Disability and Rehabilitation: Assistive Technology

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Benefits of the Genium microprocessor controlled

prosthetic knee on ambulation, mobility, activities
of daily living and quality of life: a systematic
literature review

Milana P. Mileusnic, Lena Rettinger, M. Jason Highsmith & Andreas Hahn

To cite this article: Milana P. Mileusnic, Lena Rettinger, M. Jason Highsmith & Andreas
Hahn (2021) Benefits of the Genium microprocessor controlled prosthetic knee on ambulation,
mobility, activities of daily living and quality of life: a systematic literature review, Disability and
Rehabilitation: Assistive Technology, 16:5, 453-464, DOI: 10.1080/17483107.2019.1648570

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DISABILITY AND REHABILITATION: ASSISTIVE TECHNOLOGY
2021, VOL. 16, NO. 5, 453–464
https://doi.org/10.1080/17483107.2019.1648570

REVIEW ARTICLE

Benefits of the Genium microprocessor controlled prosthetic knee on ambulation,

mobility, activities of daily living and quality of life: a systematic literature review
Milana P. Mileusnica, Lena Rettingera, M. Jason Highsmithb and Andreas Hahna
a
Otto Bock Healthcare Products GmbH, Vienna, Austria; bSchool of Physical Therapy & Rehabilitation Sciences. Morsani College of Medicine,
University of South Florida, Tampa, FL, USA

ABSTRACT ARTICLE HISTORY

Purpose: The benefits of advanced hydraulic microprocessor controlled knee (MPK) joints have been well Received 9 January 2019
established and repeatedly confirmed. The Genium knee was introduced in 2011 containing an enhanced Revised 22 July 2019
control concept including additional sensors and improved algorithms enabling a range of new functions Accepted 22 July 2019
for transfemoral amputees (TFAs). A systematic review was conducted to evaluate the effect of the
KEYWORDS
Genium knee on ambulation, mobility, activities of daily living (ADLs) and quality of life compared to Above-knee; amputee;
standard MPKs. Genium; microprocessor-
Materials and Methods: The review was conducted according to PRISMA Guidelines and Recommendations controlled knee; prosthesis;
of the State-of-Science Evidence Report Guidelines of the American Academy of Orthotists & Prosthetists. transfemoral; X2
Results: Twelve articles were included in the review and reported primarily on active subjects (MFCL-3/4)
transitioning from C-Leg to Genium knee systems. The overall validity of the evidence was medium to
high with the exception of one article having low validity. Synthesis of biomechanical analyses concludes
that gait during level walking, stairs and ramps is more physiological and symmetric following accommo-
dation and use of the Genium in community ambulating TFAs. Further, sound side loading and compen-
satory motions are reduced. Transitioning from C-Leg to the Genium knee additionally resulted in
significant improvements in mobility, quality of life and the performance in activities of daily liv-
ing (ADLs).
Conclusion: A high level of evidence was identified when assessing the ability of Genium to improve
gait quality and safety and performance in ADLs. While individual studies report significant improvements
in terms of quality of life and mobility, additional studies are needed to increase the evidence level.

ä IMPLICATIONS FOR REHABILITATION

Microprocessor controlled prosthetic knees (MPKs) are well-established devices to serve patients with
transfemoral amputation. Studies conducted mostly with the C-Leg MPK show that such knees signifi-
cantly increase patient safety, ambulation, mobility, performance in activities of daily living and qual-
ity of life.

Genium MPK includes advanced features which enable a range of new functions and functional bene-
fits to patients. Transitioning from conventional MPKs (i.e., C-Leg) to Genium MPK resulted in more
physiological gait, more equally distributed loading between the prosthetic and sound limbs, as well
as reduced compensatory movements on the sounds side. These outcomes could potentially reduce
the long-term risks of secondary physical complications in prosthetic users (i.e., osteoarthritis, osteo-
porosis). Genium significantly improved mobility, performance in activities of daily living, and quality
of life in the patients using a conventional MPK (C-Leg).

Different functioning principles of the MPKs presently available are responsible for different perform-
ance levels the knees offer to users. The amount of clinical evidence is also knee-dependent, with the
C-Leg knee being most extensively tested in clinical studies. This systematic review concludes that
Genium offers further advantages to transfemoral patients as compared to conventional MPKs
(C-Leg).

Introduction
A person living with transfemoral amputation (TFA) faces distinct
challenges, such as increased ambulatory energy requirements,
balance problems, and limitations in the ability to perform activ-
ities of daily living (ADLs) [1–3]. Adequate selection of prosthetic
components, especially the knee, is of high importance to ensure
optimal rehabilitation outcomes. In addition to restoring physio-
logical biomechanics, the knee must provide maximum safety and
stability. Microprocessor controlled prosthetic knees (MPKs) are
well-established devices to serve patients with TFA. Different

CONTACT Milana Mileusnic milana.mileusnic@ottobock.com Otto Bock Healthcare Products GmbH, Brehmstrasse 16, 1110 Vienna, Austria
ß 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/),
which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in
any way.
454 M. P. MILEUSNIC ET AL.
functioning principles of the MPKs presently available (i.e.,
hydraulic units, magnetorheologic fluid) are responsible for differ-
ent performance levels these knees offer to users [4–8]. The C-Leg
(Otto Bock Healthcare, Duderstadt, Germany) is a hydraulic MPK
and the most researched prosthetic device in clinical studies to
date with 55 publications reporting safety and performance out-
comes compared to non-microprocessor controlled knees (NMPK)
[9–27]. In contrast to most other MPKs, the C-Leg utilizes a default
stance setting, which means that it always offers high stance flex-
ion resistance to support the body weight unless its stance con-
trol is disengaged, reflecting its highest priority to provide
safety [5].
Perhaps the most clinically relevant benefit of MPKs (C-Leg) is
increased safety. Published literature suggests that falling is a
major challenge for TFAs with recurrent falls and fear of falling
leading to long-term functional deterioration, activity avoidance,
decreased mobility and independence [28,29]. Research on
MPKs, in particular on C-Leg, suggests that it reduces the num-
ber of falls, stumbles and fear of falling by up to 85%, 59% and
65.5%, respectively [9–14]. Significant improvements have also
been reported for validated clinical instruments such as the Berg
Balance Scale or the Timed up and Go test [10,15,16]. The effect
of MPKs (i.e., C-Leg) on ambulation has been extensively studied
by means of biomechanical analysis and assessments during
level walking and various obstacle parcours have reported an
increase in walking velocity [11,12,17–21]. Improved gait sym-
metry and gait pattern harmonization have also been reported
as well as more physiological swing phase control during vary-
ing speeds [14,18,22]. Transitioning from a NMPK to the MPK
resulted in faster and more symmetrical gait during ramp ascent
and descent [9,12,14,23] but also improved overall stair mobility
with the knee enabling increased loading on the prosthetic side
during step-over-step descent [11,12,24]. Significant improve-
ments in mobility have been shown in both limited (MFCL-2)
and unlimited (MFCL-3) community ambulators [11,12]. The
cumulative effect of the aforementioned benefits of MPKs con-
tribute to improved performance in ADLs and better quality of
life [11,12,25,26].
A new MPK, Genium (Otto Bock Healthcare Duderstadt,
Germany), was introduced in 2011 and is also, similar to the C-
Leg, a hydraulic default stance MPK. Advanced features (i.e., new
sensors and algorithms) enable the knee to offer a range of
new functions and functional benefits to patients [30]. A new
core function of the knee is called “Optimized Physiological
Gait.” This contains several novel features supporting more
physiological gait such as four degrees of pre-flexion at initial
contact which purportedly promotes increased stance flexion
and shock absorption, reciprocal ramp and stair descent.
Additionally, adaptive yielding control assists with stance flexion
and extension, dynamic stability control ensures appropriate tim-
ing of swing release in different directions, while swing phase
uses adaptive control to provide speed-independent knee flexion
for proper toe clearance. Furthermore, there is a new function
to support ascending stairs and crossing over obstacles, a walk
to run function, a stance function that blocks knee flexion when
the user is standing still, second modes that could be used for
programing of other activities (MyModes), and saltwater-resist-
ance which is included in the Genium X3 version. The knee also
features a novel, user-friendly software (X-Soft) which guides
prosthetists through the alignment, adjustment and coordination
of the entire system in a step by step manner. The Computer
Assisted Alignment feature provides a wireless read-out of the
Genium’s sensors in real-time and provides a graphical
representation of force application points and force vectors to
facilitate correct alignment [30,31].
It is currently unclear if the novel features of the Genium MPK
system translate into improved clinical function of the patient.
Therefore, the objective of this systematic review was to analyze
the available evidence on the effects of the Genium knee on
ambulation, mobility, ADL performance and quality of life in
patients with TFA. In particular, it was of interest to assess poten-
tial additional benefits it may provide compared to currently avail-
able conventional MPK.
Materials and methods
The systematic review was conducted according to the PRISMA
Guidelines and following the recommendations of the State-of-
Science Evidence Report Guidelines of the American Academy of
Orthotists & Prosthetists [32,33].
The databases PubMed, Cinahl and Cochrane Database of
Systematic Reviews were electronically searched for eligible stud-
ies on January 18th, 2017. Search terms used were: (Genium) OR
(knee AND microprocessor AND control) OR X2 knee. Term “X2
knee” was used in the search because it refers to the product
name used during the final stages of Genium development. It is
equivalent in terms of safety and performance to the current
Genium knee which was subsequently introduced to the market.
The results were limited to journal articles and publications since
2012. Pertinence assessment was performed by screening the
titles and abstracts in a first step and reading the full-text article
in a second step if pertinence was unclear for inclusion criteria by
one reviewer (L. R.). In case of uncertainty, a second reviewer was
consulted (M. P. M.). Publications were eligible if they were pub-
lished in the English language and included subjects with transfe-
moral amputation or knee disarticulation. Included were studies
that compared ambulation, mobility, ADLs and quality of life with
the Genium or X2 prosthetic knee to any other non-microproces-
sor controlled knee (NMPK) or MPK. Single-case studies were
excluded. Additionally, the references of identified articles were
screened for additional relevant literature.
A data extraction sheet was developed. Refinements were
made according to the applicability of the form. Data extracted
from each included study were the following: (1) characteristics of
study participants (amputation level, aetiology of the amputation,
mean age, mean time since amputation, activity level); (2) study
design (intervention, randomization, duration of treatment,
accommodation period); and (3) outcome (type of outcome meas-
ure, results). The risk of bias was evaluated by three reviewers (M.
P. M., L. R., and M. J. H.) independently by applying the State-of-
Science Evidence Report Guidelines of the American Academy of
Orthotists & Prosthetists [33]. The study design was classified
according to the Study Design Classification Scale [33] (Table 1).
The risk of bias (and therefore the quality) of the included studies
was assessed in terms of 18 potential threats to internal and 8
potential threats to external validity. Items were classified as not
applicable to the design of prosthetic studies in some cases.
Publications were classified as having “high” validity if they met
>80% of criteria, “moderate” if they met 60–80% of criteria, and
“low” if they met <60% of the criteria [45]. Internal and external
validity was rated separately while the lower of the two was used
in defining overall validity. The results of the reviewers were com-
pared and discussed in case of disagreement to reach a consen-
sus. In cases where consensus was not reached, the lead evidence
report author (M. P. M.) reached the final decision.
 GENIUM SYSTEMATIC LITERATURE REVIEW 455

The included publications were used to develop the evidence

Moderate

Moderate

Moderate

Moderate

Moderate
Moderate

tion equal between groups (IV 12), outcome measures reliable (IV 13), statistical analysis appropriate (IV 14), effect size reported (IV 15), statistical significance reported (IV 16), statistical power adequate (IV 17) and
Study design classification: S1 – meta-analysis, S2 – systematic review, E1 – randomized controlled trial, E2 – controlled trial, E3 – interrupted time series trial, E4 – single subject experimental trial, E5 – before-and-

used (IV 1), groups formed by random assignment (IV 2), groups comparable at baseline (IV 3), groups handled the same way (IV 4), control/comparison group appropriate (IV 5), intervention(s) blinded (IV 6), inclusion

free from conflicts of interest (IV 18). External treats: sample characteristics adequately described (EV 1), sample representative of the target population (EV 2), outcome measures adequately described (EV 3), outcome
measures valid for this study (EV 4), intervention adequately described (EV 5), findings clinically significant/relevant (EV 6), conclusions placed in context of existing literature (EV 7) and conclusions supported by find-
after trial, O1 – cohort study, O2 – case–control study, O3 – cross-sectional study, O4 – qualitative study, O5 – case series, X1 – group consensus, X2 – individual opinion. Internal treats: comparison or control group

criteria appropriate (IV 7), exclusion criteria appropriate (IV 8), protocol addresses fatigue and learning (IV 9), protocol addresses accommodation and washout (IV 10), attrition explained and less than 20% (IV 11), attri-
Overall V

High
High
High

High

High
Low
statements (ESs) [33]. They were grouped into four outcome
topics (ambulation, mobility, activities of daily living and quality
of life), summarizing the statistically significant findings. The ESs
Overall EV

were developed if one or more publications reported results per-

High
High
High
High
High
High
High

High
High
High
High
High
taining to a single outcome group. The ESs were then evaluated
by examining: the number of publications contributing to the ES,
the overall methodological quality of contributing studies and
# threats
External validity

whether the findings were consistent or conflicting. A level of evi-

1
0
0
0
0
0
0

0
0
0
0
0
dence for the individual ESs was defined as “high,” “moderate,”
“low” or “insufficient.” “High” evidence level was assigned to the

8

ES when multiple peer-reviewed publications of moderate to high

7

overall methodological quality reported consistent results in sup-

6

port of the statement. A “moderate” evidence level was assigned

5

when multiple peer-reviewed publications of low to moderate

overall methodological quality reported consistent results. A “low”

4

evidence level was assigned when there was a single peer-

3

ings (EV 8). “na” is a non-applicable criteria for this study type; “
” indicates fulfilled criteria; blank spaces indicate threats to the validity (criteria not fulfilled).
reviewed publication of moderate to high overall methodological

2

quality, or multiple peer-reviewed studies of low methodological

1

quality or if substantial findings among studies were inconsistent

Overall IV
Moderate

Moderate

Moderate

Moderate

Moderate
Moderate

or conflicting. Finally, “inconsistent” was used to describe insuffi-

High
High
High

High

High
Low

cient evidence to support the statement due to multiple studies

with conflicting results.
# threats
4
2
2
2
5
3
5

4
3
8
6
6

Results
18

Study selection, characteristics and risk of bias

17

The database search identified 57 articles (Figure 1). Additionally,

two articles were identified through reference searching. The titles
16

and abstracts of 51 articles were screened, 34 of which were

15

excluded for obvious non-pertinence. Seventeen full-text articles

were assessed for pertinence. After the elimination of duplicates
14

and non-eligible articles, 12 publications remained for detailed

Internal validity

13

analysis in this review (Table 2).

na
12

Six publications utilized randomized controlled cross-over

design [30,35,36,38,40,41], five publications before-and-after

11
na

design [37,39,42–44] and one study used a cross-sectional design

10

[34]. In many of the publications, the sample sizes were between

10 and 25, with the exception of one cross-sectional study that

na

9

reported data of 899 subjects. Follow-up duration ranged across

8

the publications from 2 days to 3 months. All the studies except

for one reported on subjects with the mobility grades MFCL-3

7

and MFCL-4 as defined by the Medicare Function Classification

6

Level. All subjects were long-term prosthetic users and trauma

na

5

was the most common aetiology of the amputation. All but two
na

na

na

na
na
na

4

included studies described subjects previously fitted with C-Leg

transitioning to Genium.
na

na

na

na
na
na

3

Bias risk was assessed by evaluating internal and external valid-

na

na

na

na
na
na

2

ity (Table 1). In terms of internal validity, the number of studies

scoring high, moderate and low was 5, 6 and 1, respectively.
na

na

na

na
na
na

1

None of the studies used blinding (Internal validity (IV) criteria 6)

design
Study

which represents a threat. Additional common threats to the

O3
E1
E1
E1
E5
E1
E5

E1
E1
E5
E5
E5

internal validity observed in included studies were: lack of the

Table 1. Body of evidence.

protocol addressing fatigue and learning (IV 9), no effect size

Kannenberg et al. [42]
Highsmith et al. [35]
Highsmith et al. [36]
Highsmith et al. [30]

Highsmith et al. [40]

Highsmith et al. [41]

reported (IV 15), attrition not explained and more than 20% (IV
Aldridge Whitehead

Bellmann et al. [43]

Bellmann et al. [44]

11), attrition not equal between groups (IV 12) and not free of
Hahn et al. [34]

Lura et al. [38]

Bell et al. [37]

conflict of interest (IV 18). External validity was ranked as high for
et al. [39]

all the included studies. Finally, when considering both internal

and external validity, there were five studies of high, six of moder-
ate and one of low overall validity.
456 M. P. MILEUSNIC ET AL.
Records idenfied through Addional records idenfied
database searching
(n = 57)
Records aer duplicates removed
(n = 51)
Records screened
(n = 51)
Full-text arcles assessed
for eligibility
(n = 17)
Studies included in
qualitave synthesis
(n = 12)
Figure 1. Flowchart of literature search and analysis.
Ambulation
Nine articles focused on ambulation, in particular on level walk-
ing, stairs and ramps (Table 3) [34–39,41,43,44].
Level walking
Four publications of moderate to high overall validity that investi-
gated the effect of Genium on level walking focused on biomech-
anical analyses but also stability and exhaustion commonly used
to asses prosthetic components [34,38,41,43]. Walking speed and
perceived exertion were not significantly different between
Genium and C-Leg, however numerous parameters suggest more
physiological and safer gait. Peak knee flexion angle in swing and
stance phase was significantly increased (p < 0.05) with Genium
and closer to values of able-bodied subjects, especially during
slow and medium speeds and under additional weight simulating
heavier footwear [38,43]. Speed dependency of maximum knee
flexion angle in swing phase that is an important determinant of
toe clearance was further decreased with Genium, while the peak
knee flexion during swing in small steps significantly increased
[43]. Due to four degrees of pre-flexion at initial contact, lower
vertical and horizontal ground reaction forces were seen at
weight acceptance on the prosthetic side. Increased knee flexion
moments on the prosthetic side indicating increased weight-bear-
ing were observed across different velocities but were significant
only for fast speed. Asymmetry of step length at different veloc-
ities significantly decreased [43]. While postural stability control
was not different between the knees, in terms of limits of stability
there were some differences with C-Leg significantly improving
directional stability (p  0.05) anterolaterally over the prosthesis,
whereas Genium use resulted in greater (p  0.05) posterolateral
directional stability over the sound side [41].
through other sources
(n = 2)
Records excluded
(n = 34)
Full-text arcles excluded
(n = 5)
Walking on Ramps
Five publications reported on ramp walking outcomes
[34,36–38,43]. Walking speed with Genium was evaluated in two
studies which reported either no change or improvement with
Genium [36,37]. Peak knee flexion in swing phase was significantly
increased with Genium during both ramp ascent and descent at
various speeds and inclinations indicating increased toe clearance
[37,38,43]. During ramp descent, Genium use resulted in signifi-
cantly more flexion at initial contact and higher peak knee flexion,
while peak knee flexion during ascent was not significantly differ-
ent from C-Leg [37,38]. Increased loading on the prosthetic side
representing increased weight-bearing during descent was found
by a significant increase in sagittal external knee flexion moments,
which resulted in a trend of decreased contralateral vertical
ground reaction forces and, thus, unloading of the sound side, at
weight acceptance [43]. Additional gait harmonization was also
reported in terms of reduction of knee moment asymmetry,
reduction of variance in peak knee flexion moments, increased
prosthetic limb step length, increased prosthetic limb impact
peaks and peak symmetry [36,37]. The ability of the knee to sup-
port standing on ramps was also assessed [43]. Average loading
and, thus, weight-bearing, during 3 min of standing on a 10
degree ramp was significantly increased with Genium (prosthetic
side), while hip moments on the prosthetic side were significantly
reduced, representing a reduction in hip compensation, as was
postural sway.
Walking on stairs
Five publications assessed the performance of subjects with
Genium on stairs [34,35,39,43,44]. Studies suggest that between
64% and 80% of subjects were able to ascend stars by using a
step-over-step method when using the Genium knee [34,39,44].
While being more physiological, the duration to ascend stairs sig-
nificantly increased during step-over-step pattern in comparison
to the common step-to pattern of TFA [35,44]. The ability to
Table 2. Study characteristics.
Mean
Number of Mean age Amputation Mean time since Study follow-up
subjects (years ± SD) Aetiology level amputation Activity level design period Products
Hahn et al. [34] 899 49.0 ± 12.9 Trauma (68.9%), tumour TF (80.1%) and First prosthesis since K 2 (12.5%), Cross-sectional 1 week Genium versus C-Leg (77%),
(15.4%), KD (18.9%) 21.2 ± 15.6 years K 3 (64.1%), various mechanical
vascular disease (6%), K 4 (22.8%) (hydrau\lic, brake,
other (9.7%) etc.) (23%)
Highsmith et al. [35] 20 46.5 ± 14.2 70% trauma, 20% TF 17.7 ± 15.6 years K3 RCT 3 months Genium versus C-Leg
malignancy, 10% vascular
Highsmith et al. [36] 20 46.5 ± 14.2 70% trauma, 20% TF 17.7 ± 15.6 years K3 RCT 3 months Genium versus C-Leg
malignancy, 10% vascular
Highsmith et al. [30] 25 (20 amp, 46.5 ± 14.2 (AMP); 75% Trauma, 20% TF 17.7 ± 15.6 years K3 RCT 3 months Genium versus C-Leg
5 nonamp) 57.2 ± 15.7 (NAMP) malignancy, 5% PVD
Bell et al. [37] 21 32.7 ± 5.3 Trauma TF More than 2 years K4 CBAT 112 days X2 versus C-Leg, Rheo knee,
total knee, Mauch
Lura et al. [38] 20 46.5 ± 14.2 70% trauma, 20% TF 17.7 ± 15.6 years K3 RCT 3 months Genium versus C-Leg
malignancy, 10% vascular
Aldridge Whitehead 14 31.1 Not reported TF More than 6 months Minimum K 3 CBAT 4 months X2 versus C-Leg (12) and
et al. [39] total knee (2)
Highsmith et al. [40] 20 46.5 ± 14.2 70% trauma, 20% TF 17.7 ± 15.6 years Minimum K 3 RCT 3 months Genium versus C-Leg
malignancy, 10% vascular
Highsmith et al. [41] 25 (20 amp, 46.5 ± 14.2 70% trauma, 20% TF 17.7 ± 15.6 years Minimum K 3 RCT 3 months Genium versus C-Leg
5 nonamp) malignancy, 10% vascular
Kannenberg et al. [42] 10 36.7 ± 10.2 Trauma TF 12.5 ± 9.6 years 40% K3, 60% K4 CBAT 90 d Genium versus C-Leg
Bellmann et al. [43] 11 37 ± 10.2 91% trauma, 9% tumour TF 12.5 years (range from 45% K3, 55% K4 CBAT 2d Genium versus C-Leg
3 to 34 years)
Bellmann et al. [44] 10 36 (range 22  54) 90% trauma, 10% tumour TF 10.4 years (range from 40% K3, 60% K4 CBAT 3 months Genium versus C-Leg
3 to 24 yrs)
TF: transfemoral amputation; KD: knee disarticulation; RCT: randomized controlled trial; CBAT: controlled before-and-after trial.
GENIUM SYSTEMATIC LITERATURE REVIEW
457
Table 3. Summary of evidence.
Study
Ambulation
Level walking
Hahn et al. [34]
Lura et al. [38]
Bellmann et al. [43]
Highsmith et al. [41]
Ramps
Hahn et al. [34]
Lura et al. [38]
Bellmann et al. [43]
458
Overall validity Outcomes Results
Moderate Prosthetist assessed functional benefits Responsivenessþ in functional benefits with Genium in range from 95% and 97% (i.e., symmetry, relief,
and advanced maneuvers attention, variable speed, effort.
Responsiveness in advanced manoeuvres with Genium: small steps (74.94%), walking backwards
(91.28%), obstacles (75.32%)
Patient perceived benefit Responsivenessþ in perceived benefit with Genium in range of 85–90% (obstacle, variable speed, small
step, walking backwards, visual obstruction)
High Motion analysis during level walking Increase in peak knee flexion angle in swing phase with Genium (5–7 ; except for fast with 2
M. P. MILEUSNIC ET AL.
and additional weight increase) and stance phase (1–2 , only slow and normal significant).
During weighted walk trial, increase in peak knee flexion angle with Genium in swing phase (3–6 ; all
speeds) and stance phase (2–30). Knee flexion angles with Genium closer to control values
Moderate Walking speed No significant difference.
Slow walking velocity (mean ± SD): 1.02 ± 0.14 m/s C-Leg, 1.09 ± 0.12 m/s Genium
Medium walking velocity (mean ± SD): 1.29 ± 0.14 m/s C-Leg, 1.29 ± 0.13 m/s Genium
Fast walking velocity (mean ± SD): 1.57 ± 0.18 m/s C-Leg, 1.53 ± 0.25 m/s Genium
Motion analysis at 3 different speeds Asymmetry of step length for slow and medium velocities decreased with Genium:
Step length asymmetry at slow speed (mean ± SD): 0.05 ± 0.06 m C-Leg, 0.02 ± 0.06 m Genium
Step length asymmetry at medium speed (mean ± SD): 0.07 ± 0.05 m C-Leg, 0.03 ± 0.07 m Genium
Step length asymmetry at fast speed (mean ± SD): 0.08 ± 0.04 m C-Leg, 0.05 ± 0.07m Genium
Peak knee flexion angle in swing phase nearly constant with Genium (63.8 ) and not speed
dependent. With C-Leg maximum knee flexion angle increase by 14.6 for 1m/s increase in speed.
Peak swing knee flexion angle during small steps increased with Genium (mean maximum knee
flexion angle was 46.1 with Genium versus 41.7 with C-Leg).
Switching into swing phase mode during small steps correctly done for 95.1% steps with Genium
versus 75.3% with C-Leg.
4 increase in knee flexion at initial contact with Genium than with C-Leg.
There are differences between subjects in performing an increased stance phase flexion (subgroup of
those using increased stance phase flexion with Genium increased).
Lower vertical and horizontal ground reaction forces at weight acceptance on prosthetic side with Genium.
Increased knee flexion moments (significant only for fast speed) with Genium.
High Walking velocity on even and uneven Similar results for C-Leg and Genium (no significant difference).
terrain Non-amputees completed all the tests faster than amputees, regardless of knee (C-Leg or Genium)
Borg’s rate of perceived exertion (RPE) RPE for nonamputees was higher than that of the amputee group regardless of knee
Postural stability (PS) and limits of PS: No difference between C-Leg and Genium.
stability (LOS) LOS:
C-Leg offered improved anterolateral directional control compared to Genium.
Genium offered improved control in rearward direction compared to C-Leg.
Non-amputees had better time to complete and control anteriorly, in the direction of the involved side
(also anterolaterally and posterolaterally).
Moderate Prosthetist assessed advanced maneuvers Responsivenessþ in ramp descent (70.86%), ramp ascent (74.53%)
Patient perceived benefit Responsivenessþ in perceived benefit in range of 85–95% (standing slope, slope down, slope up)
High Motion analysis on 5 and 10 ramp Increased prosthetic side peak swing knee flexion angle during 5 ramp ascent (3–8 , all 3 speeds),
and during descent (9 , only normal speed significant) when transitioning from C-Leg to Genium .
No significant differences during ascent in the stance phase between knees. During descent,
Genium knee flexion in stance increased (slow 3 ; fast 4 ). Similar results observed on 10 ramp
Moderate Standing on slope (loading, moments Increased loading on prosthetic side with Genium (353N) than C-Leg (190 N). Increased sagittal
and postural sway) external flexion moment of the prosthetic knee join axis (17.5 Ncm/kg Genium versus 9.1 Ncm/kg C-
Leg). Reduced moments of the hip centre of rotation on affected side (1.4 Ncm/kg Genium versus
4.5Ncm/kg C-Leg). Sway (total distance of centre of pressure) increased with C-Leg.
Motion analysis during 10 ascent and Increased prosthetic knee flexion during ascent and descent with Genium (ascending: Genium 56.7 ,
descent C-Leg 49.9 ; descending: Genium 72.4 , C-Leg 63.5 ). During descent, prosthetic sagittal external
knee flexion moments increased (Genium 0.85 Nm/kg, C-Leg 0.76 Nm/kg).
Trend of decrease in contralateral vertical ground reaction forces at weight acceptance
(continued)
Table 3. Continued.
Study
Bell et al. [37]
Highsmith et al. [36]
Stairs
Hahn et al. [34]
Aldridge Whitehead et al. [39]
Bellmann et al. [43]
Bellmann et al. [44]
Highsmith et al. [35]
Overall validity Outcomes Results
Moderate Walking speed Self-selected speed increased by 0.1 m/s when transition from MPKs (C-Leg, Rheo, 1.04 m/s) to
Genium (1.14 m/s)
Hill Assessment Index No difference between MPK (C-Leg, Rheo, score 11) group and Genium (score 11).
Index increased from 8.5 with mechanical knee to 11 with Genium
Motion analysis during slope descent Transitioning from MPKs to Genium: increased prosthetic knee flexion to a median 6.40  at initial
contact and 73.70 degrees in swing phase, longer prosthetic limb step, increased prosthetic limb
impact peaks, improved impact peak symmetry
High Motion analysis of 5 ramp Knee moment DoA better with Genium for slow speed up the ramp (ES medium) and down the
ramp (ES small), comfortable speed down the ramp (ES large), as well as fast speed up the ramp
(ES small). No difference between Genium and C-Leg during self-selected up and fast down the
ramp. Variance in peak knee flexion moment was reduced with Genium during uphill and self-
selected downhill, and with C-Leg during slow and fast downhill walking
Moderate Prosthetist assessed advanced Responsivenessþ in stairs down (70.52%), stairs up alternatingly (32.81%), descent (66–70%).
maneuvers
Patient perceived benefit Responsivenessþ in stairs down (approx. 65%), stairs up alternatingly (approx. 90%)
Percent of subjects ascending stairs 64.29%
alternatingly
Moderate Stair Assessment Index ascent SAI ascent improved from 5 to 11
Self-selected ascent strategy 7% with C-Leg/Total Knee and 71% with Genium self-selected step-over-step
Motion analysis Mean increase in maximum knee flexion (increase of 62 , Genium 68.2 versus conventional/C-Leg 2 )
and hip flexion (increase of 22 , Genium 75.7 versus conventional/C-Leg 53.8 ) during swing and
in knee flexion at heel strike on prosthetic side with Genium when ascending stairs.
Normalized knee mechanics with Genium during stair ascent when compared to non-amputees during
swing phase (88.4 , p ¼ 0.179), but not during initial contact (65.7 , p ¼ 0.002). Positive correlation
to prosthetic limb hip power during pull-up (r ¼ 0.641) and push-up/early swing (r ¼ 0.993)
Moderate Motion analysis during ascent and Descent: increased sagittal external knee flexion moments on the prosthetic side at midstance with
descent Genium. Similar maximum vertical ground reaction forces on contralateral side for both knees
(p ¼ 0.59)
Ascent: increased duration of stride between step-over-step (Genium) and conventional method (C-
Leg). Hip and knee range of motion on contralateral side during conventional (step-to, C-Leg)
method was higher than on the prosthetic and contralateral side during step-over-step with
Genium. During step-over-step method, loading of contralateral knee and hip reduced. Maximum
residual limb extension power on prosthetic side with Genium comparable to
nonamputees (p ¼ 0.63)
Moderate Ascent strategy 80% of subjects able to use step-over-step strategy with Genium, 20% step-to pattern. 100% of
subjects used step-to method with C-Leg
Motion analysis during ascent and Duration to climb a stair increased during step-over-step method compared to step-to.
descent Number of stairs climbed daily is 100 stair steps.
Step-to stair ascent pattern (typical for C-Leg users) results in increased hip and knee movement on
the contralateral side compared to step-over-step method (80% of Genium users use the method)
and healthy group. Increased ankle movement on contralateral side during step-over-step method
compared to healthy group. Reduced contralateral knee extension power and increased ankle joint
power during step-over-step compared to step-to method
High Stair Assessment Index Median SAI ascent score improved from 6 with C-Leg to 11 with Genium. Mean SAI ascent score for
three trails improved from 5.6, 6.0 and 5.6 with C-Leg to 9.7, 9.9 and 10.1 with Genium.
Median SAI descent score improved with Genium. Mean SAI descent score for three trails improved
from 11.0, 10.3 and 11.2 with C-Leg to 12, 11.7 and 11.8 with Genium
Time to ambulate stairs Stepping rate during ascent higher with C-leg (1.1 steps/) than with Genium (0.8 steps/s).
Step rate during descent similar between knees (1.2 steps/s C-Leg versus 1.1 steps/s Genium)
GENIUM SYSTEMATIC LITERATURE REVIEW
(continued)
459
 460

Table 3. Continued.
Study Overall validity Outcomes Results
M. P. MILEUSNIC ET AL.

Mobility
Highsmith et al. [35] High Four Square Step Test Decreased by 1.1 s (from mean 12.2 s with C-Leg to mean 11.1 s with Genium). ES small
Amputee Mobility Predictor Increased by 2 points (from median 42 with C-Leg to median 44 with Genium)
Step activity derived functional level Increased by 0.2 points (from median 3.4 with C-Leg to median 3.6 with Genium)
(K-level)
Activities of daily living
Hahn et al. [34] Moderate Prosthetist assessed advanced Responsiveness in range of 72–82% (i.e., door test, carrying objects, obstacle and uneven terrain,
manoeuvres toileting)
Patient perceived benefit Responsiveness in range of 80–90% (heavy load, busy crowd, trolley, heavy door)
Highsmith et al. [30] High Continuous Scale Physical Functional When comparing Genium to C-Leg, the total score improved by 7.4% ( ES ¼ 0.28; C-Leg 55.2,
Performance Genium 59.6).
CS-PFP10 Improvement in 3 domains: upper-body flexibility (7.0%, ES ¼ 0.45), balance (7.6%, ES ¼ 0.28),
endurance (8.4%, ES ¼ 0.32).
Positive trend in 2 domains: upper-body strength (5.4%), Lower-body strength (8.1%).
When comparing non-amputees with amputees:

1/5 domains significantly better for non-amputees when compared to Genium users (endurance).

4/5 domains significantly better for non-amputees when compared to C-Leg users (endurance,
lower-body strength, upper-body strength, balance and coordination)
Highsmith et al. [35] High ADLs questionnaire Improvements in perceived function and safety in 3 of 5 of the domains: Family and Social Roles,
Leisure Time Activities; Mobility and Transportation; Other activities
No difference in 2 domains: Personal Care and Dressing; Health-related Exercise
Kannenberg et al. [42] Low ADLs questionnaire Subjects report of clinically relevant:

gain in safety with 27 out of 45 of ADLs (60%) ;

decrease in difficulty with 24 out of 45 ADLs (53%)
Improvements seen in the categories of family and social life, mobility and transportation
Quality of life
Highsmith et al. [40] Moderate Prosthetic Evaluation Questionnaire Improvement in 4 out of 9 scales:
Perceived Response,
Social Burden, Utility, Well-Being. Positive trend in 2 out of 9 scales: Appearance and Sounds.
Unchanged 3 out of 9 scales: Ambulation, Frustration, Residual Limb Health.
7/10 items related to physical performance were improved (comfort standing, walking in close spaces,
going down stairs, walking steep hill, walking slippery surface, satisfaction when walking). 3/10 not
significant: feeling off balance, satisfaction, satisfaction with training
SAI: stair assessment index; SSWS, FPWS, AM, NAM; þResponsiveness: percentage of subjects showing ‘clear’ or ‘very clear’ benefit; DoA: degree of asymmetry; ES: effect size.
Significant (p < 0.05).

utilize the step-over-step ascent method resulted in the more
physiological increase in knee and hip range of motion on the
prosthetic side and decrease of compensations on the sound side
[39,43,44]. Increased ankle movement on the contralateral side
was also reported and comparable to able-bodied subjects
(p < 0.01) [44]. During the step-over-step method, loading of the
contralateral knee (p < 0.05) and hip (p ¼ 0.33) was reduced [43].
While the maximum residual limb extension power on the
prosthetic side with Genium was increased and comparable to
able-bodied subjects (p ¼ 0.63), a reduction was measured for
contralateral knee extension power (p ¼ 0.13) [43,44]. Finally, ankle
joint power on the contralateral side was increased with the step-
over-step method [44]. Stair assessment index (SAI) was used in
two studies reporting significant qualitative improvements during
stair ascent represented by an average score increase from 5 or 6,
respectively, with the C-Leg (5: “without rail or assistive device,
step-to”; 6: “with rail or assistive device, skipping step pattern”) to
11 with Genium (“with rail, step-over-step pattern”) [35,39]. A sig-
nificant improvement was also reported for the SAI descent score,
but much smaller in magnitude [35]. Duration to descend stairs
was unchanged when transitioning from C-Leg to Genium [35].
Finally, while sagittal external knee flexion moments on the pros-
thetic side at midstance were significantly increased with Genium,
vertical ground reaction forces on the contralateral side were not
affected [43].
The ES was defined as “Genium results in more physiological
gait, unloading and reduced compensatory mechanisms of the
sound side compared to conventional MPKs.” Due to nine publica-
tions of high to moderate quality and consistent findings, a “high”
evidence level was assigned to the statement.
Mobility
One article of high overall validity addressed the effect of
Genium on subjects’ mobility (Table 3) [35]. Four square step test
completion times were significantly reduced (small effect size).
Furthermore, transitioning from C-Leg to Genium resulted in the
significant increase in the Amputee Mobility Predictor (AMP) by 2
points. Highsmith et al. used StepWatch (Orthocare Innovations.
Edmonds, Washington) devices to record step activity derived
functional levels [35]. Following two weeks of recording of step
activity, the data was uploaded into the Galileo cloud whose soft-
ware generated the activity report and functional level (MFCL or
“K”-level). The functional level calculation was based on multiple
factors, including cadence variability, potential to ambulate,
ambulation requirement and the clinician’s observation of func-
tional level. The calculated average functional level was signifi-
cantly improved from 3.4 with C-Leg to 3.6 with Genium.
The following ES was developed: “Genium improves mobility
of unilateral TF amputees when compared to conventional MPKs.”
Due to the existence of only one high quality publication, the evi-
dence level “low” was assigned to the ES.
Activities of daily living
Effect of Genium use on ADL performance was reported in four
publications having an overall validity ranging from low to high
(Table 3) [30,34,35,42]. Scores on a validated instrument, short
form Continuous Scale – Physical Functional Performance (CS-
PFP10), was significantly improved when transitioning from C-Leg
to Genium. Significant improvements were shown in three
domains (Upper-body flexibility, Balance and Endurance) and posi-
tive trends in two domains (Upper-body strength and Lower-body
GENIUM SYSTEMATIC LITERATURE REVIEW 461
strength). Able-bodied controls demonstrated significantly better
CS-PFP10 scores in only one domain (Endurance) as compared to
TFA using Genium but in four domains (Endurance, Lower-body
strength, Upper-body strength, Balance and coordination) as com-
pared to the same TFA using C-Leg. In two other studies, a non-
validated questionnaire was used to evaluate the patient-per-
ceived safety and difficulty of 45 ADLs with Genium as compared
to C-Leg [35,42]. Both publications report significant improve-
ments in perceived safety and difficulty, especially in activities
dealing with Family and Social Role and Mobility and
Transportation. Kannenberg et al. reported clinically relevant gain
in safety for 27 out of 45 of ADLs (60%) and greater ease of per-
forming 24 out of 45 ADLs (53%) [42]. Finally, prosthetists
appraised that over 70% of tested Genium users showed ‘clear’ or
‘very clear’ improvement in the ability to perform advanced
manoeuvres (i.e., door test, carrying objects, obstacle and uneven
terrain, toileting) [34]. Similar feedback was obtained from the
patients themselves, who reported benefits in performing activ-
ities such as carrying heavy loads, navigating in busy crowds,
pushing a trolley or heavy door in 80–90% of cases.
The following ES was developed: “Genium use improves per-
formance in and safety of conducting ADLs compared to conven-
tional MPKs.” Due to three high or moderate quality publications
with consistent findings, it was decided that a single low-validity
publication should not be allowed to dilute the overall evidence
level. Therefore, a high evidence level was assigned to the
statement.
Quality of life
Quality of life was addressed in one article having moderate valid-
ity (Table 3) [40]. Significant improvements in Prosthetic
Evaluation Questionnaire (PEQ) domain scores were reported after
3 months when transitioning from C-Leg to Genium. Four scales
were significantly improved: Perceived Response, Social Burden,
Utility, and Well-Being (all p < 0.05), while positive trends were
observed in two scales (Appearance and Sounds). No difference
was found in the scales of Ambulation, Frustration and Residual
Limb Health. Seven out of ten PEQ items related to physical per-
formance were significantly improved with the Genium (comfort
while standing, walking in tight spaces, walking down stairs, walk-
ing steep hills, walking slippery surfaces, satisfaction with walking;
p < 0.025). An ES was developed stating “Genium further improves
prosthesis-related quality of life of unilateral TF amputees as com-
pared to conventional MPKs.” Due to the availability of only one
moderate-quality publication, the evidence level “low” was
assigned to the ES.
Discussion
Summary of the evidence
Twelve publications reporting on TFAs (MFCL-3 and 4) predomin-
antly transitioning from C-Leg to Genium were included in the
systematic review. The overall quality of the evidence was moder-
ate to high with the exception of one article having low meth-
odological quality. The studies were selected and their results
evaluated to assess the effects of Genium on ambulation, mobil-
ity, ADL performance and quality of life in above-knee amputees
as compared to conventional MPK and NMPK.
The effect of Genium on ambulation was assessed for level
walking, ramps and stairs. While there was no significant influence
on the speed of conducting those activities, biomechanical find-
ings suggest that gait kinetics and kinematics as well as several
462 M. P. MILEUSNIC ET AL.
spatiotemporal parameters were more physiological with Genium
than with conventional MPKs. The evidence supports more
physiological knee flexion in both stance and swing phase, repre-
senting increased weight-bearing and improved toe clearance,
reduction of speed-dependency of maximum knee flexion angle
in swing phase, representing more consistent speed-independent
toe clearance, improved symmetry of step length, as well as
increased toe clearance especially during small steps and simulat-
ing heavier footwear during level walking. The new stair function
enabling up to 80% of subjects to perform step-over-step stair
ascent resulted in more physiological movement patterns on the
prosthetic side but also significant reductions in compensatory
movements on the sound side. While weight acceptance on the
prosthetic side was more comfortable as shown by reduced
ground reaction forces, the flexion moments on the hip and knee
suggest greater prosthetic side loading, i.e., weight-bearing. This
finding was statistically significant for fast walking. Gait analyses
on ramps showed increased maximum knee flexion angle and,
thus, foot clearance similar to those measured on the sound side.
The new standing function resulted in significantly more loading
and, thus, weight-bearing, on the prosthetic side during standing
on ramps.
The reported improvements in kinetic gait parameters as well
as loading symmetry, representing a more even distribution of
the body weight with Genium may be clinically relevant.
Published evidence on the amputee population suggests that
asymmetry, especially in loading is related to long-term conse-
quences to the locomotor system resulting in secondary physical
complications among lower limb prosthetic users, such as knee
osteoarthritis [46,47]. A recent systematic review examining the
risk of degenerative changes in lower limb amputees concluded
that 56% of amputees suffer from back pain, 35% of patients
from osteoarthritis of the sound knee, and 15% and 20% from hip
osteoarthritis on the prosthetic and sound side, respectively [47].
Reduced bone density was observed in 87% of patients in their
prosthetic side hip, and all amputees exhibited residual limb
muscle atrophy. The prevalence of back pain and knee osteoarth-
ritis was shown to increase in more proximal amputations. Similar
conclusions were reached in a review by Gailey et al. [46].
Asymmetry, especially in terms of loading, has been identified as
a major cause for those observations. Long-term exposure to high
repetitive loading forces leads to the degeneration of weight-
bearing joints that can contribute to joint pain [48,49]. Burke
et al. attributed gait asymmetry and increased load to the intact
limb to the higher incidence of osteoarthritis in long-term pros-
thesis users [50]. While optimized prosthetic fitting may reduce
these risks, prosthetic components such as the Genium knee, may
do so as well by facilitating a more physiologic gait as demon-
strated by the aggregate results of the included studies
[36–39,43,44]. More symmetrical gait and more physiological,
more evenly distributed loading of the sound and prosthetic sides
could reduce the long-term risks of secondary physical complica-
tions in prosthetic wearers.
Validated clinical instruments, such as the AMP and MFCL-level
derived from StepWatch, recordings were used to assess mobility
with Genium. Significant improvements were observed. However,
conclusions regarding clinical relevance cannot be drawn due to
lack of established reference values for the lower limb amputee
population. A validated instrument assessing ADL performance
further suggested that Genium reduced the functional gap
between able-bodied subjects and prosthetic users. It is interest-
ing that significant improvements were observed in upper-body
flexibility that researchers attributed to greater lower body
stability and reduced necessary concentration on lower extremity
function as the foundation for performing upper extremity activ-
ities. Significant improvements in both perceived endurance and
balance measured by a non-validated ADL questionnaire were
supported by the same performance-based validated instrument
(CS-PFP10). Not a single item of 45 activities was rated easier or
safer to perform by subjects when done with a conventional MPK.
Many activities were improved with Genium both in terms of
safety and ease of execution. Prosthesis-related quality of life as
measured by the PEQ was significantly improved when transition-
ing from C-Leg to Genium, particularly in the subscales of
Perceived Response, Social Burden, Utility and Well-Being. Finally,
approximately 80% of previous C-Leg users preferred Genium
after training with and using it for approximately 3 months.
The reviewed results were used to develop four ES. The state-
ments related to the ability of Genium to improve gait quality,
and that regarding safety of and performance in ADL execution
were evaluated as having “high” evidence levels. The other two
statements assessing the ability of Genium to affect quality of life
and mobility were rated as “low evidence level” due to the avail-
ability of a single high or moderate quality study only. Therefore,
additional studies are needed to further corroborate the evidence
of these two statements.
It should also be noted that in most studies subjects were spe-
cifically trained in the use of the Genium features and assessed
for accommodation prior to assessing outcomes. One study
reported for example that, when using the Genium, subjects
required 0.7 ± 1.0 additional visits (0–4) for post-fitting prosthetic
adjustments. Subjects required additional 3.0 ± 1.8 visits (1–8) with
the study physical therapist for functional training to master new
features with the Genium knee, including stance locking (i.e., the
so-called intuitive stance), reciprocal stair ascent, obstacle cross-
ing, and stance flexion feature. Subjects required 67.9 ± 27.1 d
(18–119 d) to successfully complete the accommodation test with
the Genium knee [30]. Results and outcomes reported in that
studies are the result of the reported accommodation and train-
ing. Outcomes observed in the present review may not be gener-
alizable in cases where training was not provided.
Limitations
Several systematic reviews conducted so far on various prosthetic
components concluded that evidence in prosthetic research is of
mostly low to moderate quality [51,52]. While very much true for
older studies, it should be acknowledged that several attempts
were made in recent years to improve the quality of studies in
prosthetics. This trend is already apparent in the evidence
reviewed in this systematic review with the oldest article pub-
lished in 2012, resulting in most articles having moderate to high
quality. Randomization (of the order of interventions) was imple-
mented in several reviewed studies to reduce bias. On the other
hand, the absence of blinding was still observed in all included
studies. While subject blinding may be difficult in prosthetic
research, blinding of assessors should be possible in future stud-
ies. The acclimation period when transitioning from MPKs (pre-
dominantly hydraulic knees) to Genium in most publications was
three months or longer. This was considered sufficient as studies
assessing transitioning from NMPKs to MPKs report similar dur-
ation of acclimation [9,53]. The acclimation period in a few studies
was only two days. While this period is short, the conclusions
reached in the studies were similar to those reached in studies
having longer acclimation periods [37,38].

The sample size in most publications was between 10 and 25
subjects with the exception of a larger cross-sectional study, yet
samples were sufficient to obtain several significant results.
Internal validity of the reviewed studies could be further
improved by including information addressing fatigue and learn-
ing, effect size calculation and reporting attrition rate as well as
conflict of interest.
The order in which the effect of prosthetic knees was assessed
varied across studies. In all the studies, subjects entering the
study were using the C-Leg (or NMPK). Five publications that uti-
lized a controlled before-and-after design assessed the patients
with the C-Leg (or NMPK) prior to fitting and subsequent assess-
ment with Genium [37,39,42–44]. In six publications where a
randomized order controlled design was used, the C-Leg accom-
modated patients were randomized to either the C-Leg or
Genium and allowed to accommodate prior to their first assess-
ment [30,35,36,38,40,41]. After the cross-over, they were fitted
with the other device prior to re-assessment. Therefore, the order
in which prostheses were assessed varied and, therefore, an order
effect on the results was reduced.
Conclusions
Most of the reviewed evidence reports on active, community
ambulating transfemoral amputees transitioning from C-Leg to
Genium. The quality of the evidence is predominantly moderate
and high showing improvements in outcomes when compared to
conventional MPKs and NMPKs. Accommodation with and use of
Genium resulted in more physiological gait during level walking,
ramp and stair ambulation, as well as reduced loading and com-
pensatory mechanisms of the sounds side. More symmetrical gait
and more physiological, evenly distributed loading of sound and
prosthetic sides could perhaps contribute to reducing the long-
term risks of secondary physical complications in prosthetic users
(i.e., osteoarthritis, osteoporosis). Mobility and functional levels
were both significantly improved, while positive effects on per-
formance in and safety of activities of daily living were demon-
strated by both performance-based and patient-reported outcome
measures. Significant improvements in quality of life, as measured
by the PEQ, were also reported. At this time, it is unclear if results
are generalizable beyond unilaterally involved, community ambu-
lators with TFA.
Acknowledgements
M. P. Mileusnic, L. Rettinger and M. J. Highsmith were responsible
for reviewing the bias risk and for drafting the manuscript. A.
Hahn provided input during drafting of the manuscript and pro-
vided critical review.
Disclosure statement
M. J. Highsmith has no financial disclosures related to preparation
and drafting of this manuscript. The other authors (M. P.
Mileusnic, L. Rettinger and A. Hahn) are employees of Otto Bock
Healthcare Products (Vienna, Austria), the manufacturer of the
MPK subject to this review. The company did not influence the
design and execution of the review nor the interpretation of
results. However, Ottobock allowed the authors to work on this
systematic review during their regular office hours and to use the
company’s office equipment (computers, software, Internet access,
database access).
GENIUM SYSTEMATIC LITERATURE REVIEW 463
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