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Sustainable Development: A Fabricable Below-knee Prostheses Liner for

Resource Limited Environments

Article  in  Journal of Medical Devices · December 2019

DOI: 10.1115/1.4045835

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Sustainable Development: A Below-
Knee Prostheses Liner for Resource
Limited Environments
Kazuhiko Sasaki
Sirindhorn School of Prosthetics and Orthotics,
Faculty of Medicine, Siriraj Hospital,
Mahidol University,
Bangkok 10100, Thailand
Gary Guerra1
Sirindhorn School of Prosthetics and Orthotics,
Faculty of Medicine, Siriraj Hospital,
Mahidol University,
Bangkok 10100, Thailand
e-mail: gary.gue@mahidol.edu
Jutima Rattanakoch
Sirindhorn School of Prosthetics and Orthotics,
Faculty of Medicine, Siriraj Hospital,
Mahidol University,
Bangkok 10100, Thailand
Yusuke Miyata
Sirindhorn School of Prosthetics and Orthotics,
Faculty of Medicine, Siriraj Hospital,
Mahidol University,
Bangkok 10100, Thailand
Sharmila Suntharalingam
Sri Lanka School of Prosthetics and Orthotics,
Ragama 11010, Sri Lanka
This research sought to develop a fabricable prosthetic liner that
could be fabricable, intuitive, and a cost-effective means of pro-
viding advanced prosthetics in developing settings. An affordable
ethyl-vinyl-acetate roll-on (AERO) liner for permitting a total sur-
face bearing suction socket design was created and provided to a
single participant for in vivo outcome measurements. The liner
was fabricated from locally produced low-density ethyl-vinyl-
acetate (EVA) foam. A liner fabrication process was developed
and described, and one participant was provided 3 mm and 6 mm
AERO liner variants for outcome evaluations. Six-minute walk
test, residual limb temperature, and socket comfort score (SCS)
while in AERO liner were collected. Thirty-day step counts of
AERO liner with prosthesis and thermoplastic elastomer (TPE)
liner with prosthesis were collected. The results of in vivo evalua-
tions indicate increased speed, slightly higher residuum tempera-
ture, and increased comfort of the 6 mm AERO liner. Pedometer
tallied step counts for the AERO liner and TPE liner prostheses
were similar. The 6 mm AERO liner provided the best comfort and
function of the two thicknesses in liners, and step count data indi-
cated that the volume of patient activity was similar to when wear-
ing the TPE liner prosthesis. Roll-on fabricable low-cost liners
offer an affordable means of providing total surface bearing suc-
tion prostheses for resource limited environments (RLE). A pros-
thetist or technician can use the existing skills and lab to create
liners. [DOI: 10.1115/1.4045835]
1
Corresponding author.
Manuscript received July 13, 2019; final manuscript received December 15,
2019; published online January 31, 2020. Assoc. Editor: R. Lyle Hood.
Journal of Medical Devices Copyright V
C 2020 by ASME
Background
Considering the structure of the below-knee prosthesis, the vast
majority of amputees in resource limited environments (RLE)
receive a prosthesis which today comprises low-cost locally
sourced components, e.g., carved wood, molded leather, rubber,
or other widely adopted and reliable prosthetic systems, such as
the polypropylene International Committee of the Red Cross
(ICRC) prostheses [1,2]. The amputee begins by first donning a
soft liner onto their residual limb and then seats their limb into the
prosthetic leg. The prosthetic leg comprises a socket which
encompasses the residual limb, prosthetic pylon, and finally a
prosthetic foot [3]. The socket is the single most important piece
of the prosthesis because it must cradle not smash the residual
limb and also support the weight of the body.
In RLE, the patellar-tendon bearing (PTB) style socket is uti-
lized. This style was designed at UC Berkeley and San Francisco
in the 1960s [4], and is combined with a closed cell sponge foam
(Pelite) soft liner [5]. The prosthetist designed the socket so that
the brunt of weight bearing occurred anteriorly and posteriorly
along the patella tendon and popliteal area of the limb, while the
Pelite liner aided cushioning and suspension of the prosthesis [6].
However, in the 1980–1990 s, new socket technologies like Staats
€
and Lundts’ total-surface bearing (TSB) socket [7], and the Ossur
gel silicone liner, markedly improved cushioning and suspension
[8]. Moreover, these novel solutions revolutionized the field by
allowing a more intimate fit with the residuum and a reduction in
pistoning of the limb within the socket [9].
More recently, researchers have developed affordable pathways
for prosthetic limb creation using computer-aided design and
modeling [10]. Other researchers have also employed a low-cost
patient-specific finite element analysis (FEA) for prosthetics and
are working toward clinical efficacy [11].
Despite the rise of better prostheses, persons residing in the
developing nations have limited resources to purchase silicone
and gel liners, and if desired, must purchase these liners from
abroad at a high cost. In fact, it costs approximately $700 for a
below-knee silicone liner in Thailand. This is due in part to an
inability to produce a local alternative to imported liners. Still, the
TSB socket technique does not require the use of a gel liner, but
will greatly benefit from the use of the gel liner. Elastomer liners
can certainly be utilized in combination with the PTB socket,
however, our anecdotal experience has been punctuated with reoc-
curring wear and tear of these liners as a result of pressure created
along the patella tendon bar. The literature is marked with
Fig. 1 Illustration of pattern for AERO liner fabrication: (A)
total height: suprapatella to apex of distal end of residuum (pre-
fabricated liner is 330 mm for size S, M, and L), (B) circumfer-
ence at the apex of femoral condyle (prefabricated S 5 330 mm,
M 5 350 mm, and L 5 370 mm), (C) circumference at distal 4 cm
level (prefabricated S 5 240 mm, M 5 260 mm, and L 5 280 mm),
and (D) circumference at midlevel (prefabricated liner: not nec-
essary, however, it is necessary when residuum is conical or
long)
MARCH 2020, Vol. 14 / 014501-1
 Fig. 2 Image illustrating roll-on function of the AERO liner for transtibial device user
research in favor of either TSB or PTB, however, Selles et al.
showed no differences between the two socket types [12].
To help address the liner issue in developing settings, a locally
fabricated and affordable prosthesis liner was created (affordable
ethyl-vinyl-acetate roll-on liner (AERO)) which can be rolled-on
and used with a TSB suction suspension style prosthetic socket. In
this technical brief, we introduce the device and present an in vivo
case study in a transtibial prosthesis wearer. To the best of our
knowledge, no prior scholarship has explored this type of material
as a roll-on liner for the TSB suction suspension prosthesis. These
aforementioned factors served as the basis for this research.
Methods
Liner Fabrication. The material chosen for liner material was
a low-density ethyl-vinyl-acetate (EVA) foam locally produced
and distributed in Thailand. This material is similar to the Pelite
(polyethylene) liner in that they both have a high percentage of
EVA in the final material. This material is used as a shock absorb-
ing and vibration dampening barrier for products, packaging, and
as postoperative compression dressings [13]. The material has a
Shore A hardness value of 10.96 and density of 92.06 kg/m3. One
1  2 m2 sheet of EVA was used for prosthesis liner development
and costs $8.11 USD per sq/meter. The AERO liner can be
prefabricated or created from three residuum measurements.
Measurements were used to create a paper pattern that was traced
onto the liner material. A liner from the material was then cutout
and seamed using polychloroprene adhesive. An illustration of
what the paper pattern looks like is seen in Fig. 1. The liner was
heated and thermoformed over a simple mandrel to round the dis-
tal end. While still on the mandrel, the same adhesive was lathered
onto the liner and a nylon or stockinet fabric is carefully donned
onto the liner, see Fig. 2.2 This fabric outer layer makes rolling on
the liner easier and reduces inadvertent tears in the liner while the
patient dons the liner. A step-by-step fabrication guide is provided
in the Appendix, as well as in a video tutorial.
2
Video: http://vimeo.com/348631595; video special residuum: https://vimeo.com/
348631926; donning of prosthesis: https://vimeo.com/348632163
014501-2 / Vol. 14, MARCH 2020
In Vivo Provision for Transtibial Amputee. This case study
was granted approval through policies of the ethical committee of
Siriraj Faculty of Medicine. The participant provided written-
informed consent prior to testing. This 28-year-old male
participant received a left transtibial amputation as a result of a
congenital anomaly. He had a height of 169 cm, weight of 78 kg,
and was classified as a K3 ambulator (MFCL) [14]. This partici-
pant had been ambulating in a prosthesis for over 20 years. An
AERO liner (3 mm and 6 mm) was provided for the participant in
the manner described above, and an endoskeletal alignable pros-
thesis was designed. The socket was TSB with a rigid socket, and
€
foot was a Vari-Flex (Ossur, Iceland). Because of the roll-on abil-
ity of the liner, a suction suspension was achievable. A one-way
suction valve created in the lab was placed at the distal anterior
section of the hard socket which permitted evacuation of air
between the liner and the rigid socket (Fig. 3). For each type of
device, the device was aligned and the participant accommodated
to using the device while walking at a self-selected walking speed
for 435 m before outcome measures were performed. Outcome
measurements were performed for devices with both 3 mm and
6 mm liner prosthesis.
Outcomes. Outcome measures were performed upon comple-
tion of accommodation period. Outcomes were performed while
the participant wore the 3 mm and 6 mm liners in their prosthesis.
The participant performed the 6 min walk test (6 MWT) [15] and
was asked to walk as fast as possible during the duration of the
test. Distance covered was determined and then converted to
speed in meters per second. Prior to the 6 MWT, the participant’s
residual limb temperature was measured at the popliteal area of
the limb using an InfraRed thermometer Extech 42520 (Extech
Instruments, Watham, MA). Room air temperature during testing
remained at 31  C. Liner thickness in millimeters was also meas-
ured before and immediately after 6 MWT using a modified dial
height gage (Winton, Marunouchi, Chiyoda, Tokyo, Japan) that
allowed for the measurement of liner thickness at the distal end of
the liner. Socket comfort score (SCS) was assessed by asking the
participant to note comfort after performing the 6 MWT [16]. The
prosthetist visually inspected the residual limb for any noticeable
discoloration or redness. After completing the preliminary outcome
Transactions of the ASME
measures with both liners, the liner with the highest SCS was pro-
vided to the participant for a 30-day trial period after which the
liner condition and thickness were evaluated at midpatella tendon,
fibula head, anterior distal end of tibia, and distal end of residuum.
To ensure that the participant was ambulating in a manner represen-
tative of their habitual activity, an Omron HJ-329 pedometer
(Omron Healthcare, Shimogyo, Kyoto, Japan) was provided for 30-
day step count collection. The pedometer was placed in their pros-
thesis side pocket as suggested in the previous research [17]. This
step count was expected to be similar to that of their 30-day step
count in their own prosthesis, which was similar in design with the
exception being a thermoplastic elastomer (TPE) liner. In addition,
30-day step count for the participant in their own prosthesis was
performed prior to AERO liner intervention.
Results
Density and Shore values for AERO liner, evazote, and Pelite
liners, are provided in Table 1. The results of the 6 MWT indi-
cated that the participant ambulated further and therefore faster
while wearing the 6 mm liner than when wearing the 3 mm liner,
1.49 m/s and 1.42 m/s, respectively. The speed difference was not
significant; moreover, the participants walking speed in their own
device (TPE) was 1.65 m/s. Temperature changes of the residual
limb before and after completion of the 6 MWT were small for
both liner sizes but when the two liners were compared, a differ-
ence of 1  C was observed, 33  C for 3 mm liner and 34  C for
6 mm. For each of the tested liners, the skin of the participant
showed some redness, however, this quickly dissipated. There

Fig. 3 Illustration depicting AERO liner with prosthesis donning procedure. (1) Reflect the
AERO liner, precisely don to distal end of limb. (2) Roll-on the AERO liner. (3) AERO liner is
donned. (4) Don the transtibial prosthesis, with consummate evacuation of air from inside the
socket via a one-way expulsion valve (A). (5) Roll up a gel suction sleeve in order to seal
device to limb (B). (6) Prosthesis is donned.

Journal of Medical Devices MARCH 2020, Vol. 14 / 014501-3

Table 1 Density and Shore A hardness values for ethyl-vinyl-
acetate foam prosthesis liners
Density Shore A hardness
Mean (6SD) Mean (6SD)
Local EVA 92.06 (0.7) 10.96 (0.9)
EVA Zote 69.8 (26.1) 3.79 (0.5)
Thailand Pelite 296.72 (0.0) 42.78 (1.0)
ICRC Pelite 209.68 (0.4) 40.11 (1.1)
Note: EVA—ethyl-vinyl-acetate; ICRC—International Committee of The
Red Cross.
were no differences in liner thickness for either of the liners after
the 6 MWT and SCS were 7.5 for 3 mm and 8.5 for 6 mm. The
patient preferred 6 mm for long-term use and step count measure-
ment. Moreover, 30-day step counts between the participant’s
own device (TPE) and 6 mm liner were similar with an average
daily step count of 7236 TPE and 7037 6 mm AERO liner. Liner
thickness reduced by 1 mm at MPT and distal end of residuum,
respectively, and no reductions were observed at fibular head and
anterior distal end of tibia. Total month step counts of the devices
and other outcome metrics can be seen in Table 2.
Discussion
The goal of this project was to create a transtibial prosthesis
liner that would permit roll-on ability, total surface bearing socket
design, and for which raw materials could be sourced. We identi-
fied a locally available material for which local prosthetists can
purchase for approximately $7. The participant expressed greater
comfort during the 6 MWT while wearing the 6 mm liner. Tem-
peratures increased after walking but were slightly higher in the
slightly thicker 6 mm liner. Transtibial prosthesis users have
expressed the experience of increased residual limb heat while
wearing soft liners [18]. Although recent liner developments pro-
vide insight into possible heat dissipation solutions, some have
employed the use of perforations in the gel liner to allow breath-
ability [19], and some gel liners have unique materials for internal
temperature control [20]. Moreover, 30-day step counts between
the 6 mm liner and the participant’s TPE liner were similar, sug-
gesting that the participant was on average as physically active in
the study liner as in the TPE liner. The participant in our study
was more active than amputee activity reported in other research,
suggesting that the liner might be suitable for the high-active
amputee [21]. After the 30-day evaluation period, the liner thick-
ness had reduced at the MPT and distal end, but by only 1 mm.
There are limitations to this single case study, with a limited
30-day trial being one limitation. Durability of the liner over pro-
longed use was not evaluated. An on-going study is evaluating the
liner use over an extended period of time, and although small, the
minor “packing out” of the material merits a solution. Moreover,
our participant had a congenital-related amputation, presented
with a healthy cylindrical residuum with no invaginations or
Table 2 Results of outcome measurements for a transtibial
prosthesis wearer
3 mm AERO 6 mm AERO
6 MWT 1.42 m/s 1.49 m/s
IR temperature 33 6  C 34  C
Liner thickness (packing out) 0 mm 0 mm
SCS 7.5 8.5
TPE liner 6 mm AERO
Average 30-day step count 7236.462915.2 7037.462224.1
Total 30-day step count 217,093 211,123
Note: AERO—affordable ethyl-vinyl-acetate roll-on, 6 MWT—six-minute
walk test, IR—infra-red, SCS—socket comfort score, TPE—thermoplastic
elastomer, mm—millimeters, and m/s—meter per second.
014501-4 / Vol. 14, MARCH 2020
adhered scar tissue. These residual limb issues might be present in
other etiologies, and as a result, a future study should recruit a
wider range of patient populations. The results from this study are
from a single participant and cannot serve to support any type of
broad generalization for other prosthesis users. Our work is best
viewed as a proof of principle in which continued research can
begin to build on.
At a cost of $10 USD per liner, the prosthetist could provide a
set of liners to the patient for replacement when necessary. In
addition, because the AERO liner thickness is adjustable, residual
limb volume fluctuations can be accommodated by simply adher-
ing multiple liners together. The evidence is clear; amputees in
TSB sockets have greater physical activity and satisfaction [22],
favor TSB with pin/lock gel liner suspension, and feel most com-
fort and function in gel liner systems [23]. The use of TSB, roll-
on liners, and suction suspension might seem like a “pipe dream”
for the amputee residing in RLE, however, it does not have to be.
The AERO liner, combined with a low-price high-volume pricing
model, has potential for shared value for patients, prosthetics, and
industry in a sustainable manner.
Appendix: AERO Liner Fabrication Technique
These methods allow us to take measurements and create a
paper model which can be used for tracing of liner material and
fabrication of the AERO liner. Materials needed are measuring
tape, scissors, mandrel, paper, pencil, protractor, and AERO liner
material. The fabricator may choose to view the video guide for
further instruction.2
(1) Begin with one 1  2 m2 sheet of EVA. The AERO liner
can be prefabricated or created from patient
measurements.
(2) If the patient has a residual limb that is atypical in presen-
tation, then you can take residual limb measurements and
create a paper pattern from which you trace onto the liner
material.
(3) Record these measurements: (a) define 30 cm in length,
(b) a perimeter of 33 cm at the base (widest part), and (c) a
perimeter of 24 cm at a point 7 cm from the distal apex of
the model.
(4) If the residual limb is long and conical, we recommend
taking four measurements: (a) define the length of the
limb (suprapatellar to apex of distal end), (b) a perimeter
at the knee condyles (widest part), (c) a perimeter midway
down the residual limb, and (d) a perimeter at a point 7 cm
from the distal apex of the model.
(5) Use your measurements to create the paper pattern. We
provide an illustration of what the paper pattern looks like
in Fig. 1.
(6) It is important to create the distal end radius properly; to
do so, identify 4 cm to distal level on the paper patter.
Then, use the protractor to create radii of 1=4 the measure-
ment at this level. This will provide the proper distal
round shape of the liner.
(7) Once this pattern is created, the pattern can be placed over
the AERO liner material and traced to create the flat liner.
(8) The liner is then cut out of the material for smoothing and
final fabrication.
(9) Finally, the liner is glued together using polychloroprene
adhesive. The adhesive dries easily and will not drip
throughout the liner seam.
(10) Once completed, the liner can be heated and thermo-
formed over a simple mandrel, we used a gel liner stand.
Doing so will make the liner distal end become more
rounded. While the liner is on the mandrel, the same
2
Video: http://vimeo.com/348631595; video special residuum: https://vimeo.com/
348631926; donning of prosthesis: https://vimeo.com/348632163
Transactions of the ASME
 adhesive is lathered onto the liner, and a nylon or stocki-
net fabric is carefully donned onto the liner. This fabric
outer layer makes rolling on the liner easier and reduces
inadvertent tears in the liner while the patient dons the
liner. We have created a step-by-step video tutorial for the
fabrication of the paper pattern and liner which can be
accessed in previously provided links.
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