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Comparison of prosthetic feet prescribed to active individuals using ISO

standards

Article in Prosthetics and Orthotics International · December 2011

DOI: 10.1177/0309364611421692 · Source: PubMed

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21692 POI35410.1177/0309364611421692Mason et al.Prosthetics and Orthotics International

INTERNATIONAL
SOCIETY FOR PROSTHETICS
AND ORTHOTICS

Original Research Report

Prosthetics and Orthotics International

Comparison of prosthetic feet prescribed 35(4) 418­–424

© The International Society for
Prosthetics and Orthotics 2011
to active individuals using ISO standards Reprints and permission:
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DOI: 10.1177/0309364611421692
poi.sagepub.com

Zachary D Mason1,2, Jon Pearlman1,3,4, Rory A Cooper1,3,4

and Justin Z Laferrier1,3,4

Abstract
Background: Little research has been done on the robustness of prosthetic feet prescribed to military personnel, and
manufacturers are not required to test their products prior to sale. This is problematic because the prosthetic feet used
by active individuals are subjected to loading conditions not seen in normal gait.
Objectives: To evaluate whether commercially available heavy-duty prosthetic feet intended for use by military personnel
meet ISO 10328 standards.
Study Design: Bench testing of heavy-duty prosthetic feet using ISO 10328 standards.
Methods: Prosthetic feet from three different manufacturers were tested according to ISO 10328 standards, using a
testing frame fitted with axial load and displacement transducers. Pass/fail information was recorded as well as the
stiffness and creep of each foot before and after cyclic testing.
Results: All feet passed the ISO 10328 standards at the highest loading level, and some significant differences were found
within a given model of prosthesis when comparing stiffness and creep before and after cyclic testing.
Conclusions: This study demonstrated that manufacturers of heavy-duty prosthetic feet adhere to the voluntary
ISO 10328 standards. However, these standards may be insufficient because the tests simulate only idealized gait. Further
development of the standards may be necessary to reproduce the circumstances that occur during extreme usage to
ensure that prosthetic feet do not fail.

Clinical relevance
This study contributes to the understanding of the mechanical behaviour of prosthetics prescribed to active individuals,
such as active-duty military service members and paralympic athletes. The results of this study suggest that while
existing prosthetic feet may meet the requirements of ISO standards, the tests may not accurately reflect in vivo loading
conditions.

Keywords
Prosthetic feet, testing of prosthetic and orthotic components
Date received: 4 March 2011; accepted: 6 August 2011

Introduction
The incidence of lower-limb amputation has risen in recent Approximately 24% of amputees in the current conflicts are
years due to the increase in dysvascular disease and the returning to active duty, which is a substantial increase over
conflicts in Iraq and Afganistan.1 Traumatic injuries that led
to major limb amputation (at or above the wrist or ankle) 1 Human Engineering Research Laboratories, Pittsburgh, USA
associated with Operation Iraqi Freedom and Operation 2 Department of Physical Medicine and Rehabilitation, University of
Pittsburgh, USA
Enduring Freedom totalled 1100 by the end of 2009.2 3 VA Pittsburgh Healthcare System, Pittsburgh, USA
Individuals receiving amputations due to combat-related 4 Department of Rehabilitation Science and Technology, University of
injuries are most frequently young and active adults who Pittsburgh, USA
were in good health prior to their injury. The military states
Corresponding author:
that wounded service members may be returned to active Jon Pearlman, Human Engineering Research Labs, 7180 Highland
duty if they are making satisfactory rehabilitation progress Dr 151R-1H, Pittsburgh, 15206, USA.
and if they or their units can manage their medical needs.3 Email: [email protected]

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Mason et al. 419

the 7% who returned in Vietnam.4,5 Even if military person- ISO 10328:2006 and ISO 22675:2006 include protocols
nel do not return to active duty, their relative youth and to test the performance and durability of lower-limb pros-
active-duty training implies that they are likely to return to theses.13,14 For prosthetic feet, ISO 10328 prescribes the
and maintain an active lifestyle. This is feasible, in part, following tests in the order presented: static proof test, ulti-
because of recent advances in the quality of treatment and mate strength test, cyclic test, and a final static proof test.
the introduction of more sophisticated prosthetic technol- Tests can be performed at three different loading levels (P3,
ogy for different activities.6,7 As these technologies advance, P4 and P5) where P5 is the highest loading level and meant
allowing users to place more rigorous demands on them, it for prosthetic components prescribed for heavier individu-
is crucial to ensure that they are robust and reliable. als.13 A more in-depth description of these loading levels is
Ensuring the quality of prosthetic feet is extremely impor- presented in the methods section.
tant under the circumstances of combat-related operations, A possible solution to the shortcomings in the regulatory
where service members perform highly strenuous activities mechanisms for prosthetic feet would be for the FDA or
that load the prostheses in unusual ways. These unique load- CMS to require each product to pass ISO tests before they
ing conditions may be attributed to equipment weight, can be sold or reimbursed in the US. However, this is
adverse environmental conditions and strenuous gait cycles, unlikely to occur without an impetus, such as reported evi-
such as side-stepping, cutting, twisting and moving over dence of failure in the field or through independent ISO
uneven terrain.1 When loading changes dramatically, such as testing, which is not currently the case. Geil et al. (2001)
when a service member performs the abovementioned activ- conducted cyclic testing on 11 prosthetic feet and recom-
ities, the performance of the prosthetic foot may not be ade- mended classifications based on stiffness and hysteresis.15
quate. Furthermore, actual combat operations involve Another study by Zeller16 investigated the stiffness proper-
potentially loading the prosthesis beyond its original design ties of prosthetic feet under various cross-slope conditions,
criteria. This scenario could cause catastrophic failure of the and reported significant differences in stiffness among feet
prosthesis, placing the life of the service member and others of the same brand. The only study we have identified that
at risk, which underscores the need to ensure high quality reported ISO 10328 results was by Jensen and Treichl17,
prostheses. To accommodate the unusual loading conditions which tested 21 prosthetic feet commercially available in
on prosthetic components, active duty service members often developing countries. None of the feet passed the stand-
have several limbs that have been prescribed for different ards, reportedly due to the fact that they were made of sub-
expected load levels. While this is a feasible solution, it has standard materials such as rubber, polyurethane and
several obvious drawbacks: it adds additional cargo weight, ethyl-vinyl acetate. Jensen also reported a significant rela-
it is inconvenient for a soldier to have to frequently change tionship between internal architecture, quality of material
the limb, and changing the limb may not be possible when and failure.17
conditions change spontaneously. With a goal similar to Jensen and colleagues, we per-
The US Food and Drug Administration (FDA), as with formed this study to better understand the performance
all medical devices, provides approval for the sale of pros- and robustness, according to the ISO 10328 testing stand-
theses. Prosthetic devices, including prosthetic feet, are ards, of commercially available prosthetic feet commonly
Class-1 medical devices requiring only a pre-market notifi- ­prescribed to injured service members who wish to return
cation (510(k)) prior to sale in the US. The FDA does not to active duty or maintain an active lifestyle. We hypoth-
require structural or performance test reports to be filed for esized that not all of these feet would pass the ISO 10328
the 510(k), although testing protocols (described below) standards at the highest loading level due to shortcom-
have been developed. In addition to these testing protocols, ings in engineering or materials, as found by Jensen.
the American Orthotic and Prosthetic Association has pub- Furthermore, we sought to identify whether the perfor-
lished advice on design characteristics that should be met mance of these devices (e.g. stiffness and dampening)
for different Center for Medicare and Medicaid Services changed as a result of these tests. We also hypothesized
(CMS) reimbursement codes.8 that the prostheses would show a reduction in stiffness
This current regulatory mechanism for prostheses has and an increase in creep due to the cyclic portion of the
potential shortcomings. Most importantly, because ISO ISO 10328 standards. As with the Jensen study17 and sev-
testing is not required for a 510(k) or for reimbursement eral others related to wheelchair durability,9-12 the out-
from CMS, the onus to maintain high-quality products is on comes may have an important impact on product selection,
the manufacturers. This has proven problematic with other design and regulation.
medical devices, most specifically wheelchairs. Several
comparison studies performed by independent researchers
have demonstrated that wheelchairs frequently do not meet Methods
voluntary standards.9-12 Results of these wheelchair com- Prosthetic feet from three different manufacturers were
parison studies are one reason the CMS and the Department obtained for testing to the ISO 10328 protocol. The feet
of Veterans Affairs began requiring the inclusion of test selected were three Sierras from Freedom Innovations,
results when applying for a reimbursement code. three Re-Flex VSPs from Ossur and three Pathfinder IIs

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420 Prosthetics and Orthotics International 35(4)

Figure 1. The three feet investigated in this study: Sierra (left), Re-flex VSP (middle), and Pathfinder II (right).

Table 1. Important characteristics of tested prostheses.

Prosthesis Manufacturer Maximum Dominant Shock-absorbing

weight (kg) material component
Sierra Freedom Innovations 166 Carbon fibre No
Re-flex VSP Ossur 166 Carbon fibre Yes
Pathfinder II Ohio Willow Wood 160 Carbon fibre Yes

from Ohio Willow Wood, resulting in a total sample size of

nine. These particular models were selected because they
are the ones most commonly prescribed to wounded service
members by the Veteran Health Administration and the
Armed Forces Amputee Patient Care Program, based on
suggestions from clinicians at Military Treatment Facilities
(MTFs). The prostheses and their important characteristics
can be seen in Figure 1 and Table 1.
To ensure that regular production feet were obtained for
the study, vendors were not informed that the prosthetic
components would be tested. Each foot was inspected and
photographed prior to testing to ensure that no visible
defects were present that could affect results. The feet were
tested in a randomized order to minimize testing bias.
While the Re-flex VSP and Pathfinder II both possess
shock-absorbing components, the stiffness of the shock-
absorbing unit on Pathfinder II feet can be altered by a cli-
nician to properly adjust the prosthetic for a given patient.
The Pathfinder II feet were tested with their shock-absorb-
ing unit pressure set to 40 psi, which is the manufacturer’s
pressure setting.
A jig was fabricated to hold the feet according to speci-
fications found in ISO 10328, which can be seen in Figure 2.
The jig was constructed so that the longitudinal axis of the
Figure 2. Prosthetic foot in jig constructed to ISO 10328
foot was 7° off axis (a ‘toe out’ position), the forefoot load- specifications.
ing platen angle was 20° from the vertical, and the heel
loading platen angle was 15° from the vertical.
All testing was performed with a testing frame (858 prosthetic feet were made low-friction by adding Teflon
Bionix II, MTS Corporation, Eden Prairie, MN) with sheets and Teflon tape, respectively, resulting in a friction
hydraulically actuated pistons fitted with axial load cells, coefficient of approximately 0.05.
linear variable displacement transducers (LVDT), and low In order to simulate the variety of loading conditions
friction platens applying force and displacement to the prosthetic feet may experience, the ISO 10328 testing pro-
prosthesis. The loading surface of the platens and the tocol is divided into four sequential sections: an initial

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Mason et al. 421

static proof test, an ultimate strength test, a cyclic test and a Visual inspection was used because a prosthesis user or a
final static proof test. These tests can be performed at three clinician in the field would be limited to this type of inspec-
increasing loading levels: P3, P4 and P5. According to tion. If there was no visible damage during or after the bat-
Annex B of the ISO 10328 standards, the loading levels are tery of testing, the foot was considered to have passed the
based on locomotion data collected from amputees.13 The ISO 10328 standard. During all tests, force and displace-
P3 and P4 loading levels are based on data collected from ment data were collected from each platen’s load cell and
prosthesis users whose body mass was approximately 60 kg LVDT for further analysis. From this data, stiffness and
and 80 kg, respectively. The P5 loading level is based on creep information was obtained using Matlab (version
data collected from users with a body mass exceeding R2009b). Stiffness was obtained by finding a linear best-fit
100 kg.13 To simulate the most extreme usage, the P5 load- approximation of the slope of the force-displacement curve
ing level was used for all tests. during the loading portion of the initial and final static
Before the series of tests, the foot was loaded into the jig proof test. Creep was calculated by finding the difference
and the low-friction platens set to a zero displacement posi- between the first and last displacement values during the
tion, determined by the point at which the platens made initial and final static proof tests.
initial contact with the heel or forefoot portion of the To investigate whether a given model foot suffered
prosthesis. internal or non-visible damage during the cyclic test, a two
The first test performed was the static proof test, which repeated measures ANOVA with a Tukey post-hoc test
simulates a sustained load of double the body weight of a were used to determine any differences in stiffness or creep
100 kg individual. This test entails sequentially loading the between initial and final static proof tests. A non-paramet-
heel and then the forefoot of the prosthesis to 2240 N at a ric Kruskal-Wallis test was used to determine whether the
rate of 175 N/sec, and maintaining that force for 30 seconds prosthetic feet models were affected differently by the
before ramp-down. The ramp-down was programmed so as cyclic portion of the standard, by comparing stiffness and
to allow the platens to back off to the zero displacement creep experienced during the final static proof test. All sta-
position in displacement control over a ten second period. tistical analyses were done with SPSS (version 16) with a
The next portion of the standard was the static ultimate significance level of 0.05.18,19
test, so named not because it is a test to failure, but because
it simulates an acute prosthesis overload of four times the
body weight of a 100 kg user. This test consists of loading Results
the heel and forefoot sequentially to 4480 N at a rate of All feet were considered to have passed the ISO 10328
175 N/sec with no hold period. Once again, after reaching standard at the P5 loading level because no visible damage
the maximum load of 4480 N, the platen immediately backs was detected on the prostheses during or after each section
off in displacement control to the zero displacement posi- of testing. To further differentiate the behaviour and robust-
tion over a ten second period. ness of the feet, force and displacement data from the initial
Next, the cyclic test was performed on the foot, which and final static proof tests were analysed to ascertain the
involved sinusoidally loading the heel and forefoot alter- stiffness and creep experienced by each section of the pros-
nately between 50 and 1330 N at a frequency 1 Hz. Lastly, thesis (forefoot and heel). Table 2 summarizes the means
after 2,000,000 cycles, the ISO 10328 standard prescribes a and standard deviations (SD) of this data:
final static proof test identical to the initial static proof test. Table 3 summarizes the results of the repeated measures
The models were visually inspected by the author after ANOVA test with a Tukey post-hoc test.
each test and at regular scheduled intervals during the Finally, the Kruskal-Wallis result indicated no differences
cyclic test, to look for any damage (i.e. fractures or cracks) in stiffness (p=0.393) or creep (p=0.193) among the three
visible to the naked eye on the surface of the prosthesis. models of prosthetic feet during the final static proof test.

Table 2. Summary of stiffness and creep data from initial and final static proof tests.

Prosthesis Section Stiffness in initial Stiffness in final Creep in initial Creep in final
static proof test static proof test static proof static proof test
(N/mm) (N/mm) test (mm) (mm)
Mean±SD Mean±SD Mean±SD Mean±SD
Sierra Forefoot 100.3±4.1 126.4±7.7 0.47±0.24 0.46±0.43
Heel 172.8±22.6 213.1±6.6 0.41±0.28 0.58±0.33
Re-flex VSP Forefoot 48.8±1.1 56.2±1.8 1.48±0.78 1.06±0.19
Heel 77.9±3.3 78.8±5.9 0.79±0.21 0.66±0.55
Pathfinder II Forefoot 55.9±5.9 68.2±14.9 1.23±1.17 1.09±0.05
Heel 59.2±6.9 59.2±4.5 1.53±0.43 0.90±0.14

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422 Prosthetics and Orthotics International 35(4)

Table 3. Summary of repeated measures ANOVA comparing stiffness and creep between initial and final static proof tests for a
given model of prosthesis.

Prosthesis Section Parameter p value Post-hoc test result

Sierra Forefoot Stiffness 0.001 Initial<final
Creep 0.292 NA
Heel Stiffness 0.002 Initial<final
Creep 0.301 NA
Re-flex VSP Forefoot Stiffness 0.001 Initial<final
Creep 0.042 Initial>final
Heel Stiffness 0.801 NA
Creep 0.043 Initial>final
Pathfinder II Forefoot Stiffness 0.017 Initial<final
Creep 0.571 NA
Heel Stiffness 0.795 NA
Creep 0.143 NA

Discussion
Pathfinder II possess shock-absorbing components while
All heavy-duty prosthetic feet tested passed the ISO 10328 the Sierra does not. This key difference could affect stiff-
standards at the P5 loading level. This result contradicts our ness and creep results, since feet with shock-absorbing
major hypothesis and suggests that the particular models capability are designed to deform much more under load
tested and their manufacturers adhere to the voluntary ISO and to dissipate this energy during gait, providing a
standards. Lower-rated prosthetic components may perform smoother step than a foot without shock absorption. Further
differently, as Jensen and colleagues17,20 found for low-cost investigation should be done to differentiate the effective-
prosthetic feet, such as those available in low-income coun- ness and robustness of shock-absorbing versus non-shock-
tries. While this study focused on high-cost prostheses absorbing prosthetic feet.
intended for use by military service members and other It is important to note a few limitations of this study. First,
active individuals, further study is necessary to determine only three feet from each manufacturer were tested, resulting
whether lower-cost feet available in the US meet the in a sample size of nine. Due to the length of the cyclic test-
ISO 10328 standards. ing (over three weeks), it is extremely time-consuming to test
Usually, materials exposed to fatigue tests, such as the additional feet to reach a more powered sample size. Also,
cyclic test prescribed by the ISO 10328 standards, experi- calculating stress and measuring strain during the tests would
ence a reduction in modulus and an increase in creep.21 paint a more vivid picture of how the prosthesis materials
Since the modulus of the prosthetic feet could not be deter- react to the loading conditions in the ISO 10328 standards.
mined by the test methods used in this study, stiffness was An important limitation in applying the ISO 10328 stand-
used as an analogue for the modulus. After the repeated ards to evaluate the robustness of prostheses used by active
loading experienced by each prosthesis during the cyclic individuals is that these standards only address durability
test, we expected a decrease in stiffness from the initial to under the loading conditions of an idealized gait. These con-
the final static proof test, and an increase in creep because ditions may not be representative of actual performance
of internal damage propagation. As shown by the repeated during use. Current tests are uni-axial, simulating the gait
measures ANOVA test of this data, in many cases the exact cycle during fatigue testing, and acute overloading during
opposite occurred. This may be due to cycle-dependent proof and ultimate strength testing. The prosthetic feet used
hardening, which some materials experience during fatigue by active military personnel with lower limb amputations
tests, especially those tested at stresses well below the yield can be exposed to many different loading conditions, such
stress of the material.21 Since these prosthetic feet are com- as those caused by moving over uneven terrain, donning
posed of several different materials and the testing was and doffing heavy equipment, or side-stepping maneuvers.
purely structural, we cannot be sure which component or Lateral and torsional loads that may occur when performing
components experienced this hardening. these activities are not applied to the foot during testing.22
Even though the Kruskal-Wallis test showed no signifi- Consequently, failure modes that may occur during these
cant differences in stiffness or creep during the final static maneuvers are not addressed during ISO testing, and thus
proof test, a potential interpretation of the data in Table 2 design deficiencies would be unknown prior to commer-
may be that the Sierra feet are the most robust, because the cialization. Failure of these components under critical cir-
trends indicate higher stiffness and lower creep compared cumstances in combat could lead to additional injuries and
to the other models tested. However, the Reflex VSP and could potentially be fatal. With this in mind, it may be

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Mason et al. 423

necessary to include tests that apply torsion and bending in References

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