Genium | Genium X3
Clinically proven superiority
Incomparably close to nature
To this day, about 65 000 amputees around the
world have been covering distances amounting
to 180 million kilometers – using intelligent
knee joints made by Ottobock. Altogether, they
covered a distance larger than a one-way
journey from the planet earth to the sun – not
in a space shuttle, but with prosthetic legs.
C-Leg began to set a new standard in
prosthetics in 1997 and still today, in its
4th generation, it is the most widely used
and studied microprocessor-controlled
knee on the market.
More than 40 studies prove the benefits of
C-Leg over other prosthetic solutions.
The launch of the Genium was a breakthrough in the
field of knee prosthetics. For the first time, a virtually
natural replication of the physiological human gait
was possible with a prosthetic leg. Valuable experience from technicians and users worldwide continually influenced the further development of the
Genium product family.
2 Ottobock | Genium and Genium X3. Clinically proven superiority.
The Genium X3 is based on the Genium but goes a
few steps further. It is not only fully functional in
fresh and salt water, but also extra-robust which
makes it suitable for heavy-duty use in all sorts of
jobs or family tasks.
10 publications from 2011–2015 clinically prove
the superiority of the Genium family over C-Leg as
a long-term industry standard.
Genium and Genium X3. Clinically proven superiority. | Ottobock 3
4 Ottobock | Genium and Genium X3. Clinically proven superiority.
Index
Safety
Increased safety while walking and during
a variety of activities of daily living
Activities of daily living �������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 6
Toe clearance ����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 7
Swing phase initiation ���������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 8
Protection
Fewer orthopedic problems thanks
to protection of the body
Gait symmetry ������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 10
Knee flexion at heel strike �������������������������������������������������������������������������������������������������������������������������������������������������������������� 11
Climbing stairs ���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 12
Endurance
Effort-saving on all terrains and greater perceived
endurance over long distances
Exhaustion while walking ���������������������������������������������������������������������������������������������������������������������������������������������������������������� 14
Difficulty of activities of daily living ������������������������������������������������������������������������������������������������������������������������������������ 14
Quality of Life
Advanced features and highest level of intuitiveness
lead to an increased quality of life
Impact on quality of life and overall satisfaction �������������������������������������������������������������������������������������������� 15
Genium and Genium X3. Clinically proven superiority. | Ottobock 5
Safety
Activities of daily living
Safety
• Increased safety
Activities of daily living
1
safety
I
n aIncreased
clinical study
amputees were asked to rate the importance and
safety of 45 activities of daily living when using C-Leg and Genium.
After
3 months
of Genium
allto45
wereand
rated as safer with
In a clinical
study1 amputees
wereuse
asked
rateactivities
the importance
safety
of
45
activities
of
daily
living
when
using
C-Leg
and
Genium.
Genium. The graph shows some examples.
After 3 months of Genium use all 45 activities were rated as safer with
Genium. The graph shows some examples.
Moving around in a confined place
Stepping over minor obstacles
Stepping on minor obstacles like rocks
Walking up stairs
Walking down stairs
Walking up ramps
Walking down ramps
Walking with different speeds
Safer with Genium
Chasing with a child
Extent of improvement:
0 = no difference
1 = safer
2 = much safer
Walking in a crowd
Walking on uneven terrain
0
0,5
Clinically relevant threshold
1
1,5
2
also is highly associated with its balance
Background: Studies have investigated the risk
confidence.11 It was shown that the balance
of falling and fear of falling in lower limb
confidence
people
a lower
limb
amputees. Of 435 Studies
lower limbhave
amputees
that
alsowith
highly
associated
with its balance
Background:
investigated
the
risk of is
amputation is diminished in a12lot of activities as
were surveyed in a study, approximately 50 %
It was shown that the balance
of
falling and fear of falling in lower limb walking up andconfidence.
down stairs and ramps, walking
reported falling in the past year or a fear of
confidence
of peoplefrom
with a lower limb
amputees.
Out
of reports
435 lower
in a that
crowed mall,
picking up something
study
that 50limb
% of amputees
the
falling.9 Another
10
the
floor
or
simply
walking around
the house.12 in a lot of activities as
amputation
is diminished
Fear
participants
had a fall
the last month.
were
surveyed
in in
a study,
approximately
50 %
Genium can reduce
the risk
falling
and stairs and ramps, walking
of falling can
have a in
bigthe
impact
onyear
a person’s
walking
up of
and
down
reported
falling
past
or a fear of
increase the safety in activities of daily living.1, 2
daily living
10 and lead to activity restriction and
in a crowed mall, picking up something from
Another
study
reports
that
50 %
of
the
falling.
loss of independence. A person’s fear of falling
participants had a fall in the last month.11 Fear
of falling can have a big impact on a person’s
daily living and lead to activity restriction and
loss of independence. A person’s fear of falling
6
the floor or simply walking around the house.13
Genium can reduce the risk of falling and
increase the safety in activities of daily living.1, 2
Ottobock | Clinical Evidence Genium and Genium X3
6 Ottobock | Genium and Genium X3. Clinically proven superiority.
Toe Clearance
• Genium may reduce the risk of stumbling and falling
Toe Clearance
Genium may reduce the risk of stumbling and falling
64°
64°
may result in a further reduction of stumbling
and falling.2 Also the knee demonstrated an
increased adaptability during ramp ambulation
and when wearing different weight shoes.3
64°
66°
Knee flexion degree
64°
A study has shown that with Genium the
maximum knee flexion angle is at approximately
during swing phase at slow, mid and fast walking speed.
This knee angle ensures an adequate toe clearance across
A study hasall
shown
that with
Geniumthat may result in a further reduction of
walking
speeds
the knee flexion angle is at approximately
stumbling and falling.2 Also the knee demonstrated an
while swing phase at slow, mid and fast walking
adaptability
and toe clearance during ramp
speed. Thisincreased
knee angle ensures
an adequate
ambulation
and when
shoes with different weights.3
toe clearance
across all walking
speedswearing
that
63–65° physiological
knee flexion angle
64°
62°
60°
58°
Genium
56°
C-Leg
54°
Slow
walking speed
Mid
walking speed
Background: Tripping is known to be a major
Fast
walking speed
Toe clearance is among other things ensured
Background:
known(the
to space
be a major
Toe clearance
is among
things ensured
reason of falling.Tripping
A low toe is
clearance
through an adequate
knee flexion
angle. Isother
the
reason
ofthe
falling.
A low
toethe
clearance
knee flexion angle.
between
tip of the
toe and
floor while (the space
knee flexionthrough
angle too an
low adequate
the risk of stumbling
walking) the
or a high
variability
toe clearance
is increased.
it isknee
too high
the legangle
might not
between
tip of
the toein and
the flooris while
If Ifthe
flexion
is too low, the risk of
associated with tripping.13 Wearing heavy shoes
be ready for the next step at the end of the
walking)
or
a
high
variability
in
toe
clearance
is
stumbling
is
increased.
If
it is too high, the leg
additionally decreases the toe clearance.
swing phase. Sufficient toe clearance is
associated with tripping.14 Wearing heavy shoes
mightfornot
be readyamputees
for the next step at the end
especially critical
transfemoral
thethe
lackswing
of compensation
additionally decreases the toe clearance. because of of
phase. mechaSufficient toe clearance is
nisms of theespecially
foot.
critical for transfemoral amputees
because of the lack of compensation mechanisms of the foot.
Clinical Evidence Genium and Genium X3 | Ottobock
7
Genium and Genium X3. Clinically proven superiority. | Ottobock 7
Swing phase initiation
• Reliable swing phase initiation while taking small steps
Swing phase initiation
• Reliable swing phase initiation at small steps
Swing phase initiation
An investigation with eleven transfemoral amputees showed
that with Genium the swing phase is initiated very reliably
• Reliable swing phase initiation at small steps
In investigation
with eleven transfemoral amputees showed
when walking
with small steps. Furthermore it was shown that
that with Genium the swing phase is initiated very reliably
2
it was easier
userswith
to initiate
theFurthermore
swing phase.
whenfor
walking
small steps.
it was shown that
it was easier for users to initiate the swing phase.2
In investigation with eleven transfemoral amputees showed
that with Genium the swing phase is initiated very reliably
when walking with small steps. Furthermore it was shown that
it was easier for users to initiate the swing phase.2
Swing phase initiation at small steps
Swing phase initiation at small steps
95.1 %
Genium
95.1%
Swing phase initiation at small steps
95.1 %
Genium
C-Leg
Swing phase initiation at small steps
75.5 % C-Leg
Swing phase initiation at small steps
Swing phase initiation at small steps
75.5 % 75.5%
confined place or walking in a crowd are such Background: A reliable swing phase initiation situations that are very important to them1. is very important for walking without having to Moreover initiating the swing phase should not concentrate too much on the prosthesis while be too exhausting for the users and to conserve still maintaining safety. There are some other body parts as the hip and the back. situations in daily living where it is necessary to walk with small steps. A survey of lower limb confined place or walking in a crowd are such Background: A reliable swing phase initiation amputees showed that moving around in a situations that are very important to them1. is very important for walking without having to confined
space or walking in a crowd are such
Moreover initiating the swing phase should not Background:concentrate too much on the prosthesis while A reliable swing phase initiation
be too exhausting for the users and to conserve still maintaining safety. There are some situations
that are rated as very important.1
is very important
for walking without having to
other body parts as the hip and the back. situations in daily living where it is necessary to Moreover,
initiating the swing phase should not
concentrate too
much on the prosthesis while
walk with small steps. A survey of lower limb be too exhausting for the users in order to
still maintaining
safety. There are some
amputees showed that moving around in a 8 situations in daily life where it is necessary to
walk with small steps. A survey of lower limb
amputees showed that moving around in a
Ottobock | Clinical Evidence Genium and Genium X3
8 Ottobock | Clinical Evidence Genium and Genium X3
8 Ottobock | Genium and Genium X3. Clinically proven superiority.
conserve other body parts as the hip and
the back.
Genium and Genium X3. Clinically proven superiority. | Ottobock 9
Protection
Gait Symmetry
• More symmetrical gait pattern protects the body
Protection
Gait Symmetry
Bellmann
et al. (2012) investigated the step
•
More symmetrical gait pattern protects the body
length symmetry of patients walking with Genium
and C-Leg. With Genium walking was more symmetrical than with C-Leg.2
Bellmann et al. (2012) investigated the step
length symmetry of patients walking with Genium
and C-Leg. With Genium walking was more symmetrical than with C-Leg.2
0,09
0,08
Difference in step length
0,07
0,06
0,05
0,04
0,03
Genium
C-Leg
0,02
0,01
0
Slow walking speed
Mid walking speed
Fast walking speed
perfect symmetry = 0 Background: People with a unilateral lower Osteoporosis, osteoarthritis and pain may lead transfemoral amputation generally have an to difficulties in the activities of daily living and a 14 asymmetrical gait. Walking with such a gait reduced quality of life.18, 19 Therefore it is pattern can lead to some secondary problems important for lower limb amputees to decrease in the sound leg, the residual limb and the the risk of those secondary problems. Osteoporosis, osteoarthritis and pain may lead
Background: People with a unilateral lower
back. Clinical studies have shown that lower Genium can reduce gait asymmetries and to difficulties in activities of daily living and a
transfemoral amputation generally have an
limb amputees could have an increased risk of enable amputees to walk with a more natural quality of life.19, 20 Therefore it is
asymmetrical
gait.15 Walking
15, 16 with such a gait
This is an important contribution • osteoarthritis in the sound leg gait pattern.2, 3 reduced
15
pattern
can lead to some secondary
problems
important for lower limb amputees to decrease
• osteoporosis in the residual limb to remain the sound leg healthy.
15, 1
• inpain in the back and in the sound leg
the sound leg, the residual limb and the
the risk of those secondary problems.
back. Clinical studies have shown that lower
limb amputees could have an increased risk of
• osteoarthritis in the sound leg. 16, 17
• osteoporosis in the residual limb. 16
• pain in the back and in the sound leg. 16, 17
Genium can reduce gait asymmetries and
enable amputees to walk with a more natural
gait pattern.2, 3 This is an important contribution
to keep the sound leg healthy.
10 Ottobock | Clinical Evidence Genium and Genium X3
10 Ottobock | Genium and Genium X3. Clinically proven superiority.
Knee flexion at heel strike
• More natural walking with PreFlex
Stance phase flexion
•biomechanical
A
study
confirmed
thatstance
with phase
More natural
walking
with
Genium the knee is 3 – 4° pre-flexed at heel strike
across different walking speeds.3
flexion
A biomechanical study confirmed that with
Genium the knee is 3–4° pre-flexed at heel strike
across different walking speeds.3
Knee flexion angle
at heel strike (°)
5
4
3
2
1
0
Genium
Very slow
walking
Slow
walking
Normal
walking
Fast
walking
Background: During normal gait, the knee is flexed a few degrees
at the beginning of the stance phase. This is done for reasons of
shock absorption, stabilization of the knee and forward progression.20 With the most mechanical knee prosthesis this stance phase
Background:
During
normal
the knee
flexion is not possible
and the
persongait,
is stepping
on a is
fully extended
21, 22
flexed
few degrees
the
beginning
of thethe knee is
With
Genium PreFlex
or even ahyperextended
leg.at
already flexed
at 4°
at heel
strike and
allows of
for shock
controlled
stance
phase.
This
is done
for also
reasons
flexing the knee during stance phase.
absorption, stabilisation of the knee and forward
progression.21 With most knee joints this is not
possible and people step on a fully extended or
even hyperextended leg.22, 23 With Genium
PreFlex the knee is already flexed at 4° at heel
strike and also allows controlled flexing of the
knee during stance phase.
Clinical Evidence Genium and Genium X3 | Ottobock
11
Genium and Genium X3. Clinically proven superiority. | Ottobock 11
Climbing stairs
• Climbing stairs with a natural step-over-step pattern
Climbing stairs
• Climbing stairs with a natural step-over-step pattern
ith most conventional as well as the majority of
W
microprocessor controlled knees it is only possiWith with
most conventional
as well
as the majority
ble to climb stairs
a step-to-step
pattern.
This of
microprocessor
controlled
knees
it
is
only
obviously puts a higher stress on the sound leg.possible to climb stairs with a step-to-step pattern. This
Since 2011 Genium
allows users worldwide to
obviously puts a higher stress on the sound leg.
walk upstairs in
a well-proven,
natural
Since
2011 Genium allows
usersstep-overworldwide to
6, 7
walk upstairs
a well-proven,
step-overstep pattern relieving
the in
sound
side.4, 5,natural
step pattern relieving the sound side.4, 5, 6
Out of 10 users who were not able to
walk
step-over-step
Out of all users
who
were notbefore
able to
walk step-over-step before
80%
72%
could use this pattern with Genium.4 This walking pattern was shown to reduce the loading of the sound leg to a could use this pattern4,5with
more physiological range.
4
Genium within one day. This walking pattern
was shown to reduce the loading of the
sound leg to a more physiological range.4,5
Step-over-step
Step-to-step
12 Ottobock | Clinical Evidence Genium and Genium X3
12 Ottobock | Genium and Genium X3. Clinically proven superiority.
Genium and Genium X3. Clinically proven superiority. | Ottobock 13
Endurance
Exhaustion while walking
• Walking is perceived as less exhausting with Genium
Endurance
Study participants were asked to rate their perceived
exhaustion while walking with Genium and C-Leg at
different speeds and distances. Walking with Genium
was ranked as less exhausting than with C-Leg.8
Exhaustion while walking
• Walking is perceived as less exhausting with Genium
Background: Lower limb amputees need up to
With Genium walking becomes more efficient
34% more energy while walking than nonas part of the energy at heel strike is converted
amputated individuals.24 Especially on inclines
into a forward movement.25
Study
participants
were asked
for the perceived
and
declines
the energy
expenditure
is even exhaustion
while walking
with
Genium
and C-Leg
different speeds
higher.
This can
lead
to a limitation
in at
the
and distances.
Walking
with
Genium
was ranked
activities
of daily
living for
people
walking
with as less
with C-Leg.7
aexhausting
lower limbthan
prosthesis.
Background: Lower limb amputees need up to 34% more energy while walking than nonamputated individuals.23 Especially on inclines and declines the energy expenditure is even higher. This can lead to a limitation in the activities of daily living of people walking with a lower limb prostheses.
With Genium walking becomes more efficient as part of the energy at the heel strike is converted into a forward movement.24
Difficulty of activities of daily living
•Daily activities are perceived as less difficult with Genium
Difficulty of activities of daily living
• Daily activities are perceived as less difficult with Genium
Amputees rated the perceived difficulty of activities of
daily living with C-Leg and Genium.1
Amputees
were
asked some
for the perceived
of activities
The
graph
shows
activitiesdifficulty
that are
expected to
of daily living with C-Leg and Genium.1
require a high level of endurance and that were rated
The graph shows some activities that are expected to require
to
be easier
with Genium
at were
a clinically
relevant
a high
level of endurance
and that
rated as easier
with level.
Genium at a clinically relevant level.
Going for a walk
Walking on uneven terrain
Walking with different speeds
Chasing with a child Standing in a line
Easier with Genium Standing in a crowded bus
Extent of improvement:
0 = no difference
1 = easier 2 = much easier
Standing still for a longer period of time
0
0,5
Clinically relevant threshold
14 Ottobock | Clinical Evidence Genium and Genium X3
14 Ottobock | Genium and Genium X3. Clinically proven superiority.
1
1,5
2
Quality of Life
Impact on quality of life and
overall satisfaction
• Genium has the ability to improve the quality of life
20 amputees were asked to rank their quality of life
using the Prosthesis Evaluation Questionnaire.
Genium was compared to C-Leg. There was a gain in
quality of life when using Genium.10
Item
Significantly
improved
Improved
Natural standing with the prosthesis
Feeling of balance
Ability to walk in confined spaces
Going down stairs
Ability to walk up steep hills
Ability to walk down steep hills
Ability to walk on slippery surfaces
Satisfaction with the prosthesis
Satisfaction with walking in general
Background: It is known that lower limb
amputees are at risk to have a reduced quality
of life.26 People often suffer from skin related
problems, inability to navigate in certain
environments or to walk quickly or they
experience pain in the residual limb, the sound
leg or phantom pain. These and other factors
can affect the quality of life negatively.
Genium has the ability to improve the general
well-being and the satisfaction with walking
while reducing social burden.9
Genium and Genium X3. Clinically proven superiority. | Ottobock 15
References of studies investigating Genium
1.Kannenberg, A.; Zacharias, B.; Mileusnic, M.; Seyr, M.; Kannenberg, Andreas; Zacharias, Britta et al. (2013): Activities of Daily Living: Genium
Bionic Prosthetic Knee Compared With C-Leg. In: JPO Journal of Prosthetics and Orthotics 25 (3), S. 110 – 117. DOI: 10.1097/
JPO.0b013e31829c221f.
2.Bellmann, Malte; Schmalz, Thomas; Ludwigs, Eva; Blumentritt, Siegmar (2012): Immediate effects of a new microprocessor-controlled prosthetic
knee joint: a comparative biomechanical evaluation. In: Arch Phys Med Rehabil 93 (3), S. 541 – 549. DOI: 10.1016/j.apmr.2011.10.017.
3.Lura, Derek J.; Wernke, Matthew M.; Carey, Stephanie L.; Kahle, Jason T.; Miro, Rebecca M.; Highsmith, M. Jason (2015): Differences in knee
flexion between the Genium and C-Leg microprocessor knees while walking on level ground and ramps. In: Clinical Biomechanics 30 (2),
S. 175 – 181. DOI: 10.1016/j.clinbiomech.2014.12.003.
4.Bellmann, Malte; Schmalz, Thomas; Ludwigs, Eva; Blumentritt, Siegmar (2012): Stair ascent with an innovative microprocessor-controlled
exoprosthetic knee joint. In: Biomed Tech (Berl) 57 (6), S. 435 – 444. DOI: 10.1515/bmt-2011-0029.
5.Blumentritt, Siegmar; Bellmann, M.; Ludwigs, Eva; Schmalz, Thomas (2012): Zur Biomechanik des mikroprozessorgesteuerten Prothesenkniegelenks Genium. In: Orthopädie-Technik 01 (12), S. 24 – 35.
6.Highsmith, M. Jason; Kahle, Jason T.; Lura, Derek J.; Lewandowski, Amanda L.; Quillen, William S.; Kim, Seok Hun (2014): STAIR ASCENT
AND RAMP GAIT TRAINING WITH THE GENIUM KNEE. In: Technology & Innovation 15 (4), S. 349 – 358. DOI: 10.3727/194982413X138444888
79267.
7.Aldridge Whitehead, Jennifer M; Wolf, Erik J.; Scoville, Charles R.; Wilken, Jason M. (2014): Does a microprocessor-controlled prosthetic knee
affect stair ascent strategies in persons with transfemoral amputation? In: Clinical orthopaedics and related research 472 (10), S. 3093 – 3101.
DOI: 10.1007/s11999-014-3484-2.
8.Highsmith, M. Jason; Kahle, Jason T.; Lura, Derek J.; Dubey, Rajiv V.; Carey, Stephanie L.; Quillen, William S.; Mengelkoch, Larry J. (2014):
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