candidates so, they are still the most employed
agents.
It is concluded that a material that exhibits the best performance index is not necessarily the
most suitable material for an implant product and there will be always a demand to check the
results with experimental data since, as far as mechanical analysis concerns, specifications
such as biocompatibility are not capable to be formulated mathematically. Other factors and
requirements need to be taken into consideration in such a selection, as instance, cost,
formability, service condition, etc.
REFERENCES
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