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Physical and Engineering Sciences in Medicine

https://doi.org/10.1007/s13246-020-00882-3

INVITED REVIEW

A systematic review on design technology and application


of polycentric prosthetic knee in amputee rehabilitation
Rajesh Kumar Mohanty1,2   · R C Mohanty3 · Sukanta Kumar Sabut4

Received: 27 March 2020 / Accepted: 27 May 2020


© Australasian College of Physical Scientists and Engineers in Medicine 2020

Abstract
The objective of this paper is to conduct a systematic review on design technology and clinical application of polycentric
prosthetic knee joint in the rehabilitation of trans-femoral amputees. Relevant studies were identified using electronic
database such as PubMed, EMBASE, SCOPUS and the Cochrane Controlled Trials Register (Rehabilitation and Related
Therapies) up to February 2020. Screening of abstracts and application of inclusion and exclusion criteria were made.
Design, modeling, material use, kinematic study, simulation technique and clinical application of polycentric knee models
used in many developed and developing countries have been reviewed. Out of 516 potentially relevant studies, 43 articles
were included. Specific variables on technical and clinical aspects were extracted and added to summary tables. The results
reveal that polycentric knees have a variety of geometries but the methods for comparing their performances are rare. The
data of structural analysis using different simulation techniques are validated with experimental results for determining
model accuracy. Gait analysis using the polycentric knee components provides a valid tool to correlate with experimental
results. There are well-designed studies on the technological development of polycentric knees, however, high-quality clini-
cal researches are scarce. Conventional clinical knowledge had considerable gaps concerning the effects of polycentric knee
and their mechanical characteristics on human functioning with a lower-limb prosthesis. Still, further research is needed
to develop and implement standardized measures on prosthetic knee joints for their effective use, function, durability, and
cost-effectiveness.

Keywords  Amputation · Clinical application · Finite element · Polycentric · Prosthetic knee · Trans-femoral

Introduction globally [1, 2] and those performed in lower limb accounts


for majority up to 90% [2]. It is estimated that by 2050, the
The major cause of amputation may be classified into trau- numbers may double [3]. According to a survey by World
matic and dys-vascular whereas oncological disorders and Health Organization (WHO), the estimated number of ampu-
infection are also prevalent. According to sources, the inci- tees is 40 million in the developing world. As per Census
dence of amputation is 1.2 to 4.4 per 10,000 population 2011, the population of persons with disabilities in our coun-
try is about 2.68 crore which is 2.22% of total population.
Amputation is one of the major cause of disability in India
* Rajesh Kumar Mohanty but a very few of them (about 5%) have any access to pros-
rajeshmpo48@gmail.com
thetic devices [4].
1
Centurion University of Technology and Management, With lower limb amputations, inconveniences are caused
Bhubaneswar, Odisha, India due to loss of walking ability and performing other activities
2
Post Graduate Department of Prosthetics and Orthotics, of daily living (ADL) along with psychological and social
Swami Vivekanand National Institute of Rehabilitation issues. The most productive way to reestablish walking abil-
Training and Research, Cuttack, Odisha, India ity is through properly designed prosthetic system as shown
3
Department of Mechanical Engineering, Centurion in Fig. 1. The prescription of prosthesis is a combination
University of Technology & Management, Bhubaneswar, of art and science predominantly based on factual com-
Odisha, India
prehensive understanding. There are broad ranges of pros-
4
School of Electronics Engineering, Kalinga Institute thetic components; however, the yardstick of prescription
of Industrial Technology, Bhubaneswar, Odisha, India

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Physical and Engineering Sciences in Medicine

Fig. 2  a Single axis and b polycntric prosthetic knee [12]

stability with constant change in instantaneous center of


rotation (ICOR) at varying knee flexion angle. Compared
to other prosthetic knees, the 4-bar linkage polycentric
mechanism is still most predominant globally. In spite of
its simplicity, it has the feature of inherent stability during
static loading and reproduces natural motion of knee with
high reliability [9]. However, they are comparatively more
expensive. The best compromise solution considering cost,
Fig. 1  Above knee amputation and prosthesis functionality and aesthetic aspect is a polycentric prosthetic
joint based on the 4-bar linkage mechanism which is widely
described in literature for prosthetic applications [10, 11].
primarily relies on instinctive experiences of physiatrists, Considering the impact of prosthetic rehabilitation,
therapists, and prosthetists [5, 6]. In other words, the idea problem identification and necessary footsteps required
for a suitable prosthetic prescription is to adjust the mechani- for improving existing practices in developing countries, a
cal characteristics of a prosthesis to the functional needs of significant number of publications have been elucidated in
subjects [7]. Out of all prosthetic components for subjects mid-1990s [10, 13–21]. The key issues identified were poor
with trans-femoral amputation, prosthetic knees are most durability and failure of prosthetic foot, the discomfort due
vital element that can affect the performance during gait to inadequate prosthetic socket fit, poor alignment and func-
and ADL. Many works have been performed to improve the tioning of components including knee joints. In an extensive
design and performance of prosthetic knees in last few dec- literature survey from 1994 to 2010 on lower limb prosthetic
ades. The optimal design of a prosthetic knee is a fundamen- technology in developing world, J. Andrysek [20] suggested
tal requirement to restore the lost function, improve cosmetic that there is a requirement for prosthetic components to be
appearance and achieve social acceptance. more functional irrespective of continuing action to improve
Prosthetic knees for trans-femoral amputations are distin- prosthetic technology. He emphasized on design and devel-
guishable by the different means of linking thigh and shank opment of cost effective and durable prosthetic knee joints
(single-axis and polycentric) and by control methods [8]. through simplifying fabrication techniques [21].
The single-axis prosthetic knees as displayed in Fig. 2a are Through systematic literature search with a methodical
characterized by a fixed center of rotation. However, they strategy, we explored across four major technical databases
are relatively inexpensive. They simulate the motion of the and retrieved records were screened for their relevance.
anatomic knee with moderate levels of accuracy but are not Though, different types of polycentric prosthetic knee
sufficiently stable during the stance phase. In contrast, the joints have been synthesised globally in last fifteen years,
polycentric knees as presented in Fig. 2(b) have inherent there has been equivocacy over prescription criteria, design

13
Physical and Engineering Sciences in Medicine

parameters, kinematic performance of its various designs Papers were excluded when any of the inclusion criteria
and counterparts. Therefore, objectives of this paper is to were not met and when their focus centered on joint replac-
review the design, modelling, material use, kinematic study, ing endo-prosthesis.
simulation techniques, and clinical applications of polycen- Two investigators (R.K.M. and S.S.) screened the
tric knee models and its counterparts. abstracts identified in the database searches. R.K.M. was
responsible for reviewing abstracts identified in PubMed,
EMBASE, and S.S. reviewed abstracts from SCOPUS and
Methods the Cochrane Controlled Trials Register databases (Reha-
bilitation and Related Therapies). These 2 investigators then
Literature search applied the inclusion and exclusion criteria to the abstracts.
Abstracts which did not meet the inclusion criteria were
Our review covers both the technological developments excluded and the reason for exclusion was recorded. Dupli-
and clinical applications of polycentric knee joints for pros- cate articles were removed. The remaining full-length arti-
thetic rehabilitation of trans-femoral and higher level lower cles were then retrieved and reviewed by these two review-
extremity amputees. Relevant articles have been obtained ers to further determine whether the study met inclusion or
through a search of articles in the PubMed, EMBASE, SCO- exclusion criteria. A senior investigator (R.C.M.) verified
PUS and the Cochrane Controlled Trials Register databases and made final decision.
(Rehabilitation and Related Therapies) up to February 2020.
The following key words have been used in the litera-
ture search: amputation, polycentric, prosthetic knee joint, Data extraction
technology, materials, lower extremities, finite element,
modelling, design, clinical application, and optimization The variables that were extracted from the included studies
techniques. are design, mechanism, simulation, kinematic, optimiza-
tion and clinical applications of polycentric knee focused
Study selection on prosthetic rehabilitation of amputees.

The following topics have been selected for review: Data synthesis and analysis
(1) Technology of prosthetic knee devices, Specific variables on technical and clinical aspects were
(2) Study of polycentric knee mechanism, extracted and added to summary tables. Summary tables
(3) Design, modelling, materials used and kinematic analy- were used to categorize studies according to themes. Dur-
sis of polycentric knee joint, ing screening, grouping of articles are performed by study
(4) Finite element analysis (FEA) and optimization tech- design and categorized as technical development, clinical
niques, and studies through lab testing and/or field trial. The category
(5) Clinical applications focused on prosthetic rehabilita- of technical development includes studies focusing on tech-
tion of amputees. nology related research and development without patient
clinical trial. Clinical lab testing study involves patients,
This will help in understanding how technological lab-based tests and outcome measures like analysis of bio-
advancements in designing of prosthetic knees ensure clini- mechanics and function. Clinical field trial study involves
cal prosthetic rehabilitation of subjects with trans-femoral time based testing of patients in physical world to know the
amputation. The following inclusion criteria are set for actuality. Level of evidence was marked as “A” for studies
selection of articles: with adequate sample size and conducted by RCTs and those
with inconvenient samples using case studies were marked
a. Study design for clinical analysis ranging from sophisti- as “B”.
cated randomized controlled trial (RCT) to a simple case
study based on innovations.
b. Patients with only trans-femoral and through-knee
amputation. Results
c. Outcome measures like subjective findings, ADL meas-
ures, gait parameters and electromyography (EMG) only The flowchart showing the results from literature search was
d. Study of mechanical polycentric prosthetic knee and its illustrated in Fig. 3. The search generated abstracts from 512
comparison with counterparts. studies. After applying inclusion and exclusion criteria, a
total of 43 studies were included in the systematic review.

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Physical and Engineering Sciences in Medicine

Fig. 3  PRISMA Flow chart of


the included studies

Technology for prosthetic knee systems friction brake during heel strike are still being used as old
designs in developed countries [25]. The knee mechanisms
The technical ability and function of a prosthetic knee joint working by fluid-controlled systems offer variable swing
significantly facilitate walking pattern that mimics to nor- control and cadences [26]. Compared to pneumatic system,
mal subjects biomechanics and thus increases efficiency in the hydraulic controlled knee offers stable stance control in
energy consumption of amputee walking [21]. Therefore, the addition to achieve a wider range of cadences and walking on
extent to which the amputee can achieve normal gait biome- different terrains [27]. An optimized polycentric prosthetic
chanics highly depends on the appropriate use and integra- knee with multiple linkage mechanism with ICOR offers
tion of prosthetic knees. Specifically, the literature has drawn inherent stance stability and provides better swing clearance
distinctions according to methods of dampening movement depending on the requirements [28]. The microprocessor
(mechanical friction vs. fluid damping) and method of con- controlled prosthetic knee designs offer changing pneumatic
trol (mechanical design vs. microprocessor regulation) [22]. or hydraulic swing control through on-board sensors and
There is a significant difference in the use of prosthetic knee electronic signal processing [21]. In order to achieve best
technology between developing and developed countries. functional outcomes of amputees, sampled feedback signals
are programmed and optimized in real time manner.
Use of prosthetic knee technology in developed countries
Use of prosthetic knee technology in developing countries
On the basis of performance characteristics, the broad cat-
egory of prosthetic knees is mechanical and microproces- Most prosthetic knees used in developing countries are
sor-controlled [23]. Swing control single axis knee having mechanical in nature due to economic constraints. There
friction or dampening mechanism [24] and weight-activated is a constant need to develop durable, functional and cost

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Physical and Engineering Sciences in Medicine

effective prosthetic knees due to limited opportunity to a typical 4-bar linkage knee. The thigh and shin are consid-
approach medical or health services. Single axis knees with ered as a link or bar joining at different points. Together, all
little or no maintenance requirements are commonly used, four links join at four points to complete the 4-bar linkage.
however it is less stable and does not offer multiple cadence
[23]. The 4-bar linkage polycentric knees developed from Design, modelling and materials used in polycentric
inexpensive materials and fabrication techniques are widely knee
used and popular due to good functional and cost effective
characteristics [29]. Constant work towards improvement Design
in design parameters to improve stability, to suit different
functional demands (cross leg sitting and squatting) and to The design of budget trans-femoral prosthesis can be
improve cosmetic appearance of trans-femoral amputees are obtained by utilizing concept of artificial knee joint based
undertaken. on the 4-bar mechanism. Its kinematic dimensions are deter-
In the context of above discussions, it may be noted that mined by multi-criteria optimization based on systematic
polycentric knees are commonly used both in developed study of parameter space of points uniformly distributed in
and developing countries. According to their designs, 4-bar multidimensional cube [31]. Some techniques of synthesis
linkage, 6-bar linkage [20] and spherical mechanisms [20] have been investigated by Poliakov et al. [32]. Some latest
with different functional requirements may be considered for design of polycentric prosthetic knee has been studied in
subjects with trans-femoral amputation. However, the 4-bar detail [33, 34]. Commercially, different designs are being
mechanism is commonly used. offered by world known manufacturers like Ossur, Otto
Bock, Hosmer, Endolite, Teh Lin and others [32]. However,
Study of polycentric knee mechanism it should be noted that almost all of them significantly differ
in terms of geometry and function. Figure 5 shows some
The 4-bar linkage polycentric knee is of three types: 4-bar schemes of the 4-bar polycentric prosthetic knee and their
linkage with elevated instantaneous centre [30], hyper-sta- centrodes obtained through shank-thigh relative motion.
bilized 4-bar knee mechanism and voluntary control 4-bar Thus it can be stated that in spite of the advantages
mechanism [27]. The elevated instantaneous center provides being offered by these designs, none of them is globally
stability at heel contact for subjects who lack active volun-
tary control. The hyper-stabilized knee provides alignment
stability like locked knees for less active amputees. Active
subjects having good hip muscle power can be benefited
with voluntary control 4-bar mechanism that provides stabil-
ity during initial contact and pre-swing [26]. Figure 4 shows

Fig. 4  Orientation of ICOR at different knee flexion of a typical 4-bar Fig. 5  Polycentric prosthetic knee joints and their corresponding cen-
linkage knee [31] troids obtained through shank-thigh relative motion (red) [32]

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Physical and Engineering Sciences in Medicine

optimal. An overview of polycentric knees manufactured designing a polycentric prosthetic knee joint. Different meth-
by global manufacturers and their technical specifications ods are introduced to optimize the problems including mod-
are presented in Table 1. However, all of them satisfy cer- ern calculations through use of computers.
tain quality criteria which are taken into consideration when

Table 1  Overview of polycentric knees manufactured by global manufacturers


Manufacturer Model Type Max. knee Mass (g) Length (mm) Max. user
flexion (*) weight
(kg)

Otto Bock HealthCare 3R46 [35] Polycentric + hydraulic 110 740 N/A 125
GmbH. Duderstadt, Ger- 3R60 [36] Polycentric + hydraulic 175 845 N/A 125
many
3R78 [37] Polycentric (4 bar) + pneu- 150 750 120 100
matic
3R66 (Pediatric) [38] 4-bar & rotator 165 255 N/A 35
Ossur hf. Reykjavik, Iceland OH7 Hydraulic polycentric knee 150 930 186 136
joint
OP5 Pneumatic polycentric knee 145 900 210 125
joint,
OP2 Pneumatic polycentric knee 160 650 N/A 125
joint
Total knee Jr. (Pediatric) [38] 6-bar & stance flexion 145 340 146 45
Chas. A. Blatchford & KX06 [39] Polycentric prosthetic knee N/A 1230 230 150
Sons Ltd, Hampshire, with hydraulic swing and
United Kingdom  stance control
S400 Polycentric locking knee N/A 678 130 125
S500 Polycentric with pneumatic N/A 882 220 125
swing control
Children’s Transfemoral Polycentric 4-bar 130 333 107 60
Prosthesis (Pediatric)
Fillauer Inc./ Hosmer Dor- MightyMite (Pediatric) [40] Polycentric 4-bar 130 290 108 60
rance Corp. Chattanooga,
TN, United States
DAW Industries San Diego, The 4000 Ultra-Lite™ Polycentric 4-bar 155 669 158 113
CA, United States The 4001 Ultra-Lite™ Polycentric 4-bar 155 591 158 113
5PS10 KD™ With Manual Lock 135 997 210 125
4P00 Ultra-Lite™ Polycentric 5-bar 140 764 188 113
TK-4P0C (Pediatric) [41] Polycentric 4-bar with pneu- 160 369 165 54
matic
Seattle Systems Inc. Poulsbo, NSSK615 Polycentric 4-bar with pneu- 145 1100 N/A 100
WA, United States matic
SSK615 [42] Polycentric 4-bar with pneu- 145 1025 N/A 100
matic
SSK602A Pneumatic 5-bar knee 145 520 N/A 100
SSK610 [41] Polycentric, 4-bar knee 140 281 115 36
Teh Lin Prosthetic & Ortho- A-TGK-5PS10 5-Bar Pneumatic Knee 135 1000 250 100
paedic Co., Taipei, Taiwan A-TGK-4P10 [35] 4-Bar Pneumatic knee 138 1078 265 100
C-TK-4010 4-Bar polycentric knee 140 910 210 100
C-TK-4001S 4-Bar Polycentric knee with 120 880 178 100
manual lock
Proteor Group, Cedex, France  1P200 Pneumatic 4-axis knee 170 743 204 N/A
1M03 [43] 4-axis knee 140 510 166 100
M112 (Pediatric) [41] 4 bar friction 135 323 94 55

N.B. Data were obtained by company literature. N/A = Data not available

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Physical and Engineering Sciences in Medicine

model of a 4-bar polycentric knee using a geometric analy-


sis and the Grashof Law for a double rocker and its design
scheme is shown in Fig. 6 [32]. Let an optimized PMAK has
a four bar linkage structure. Its design scheme is proposed
by Poliakov et.al [32]. and is discussed below. In this mecha-
nism AB is the input link. It is assumed that it is tightly
associated with the hip and moves plane parallel relatively
to 1arbitrarily still link O­ 1O3, fixed to the shank, which is
associated with moving system of coordinates ­O1x1y1. Dur-
ing the motion relative to the joint A, link AB rotates at an
angle θ3 which is taken as an independent generalized coor-
dinate. Thus, θ2 = θ2 (θ3) and θ4 = θ4 (θ3)—the functions of
the generalized coordinate θ3. Rotation angles of all links
are measured from the positive direction of the x-axis and
considered positive if directed counterclockwise.
In order to unify the following notations were introduced:
lO3O1 = x1, lAB = x3, lBO3 = x4, ­xO1 = x5, ­yO1 = x6, γ1 = x7,
θ2 − θF = x8, lAP = x9, γ3 = x10. Here the symbol l denotes the
length of the links indicated in the indexes: ­xO1, ­yO1—the
global Cartesian coordinates of the joint O1:γ1—the inclina-
tion angle of the link O1O3 relative to the x-axis of the global
coordinate system: γ3—the angle between the segments AB
and AP: θF—the knee flexion angle.
From the conditions that the circuit O1ABO3O1is closed,
the following can be obtained:

⎛ ⎞
⎜ F1 ± F12 + F22 − F32 ⎟
𝜃2 = 2 arctan ⎜ ⎟ (1)
⎜ F2 + F3 ⎟
Fig. 6  A kinematic model of a 4-bar polycentric knee joint [32]
⎝ ⎠

( ( ) ( ))
Modelling and mathematical model of polycentric knee x1 sin 𝜃2 + x2 sin 𝜃3
joint 𝜃4 = arcsin (2)
x4

From the measurements obtained from CT scan or MRI ( ) ( ) ( )


images and available literatures of the knee, approximate tan 𝜃4 + x7 cos x7 − sin x7
size of the prosthetic knee joint can be constructed using xICR = x5 + ( ) ( ) ⋅ x1 (3)
tan 𝜃4 + x7 − tan 𝜃2 + x7
computer based software for different sagittal radius and
flexion angles [44]. Measurement of the relevant parameters ( )[ ( ) ( ) ( )]
of the knee including mean, variance etc. are important to tan 𝜃2 + x7 tan 𝜃4 + x7 cos x7 − sin x7
yICR = x6 + ( ) ( ) ⋅ x1
design the knee prosthesis. tan 𝜃4 + x7 − tan 𝜃2 + x7
Generally, the trans-femoral prosthesis with polycentric (4)
4-bar linkage knee is subjected to high degrees of wear and ( ) ( )
xP = x5 + x2 cos 𝜃2 + x7 + x9 cos 𝜃3 + x10 + x7 (5)
tear during static and dynamic loading. Therefore, math-
ematical models of the mechanical knees are commonly ( ) ( )
used for kinetic analysis, simulation and determining pos- yP = x6 + x2 sin 𝜃2 + x7 + x9 sin 𝜃3 + x10 + x7 (6)
sible failures [27, 45]. A method for determining a kinematic
where,

( ) ( ) x1 x12 + x22 + x32 − x42 x1 ( )


F1 = sin 𝜃3 , F2 = cos 𝜃3 − , F3 = − + cos 𝜃3
x3 2x2 x3 x2

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Physical and Engineering Sciences in Medicine

Materials used in polycentric knee It is seen from literature that some common materials
used in prosthetic knees in both developing and developed
The use of proper materials in any prosthetic knee should be countries are Nylon 6, Nylon 6–6, oil-filled Nylon, isotactic
to eliminate failure with minimum fatigue wear and decay. polypropylene, acrylonitrile butadiene styrene (ABS), polya-
An average survival rate of 70% after 16 months of use of cetyl resin (Delrin), stainless steel, aluminum (60- series),
knee prosthesis and an average lifespan 3 to 4 years are titanium, polyethylene (high density), and polyvinyl chlorine
observed from the literature [20, 26]. (PVC). Their material properties are presented in Table 2.

Materials used in developed country Finite element analysis (FEA) and optimization


techniques
Due to good economic conditions, materials used for the
manufacturing of prosthetic knees in the developed countries To simulate and optimize a functionally effective prosthetic
exhibit sufficient strength (good mechanical, thermal and knee, a mathematical model based technique known as finite
viscoelastic properties) without considering cost. Mechani- element method (FEM) is considerably used as a valid tool
cal properties of metals or metal alloys (titanium, stainless for any physical system modelling in physics and engineer-
steel and aluminium alloys) used in these units should have ing disciplines [46]. It plays a vital role in prosthetic design
high yield strength, hardness, toughness, good fatigue life, and development.
corrosion resistant features [29]. Even some models are Finite element modelling and analysis of stump-socket
manufactured in the developed markets with cost range interface is performed to determine pressures and shear
of hundreds of US dollars with polymers, fiber reinforced stresses [47–50] and is well-suited in the design of various
plastics and its fabrication technologies for better material prosthetic components. FEA enables to estimate collapse of
property and durability. components through simulation results with the prediction
of knee kinematics. Zach et al. [51] analysed the stability,
Materials used in developing country stress and contact pressure distribution of the prosthetic knee
implants using FEA. The variations between bipolar and
Due to economic constraints and environmental factors unipolar knee prosthesis are observed by Lian et al. [52] in
(access to medical care), material selection for develop- static and dynamic posture. However, application of FEA in
ment of prosthetic knees are from locally available materials the design and analysis of a prosthetic knee used for trans-
using standard production techniques at relatively cheaper femoral amputees is still lacking [53]. Thus FEA is used to
costs and moderate wear life [29]. Thermoplastics with low simulate a polycentric knee under various loading conditions
price, easy machinability, low friction, abrasion and wear and the results of experimental validation are furnished to
properties are generally used for design of prosthetic knees. confirm the accuracy of the model. The design summary of
They have good recycling and reuse features. Metals of high prosthetic knee model is presented in Table 3.
strength and relative low machining characteristics are pri- Optimization and kinematic simulation techniques
marily used for load bearing central pylon components. are being used successfully for obtaining optimal ICOR

Table 2  Common materials used in prosthetic knee and their mechanical properties


Material Corrosion resist- Yield strength Impact strength Fatigue life Abrasion resistance Coefficient of Density
ance (MPa)@ 20 °C friction (g/cc)

Nylon 6 High 78 9 J/cm2 High High 0.2–0.3 1.13


Nylon 6/6 High 82.7 10.9 kJ/cm2 High High 0.43 1.14
Polypropylene, High 40 15.8 J/cc High High 0.1–0.3 0.9–0.93
isotactic
ABS Medium 42.44 120 kJ/m2 Medium High 0.5 1.04
Delrin High 70 60–350 kJ/m2 High Low 0.2–0.35 1.42
Stainless Steel High 205 47.45 J High High 0.57–0.74 8
Aluminium High 200–600 2–3E4 to Low Low 1.05–1.35 2.70
30–40E4 N/m
(Low)
Titanium High 880 17 J High High 0.3–0.36 4.506
HDPE High 26.2–200 80–400 kJ/m2 Medium Medium 0.2–0.28 0.936–1.46
PVC High 44.8 172 kJ/m2 Medium High 0.23–0.5 1.42

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Table 3  Summary of FEA and Technical work performed on prosthetic knee joint
Study Title Aim Technical work Conclusion

Kadhim et al. (2020) [54] Evaluation and analysis of different Evaluation and analysis of structural FEA used to obtain a safety factor Polycentric 6 bar, knee with hydraulic
types of prosthetic knee joint used by strength of prosthetic knee unit yielded minimum Von-Mises
above knee amputee stress of 14.24 MPa and a maximum
factor of safety of 3.11
Sudeesh et al. (2019) [44] On the possibility of achieving near- To compare polycentric and single axis Simulation based dynamic analysis Polycentric knee is superior to single
normal swing phase of walking with knee for improving design criteria axis. The analysis showed potential for
passive single-axis and polycentric and enable further development to well-designed cost effective knee
knees: a simulation approach provide better functionality
Liu et al. (2019) [45] Kineto-static analysis for four-bar To investigate the prosthetic knee joint, Mathematical modelling and simula- This method provides a basis for the
linkage mechanism of prosthetic by means of the bar group method, tion by motion analysis software designing prosthetic knee mechanism
knee joint and the motion of the prosthetic knee with longer life and better damping
Physical and Engineering Sciences in Medicine

joint effect
Price et al. (2019) [55] Design optimization in lower limb To develop a knowledge base and Systematic review Experimental parameterization of
prostheses: a review identify the promising research path- designs and model-based simulations
ways toward designing lower limb are necessary for optimal biomechani-
prostheses for optimal biomechanical cal design
and clinical outcomes
Cruz et. al. (2018) [56] Synthesis of a non-Grashof 6-bar To synthesize a polycentric 6-bar Differential evolution algorithm based Knee mechanism was compact fol-
Polycentric knee prostheses using an mechanism numerical optimization and simula- lowing desired trajectory and avoid
evolutionary optimization algorithm tion hyperextension
Russell et al. (2018) [57] A kinematic model for the design of a To propose a design methodology Kinematic computer model developed Path of COR matched for physical and
bi-condylar mechanical knee for a bi-condylar joint that mimic in MATLAB. Physical model was computer model with a mean euclid-
anatomic knee tested in squatting with active mark- ean difference of 2.85 mm
ers and reflective cameras
Kadhim et al. (2018) [58] Design and manufacturing knee joint To enhance the passive prosthesis to a Solid Works for designing and FEA to Aluminium 6061 is most suitable to
for smart trans-femoral prosthesis microcontroller-based trans-femoral discover whether proposed prosthesis manufacture the prosthetic knees with
prosthesis can bear certain loads features like stability, comfortable,
low cost, light weight, and acceptable
safety factors
Manger et al. (2018) [59] Optimal material selection for the To select an optimize material for FEA simulating the ISO 10,328:2006 Aluminium 7175 is the optimal material
construction of a pediatric prosthetic pediatric prosthetic knee standard for structural testing and for pediatric prosthetic knee
knee Multi-criteria decision analysis
method
Phanphet et. al. (2017) [60] Above-knee prosthesis design based To improve the design of knee joint Structural tests by FEA, Morrow’s The optimized design confirmed the
on fatigue life using FEM and design from the existing model approach for fatigue analysis that finite element prediction
of experiments predicts life span of knee component,
and materials used
Sugiyanto et al. (2017) [61] Stress Analysis of Four-Bar Link- To investigate the stress distribution FEM based on commercial software Based on stress analysis, the developed
age Transfemoral Prosthetic in Gait of a prototype of four-bar linkage Solidworks® is used to analyze Above Knee Prosthesis is safe because
Cycle mechanical joints the knee joint reaction due to the the maximum stress is lower than the
dynamic loading when transfemoral yield stress
prosthetic driven for one gait cycle of
motion is applied

13

Table 3  (continued)
Study Title Aim Technical work Conclusion

13
Huiqun et al. (2016) [62] A novel prosthetic knee joint with a To design a high performance and low- The influence of the four-bar link- Consistency of the designed PKJ and
parallel spring and damping mecha- cost passive PKJ and to evaluate the age parameters on the stability was biological knee found. Experimental
nism performance of the PKJ analysed, FEMs of the PKJ’s block results show that no design and quality
performed, and the parameters were problems were found in the fatigue
optimized, and kinematic simulation test. Gait curve is close to that of the
of the ICR curve was conducted healthy leg
Diaz et al. (2016) [63] External knee prosthesis with four bar To design and construct a prosthetic FEA used to obtain a safety factor The device is intended to be incorpo-
linkage mechanism knee external four-bar mechanism rated into a modular prosthesis and
work in an optimal control mechanism
to regulate the acceleration walk
Mihradi et al. (2015) [64] Design of above knee prosthesis: A To determine whether or not the four FEM was used for static loading simu- The results show that the last iteration
finite element stress analysis bar knee design has fulfilled strength lation. Single leg stance condition of 3D model of knee prosthesis has
criteria where the prosthesis hold the weight satisfied the criteria
of whole body was considered for
simulation
Lapapong et al. (2014) [53] Finite element modeling and validation To present a procedure to simulate the FEM to simulate the prosthesis under The validation results confirm the
of a four-bar linkage prosthetic knee static and cyclic strength tests for the tests, stress distribution induced fidelity of the proposed finite element
under static and cyclic strength tests Polycentric knee and fatigue life. Explicit nonlinear model
transient stress analysis is applied to
determine the strength of prosthesis
Afzal et al. (2014) [65] A cost effective design and analysis of To design a cost effective, light weight System model created using Solid Cost controlled by the use of non-expen-
an active prosthetic knee for trans- and durable lower extremity pros- Works®. Structural analysis by sive materials and actuators. Design
femoral amputees thetic device ANSYS®, functional verification by kept as simple as possible to increase
Simulink® Software reliability
Amador et al. (2013) [66] Comparison of the contact condi- To show the results of the stress FEM and three different contact Results show an important difference
tions in the structural analysis of a analyses performed during the struc- conditions between the assembly in the stresses yielded by each of the
polycentric knee prosthesis tural design of a polycentric knee parts. The analyses were performed simulated conditions
prosthesis under the most critical load condition
defined by the standard ISO 10,328
for the principal structural test
Amador et al. (2013) [67] Structural analysis during the design To find the proper dimensions of a Stress analysis by FEM under three For the most critical load condition, 5
of polycentric prosthetic knee polycentric knee under a structural different load conditions of the 9 prosthesis components yield a
perspective safety factor less than 1, which impli-
cated a redesign
Furse et al. (2008) [68] Design and analysis of a prosthetic To develop an accurate FEA model of FEA along with mechanical and clini- Incorporating geometric changes and
knee joint a currently designed prosthetic knee cal testing performed strength mechanisms resulted in stress
joint reduction in critical areas of 2–6 times
the original design
Valentino et al. (2008) [69] Development of external knee prosthe- To propose a knee design of polycen- The mechanism was subjected to an The parts support the load produced by
sis with polycentric mechanism tric type, which is modular and cost analysis of efforts in ANSYS®, plac- a patient of 160 kg without suffering
effective ing the analysis on the links where deformation and significant wear
80% of the loads are located
Physical and Engineering Sciences in Medicine
Physical and Engineering Sciences in Medicine

trajectory [56, 57, 62]. Cruz et al. [56] have used numerical Review of clinical application of prosthetic knee
optimization and simulation methods to synthesize a com-
pact 6-bar polycentric mechanism with desired trajectory. The review of clinical application of prosthetic knee ranged
Russell et al. [57] used kinematic computer model with from pure mechanical system to intelligent microprocessor
inputs from cadaver studies, compared it with a prototype control mechanism and presented in Table 4. Level of evi-
physical model and found matching path for ICOR. FEA dence was marked as “A” for studies with adequate sample
has been used for optimal material selection for prosthetic size and conducted by RCTs and those with inconvenient
knees [58, 59]. Considering ISO 10328 standard for struc- samples using case studies were marked as “B”. Compared
tural testing and multi-criteria decision analysis methods, to mechanical passive prosthetic knee, the Microprocessor
Aluminium 6061 and Aluminium 7175 has been found suit- Controlled Knee (MPK) improved reduction in falls [70],
able for fabrication of prosthetic knees. Phanphet et al. [60] perceived performance and everyday life activity level [71]
have found optimal dimensions for best design for improve- and kinetic symmetry for unilateral trans-femoral ampu-
ment of existing knee prosthesis. The test result confirmed tees walking at self-selected speeds on level ground [72].
the finite element prediction under ultimate loading as per Stance phase knee moment between the prosthetic and non-
requirements of the ISO 10328 structural test. In another prosthetic limb showed greater difference. Use of NMPK
study Diaz et al. [63] established knee mechanism to sus- reflected a symmetry index of 0.459 as compared to 0.640
tain body weight up to 100 kg of subjects using FEA incor- when using the MPK. The A-level study based on question-
porating aluminum 6063, stainless steel 304 and bronze. naires by Boonstra et al. concluded that a Tehlin knee with
They confirmed that a cost-effective and functional knee pneumatic swing control resulted in a more comfortable with
prosthesis with reliable safety factor can be obtained. The increased velocity compared to mechanical swing phase con-
work of Lapapong et al. [53] outlined the virtual static and trol [73]. This was due to reduced swing time of prosthetic
cyclic strength tests of a 4-bar linkage prosthetic knee for leg caused by delayed knee flexion. Fast walking speed was
confirming ISO 10328:2006 standard. Results of simulation higher with the Tehlin knee (0.02 m/s) than with the 3R20
and validation revealed that FEM is valid and reliable tool (0.09 m/s) while comfortable walking speed was not higher
to compute structural stress with accuracy. Afzal et al. [65] with the Tehlin knee. Walking symmetry in terms of swing
used Solid Works® for creation of model, FEA for structural phase duration was closer to 100% with the Tehlin knee than
analysis and Simulink® software for functional verification with the 3R20. However, metabolic cost was higher with the
and concluded that using these methods a simple, reliable, Tehlin knee [74].
anthropometric and cost effective component can be gener- The B-level studies revealed similar findings. The study
ated. The same methodology has been performed success- by Dumas et al. [77] found no difference in single axis and
fully by Sugiyanto et al. [61] and Kadhim et al. [58]. Amador polycentric swing control knee joints computed by inverse
et al. [66] performed stress analysis of structural design of a dynamics. Knee joint forces and moments presented sub-
polycentric knee prosthesis by FEM in three different con- stantial errors, especially during the swing phase of gait. The
tact conditions between the assembly parts for standard ISO median errors in percentage of the moment magnitude were
10328. In another study, the same authors using FEA sug- 4% and 26% in extension/flexion, 6% and 19% in adduc-
gested for a redesign of polycentric knee that included the tion/abduction as well as 14% and 27% in internal/external
increase in diameter of the axes as well as modifications in rotation during stance and swing phase, respectively. The
four of the links for obtaining stable kinematic function [67]. authors proposed that one should be cautious in using dur-
The purpose of Furse et al. [68] was to develop an accurate ing inverse dynamics gait analysis. With advancements in
FEA model to redesign currently used knee component to 3D printing technology, Ramakrishnan et al. [78] designed
enable the part to be injection molded of Delrin by reducing and studied prosthetic knee out of a carbon-fiber and nylon
the main body thickness. The incorporation of various geo- composite with gear-mesh coupling. The average peak knee
metric changes and strength mechanisms resulted in stress angle asymmetry of the 3D printed anatomically scalable
reduction in critical areas to 2–6 times the original design. prosthesis knee (ASPK) is larger than the Ossur Total Knee.
Valentino et al. [69] explained the three step process carried They observed more strenuous activity with 3D printed
out to build a 4-bar polycentric knee using a mechanical ASPK and suggested that this can be overcome by tuning
actuator. They used AutoCAD for designing with materials the cross-linked spring mechanism to match the dynamics of
such as stainless steel 304 and aluminum 6061 and did effort the subject better. Many researchers have directly compared
analysis by using ANSYS. This resulted in a true polycentric mechanical polycentric with single axis knees and found
knee with capability of modifying center of rotation with improved gait parameters, balance, foot clearance and sym-
good clinical results. metry in favor of polycentric knees [79, 81, 83, 88]. Lon-
caric et al. [79] found statistically significant differences in
favour of the polycentric knee module regarding the mobility

13
Physical and Engineering Sciences in Medicine

scoring, TUG test time, 10-m walking speed and BBS score. ankle enabled by the hydra-cadence knee seems to increase
Sensinger et al. [81] differentiated the effects of toe clear- stability. No significant difference was found between hydra-
ance between four-bar mechanisms and single axis knee. cadence and other mechanical prosthetic knee in terms of
They observed an empirical average of 2.2 cm more mini- walking speed (1.0 + 0.2 m/s and 1.1 + 0.2 m/s, respectively;
mum toe clearance in four-bar mechanism than single-axis p = 0.54).
knee (P < 0.01). In the simulation study, single-axis knees In contrast, B-level study by Isakov et al. [91] showed
provided the least clearance (4.6 cm) during prosthetic swing that hydraulic knee with a locked mechanism may help dys-
phase, followed by four-bar knees (5.8 cm), and the two vascular subjects to achieve increased velocity compared to
ankle mechanisms (6.4 and 8.7 cm). In another study, Taheri an unlocked unit. Mixed results were also obtained for com-
and Karimi [83] noticed that the walking velocity with parative studies on fluid and mechanical friction knee units.
3R15 knee joint (30.04 ± 0.38 m/min) was less than that of Murray et al. [92] found that hydraulic knee enable the user
3R20 (66.081 ± 3 m/min) and showed statistical differences to walk with better velocity and improved balance of swing
(P = 0.045). The stride length with 3R15 was 28.8 ± 14.4 m and stance time. In another study, Jergesen et al. [90] used
compared to 46.35 ± 18.3 m for 3R20 (P = 0.045). The per- newly designed polycentric knee of California Biomechan-
centage of stance phase was 65.4 ± 5 for 3R15 and 35.9 ± 7 ics Laboratory (UCBL) and observed increased knee flex-
for 3R20. Farahmand et al. [88] found no significant dif- ion afforded by the mechanism and no significant change in
ference in spatio-temporal parameters between the intact various fundamental gait parameters. The findings of above
and prosthetic limbs of amputees. There were significant contrast studies should be analyzed carefully because their
differences in stride length, step length, stepping speed and study sample were older and vascular compared to the stud-
step duration of the normal subjects and amputees. The hip ies of Boonstra et al. [74, 73] and Heller et al. [93] with
joint of the prosthetic limb of the amputees experienced active adult groups.
lower than normal joint moments (with a maximum value
of 0.97 compared to 1.67 Nm/Kg). Some studies [80, 82,
85] compared polycentric knee with MPK and found mixed Discussion
results. Uchytil et al. [80] observed better gait symmetry in
bionic knee compared to mechanically passive knee joint. Polycentric four or six bar mechanisms have been utilized
The stance and the swing times for amputees with a bionic successfully to enhance function in rehabilitation of ampu-
knee were similar to those of non-amputees. The swing tees in developed and developing countries. FEA is carried
time of the prosthetic limb in patients fitted with a mechani- out to optimize and validate each step of a prosthetic com-
cally passive knee was longer by 0.042 s (effect size = 2.1) ponent design including its quality, performance and safety.
and the stance time of the non-affected limb was longer by Displacement, strain, and stress of the components under
0.047 s (effect size = 1.07). Barr et al. [82] compared three internal and external loads are calculated using the displace-
knee/foot combinations and observed that maximum brak- ment formula of the FEM [94]. FEA and Taguchi method
ing force when using the C-leg was 0.31 body weight units was shown to be an effective method in optimizing the struc-
vs. 0.19 and 0.20 for the other two prostheses. On the intact tural design of prostheses. Further prosthetic design can be
limb the mean step length progressively increased (55.1; facilitated based on the degree of importance of the design
66.6; 73.2 cm) across the three combinations. The improved factors on the structural behavior of the prosthesis. Design-
step length was corroborated by progressively greater mean ing and synthesis of a knee mechanism for a desired motion
walking velocity (97.3; 99.7; 112.5 m/sec) and a progressive is being done using optimization. The changing parameters
decrease in the intact limb initial double support time (14.2; must be observed and regional constraints are applied such
12.3; 10.5% cycle). Yokogushi et al. [88] had designed an that the final mechanism conforms to them.
intelligent based knee with hydraulic and polycentric mecha- Gait analysis of amputees is commonly used clinical
nism and found no significant variation in individuals in tool to quantify the performance of polycentric knee joints.
the different cadences and same was noticed in the able From the review of clinical applications of prosthetic knees,
bodied subjects. Some hybrid prosthetic knee incorporating it can be concluded that a prosthesis with fluid controlled
polycentric with pneumatic or hydraulic control has been mechanism is better than simple mechanical based friction
successfully studied [84, 86, 89]. Lythgo et al. [84] found devices like polycentric knee in terms of better swing con-
no significant differences in gait parameters and symmetry. trol, cadence responsiveness and gait symmetry for active
However, large asymmetries remained across the prostheses adult population [92, 93]. In contrast, geriatric and/or vas-
for the temporal measures of step time (20%), single support cular patients can be benefited much using knee units incor-
(30%), and stance time (19%). Gait speed was 5 cm/s less porating stance stability such as manual lock and weight
with 3R92 than with 3R90 knee joint (P = 0.017). The results activated friction brake knees and are poor candidates to be
of Sapin et al. [86] revealed that the plantar flexion of the fitted with polycentric designs [91]. Due to less supportive

13
Table 4  Clinical applications and findings on prosthetic knee
Study Intervention Subjects (N) Outcome Level of
evidence

Kaufman et al. (2018) [70] Non MPK (74% were polycentric) vs. MPK 50 TF Reduction in falls, increased activity and satisfaction in the A
MPK for low mobility subjects
Theeven et al. (2012) [71] Mechanical vs. MPK 30 TF or KD Participants’ perceptions were significantly higher in the A
MPK compared to mechanical
Kaufman et al. (2012) [72] Passive mechanical knee joint vs. MPK 15 TF and 20 AB MPK resulted in improved gait symmetry and joint kinetics A
Boonstra et al. (1996) [74] Mechanical (Ottobock) vs. pneumatic (Tehlin) swing phase 28 TF In Tehlin Knee, normal and fast walking is easier, duration of A
control swing and stride time improved
Boonstra et al. (1995) [73] Mechanical swing phase control (Otto Bock) and pneumatic 28 TF Six preferred Otto Bock knee and nineteen preferred Tehlin. A
swing phase control (Tehlin knee) Flexing Tehlin knee was easy giving unsafe feeling but
Physical and Engineering Sciences in Medicine

walking was more easy and faster


Arun et al. (2019) [75] Polymeric based passive polycentric Knee 3 TF Health related quality of life and global score of prosthetic B
function improved
Arelekattiet al. (2018) [76] Passive mechanical knee with automatic lock-unlock mecha- 4 TF Enabled early stance lock and smooth stance to swing transi- B
nism tion
Dumas et al. (2017) [77] Total Knee 2000 (polycentric knee with a 3-phase swing 10 TF No significant differences in joint moments and joint forces B
control) Vs. Mauch Knee (Single axis swing control) Vs. during stance and swing
C-Leg MPK
Ramakrishnan et al. (2017) [78] Total Knee 2000 Vs. 3D Printed ASPK with weight-actuated 1 TF The ASPK had higher peak knee flexion resulting in exhaust B
lock and cross-linked four-bar spring mechanism walking for compensatory mechanism
Loncaric et al. (2016) [79] Single axis Vs. Polycentric Knee 15 TF Polycentric knee module for people with trans-femoral ampu- B
tation allows better control of balance and speed as well as
greater mobility
Uchytil et al. (2013) [80] Bionic Vs. mechanically passive knee joints 8 TF Bionic knee provided gait symmetry with stance and swing B
time similar to those of able bodied
Sensinger et al. (2013) [81] Single axis vs. Four bar knees 10 TF Four-bar knees provide greater swing clearance than single- B
axis knees
Barr et al. (2012) [82] Knee/foot pairs: Four Bar knee & Dynamic Response foot 1 TF Braking action, stability and gait speed improved in C-Leg. B
(Endolite); Total Knee 2000 & Pathfinder I foot (Ossur); and Progressive change observed across all combinations includ-
C-Leg & IC40 C-walk foot (Ottobock) ing increased step length and gait speed, and decreased
double limb support time
Taheri and Karimi (2012) [83] Mechanical Knee (Polycentric Four bar Vs. Single axis). i.e. 7 TF The symmetry and speed of walking with 3R20 was more than B
3R 20 Vs. 3R 15 that with 3R15
Lythgo et al. (2010) [84] Mechanical Passive Knee (3R 90 Vs 3R 92) 5 TF Gait and symmetry measures were unchanged B
Gerzeli et al. (2009) [85] MPK (C-Leg) vs. mechanical polycentric 100 TF C-leg improved health and quality of life B
Sapin et al. (2008) [86] Hydracadence Knee vs. other prosthetic knees 11 TF Hydracadence knee offered increased stability. No difference B
in swing hip and knee kinematics observed for both varieties
Farahmand et al. (2006) [87] Mechanical Knee (3R 15—single axis, 3R 20—polycentric, 5 TF and 5 AB The stride length, step length and stepping speed were signifi- B
3R 21—polycentric) cantly higher and the step duration was significantly lower
for normal subjects in comparison with the prosthetic and
sound limbs of the amputees (P < 0:05)

13
Physical and Engineering Sciences in Medicine

clinical evidences, it is difficult to interpret to what extent


evidence
Level of MPK prosthetic knees be prescribed in terms of its practical
usefulness. Hence, subject specific considerations on activity

B
B

B
B

B
level and functional requirements should ultimately deter-

found to be an advantage. There was no significant change in


Six bar linkage knee ankle mechanism provided normal squat-
ting pattern, knee moments and knee angle variations during

stride length and walking speed was observed with Hydrau-


The increase in knee flexion afforded by the mechanism was
mine the choice and prescription of the prosthetic knee from

During self-selected and fast walking, increase in cadence,


available options [95].

With locked knee an increase in velocity and heart rate


Some active polycentric knees were developed to control
gait motions using machine learning and control algorithms.
Xu et al. [96] proposed novel four-bar linkage polycentric
Provided stable walking at different cadences

various fundamental gait parameters prosthetic knee based on magneto-rheological (MR) effect.
The driving equation of the MR damper is established and

TF persons with transfemoral amputations, AB able-bodied controls, KD persons with knee disarticulation amputation, MPK microprocessor controlled knee
control algorithm was developed. The results showed that
with the controlled currents by the control algorithm devel-
oped, the knee prosthesis was able to track the motions well
and imitated the natural motions of anatomic knee. Attia
et al. [97] introduced a dynamic model of a four bar mecha-
nism connected by a MR damper to control the motions of
swing phase

daily activities of amputees. A clipped-optimal control algo-


observed

lic Knee
Outcome

rithm was used based on acceleration feedback, along with


MR damper to approximately generate the desired control
force. The model results represent the voltage required for
the MR damper during most daily activities and the results
3 TF and 10 AB

showed that the required voltage depends on displacement,


Subjects (N)

velocity and calculated force. Torres et al. [98] presented


20 TF

17 TF

the design and analysis of active polycentric transfemoral


7 TF
1 TF

knee prosthesis to mimic the human gait. An echo-control


strategy has been proposed for the activation of the knee
Four-bar polycentric prosthetic knee linkage developed by the
University of California Biomechanics Laboratory (UCBL)
Intelligent based knee with hydraulic and polycentric mecha-

prosthesis. The experimental results demonstrated that the


proposed prosthesis was able to bio-mimic the biomechanics
Patil and Chakraborty (1991) [89] Polycentric Knee with Pneumatic swing phase control

of a natural knee during gait and to provide extra power to


the transfemoral amputee during walking. The results have
Hydraulic vs. mechanical constant friction knee

also shown that the minimization of “autonomous intelli-


gence” in an actuated prosthesis, in combination with the
Open-knee vs. locked-knee mechanism

close observation of the user, allowed the incorporation of


the human’s superior control in a cooperative and intuitive
way.

Implications of review

India alone accounts more than 230,000 trans-femoral


Intervention

amputees out of an estimated number of 6.7 million found


in Asia [76]. Prosthetic knees used in developing countries
nism

are mostly passive in nature to meet the huge demand and for
enabling the subjects with trans-femoral amputation achieve
normal kinematics during gait and other ADLs. Polycentric
prosthetic knees with four and six bar mechanisms can be
Yokogushi et al. (2004) [88]

Jergesen et al. (1986) [90]

utilized successfully to enhance stance stability and swing


Murray et al. (1983) [92]
Isakov et al. (1985) [91]

kinematics in developed countries. However, increased


Table 4  (continued)

complexity, cost, associated repair, maintenance and low


strength make these units less appropriate for use in develop-
ing countries for people of all ages [99, 100, 11]. The appli-
cation of polycentric prosthetic knee mechanisms made of
Study

steel or duraluminium is preferred whereas use of titanium

13
Physical and Engineering Sciences in Medicine

or carbon, can make it lighter, but are more expensive [43]. Funding:  This research did not receive any specific grant from funding
Well-designed polycentric knees focusing on patients’ clini- agencies in the public, commercial, or not-for-profit sectors.
cal requirement in daily context could be more effective than
those studied in review. Compliance with ethical standards 

Conflict of interest:  The authors declare that there is no conflict of in-


Summary of evidences terest regarding the publication of this article.

FEA in integration with Taguchi method is carried out to Ethical approval:  Not required.
optimize and validate each step of a prosthetic component
design including its quality, performance and safety in order
to obtain a knee mechanism for a desired motion [94]. Addi-
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