Optimization Studies of Trans-tibial Prostheses:
Numerical Models and Experimental Tests
C. Colombo1, E.G. Marchesin1, L. Vergani1 , E. Boccafogli2 , G. Verni2
1) Dipartimento di Meccanica, Politecnico di Milano
2) Inail – Centro Protesi Budrio
Abstract— This paper describes the work done at the
Department of Mechanics in collaboration with INAIL, on a
particular type of transtibial prosthesis. The discussed topics
are different: firstly, an adaptable test bench was designed, in
accordance with the standard, to run static strength and
fatigue tests on the transtibial prostheses. By means this
equipment, it is possible to perform tests on the prosthesis and
on its individual components. After the description of some
static tests, the prosthesis is also analysed by numerical FE
simulations, performing structural analyses and simulating
the experimental tests carried out using the bench. The
numerical results of strains and displacements are compared
with the corresponding experimental values measured on the
prosthesis. The comparison allows validating the numerical
models, which become a reliable and secure tool to perform
optimizations varying the geometry and materials of the
prosthesis.
I. INTRODUCTION
Limb loss is a traumatic event, both from physical as
well as psychological point of view. During the post-
operation and the rehabilitation phases, the medical team
helps the patient to recover joint motion in order to restore
the natural range of motion [1]. During this period, the
patient is helped with a rehabilitative therapy of the residual
limb muscles, to allow a full and proper prosthesis use. In
this stage of the rehabilitation, the prosthesis moves from a
provisional model to a final one. By this time the patient’s
primary requirement becomes to lead a normal life by
providing a mechanism that can replace the lost limb as
close as possible to the original, both functionally and
aesthetically. This goal is achieved by requiring higher
performance to the prosthesis individual components and
adapting the prosthesis to the person. In particular, the
prosthesis must meet patients’ individual needs in terms of
different requirements such as stability, durability and
comfort. For this reason, when selecting components, the
main parameters that must be taken into account are
amputee weight, amputation type, stump conditions, habits
and habitats [2].
Besides all these considerations, it is evident that the
safety and the reliability of the prosthesis should be a
primary goal. The aim of the experimental tests on such
devices is, therefore, to achieve a tool to test the prosthesis
safety, following the standards.
Furthermore, developing a numerical model of a
prosthesis means that the device optimization can be started
1
already in the earliest design phase, taking into account
from the beginning the individual factors above mentioned.
In this way designers take possession of a powerful tool
with a dual purpose: to maximize reliability and comfort.
In particular, object of the present study is a multi-
purpose ankle-foot device designed by INAIL: two
configurations are possible, for walking and swimming.
This is possible by a relative inclination between the tibia
axis and the foot, as shown in Fig. 1.
The ankle is required to be water and seawater
compatible, so the manufacturer’s decision was to produce
it in titanium. In this study, in parallel with the
experimental tests for the compliance to the standard, the
attention is also focussed to the numerical model created
starting from the design drawings. After its validation by a
comparison between the FE simulation and the results of
experimental tests on the device, other possible solutions in
terms of materials and geometry are taken into
consideration.
Fig. 1. INAIL prosthesis: walking (A) and swimming configurations (B).
II. EXPERIMENTAL TEST EQUIPMENT
ACCORDING TO ISO 10328
Object of this study is a modular prosthesis for transtibial
amputees. In general, these kinds of prostheses are made of:
− a liner: it is the direct interface with the stump. Its role
is to create a soft gap, to avoid excessive forces transfer
to the limb stump;
− a socket: the rigid and custom-made element that covers
the liner. Its function is to create a structural support for
the whole prosthesis;
− the attachments: they connect the various parts, acting
as a coupling interface between the upper and lower
prosthesis;
− a pylon: equivalent to the tibia in a healthy subject, it is
a tube of variable length linking the socket to the
 prosthetic foot; u
− an ankle: the component simulating the ankle joint to
give a natural connotation to the walk;
− a prosthetic foot: it guarantees the subject support and
reflecting the behavior of a healthy foot in every stage
of the walk. It is generally provided with an aesthetic
coverage.
For the compliance of this type of prostheses the
reference standard is ISO 10328 [3], which sets out the
procedures for carrying out experimental tests on all types
of lower limb prostheses (transtibial and transfemoral). The
standard identifies two load configurations at the maximum
stress levels undergone by the limb during normal walk
(shown in Fig. 2):
− condition I: related to the instant of maximum loading
occurring early in the stance phase of walking (heel
contact);
o
− condition II: related to the instant of maximum loading
occurring late in the stance phase of walking (toe-off). f
For each load configuration there are three different load
Fig. 3. Reference coordinate system f-o-u, from ISO 10328.
levels depending on physical parameters, locomotion
characteristics and other factors related to the patient. In
In the specific case of the prosthesis object of this study,
Table 1, the categories are given in detail.
principal static proof tests are required. Due to the
For the experimental tests according to these specifics, a
particular nature of this device, only static tests were
test bench was designed and manufactured. It consists of
planned, since it is not designed for common walking. The
two hydraulic actuators and a base for prosthesis
load level chosen for the tests is related to the P5 category,
constraining. The test bench is versatile to allow tests of all
that is the most critical one. For the same reason, the foot
prostheses types in all configurations required by the
size used for the test is the biggest available, generating the
standard. Depending on the required test, in fact, the load
highest bending at the ankle.
line has to be three-dimensional or two-dimensional
At first, the origin of the coordinate system is placed at
according to the coordinate system f-o-u, which is integral
the intersection between the longitudinal axis of the foot
with the prosthesis. A scheme of the prosthesis coordinate
and the effective ankle-joint centerline. In this way the
system is shown in Fig. 3.
reference planes of the ankle (uA) and knee (uK) are also
identified, since their offsets are specified in the standard.
The standard also includes the reference points on the
planes where the load line has to pass at. Once the load line
is fixed in a three-dimensional configuration, it is possible
a) st
| 1 phase | 2
nd
phase |
rd
3 phase | to find its inclination angles compared to the three principal
axis, as shown in Tab. 2.

Table 2. Summary of the characteristic measurements for the correct

placing of the prosthesis for the experimental tests.

Loading
b) Condition I Condition II Plane
condition
Load line equation Angle [°]
o-u I u = - 5.243⋅o + 236.7 11
Fig. 2. Schematization of the stance and of the normal walk (a) and f-u I 11
u = 5⋅f + 240
relative interpretation of the ISO 10328 standard with the two loading
conditions (b). f-o I o = - 0.953⋅f - 0.626 46
o-u II u = - 31.34⋅o - 601.3 2
Table 1. Categories of patients according to ISO 10328 standard. f-u II u = - 8.77⋅f + 1132 7
f-o II o = 0.279⋅f - 55.30 16
Category Patient’s weight
P3 Max 60 kg On the test bench these calculations are reflected by
P4 Max 80 kg tilting the prosthesis axis with respect to the hydraulic
P5 Max 90 kg actuator piston one. In this case only one actuator is used

2
because the two load configurations can be implemented
separately. Fig. 3 shows the experimental configuration and
used equipment for the principal static proof test. During
the experimental tests, in load control, piston displacements
and ankle strains are recorded, in the different test
configurations, for the prosthesis in walking arrangement.
The arrangement for swimming, indeed, is not taken into
consideration in the experimental tests, since the prosthesis
results less loaded in this condition [4].
Loading condition I Loading condition II
Fig. 3. Experimental principal static proof test: three-dimensional
configuration.
III. NUMERICAL SIMULATIONS
The problems related to this particular prosthesis are
different and depend on its specific use. During the
amputee walking, it is important to take into consideration
the mechanical loading conditions, while when he/she is
swimming the environmental factors become important.
Mechanical and chemical conditions are therefore to be
taken into account in the design and compliance of the
ankle prosthesis.
Since the foot prosthesis is made of different
components, numerical simulations dealing with its
structural analysis have to take into account the stiffness of
each part. Three types of FE analyses are run [4]:
− on the foot unit, as a standing alone component;
− on the foot and ankle device, joined together;
− on single components of the ankle device (sub-models).
In particular, in this work the attention is focussed on the
3
ankle prosthesis mechanical behaviour. Therefore, the
prosthetic foot is considered in the numerical simulations as
a “black box”, whose characteristics, in terms of stiffness,
are obtained from experimental tests carried out in similar
conditions as the ones shown in Fig. 3 for the single foot
unit. Experimental measured stiffness varies in function of
the considered loading conditions (I or II) as well as of the
applied load. The inner part of the prosthetic foot is indeed
made of different materials: wood, for the structural part
near to the ankle joint, composite and rubber, for the
intermediate and external parts. The mechanical answer to
different load levels is therefore different since the
behaviour is globally non linear. To avoid such simulations,
not object of interest for the ankle manufacturer, but with
the aim of providing a valid tool by the numerical model, a
linear behaviour is used to describe the foot equivalent
stiffness. The foot equivalent stiffness is obtained by
comparing the experimental displacements of the piston to
the numerical values, as shown in Fig. 4. The geometry of
the prosthetic foot is obtained by means of a triangulation
3D laser scanner and the reverse engineering technique.
Fig. 4. An example of the comparison between experimental and
numerical displacements, for the foot component and toe-off loading
condition (II).
Further numerical simulations are run afterwards
considering the foot and the ankle units, joined together by
rigid coupling. The ankle is made of different sub-
components, all in titanium and the behaviour of these parts
is modelled as linear. In this second type of simulations,
comparisons for the models’ validation are provided by
means of comparisons not only with experimentally
measured displacements, but also with strains placed on the
ankle. Strain gauges are applied on the ankle, in easily
accessible regions, where a sufficient strain is generated to
provide a valid signal. In this way, the validated numerical
models by means of the comparison with experimental
results becomes a valid tool for further considerations on
the prosthesis design.
In Tab. 3 the comparison between the numerical (εnum)
and experimental (εecp) strains is shown. The values of the
numerical strains are calculated in correspondence of the
strain gages applied to the ankle.
 Table 3. Comparison between experimental and numerical results in the use of different cheaper materials, instead of titanium.
terms of strains.
For instance, three other materials, resistant to the
corrosion, are considered: an inox austenitic steel
Loading Applied εexp εnum Diff.
condition force [N] [με] [με] [%] (AISI310), an Aluminium alloy (Al7075) and an inox
I 1024 -96 -106 -10.4 duplex steel (1.4462 or X2CrNiMoN22-5-3). As indicated
I 2240 -120 -121 -0.8 by the safety factor in Tab. 3 for each analysed material, the
II 920 129 141 -9.3 choice of Al alloy resulted too strict, while it is possible the
II 2013 257 258 -0.4
use of the two inox steels.
The comparison is proposed at two different force levels, Table 4. Comparisons of the maximum Von Mises stress in the ankle
for both the loading conditions I/II. These two forces from numerical simulations – loading condition II. Model 1: as designed
correspond to the settling and to the proof test force to be by INAIL, model 2: optimized geometry.
applied for static tests according to [3]. In Tab. 3 it is
Numerical Max VM Diff. UTS Safety
evident that the percentage differences between the
model stress [MPa] [%] [MPa] factor
experimental and numerical strain values are vey reduced in 1_Ti6Al4V 535.1 - 920 1.72
correspondence of the maximum applied load during the 2_Ti6Al4V 301.9 -43.6 920 3.09
tests. 2_AISI310 223.4 -58.3 500 2.24
Numerical simulations are therefore also run on single 2_Al7075 312.3 -41.6 370 1.18
2_Duplex 315.4 -41.1 450 1.43
components of the ankle device, as sub-models. Object of
this part of the study are in particular two pins placed inside
the titanium ankle, where the stress condition resulted the
highest during the previous simulation. These sub-models IV. CONCLUSIONS
are loaded considering displacement fields. Results in terms In the present paper, after a general introduction on
of Von Mises stresses are shown in Fig. 5. transtibial lower limb prostheses and related standard, two
After the validation of the numerical models, these main points were discussed. From the experimental point of
become a reliable and secure tool to perform optimizations view a description was presented on:
on the designed device. In particular, considerations can be − the preparation of the test equipment, which need to be
proposed by varying the geometry and materials of the versatile and applicable to different tests, such as
ankle prosthesis designed by INAIL, called model 1. principal (3D) and separate (2D arrangement) static
tests, as well as fatigue (2D). This resulted in the use of
a bench consisting of two hydraulic actuators, a control
system and a fixed support boundary condition.
− the experimental test on an ankle foot prosthesis, with a
static tests in three dimensional configuration. During
these tests, piston displacements and prosthesis strains
are recorded.
Considering the numerical FE simulation, a model of the
prosthesis was developed and validated by a comparison
with the experimental results. Once validated, the model
was used as a powerful tool for the optimization of:
− the prosthetic ankle geometry, varying in particular a
fillet where stresses concentrated;
− the used material and alternative solutions.
These proposed solutions resulted in an improvement of the
Fig. 5. Stress field in two sub-models of the ankle device: Von Mises stress condition on the ankle device, and in a cheaper and
stress component.
more reasoned use of the commercially available materials.
An optimized geometry is studied (model 2), paying REFERENCES
attention to the region of maximum Von Mises stress. In
[1] Whittle MW, Gait analysis: an introduction, Elsevier, 2003.
particular, a modification of a fillet radius deeply changes [2] October 2010: http://www.dmti.unifi.it/bioingegneria/ita/didattica_ita
the stress value, as indicated in Tab. 4. In this table, the /Protesi%20ed%20ortesi/09%20-%20protesi%20arto%20inferiori.pdf
maximum Von Mises stress is compared to the ultimate [3] ISO 10328:2006, Prosthetics – Structural testing of lower-limb
tensile stress (UTS), and the safety factor is calculated as prostheses – Requirements and test methods.
[4] De Giorgi A, Studio sperimentale e numerico di protesi transtibiale per
their ratio. In model 2 the maximum stress is almost an half
cammino e nuoto, Master thesis, Politecnico di Milano, A.A. 2009-10.
with respect to model 1. This consideration gives space to