Kumar-Bhowmik2022 Article PotentialUseOfNaturalFiber-rei

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Iranian Polymer Journal

https://doi.org/10.1007/s13726-022-01077-1

REVIEW

Potential use of natural fiber‑reinforced polymer biocomposites


in knee prostheses: a review on fair inclusion in amputees
Santosh Kumar1 · Sumit Bhowmik2

Received: 6 January 2022 / Accepted: 21 May 2022


© Iran Polymer and Petrochemical Institute 2022

Abstract
Amputation is a surgical operation to remove a part or limb from the body due to some major illness, birth defect, accidents,
vascular disease, surgery, etc. The number of amputee patients is increasing day by day all over the world and in most cases
they cannot afford the imported legs because these legs are expensive and heavy. Hence the present review article explains
the development of light weight and cost-effective biocomposites for prosthesis limb applications. The details of the perfor-
mance of exiting biomaterials for knee prostheses application have been explained, and their advantages, disadvantages, and
limitation of their uses have been analyzed. To explore patients’ satisfaction, design analysis of prosthetic limb components
has been discussed to provide better suitability, stability, and comfortability for stable movement of adaptive legs. This review
also discusses the factors that affect the performance of the prosthetic limb. Fiber-reinforced composites are the best suited
and promising biomaterials for prosthetic limb application due to greater flexible design and lighter weight that provide higher
specific strength and stiffness compared to conventional biomaterials. Due to the rapid increase in patients, the availability
and cost of biomaterials are the major issues and problem in achieving cost-effective prosthesis for weaker people as well
as for short-term usages. Therefore, to meet the current challenge, naturally derived biocomposites are the best promising
and suited biomaterials for developing prosthesis sockets due to their availability, lighter weight, more cost-effective, more
biocompatible, and biostable compared to other existing materials, providing good specific strength and stiffness.
Graphical abstract

Keywords Knee prosthesis · Prosthetic biomaterials · Biocomposite · Prosthetic performances · Biocompatibility

Extended author information available on the last page of the article

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Iranian Polymer Journal

Introduction it is usually able to allow normal and easier movement


more readily than the femur part [5]. The different transti-
Prosthesis is an artificial limb made to substitute the miss- bial parts that are affected due to illness, birth defect, acci-
ing limb in the human legs due to congenital defects, ill- dents, and vascular disease of the amputees are shown in
ness, and accidents [1]. Nowadays, artificial limbs have Fig. 1. Therefore, the design and development of prosthe-
become a hot and important research area and discussion sis limbs played a positive role for amputees. The purpose
to help more and more disabled people and bring them to of the prosthesis limbs is to improve the quality of life
a normal comfortable life. The prosthesis limb is mainly and mobility of the amputee that mainly depends on com-
split into two parts, which are the upper extremity prosthe- fort, reliability, performance, and cost [6]. The knee is the
sis and lower extremity prosthesis. As the name suggests, main complex part of the human body designed for free
above the hip is known as upper extremity prosthesis that movement and mobility. Therefore, due to complexities
consists of shoulder disarticulation, transhumeral, elbow in movement associated with the knee, newer and more
disarticulation, transradial, wrist disarticulation, and par- improved design, hydraulic, mechanical linkage, motors,
tial hand. The lower extremity prosthesis consists of hip computer microprocessor, and innovative combinations of
disarticulation, transfemoral, transtibial, ankle disarticula- these technologies are employed to give more control to
tion, and partial foot amputations [2]. The lower extremity the user [4].
prosthesis is also divided into two parts, which are above This review aims to discuss briefly the design and devel-
knee prosthesis named as transfemoral and lower knee opment of composite prosthesis limb for inclusion in the
prosthesis named as transtibial part of the human body [3, disabled human limb to improve the quality of life, mobil-
4]. The transfemoral part is the strongest part of the body ity, and comfortable movements. This has been achieved
that has a thick layer of cover that may protect against by innovative design analysis, characteristics of their use,
serious disease and accidents. When the transfemoral parts and choosing the right materials such as carbon fiber, glass
have some disease or defects due to accidents, then it can fiber, plastic, and Styrofoam. Generally, the prosthetic legs
have a very difficult time to regain normal movement, are made of wooden and metallic rods, but wooden pros-
because in general, the transfemoral amputee must have thesis legs are limited due to poor durability, more weight,
used more than 80% energy to walk than a person with two corrosive in nature, and moisture-induced swelling [7, 8],
whole legs. Due to some serious disease and accident, the while metallic and ceramics have high weight, density,
transtibial part (below the knee) is mainly affected because and cost with low biocompatibility and high stiffness that
causes high-stress shielding effects [9]. The higher degree

Fig. 1  Different types of transti-


bial amputees

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Iranian Polymer Journal

of brittleness and hardness of these materials may produce limb. But it also had some drawbacks that limited knee
serious damages and uncomfortability to the patients due to flexion, skin abrasions, and dermatitis. In 1964, the PTB
incompatibility, magnetism effects, allergic tissue reactions, prosthesis was further modified such that the sides of the
corrosion, and sudden fracture [10–12]. Due to these lami- socket extended beyond the femoral part of the legs where
nations, fiber-reinforced polymer biocomposites are used to the liner was built-in with one or two wedges to provide
prepare prosthesis legs that sustain long durability with cost- suspension, and this design was called as patellar tendon
effective, lesser in weight, environmentally friendly, and also supracondylar (PTS) prosthesis [18]. The socket was light in
have sufficient strength, toughness, high creep resistance that weight and was fabricated with polyester or other synthetic
may also provide suitable biocompatibility and adjustable resins strengthened with carbon fiber [23]. Although before
movements to the human body [13–15]. 1984 the lower prostheses were made from metals, leather,
The use of biomaterials of renewable natural resources or plastic laminates with foam toe filler and were rigid, they
has been increased worldwide due to environmental aspects did not restore function lost by amputation and only main-
and economic benefits over the use of non-renewable petro- tained the rollover in the toe section [24].
leum resources. Green house effects and carbon emissions During 1984–1986, thermoplastics polymers were used
by exploration of multiple industries and human activities to fabricate custom prosthetic sockets, which were lighter in
have been the most constant and interesting topics of con- weight, more flexible, faster, and easier to fabricate where
versation in the research and scientific community. The polypropylene was used to make them flexible sockets [25].
petroleum-based materials are depleting resources with The drawbacks of thermoplastic polymers were not dura-
fluctuating cost that reduce the environmental compatibility ble and also had a shrinking behaviour that would loosen
drastically. Therefore, the scope of renewable, biodegrad- the fit. Then a silicon laminates sockets prosthesis was pro-
able and eco-friendly materials is enormous; widespread duced that had two laminations and incorporated the foot
scientific research and demonstration of research laboratory shell permanently between two laminates and a zipper was
have frequently substantiated the economic, environmental, used to the back of the sockets. This allowed the foot shell
and technical benefits of such innovative biomaterials [16]. being permanently bound to the socket, producing an elas-
Based on this, natural fibers offer numerous advantages and tic, resistive toe lever and the hollow toe in the foot shell
show definite awareness to fabricate biocomposites. The was filled with room temperature vulcanized (RTV) foam to
abundance availability of natural fibers and their synergis- attain more natural ankle motion [24]. Sometimes instead of
tic arrangement with polymers have led to a favourable and adding pigments to the silicone, a nylon stockinette matching
greater level of quality, performance, and cost that possesses the skin tone of the patient was coated on the foot shell to
enormous forecasts and potential for various applications provide better cosmesis.
and industries [17]. Fiber-reinforced polymer composite laminates are more
suitable and flexible for designing prosthesis legs. These
Background of prosthetics design laminates have high mechanical properties as well as are
more durable, lighter in weight, non-corrosive with nature,
The use of prosthesis for the inclusion in human legs is and the best option for developing the prosthesis legs [26].
around 5000 B.C and that is known as peg leg [18]. James Both thermoplastic and thermosetting polymers composites
Potts constructed “The Anglesea leg” in 1800. The socket are used to develop prosthesis legs for fair inclusion in the
and shank were made of wood while the knee joint was disabled part of the human body [27]. Thermoplastics poly-
made of steel, and it had an “articulated foot.” The shank mers such as polyetheretherketone (PEEK), polyaryletherk-
was attached to a leather thigh corset with the help of metal etone (PAEK), polyethylene, polypropylene, polyurethane,
hinges and sidebars [19]. Even up to 1940–1950 s the basic and polysulfide have strong intermolecular bonds that give
design of prosthesis limb remained unchanged where sockets good biocompatibility and resistance to moisture [28], but
for below-knee prosthesis were made with blocks of wood or it is difficult to fabricate with long fiber-reinforced compos-
leather [20]. In 1958, the University of California, Berkeley ites, whereas thermosetting polymers such as epoxy resins,
introduced its design to the public and became known as polyester, and acrylics have been commonly used for ortho-
“patellar tendon bearing” (PTB) prosthesis where the socket paedics including prosthetic limbs due to variable biocom-
was made of plastic and lined with rubber and soft leather. patibility, more durability, and easy processing and they can
The hollow wooden shank was reinforced with a plastic be fabricated with any fibers such as carbon, glass, Aramid,
laminate, and the articulated foot was replaced with a rub- Kevlar, and many more natural fibers [29, 30].
ber solid ankle cushion heel (SACH) foot [21, 22]. Leather During the past 20 years, carbon fiber and glass fiber have
straps were used above the patella to provide suspension and been the most promising reinforced materials for orthopae-
this prosthesis had the huge advantage of being much lighter dic and prosthetic applications due to their lightweight and
than the older version and fitted properly to the residual high strength properties [31]. Especially for lower limb

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prostheses, carbon fibers have been chosen due to their in between 2012 and 2016, the global market reached the
adaptabilities, flexibility, and energy storage and release growth values of US$289.3 million to US$531.3 million
properties [32, 33]. Several studies also have been reported with 11% annually compound growth rate (CGR). These
to develop the prosthesis limb and the properties of different CGR further increased to 15% in 2020 [17]. Therefore, the
fibers such as long, short, woven, and powder have been dis- estimation concluded that, NFRPCs have been grown rap-
cussed. The reinforcement fibers have been used at different idly for various applications, and thus these biocomposites
weights or volume fractions and revealed that unidirectional are better alternative to other synthetic and petroleum-based
fibers have a good modulus of elasticity, whereas woven biomaterials for limb prosthetic applications [17, 44, 45].
type fibers have better properties in transverse directions
[34]. The various mechanical properties such as fatigue and Components of below‑knee prosthesis
creep behaviour have also been discussed [35]. However,
the numbers of cases are very much increasing day by day in The main components of the lower knee prosthesis include
the entire world due to landmines, accidents, and congenital socket, ankle, suspension system, and foot and for above
defects, in addition, these materials are highly expensive knee, a knee joint is also incorporated [4]. The study
and produce harmful gases during manufacturing and not reported that foot, pylon, is purchased through the cata-
available plenty. Therefore, natural fibers-reinforced poly- logues or assembled according to patients' specific needs
meric composites (NFRPCs) and hybridization of carbon/ [46]. The prosthetic sockets are the main custom-made fab-
glass fiber with natural fibers are more reliable due to their rication part of the individual patients and that fabrication
availability, sustainability, easy processing, cost-effective, is based on their residual limb, which depends on the fitting
lighter in weight, eco-friendly, and also better mechanical and comfort of the patients [47]. The socket connects the
properties performances [36–38]. amputated limb to the prosthesis, which transfers the body
Specific characterization and properties of natural fibers weight to the prosthesis and may contain liners that act as
are very much helpful in outstanding invention for the com- padding. It protects the amputated limb and enables the user
mercialization of natural resources bio-based biomaterials. to stand, walk, and move freely [21]. Sockets are now being
Natural fibers-reinforced composites have enhanced com- manufactured with easier, cheaper, and lightweight materi-
mercial competitiveness, effectiveness, and affordability due als with the help of computer-aided designs and 3D printing
to their environmental implications and facilitating extenu- technologies, which are custom fitted for the patients and the
ation of price instabilities in the crude oil markets. The high mechanical properties of the socket are the same as those of
unpredictable price and availability of traditional plastics bone for better and equal stress transfer [2].
and synthetic fibers are creating problems and favouring The ankle combines the foot and the prosthesis. This
the use of alternative materials like natural fibers that offer part is made of some joints, which allow axial rotation and
steady price with abundant availability and also diminish should also be capable of energy storage and absorption
dependency on fossil fuel-based materials for longer periods [22]. The ankle is made from different materials depend-
of time [17]. The intrinsic advantages of natural fibers with ing on the socket materials and their use. There are differ-
their specific characteristics like emission of effluent, low ent types of prosthetic ankles with different movement axes
carbon emission, low energy consumption, biodegradability, that show different results in shock absorption and they also
and option to ease of disposal add to the sustainability of the depend on stride length, age, weight, and some other fac-
consumption, distribution, production, and disposal of com- tors [48]. The ankles are commonly available together with
postable/biodegradable biocomposites for biomedical appli- sockets but also they are available separately for use in sports
cations [39, 40]. The other factors like manufacturing/pro- and heavy physical activity.
duction process and the use of specific consumer products Foot acts as base support, which can bear all the weight
which contribute towards improving the market growth and on which it acts and also transfers body weight to the
opportunities for developing bio-based natural products with ground. It must act as a shock absorber and replace the lost
intension to condense environmental reparations and dam- muscle function and biomechanics of the foot [49]. It must
ages also have less affection and hazardous for the human also provide a cosmetic appearance and should fit in normal
health [41]. According to Nova institute, Germany, the pro- shoes. Recent artificial feet are now being made to repro-
duction of NFRPCs in 2012 was 92,000 tons, where 90,000 duce a healthy foot function. They have an energy absorp-
tons were used for automobile industries [42]. The current tion mechanism in multiple planes, as well as being able to
report in 2020–20,222 has forecast that the production of absorb vertical and tensional shocks, which act upon them
NFRPCs has rapidly increased by 400,000 tons for automo- [50, 51].
bile, while 250,000 tons for other applications that provided Suspension systems are used to hold the prosthesis and
greater and stronger incentives presented for bioproducts ensure the wearing comfort and fixation on the disabled
[43]. According to market trend and forecast of NFRPCs body. For the lower knee prosthesis, the socket must have

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Iranian Polymer Journal

been attached to the suspension mechanism so as not to fall specialists to reduce the shocks and force during walking
off. Different types of mechanisms are used for this purpose and any high impact stress generations [2]. Nowadays,
such as suction, harness, belt, gel suspension and their com- pylons are also fabricated with composites, such as carbon,
binations [52]. The gel suspension system provides cush- glass, and Kevlar fiber composites as well as with some
ioning to the residual limb using a gel elastomer and also natural fiber composites, such as ramie, kenaf, flax, and
provides better cosmesis to the amputee. Sleeves are also many more fibers composites due to their lighter weight,
a common suspension system but have some drawbacks, cost-effective, and also sufficient strength to sustain the
such as ventilation problems, becoming hot in warm and shocks and impact forces. Finally, an endoskeleton finish
humid regions [21]. However, this problem has recently covers the whole prosthesis to protect it from dust, dirt,
been resolved by putting a valve on the sleeve to provide and moisture [53].
air transfer. Generally, there are two types of prosthesis limbs, which
Transtibial prosthesis also consists of some other com- are designed. First, the cosmesis prosthesis that mostly con-
ponents and it is mainly used for connecting the major sists of cosmetic functions and has low functionality, but the
parts. It has a socket adaptor for connecting the socket design looks like a genuine limb, whereas the second one
to the rest of the prosthesis and aligning the prosthesis; has a wide range of possibilities that can be replaced by the
a tube clamp adaptor to connect the pipe to the socket; a complete respective part of the body [54]. The design analy-
pylon, which connects the knee to the foot and is used to sis and development of different components of knee pros-
transfer the body weight and maintain the proper height of thesis are shown in Fig. 2. The functional prostheses have a
the prosthetic. Pylons are usually fabricated with metals control system such as a set of cables and microprocessors,
for transferring and maintaining high strength and rigid- where the cables are used to mimic the work of the muscle
ity. However, a pylon needs to resist the shocks that are and the microprocessors process and catch the impulses rate
transferred from the ankle and foot. So that shocks absorb- to the muscles and convert them into an electric signal for
ing pylons (SAP) are recommended by the prosthetic the bionic limb [55].

Fig. 2  Design analyses of differ-


ent components of lower knee
prostheses

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Iranian Polymer Journal

Materials used for prostheses stiffer to provide proper load-bearing support, flexibility, and
comfort with the energy-saving capabilities during walking.
Prosthetics materials have been developed progressively There are various materials used for prosthesis limp appli-
over the years, starting from wood, leathers, metal, plastics, cations, such as wood, leathers, metals, ceramics, plastics,
and now various fiber-reinforced polymeric composites. and composites. Table 1 summarizes the advantages and
Figure 3 shows various exiting materials used for prosthesis disadvantages of the existing prosthesis biomaterials. From
limb applications. A lower knee prosthetic device made from ancient to early 90 s, wood and leathers were used to produce
various biomaterials is a prosthesis limb that supports and prosthetic or artificial legs, but due to some serious problems
protects human life during walking, travelling and running like weevilling behaviour and greater moisture absorption,
in daily life. The prosthetics devices are also used to repair bulkier, heavier extra sweating, skin irritations, etc., their
the gait movements and stability of the amputees. Therefore, use has been limited [7, 56]. Although, the patients put extra
ideal lower knee prosthesis must be light weight, strong and effort to move or walk, while thicknesses of the wood and

Fig. 3  Evolution of various exit-


ing limb prosthesis biomaterials

Table 1  Advantages and disadvantages of current prosthesis/orthosis materials


Materials Advantages Disadvantages

Wood—renewable -Good strength to weight ratio -Variability of wood properties


-Does not rust -Mite/weevilling of wood
-Aesthetically pleasing -Discomfort due to heavyweight
Metal and leather -High tensile strength -Produce harmful chemical wastes during production
-Tear resistant -Low biodegradability
-Good heat insulator -Bulky and heavy
-Usually comes in a modular design -Low cosmetic value
-High energy expenditure
-Cause excessive sweating and bad odor
Plastics -Easily mouldable and reduces production time -Indestructible which cause environmental pollution
- Poor heat and electricity conductor -Production of harmful gasses during AFO production
- Inflammable -Cause skin irritation after a long term usage
- Corrosive and rust resistant
- Lightweight and durable
- Good aesthetics value
- Low energy expenditure
Carbon fiber composites -Good strength to weight ratio -High production cost
- Good aesthetics value - Not often eco-friendly
- Corrosive resistant - Low reusability
- Fatigue resistant - Design and manufacturing were too time-consuming
- Rust resistant - Not cost-effective for short-term users
Natural fiber composites - High specific strength and stiffness -Hydrophobic
-Lightweight, low cost, recyclable, cheap, and easily -Inappropriate bonding with matrix materials
available - Less durability and lower fatigue resistant
-Noncorrosive, nontoxic, eco-friendly with biocompat-
ible and biodegradable
-Flexibility in design and can be moulded into any
kind of shape
-Greater sweating and reduce the thermal stress
generation

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Iranian Polymer Journal

leathers cause excessive sweating that produces an allergic Recently, polyamides, Canvas, PP, and PE have been
reaction on the skin and also reduced the stability and com- used to develop ankle–foot orthosis/prostheses with a lighter
fortability of the patients [57–59]. However, metallic and weight that increase the human comfort and walking speed
ceramic materials for prosthesis applications have been used of the patients [68]. Additive manufacturing or 3D printing
successfully since the twentieth century. Nevertheless, these is the best fabrication method to develop different types of
metallic and ceramics alloys are mainly used for orthopae- prosthetic devices with variations of shape and size [69].
dic, dental, medicine, and bone fracture applications due to Four different designs are developed with PP and PE using
high strength, toughness, stiffness, and brittleness [12, 60, 3D printing. The designs were prepared with the help of
61]. Therefore, due to various limitations and disadvantages CAD design, FEM model, results inputs, and finally devel-
of above biomaterials, plastics, and composites are the most oped the required parts. These types of prosthetics design
suited and promising biomaterials for limp applications, pro- could reduce sweating and excessive heating [70, 71]. Many
viding more flexibility and stability to improve the life and studies have been done successfully on plastics/polymeric
comfort of the amputee. materials to develop orthotics/prosthetics devices and some
of these are summarized in Table 2. Moreover, these plastic
materials do not have sufficient load-bearing strength and
Plastics and polymeric prostheses stiffness. Although plastics are not eco-friendly and biode-
gradable materials, they have polluted the environment and
Plastics are classified as semi-synthetic polymeric materials waste may produce harmful gasses to the environment that
that are widely derived from thermoplastic and thermoset- increases the carbon content in nature and reduces the ozone
ting polymers. Thermoplastics can be moulded or folded layer thickness. These plastics may also cause an inflamma-
in any shape and size due to a single monomer crystalline tory reaction in human body that irritates the skin.
structure. It can be turned into liquid form by appropriate
heating and become solid by proper freezing. Therefore, Fiber‑reinforced composites
these plastic materials are very convenient for prosthetics/
orthotics devices due to easy moulding and folding. Some Recently, polymeric composites are the most essential and
important thermoplastic polymers are polypropylene (PP), interesting materials for various applications due to their
polymethylmethacrylate (PMMA), polyethylene (PE), higher specific strength and stiffness, long durability, high
acrylic polymers, etc. Thermoset polymers that are usually fatigue resistance, non-corrosive, and lighter weight [123,
in liquid form can be moulded into any final shape, but final 124]. Furthermore, these polymeric composites are also very
moulded shape cannot be reshaped after curing due to the much useful for biomedical applications where prosthetic
crosslink density structure of the materials. Some useful devices such as sockets, AFO, foot, and pads are mostly
thermoset materials are epoxies, silicone rubbers, polyester fabricated from fiber-reinforced polymeric composites
resins, polyurethanes, etc. [62, 63]. These polymeric plastics (FRPCs). Generally, the developed composites were fabri-
have been successfully implemented in biomedical appli- cated from the combination of the matrix (polymers) and
cations due to their poor heat and electrical conductivity, reinforced materials, such as carbon, glass, Kevlar, Aramid,
inflammability, corrosive resistance, user friendly, lighter nylon fibers, and naturally derived fibers, etc. [125, 126].
weight, durability, energy-saving, and rust freely, etc. Matrix materials are in the form of thermosets or thermo-
Acrylic and PMMA bone cements were the first poly- plastics. Nowadays, bio-epoxy polymer matrix has been used
meric materials for use in prostheses and they are still very to fabricate biocompatible and biostable composite mate-
successful clinically [64]. PE is especially more attractive rials due to biodegradability and environmental concern
and suitable material for the use of total hip replacements, [127–129].
such as liner, tibial and knee prostheses due to its high Carbon fiber-reinforced polymer (CFRP) compos-
impact strength, abrasion resistance, low density, lower ites are the most and widely used materials for develop-
friction, superior toughness, biocompatibility, and biosta- ing prosthetic devices due to their lighter weight, higher
bility [65]. Many other biodegradable polymers, such as strength, and fatigue resistance compared to existing mate-
polylactide (PLA), polyhydroxyethylmethacrylate (PHB), rials like wood, metals, plastics, etc.[130, 131]. The first
polyglycolide (PGA), polyhydroxybutyrate (PHB), poly- lower knee prosthesis fabricated from CFRP composites
dioxanone (PDS), etc., are derived from nature as a good was developed in 1985 by Philips where energy absorbing
synthetic source and can be a better alternative to older bio- and return foot pads with greater flexibility were devel-
materials [66]. These polymeric materials have limited use oped [6, 132]. Energy store/return system is a technique, in
in biomedical applications like soft tissues and surgery due which energy is stored when the bodyweight shifts on the
to lower strength and stiffness as well as biocompatibility prosthetics and a compressive load is applied, while lifting
and biostability [67]. the bodyweight results in decompression and allowing the

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Iranian Polymer Journal

Table 2  Various plastics/polymeric materials used for biomedical implants


Materials Ultimate strength Elastic modulus Biomedical applications
(MPa) (GPa)

Silicon rubber (SR) 5–7 0.006–0.008 Finger joint, spine cage, feet shoes, prostheses sus-
[72–74] pension, sleeve, liner, and soft tissues
Polycarbonate (PC) 61–70 2.1–2.3 Bioabsorbable fixation, plate and screws devices,
[75–77] bone regeneration, drug delivery
Polypropylene (PP) 30–36 1.3–1.6 Archwire/brackets, socket bone plate, disc and
[78, 79] screws fixation
Polytetrafluoroethylene (PTFE) 25–35 0.4–0.55 An artificial substitute for organs and tissues, drain
[80–82] pipes, limb fixation, regeneration devices
Polyurethane (PU) 35–48 0.012–0.022 Spine cage, screw, plate, rods and disc replacement,
[83–85] tendon/ ligament vascular graft implants, socket,
and abdominal wall prosthesis
Polyethylene (PE) 30–35 0.88–1.09 Liner, acetabular hip cups, tibial and total hip
[86–88] replacement, tendon, ligament, and patellar com-
ponents
Polyethylene terephthalate (PET) 60–86 2.5–3.9 Finger, screw, tendon, cartilage, and disc joints,
[89–91] catheters to stents, scaffolds, vascular grafts, heart
valves, sutures, and wall prosthesis
Polyacetal (PA) 67–73 2.0–3.5 Joint, cups, disc and heart valve replacement, surgi-
[92–94] cal, orthopaedic, and knee prostheses implants
Polyvinylchloride (PVC) 50–62 2.8–3.3 Surgical wire, dialysis equipment, blood bags and
[95, 96] tubing, inhalation mask, ear protection, mouth-
pieces, oxygen delivery, medicine, gloves
Polysulfone (PS) 70–81 2.5–2.75 Bone fixation, disc, rods, plate and joints arthroplas-
[97, 98] ties, spine cage, dental and surgical instruments,
heart valve, dialysis filtration, pharmaceutical filter
housings
Polymethylmethacrylate (PMMA) 59–75 2.5–2.86 Bone cement, screw fixation, hip prosthesis, verte-
[99–101] brae stabilization, archwire, dental bridges, filler
for bone cavities, and skull defects
Polyetheretherketone (PEEK) 96–140 4.7–8.3 Cranioplasty, dental implants, joint and hip replace-
[102–104] ments, interbody fusion, bone and soft tissue
repairs spine and orthopaedic surgery
Polylactic and poly L-lactic acid (PLA) 51–66 2.1–3.5 Drug delivery, bioabsorbable, ligament, orthopaedic,
[105–107] prosthesis devices, and bone regenerations
Ultrahigh molecular weight polyethylene (UHM- 45–56 0.9–2.2 Cardiovascular and bone implants total knee, hip,
WPE) and plate replacement, knee prosthesis
[108–110]
Poly dimethyl sulfoxide (PDMS) [111–113] 2–6.5 0.36–0.97 Small and soft joints such as foot, finger, sleeve,
liner, and suspension
Polydioxanone (PDS) 25–40 0.9–2.0 Pin, sutures, plates, screws, clips and bioabsorbable
[114–116] fixation, bone regeneration, surgery and implants
Polycaprolactone (PCL) 11–24 0.34–0.55 Drug delivery, scaffolds, dental, vascular graft, ten-
[117–119] don and tissue engineering, bone regeneration
Polyglycolic acid (PGA) 70–100 5.0–7.2 Drug delivery, dental, orthopaedic and tissue engi-
[120–122] neering, prosthesis, plates, screw and bioabsorb-
able device, bone regeneration

materials to regain their original position, i.e., energy is the system with lower knee prostheses [133, 135]. Despite
returned [133]. The various designs of the artificial limb a large number of specialized designs sports prostheses are
prosthetic devices are available where polymeric matrixes almost made from CFRPs where flexibility and stiffness
reinforced with carbon fiber produce a flexible prosthesis play the main factor during running and jumping [136].
design [134]. Higher strength and stiffness of CFRP com- Professional sports prosthesis was introduced in 1988 at
posites provide greater flexibility with lightweight and it Paralympic Games, and thereafter, composite materials are
is possible to embed an energy absorption pad and return predominant to produce lower limb prosthetics.

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Iranian Polymer Journal

The number of amputees is increasing day by day in (SLS) that produce a different characteristic compared to
developing countries and the traditional causes of amputa- CFRP, but similar mechanical properties with energy stored
tion are often added by accidents, wars, land mines, and cus- and returned system could be achieved [39].
tom fits. Thus, highly expensive CFRPs composites are not However, the availability and cost of these synthetic fib-
always feasible for every patient. Thus, less expensive knit- ers have major problems that produce high production cost
ted fibers, such as glass, nylon, cotton, Aramid, and Kevlar as well as time-consuming process during manufacturing
are reinforced with different polymer matrices and nanopar- and design. Thus, these fibers also cannot be used for short-
ticles to produce higher specific properties and compactness term usages due to their expenses, low reusability and not
at lower maintenance and production costs with better suit- often eco-friendly. Therefore, naturally derived fibers/fill-
ability for prosthetics applications [137–139]. These types of ers-reinforced composites have the possibilities to replace
materials also have a lighter weight that provides appropri- plastics and carbon/glass composites due to their cheap raw
ate flexibility, comfort, and manufacturing reliability to the material, easily available, eco-friendly, and biodegradable
patients, while retaining the strength and stiffness of metals compared to artificial fibers as well as having similarity of
and their alloys [140, 141]. However, few studies have been specific strength and stiffness compared to these expensive
conducted on the hybridization of carbon fiber with others composites and plastics [166–168].
synthetic and natural fibers to overcome the final cost and
maintain its physical and mechanical properties for pros- Naturally derived biocomposites as a replacement
thetic applications. Carbon fiber was reinforced with glass for lower knee prosthesis
fiber [142], perlon fiber [143], cotton fiber [144], and nylon
fiber to develop hybrid composites, and their mechanical, From previous studies, it was discussed and reviewed that
thermal, impact, and fatigue properties were investigated. composites materials have greater compatibility with knee
The hybridization of fiber layers enhanced their strength, prostheses to fabricate flexible and comfortable sockets,
stiffness and fatigue resistance for prosthetics applications pylon, liner, and footpads. A prosthetics design requires
[145, 146]. Ultraviolet radiations and temperature effects on essential parameters like good strength and stiffness but
the mechanical and fatigue performance of prosthetic sock- should also be lighter weight, cost-effective and comfortable
ets have been also analyzed and revealed that the hybridiza- for amputees during walking, running and travelling [169].
tion of these various fibers with carbon fibers is less affected However, carbon, Perlon, glass, Kevlar, and nylon fiber are
and has retained their properties, while minimum degrada- much expensive compared to wood, metals, and plastics,
tion was observed due to functional changes in electrical while these biomaterials are also not fully eco-friendly and
resistance [147]. Due to the rapid increments of amputee’s biocompatible for human bodies [170]. Therefore, natural
patients, for greater availability, naturally derived fibers fiber polymeric composites will be produced and provided
like jute, flax, sisal, etc., were also reinforced with carbon cost-effective biomaterials that may allow the financially
and glass fibers for prosthetic applications. The results con- weaker disabled persons to get affordable and comfortable
cluded that the inclusion of these natural fibers improved prosthetic legs [171, 172].
the compatibility and biodegradability with better resist- Several previous studies have confirmed the potentials of
ance of strength and stiffness as well as reduced the usages natural fibers biocomposites over other biomaterials due to
of carbon fibers and provided economical products [148, greater flexibility, biodegradability, eco-friendly, and cost-
149]. Table 3 summarizes some previous studies with fiber- effective that also produced good specific strength, stiffness,
reinforced composites, which are used for prosthetics and and fatigue resistance with high fracture toughness, and cor-
orthotics devices. Originally, the main aim of the prosthetic rosive resistance [173–175]. Figure 4 compares the specific
devices was to enhance the performance and comfort by mechanical properties of different biomaterials used for limb
reducing the functional disadvantages compared to human prosthesis application. The reinforcements of natural fibers
limb/foot. However, it has been stated that sprint prostheses produced lightweight materials compared to glass/carbon
not only provided mechanical advantages but also redressed fibers and such materials are promising to reduce the energy
the functional disadvantages over the human limb/foot [165]. consumption rate and provided high performance during
Nevertheless, advances have been made to design prosthetics their usages [176–178]. Although, these cellulosic natural
for the elite and greatly specialized applications are com- fibers are hydrophilic in nature that are incompatible with
monly accepted to contribute to the recovery of previously polymer matrices and affect the performance of the devel-
unimaginable levels of sporting and recreational functions as oped composites. Therefore, to overcome these disadvan-
well as increase the quality of commercially available pros- tages, hybridization of different fibers is to be done to reduce
theses [135]. Therefore, to rapidly produce highly personal- the capabilities of water absorption, whereas chemical and
ized and tailored designs of prosthetic limb/feet, an inves- surface treatments of fibers to modify the structure of the
tigation was done with selective laser sintering techniques fibers which could predominate and improve the interfacial

13
Table 3  Various FRPs composite materials used for prosthetics devices
Authors/Year Materials Fabrication process Fabricated body parts Results obtained

Tay et al. (2002) Nylon-P301 Fused deposition modelling Socket, footpads, Prosthetic and CAD and CAM were used to design
[146] (FDM) orthotics devices prosthetic foot pads and sockets
with greater flexibility
Phillips et al. (2005) Nylon, Spectron, cotton, perlon, Vacuum resin transfer mold Socket, footpads, ankle, pylon, hip, Carbon fiber is replaced with other

13
[147] glass and carbon fiber (VRTM) knee, foot stems suited materials which are less
expensive
Rogers et al. (2008) Nylon 11 (Rilsan D80) and nylon 12 Selective laser sintering (SLS) Trans tibia sockets, footpads, ankle– Socket fabricated from solid freeform
[148] (Duraform) foot, hip prosthesis (SFF) that creates a 3D object from
a geometric database
Faustini et al. (2009) Rilsan D80, carbon fiber, Dura- Selective laser sintering (SLS) Prosthetic devices, sockets, ankle– RilasnD80 is the only SLS material
[149] Form-PA, DuraForm-GF foot orthoses, foot pads suited for large deformation
Montgomery et al. (2010) Nylon 11 and nylon 12 Selective laser sintering (SLS) Prosthetic sockets, limb stem, foot- Curve specimens achieved larger
[150] pads, hand and ankle–foot orthosis deformation than flat specimens and
greater flexibility recorded
Saito et al. (2012) Carbon fiber/filler composites VRTM, FDM, AM, layup thermo- Stem and socket prostheses, tendon, The device was able to assist the
[151] forming, prepreg layup and scaffold repair, fracture plate, movement, thus compensate for the
clip, joint and screw weakness and impairments of the
ankle joint. Movement of Gait joint
could be improved
Munguia et al. (2013) Carbon fiber polyamide composites Prepreg sheet Main strut, socket, footplate, ankle– Joints supported with hinge structure
[152] layup, thermoforming, 3D printing foot orthosis, calf, and foot pads that provided more flexibility for the
patients
Do et al. (2014) Canvas fabric and polypropylene Thermoforming polymer sheets Prosthesis stem and sockets, ankle– Better gait movement with lighter
[153] foot orthosis, foot pads weight and low production cost
Hadi et al. (2015) PMMA, carbon fiber, and silicon Thermoforming polymer sheets, Prosthetics sockets, footpads, stem Better prosthetic feet movement at
[154] rubber hand layup and ankle–foot orthosis low cost due to rubber polymer
blend
Rezaei et al. (2016) and Koh et al. Carbon fiber and PEEK Thermoforming polymer sheets, 3D Hip, knee, rod, and plates replace- Carbon/PEEK composites provided
(2019) [69, 156] printing, FEM ment femoral prostheses flatter load transfer from upper body
to leg compared to the stainless
steel/titanium
Galvao et al. (2017) Carbon fiber-reinforced polymer Thermoforming polymer sheets, 3D Footpads, calf, and sockets pros- Gait movement and force distribution
[72] composite printing, VRTM thesis at prosthetic feet were analyzed with
optical Bragg gratings
Abbas et al. (2018) Perlon, carbon and glass fiber Thermoforming polymer sheets, Prosthetic/orthotic devices, F-socket, Pressure and thermal heat were
[158] composite VRTM, FEM foot stump and pad measured using F-sensor for better
comfort
Junqueira et al. (2019) Carbon fiber-reinforced polymer None Prosthetic tube and feet, transtibial Design the feasibility of prosthetic
[159] composites prosthesis feet with lattice structure and inner
layer
Iranian Polymer Journal
Iranian Polymer Journal

better flexibility with lighter weight


expensive while, GFRP provided
provided better flexibility during

provided greater flexibility but


The fabricated blades and pads

Prosthetics devices with CFRP

and low production cost


Results obtained

running
Artificial leg, stem, prosthetics run-
ning blade, sprint, footpads, and
Prosthetic running blade, sprint,
Fabricated body parts

footpads, sockets

sockets
Compression molding, hand layup

Compression molding and VRTM


Fabrication process

methods

Fig. 4  Specific mechanical properties of different biomaterials: (a)


light with strength and stiffness, and (b) cheap with strength and stiff-
ness
fiber, Araldite epoxy resin, polyes-

interaction between fibers and matrix materials [179–181].


Perlon glass, Kevlar, and carbon
Woven and chopped glass fiber

These natural fibers biocomposites have recorded higher


thermal stability and viscoelastic properties compared to
gelcoat, clays, polyester

plastics due to char residue and synergetic effects of cellu-


losic fibers that sustained high degradation and glass transi-
tion temperature and provided better interfacial interaction
ter, Orthocryl

with high-stress transfer between fibers with matrix materi-


Materials

als [182, 183]. The surface modification and treatment of the


fibers also improve their surface roughness due to removal
of wax, impurities, hemi-cellulose and residue from the fib-
ers surface, and enhancement in structural, hardness, ero-
Ismail et al. (2021) and Abbas et al.

sion, and wear resistance properties was revealed [184–187].


Thus, the previous studies concluded that natural fiber bio-
composites could fulfil sufficient requirement for developing
and functioning the current knee prostheses. Furthermore, in
Ouarhim et al. (2020)
Table 3  (continued)

using these naturally derived biocomposites, the cost of raw


materials and weight of the prostheses can be minimized,
Authors/Year

while still maintaining the strength and stiffness of the bio-


[158, 159]
(2021)

materials [188].
[157]

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Iranian Polymer Journal

There are some studies carried out for the development used jute/Grewia optiva fiber-reinforced biocomposite with
of prosthetic sockets with natural fibers and that may allow three different polymer matrices: polyester, epoxy, and vinyl
thinking about these green materials due to their less cost ester resin and compared the results with the results of glass
and environment friendly. Developed prosthetic sockets with fiber composites. The epoxy-based composite exhibited
ramie fibers epoxy composites are compared with glass fiber lower erosive wear followed by vinyl- and polyester-based
polyester composites. The results revealed better strength composites. The high impact resistance of epoxy-based com-
and modulus with ramie fibers epoxy composite that could posites was attributed to high strength and stiffness along
be an alternative solution to prosthetic sockets [189]. Addi- with lower wear rate of jute/Grewia optiva fiber biocompos-
tive manufacturing (AM) process has been widely used and ites compared to glass fiber composites [200]. The pressure
is the best process among other manufacturing process. A distribution and fatigue life of natural fiber composites of
study developed transtibial prosthesis sets from AM process transtibial prosthetic socket were discussed and the results
with the help of micro-fibrillated cellulose fibers (MFC) and concluded 96.62% correlation between the experimental and
polypropylene (PP). The results showed that the strength numerical results. The results also showed that the virtual
and modulus of 30% MFC inclusions are twice compared prototype can be adopted to design comfortable and resistant
to those of PP biocomposite. A clinical trial has been con- transtibial prosthetic socket with higher fatigue resistance
ducted and experienced greater wear in terms of comfort- and lower pressures distribution between socket and residual
ability, reliability, and durability [190]. In a study on bam- limb due to light weight and flexible behaviour of the devel-
boo fiber-reinforced composites they were used instead of oped sockets [201].
glass, cotton and nylon composites due to their better spe-
cific strength and stiffness with greater flexibility for below Fabrication process of prosthesis
and above knee prosthesis sockets [191, 192]. Kenaf-fiber-
reinforced composites also allowed a prosthetic design and In ancient times, prosthetic devices were generally created
replacing glass/carbon/Kevlar fiber due to their superior spe- and shaped from wood and lathers. Over the years, new tech-
cific strength properties, high impact strength, comfort, and nologies, machines, and techniques were developed due to
acceptable appearance for amputees [193]. An investigation the era of the new industrial revolution in the world. There-
was done on pineapple leaf fiber- and banana fiber-reinforced fore, the field of manufacturing and production, including
polymer composites and examined the tensile, flexural, and the production of prostheses and orthoses, grew rapidly
impact strength. The results were compared with the results [202]. In the modern era, the design and fabrication of pros-
of glass fiber composites and it was found that banana and thetics and orthotics fields have evolved rapidly and have
pineapple composites have better specific properties and also become more functional and user friendly.
can be considered as an alternate biodegradable material for Nowadays, material science has played a significant role
designing cheap and biocompatible prosthetic sockets [194, to develop a new material from combination of different
195]. Similar types of performances have been observed constituents at micro/nano levels, such as plastics and com-
with some other natural fiber composites where the stud- posite materials, to improve their physical and mechanical
ies reported the development of prosthesis sockets and foot multifunctional properties [203]. Currently, prosthesis and
pads with economical, sustainable and eco-friendly materi- orthosis can be manufactured using one of these following
als like alfa, flax, sisal, and rattan fiber-reinforced compos- methods which are described below:
ites. The results showed that these biocomposite materials
are more suitable for the development of prosthetic devices Plaster molding and forming process
due to their superior specific mechanical, fatigue and wear
resistance properties with greater flexibility and biocompat- Plaster techniques are the traditional molding process, in
ibility, which provide comforts for the amputee’s life and which the prosthetic device is pressed into a foam box to
also challenge the mobility, movement, alignment and gait create a negative impression of the plantar surface. This
analysis of the developed composites [196–198]. Another negative impression is used as a mold for plaster to cre-
study developed prosthetic sockets from Agave cantala ate the positive model of the device. The positive model is
fiber composites and discussed their structural, physical, placed on a vacuum table and then draped with a preheated
and mechanical performance under the influence of micro- thermoplastic sheet. Now, vacuum is applied to mold the
crystalline cellulose. The crystallinity of the fiber increased thermoplastic sheet into the plaster mold.
to 73.65% due to treatment and higher structural, mechani-
cal, and thermal stability behaviour with greater surface Vacuum resin molding processes
energy and smaller contact angle were observed compared
to untreated composites [199]. Wear and erosive behaviour Gypsum mold is prepared according to the width of residual
also affected the performance of the prosthetic limb. A study parts of the amputees/patients. Now, this mold is clamped

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Iranian Polymer Journal

vertically and a layer of PVA is put on the mold. A stocki- then ground up with data generated using a 3D scanner with
nette is placed on the mold before and after knitting the lam- help of 3D modelling software. Once, the object model was
inate fibers. The second layer of PVA is put on the mold and prepared and then saved as an additive manufacturing (AM)
air suction between two PVA bags is started by a vacuum file format. Now, the prototype is printed layer by layer with
pump system. The vacuum pump is attached at the lower help of 3D printer by uploading the AM files. After that,
part of the clamp to remove the air between stockinette and 3D printer builds the final objects by depositing layer by
fiber laminates. The mixture of resin (matrix material) is layer materials on the objects. In 3D printers, different types
poured between layers of laminated fibers from top of the of materials can be used to build the objects, but currently
mold. Finally, the prepared sockets are pre-cured at room thermoplastic polymers like polypropylene, ABS, acrylic,
temperature for 24 h and then are removed from the mold to polyester, nylon, polystyrene, etc., and laminated fibers, such
post cure at 80 °C for 12 h. as carbon fiber, glass fibers and others are mostly used for
this process in the filament form to fabricate the final printed
Thermoforming process objects (prosthesis).

Thermoforming process is usually used for thermoplastics


polymeric materials because during heating these polymeric/ Factor affecting the performance of prostheses
plastic materials always soften. Thus, it is quiet easy to mold
into an appropriate shape and size. The following four fac- Pressure measurement and comfort
tors have been ensured for successful operation during ther-
moforming process. Prosthetic sockets are designed to hold the bodyweight with
-Heating temperature: mainly depends on the kind of good mobility and should remain comfortable and snug to
polymeric materials used. The heating temperature ranges the residual limb. If amputees feel any discomfort and pain
of homopolymeric and copolymeric materials are around during walking and travelling, this can lead to a variety of
175 to 180 °C and 165 to170 °C, respectively. causes, such as reduced blood circulation and neuroma for-
-Heating duration: the duration of the polymeric sheets mation [204]. According to prosthetic and orthotic care, the
will fluctuate as per the variation of sheet thickness. During socket design should be painless for walking, and it should
fabricating of prosthesis socket, the sheet thickness is recom- be noted that all the prosthetics legs sockets should be cast
mended around 3–5 mm that mainly depends on the patient’s and designed properly to fit comfortably without any pain
heights, weight, and width. for the body. Research has been done on a case study to
-Homogeneity of temperature: ovens are used for the measure the pressure in all transtibial amputees and reported
temperature homogeneity over the thermoformed polymeric that the highest pressure was measured on the bottom area
sheets. Proper heat distribution is an essential parameter to of the smaller leg bone located at the distal end of the resid-
achieve better quality prosthetic sockets and ensures uniform ual limb. After that, the front edge of the shin bone was
heat distribution throughout the sheets. measured with the second-highest pressure on the amputees'
-Teflon lining: a clean and suitable Teflon sheet is used to limb [205]. Pressures are also experienced on the top of
prevent the polymeric sheets during heating in the oven. It the smaller leg bone and bump of the shin bone where the
covers the oven tray and protects the damages on the poly- tendon is attached.
meric sheets from sticking. The comforts of the sockets are mainly described by the
The major difference between the plastics and laminated user’s experiences and there is no standard quantifiable scale
fibers fabrication processes is that the laminated fibers pros- to measure the comfort of the prosthetics legs sockets. The
thesis is fabricated by different layers and stacking sequence weight of the body mainly depends on the pressure tolerant
of laminated fibers with different orientation around the areas of the remaining limb and there is no longer any weight
casting of plasters until the desired thickness and shape are bearing from the bottom of the limb. Thus, bodyweight of
formed instead of prescribed thickness from thermoforming the amputees should be carried by soft tissues [206]. The
the sheets. external and internal pressure forces acting on the prosthe-
sis leads to irritation and skin problem on the body, as well
3D printing as uneven and inappropriate load-bearing, which may lead
to pain at the distal end that introduces the negative effect
3D printing process is one of the widely and extensive meth- of mechanical changes on amputee’s life [207]. Therefore,
ods to fabricate prosthesis or orthosis. It is also known as considering this necessary information, researchers have to
additive manufacturing process. In this process, a digital pay more attention (mainly to the bottom area of the socket)
model is shaped to create a 3D solid model. CAD/CAM to fabricate a comfortable and desirable socket for prosthetic
methods can be used to create a 3D prosthesis socket and patients.

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Iranian Polymer Journal

Thermal comfort of prosthesis sockets need to have basic criteria of biocompatibility according to
the International Standards Organization (ISO 10993) where
Thermal stress is the main problem affecting the many it should be nontoxic, non-antigenic, non-carcinogenic, no
prosthetic patients in their daily running life. Due to the mutagenic, and non-thrombogenic to sustain an appropriate
generation of thermal stress, conduction, convection, radia- biological and genetic responses [214]. Biocompatibility of
tions, and evaporation are affecting prosthetic use, com- biomaterials strongly depends on the biofunctional, biosta-
fort, satisfaction. During the use of prosthesis leg, 60% to ble, material properties (like crystallinity, stiffness, surface
70% of amputee’s patients claimed that perspiration is the chemistry, texture, wettability, and breakdown charges), bio-
main problem for the discomfort [208]. Thermal discomfort logical interaction with living tissues (contact with bloods,
mainly happens in a hot and humid environment that causes inflammatory, proteins adsorption) and period with types of
more perspiration, skin irritation, infection, bacterial inva- device used [215, 216].
sion, friction blisters, and unpleasant odour that may affect The biological evaluation of biomaterials has been done
the amputee’s quality of life [209]. with help of different ISO that include wide-ranging spec-
To resolve these problems, nowadays prosthetics are trum of in vitro and in vivo tests related to degradation,
designed to develop the advanced prosthesis legs, which irritation, toxicity, genotoxicity, hemocompatibility, cyto-
are made of better interface materials. In daily life, most compatibility, carcinogenicity, and sensitization. Different
amputees wear liner, socks, wool, and cotton throughout the ISO with their American Society for Testing and Materi-
day for observing perspiration and accommodate residual als (ASTM) standards for biocompatibility tests of various
limb volume fluctuations [210]. That may also reduce the biomaterials are tabulated in Table 4. The biocompatibility
skin temperature with effective heat transfer controlled by of polymeric/plastic materials is influenced with wetting
the thermal conductivity of these wearing materials [211]. abilities, functional group properties of polymers, chemi-
Researchers are also thinking to provide air circulations and cal structure, and surface morphology. Thus, these issues
ventilations between prosthetic and stump surfaces for better have generated and referred to lipid uptake, sterilization
heat transfer. residuals, extractable, protein adsorption, calcification, and
hypersensitivity [218]. Nowadays, fiber-reinforced compos-
Biocompatibility test ites biomaterials are widely used for orthopaedic and pros-
thesis applications due to high specific strength and rigid-
Biocompatibility of biomaterials for medical application is ity. Therefore, biocompatibility measurements are essential
one of the important aspects and primary requirement to parameters for the further improvement of the quality of life
examine vitro and vivo specific performance for their end for the individuals. The lipid uptake, hypersensitivity, tissue
use application. Biocompatibility of any materials is defined biomechanics matching, and surface exposure of compound
as the ability to accomplish its functional desired with suit- particles are the major biocompatibility issues associated
able host response in any specific situations that may not be with composite materials [213, 219].
causing any undesired systematic and local effects on the According to National Institute of Health Science
recipients/receivers [212, 213]. The developed biomaterials America, the biocompatibility test of any biomaterial is the

Table 4  ISO and ASTM Biological response ASTM standards ISO


standards for biocompatibility
tests of biomaterials Carcinogenicity F1439-03 10,993–3
Genotoxicity E1262-88 10,993–3
Hemocompatibility F756-08 10,993–4
Cytotoxicity F813-07, F895-84, F1027-06 10,993–5
Implantation F1408-97, F763-04, F981-04, F1904-98, 10,993–6
F1983-99
Irritation F719-81, F749-98 10,993–10
Sensitization F720-81, F214-01, F2148-07 10,993–10
Subacute toxicity F750-90 10,993–11
Acute systemic toxicity F750-87 10,993–11
Chronic toxicity – 10,993–11
Immune responsiveness F1906-98 10,993–20
Degradation F1983-14 10,993–9, 10,993–13,
10,993–14,
10,993–15

13
Iranian Polymer Journal

most essential for orthopaedic application where the liv- • Most of the modern prosthetics/orthotics devices have
ing organs, tissues and mechanism of the body are totally been developed or fabricated from plastics or artificial
contact with artificial devices to enhance and maintain the fiber composites due to their higher specific modulus,
quality of life of the patients/individuals [220]. However, strength and stiffness. However, plastics tend to pollute
limb prosthesis is used for the outer parts of the patients/ the environment during production and after their use,
amputees (residual limb). Therefore, biocompatibility test whereas composites are too much expensive to achieve
is not much essential for limb prosthesis application but the affordable and comfortable knee prostheses for finan-
main requirements of the limb prosthesis biomaterials are cially weaker disabled persons and short-term usage.
good mechanical properties, chemical stability, nontoxic, • Biocomposites from naturally derived fibers/fillers can
suitable microstructure, lower surface roughness, and high replace plastics and those composites because they are
resistance against wear and corrosion. Therefore, naturally inexpensive, readily available, environmentally friendly,
derived biocomposites biomaterials have potential to replace lighter, biocompatible and biodegradable, while still
other conventional biomaterials due to their availability, cost comparable specific strength and stiffness have been also
effective, eco-friendly, non-corrosive, nontoxic along with examined.
greater flexibility, biodegradability, and biostability.

Dynamic factors to affect prosthesis performances

Prosthesis limbs have various advantages but along with


that, the continuous use of prosthesis limbs has some adverse Conclusion
effects on their performance. Because of biomechanical
asymmetry, the inertia and the centre of mass can change Promising successful research on prosthetic legs has led us
during walking and running and this has a serious effect on to think optimistically on their future developments. The
the efficiency of the energy transformation. Excessive use present study reviewed the development of biomaterials and
of prostheses can sometimes cause back pain, hip pain, and design analysis of socket-based prosthesis according to the
arthritis due to increased forces [221]. amputee’s comfort and mobility for knee prosthesis appli-
cations. The study intended the possibilities to replace the
existing biomaterials with naturally derived biocomposites
Major findings from this review and following conclusions have been summarized below.
Prosthetics have been used since ancient civilization,
The above literature survey has been done based on previ- when they were made of various materials such as wood,
ous studies to identify the best-suited materials for prosthet- leathers, metals, ceramics, plastics, and fiber-reinforced
ics. Table 5 illustrates and discusses some previous stud- composites. Currently, carbon fiber and glass fiber-rein-
ies about design, integrity, and performances of prosthetic forced composites and plastics are the promising and most
socket materials. Several desirable characteristics for various suited materials to replace the existing conventional bioma-
materials employed as the articulating surfaces in any pros- terials due to lower weights, greater flexibility, high stiff-
thetics have been summarized and discussed below: ness, and strength. However, these FRP biomaterials are
too much expensive and produce carbon emissions during
• The ideal knee prosthesis needs to have lighter weight, processing, whereas plastics have the tendency to pollute the
superior strength, stiffness, fatigue resistance, corrosion environment after their use. Although, carbon composites
resistance and toughness to sustain high mechanical per- are very expensive to make affordable prosthesis sockets for
formances, reliability, biocompatibility, sustainability financially weaker disabled persons and a short-term usage.
and resist deformation under loading. Therefore, there is a greater possibility to replace those com-
• Better surface profile and surface hardness are also essen- posites and plastics with naturally derived biocomposites.
tial properties for supporting wear resistance and low The various components of prosthesis limb with their
friction to support the lower limb while walking and biomechanics have been discussed to provide better com-
improve the quality of life. fortability, flexibility, and stability to the patients in daily
• The integration of biomaterials, whose mechanical prop- running life. The authors also discussed the various fac-
erties, performances and feasibility closely match with tors like biocompatibility, pressure released, thermal
the human bone is best suited for prosthetics devices. stress generation, and physical factors that affect the per-
Although, cost-effective, lighter weight, comfortability formance of prosthesis limb and lead to discomfort in the
and eco-friendly materials are also effective concerns to amputee’s life. Therefore, the current review guides the
select the best appropriate prostheses for every amputee. designer to select appropriate biomaterials for improving

13
13
Table 5  Prosthetic socket materials and methods with their design, integrity, and performances
Authors Year Materials Method Findings

Neo et al 2000 Plastics, plaster of paris Aligned laminated process Mechanical performances under static and cyclic loading
[222] conditions. Orientation, alignment, and positioning of
sockets, shanks, pylon, and foot pads
Goh et al 2002 Polypropylene Polymer deposition method Structural analysis like tensile properties, and delamination
[223] under static and cyclic conditions
Faustini et al 2006 Duraform PA (Nylon) Selective laser sintering (SLS) Complex geometric design. Structural reliability under
[224] compressive and bending test up to failure
Graebner et al 2008 Carbon fiber, Nyglass stockinette Plaster layup molding method Specific strength, deflection, and failure mode under gait
[225] cycle. The relative structural strength between pylon and
socket was also investigated
Gerschut et al 2012 Polyethylene, polypropylene, laminated fiber Blister forming, Plaster molding and forming process Mechanical performance under static and cyclic loading,
[226] pressure measurement, patients comfort
Mathur et al 2016 Thermocouples Modelling, machine learning Interface temperature between limb and liner socket, thermal
[227] comfort, skin temperature
Vitali et al 2017 Plaster mold Additive manufacturing Design and development of limb prosthetic socket. Pressure
[235 distribution between limb and socket
Lindberg et al 2018 Nylon, polymeric powder 3D printing, SLS Mechanical performance, failure under different load, topol-
[229] ogy optimization, instability, discomfort
Pousett et al 2019 Thermoplastic, laminated fibers 3D printing, forming process Ultimate strength under early stance, terminal stance, and
[230] late stance phase. Stress distribution at distal
Owen et al 2020 Carbon fiber, PETG, PLA thermoplastic 3D printing, resin transfer molding, plaster molding Design features of socket system, ultimate tensile strength,
[231] maximum deflection at failure, specific strength, failure
mechanism
Gaba [232] 2021 Natural fibers Compression resin molding method Mechanical properties, cost effective, lower weight, stability,
Shahar et al. [45, 193] comfortability, and degradability. Greater replacement to
carbon and glass fiber
Garibold et al 2022 Systematic review 3D printing Structural testing like manufacturing reliability, test setup,
[233] loading and failure condition of limb prosthesis
Iranian Polymer Journal
Iranian Polymer Journal

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Authors and Affiliations

Santosh Kumar1 · Sumit Bhowmik2

2
* Sumit Bhowmik Department of Mechanical Engineering, National Institute
bhowmiksumit04@yahoo.co.in of Technology Silchar, Assam 788010, India
1
Present Address: Department of Mechanical Engineering,
National Institute of Technology Silchar, Assam 788010,
India

13

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