Ambroise GENUX 2 ORTHOSIS User manual

MANUAL GENUX®2 ORTHOSIS
Twekkeler Es 24, 7547 SM Enschede, The Nederlands tel:
[phone] | [email protected] | www.ambroise.nl
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USER
PRODUCT INFORMATION
PROFESSIONAL

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TABLE OF CONTENTS
USER ..................................................................................................................................................................................................................................................................................1
TABLE OF CONTENTS ................................................................................................................................................................................................................................................2
GENUX 2 KNEE ORTHOSIS .......................................................................................................................................................................................................................................3
USER INFORMATION...................................................................................................................................................................................................................................................3
WHEN A GENUX 2? ...............................................................................................................................................................................................................................................3
WHEN NOT TO USE A GENUX 2?....................................................................................................................................................................................................................3
TREATMENT IS NECESSARY ................................................................................................................................................................................................................................3
THE GENUX 2 –UNLOADING...........................................................................................................................................................................................................................4
THE GENUX 2 –LONG LEVER ARMS & LIGHT WEIGHT ...........................................................................................................................................................................4
THE GENUX 2 –DYNAMIC 4 POINT BALANCING .....................................................................................................................................................................................5
THE GENUX 2 –ADJUSTABLE KNEE JOINT...................................................................................................................................................................................................6
THE GENUX 2 –CUSTOM MADE BASED ON PHOTO MEASUREMENT...............................................................................................................................................6
DONNING THE GENUX.......................................................................................................................................................................................................................................7
DOFFING THE GENUX 2......................................................................................................................................................................................................................................8
FIRST USE OF THE GENUX 2............................................................................................................................................................................................................................ 10
ACTIVE USE OF THE GENUX 2........................................................................................................................................................................................................................ 10
PHOTO MEASUREMENT.................................................................................................................................................................................................................................... 10
DELIVERY ................................................................................................................................................................................................................................................................ 11
GETTING USED TO THE GENUX 2................................................................................................................................................................................................................ 11
CHECK-UP.............................................................................................................................................................................................................................................................. 11
THE ROLE OF THE PHYSIOTHERAPIST, MORE THAN JUST PRACTICE ............................................................................................................................................. 11
GENUX 2 KNEE ORTHOSIS .................................................................................................................................................................................................................................... 12
PRODUCT INFORMATION............................................................................................................................................................................................................................... 12
ITEM NUMBERS ..................................................................................................................................................................................................................................................... 12
450000 | Genux 2 lateral | left ............................................................................................................................................................................................................................. 12
450001 | Genux 2 lateral | right........................................................................................................................................................................................................................... 12
450002 | Genux 2 medial | left............................................................................................................................................................................................................................. 12
450003 | Genux 2 medial | right .......................................................................................................................................................................................................................... 12
MAINTENANCE .................................................................................................................................................................................................................................................... 12
WHAT TO DO WITH PROBLEMS................................................................................................................................................................................................................... 12
REPLACEMENT OF SPARE PARTS.................................................................................................................................................................................................................... 12
ADJUSTING THE ORTHOSIS............................................................................................................................................................................................................................. 12
GENUX 2 KNEE ORTHOSIS .................................................................................................................................................................................................................................... 13
INFORMATION FOR THE PROFESSIONAL .................................................................................................................................................................................................. 13
CONTRAINDICATIONS:.................................................................................................................................................................................................................................... 13
ADJUSTMENT OF THE PELOTTE CARRIER.................................................................................................................................................................................................. 13
PHOTO MEASUREMENT GENUX .................................................................................................................................................................................................................. 14
PLACING PELOTTES............................................................................................................................................................................................................................................ 15

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GENUX 2 KNEE ORTHOSIS
USER INFORMATION
The GENUX 2 is a knee orthosis for people suffering from instability of the knee, caused by for example arthrosis. The GENUX 2
stabilizes the knee and relieves the affected and often painful side of the knee. With the help of a GENUX 2, the user is encouraged to
use all remaining residual function. An unstable knee can make walking difficult. There is insufficient support in the leg and sometimes
also considerable pain.
WHEN A GENUX 2?
An unstable knee can have many causes. These include the effects of osteoarthritis. The knee then gives way
into an x-position (valgus: knee pointing inwards, lower leg pointing outwards) or in an o-position (varus:
knee pointing outwards, lower leg pointing inwards). The GENUX 2 helps to compensate this. This usually
leads to a quick improvement in stability and reduction of complaints.
The GENUX 2 can also be used in other knee disorders, such as hyperextension (overstretching) of the knee
in early stages.
WHEN NOT TO USE A GENUX 2?
-The GENUX 2 is a knee brace. It can offer stability and some correction for an unstable knee.
However, in severe cases of knee instability quite often the ankle will show misalignment as well.
The GENUX 2 is not designed to stabilize the ankle, so caution is required in cases of severe knee
misalignment.
-The GENUX 2 is designed for cases of mild hyperextension. In cases of severe hyperextension (>
20°) the external loading can increase to very high levels. We advise not to use the GENUX 2 in
those cases, but to choose a UTX POST orthosis.
-The maximum body weight for use of the GENUX 2 is 100 kg.
-In cases of knee flexion contractures > 10º the GENUX 2 is not recommended.
-Non-correctable valgus / varus > 10º can lead to considerable increase of the necessary stabilising
forces, since the moments of force in the frontal plane increase with increasing instability angle. If
we are able to correct the leg back to a (semi) neutral alignment we can keep the forces within
tolerable limits, but if correction is not possible, so is limiting the forces.
-Full instability: valgus and varus. The GENUX 2 works one way only in the frontal plane. It stabilises or corrects either a valgus
instability (in which case the brace is used laterally) or a varus instability (in which case the brace is used medially). Therefore it is
not possible to use this brace in cases of instability both ways.
-The GENUX has a circular calf strap around the lower leg. That strap might influence the flow of blood from the lower leg upwards.
Patients with a high risk of thrombosis are advised to consult their physician about that in their case.
TREATMENT IS NECESSARY
A leg which cannot remain sufficiently stable, can lead to insecurity, falling, but also pain. This may hinder your mobility. It is important to start
treatment in order to minimize further damage to the internal structures of the knee and to prevent falling incidents. Always consult your
physician about the best options in your individual case.
Figure 1: The Genux 2

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THE GENUX 2 –UNLOADING
What does unloading mean?
The GENUX 2 is designed to unload the affected side of the knee. Unloading means the reduction of the loading forces inside the knee at one
side of the knee.
In cases of osteoarthritis, usually one side of the knee is more affected than the other. At the most affected side more cartilage is damaged
and/or gone. The knee drops that way which makes this part more heavily loaded, leading to an increase of the associated problems. To prevent
worsening of instability, that side of the knee must be unloaded. This usually leads to a rapid reduction of complaints.
The pain is often aggravated by the occurrence of inflammatory reactions on the affected compartment. The loading levels on the inflamed
cartilage of the compartment need to drops below a certain level in order to be able to reduce the inflammatory reaction. Unloading of the
affected side of the knee (by the GENUX 2 knee orthosis) can therefore create a favourable condition to start the reduction of inflammatory
responses. This can also have a positive effect on reducing pain. This effect is noticeable only after a few days.
How does the GENUX 2 unload
The GENUX 2 unloads the knee by (partly) pushing the leg back into its neutral alignment. The frame of the brace is shaped to your leg in a
manner that it doesn’t allow for the knee to move outwards (in case of varus instability) or inwards (in case of valgus instability). When you
extend your leg with the GENUX 2 on, the frame of the brace straightens your
leg (in a frontal view). It is strong and rigid enough to create the necessary
moments of force to do that.
With your leg straightened the drop of your knee to the affected side is
counteracted. As a result the crevice in your knee on that side will open up
leading to a reduction of the forces on that side. This is called unloading.
Quite often it is sufficient to just partly realign the leg back to neutral. A full
correction of the leg would require considerable forces of the brace to the leg,
making it uncomfortable to wear, whereas the loading on the affected side will
drop to zero as soon as a crevice is created. A larger crevice (more correction)
does not reduce the loading on the affected side, but does increase the loading
of the brace to the leg. Therefore we try and correct as much as possible, but
not too much.
THE GENUX 2 –LONG LEVER ARMS & LIGHT WEIGHT
The GENUX 2 is a relatively long brace, compared to a lot of other knee
braces on the market. We do that to keep the brace light weight and
comfortable. It does sound a little contradictory, but actually it’s just plain
mechanics. A long brace has long lever-arms. With a long lever arm you can
create higher moments of force with lower forces. That means that by exerting lower forces from the brace on the leg we create higher
moments of force around the knee. These moments of force are what the brace actually needs to deliver to make it work.
The lower forces of the brace on the leg make it more comfortable, but also allow us to optimize the weight of the brace without compromising
the rigidity of the structure of the brace. So, in short: it works better and is more comfortable because it’s longer.
Figure 2: Schematic principle of unloading. In the left image the left side of
the joint shows degeneration, leading to pain and misalignment. By adding a
4 point force system in the right image, the joint is pushed back into neutral
alignment, leading to an opening up of the joint on the affected side.

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THE GENUX 2 –DYNAMIC 4 POINT BALANCING
The GENUX 2 is the first brace in the world with Dynamic 4 Point Balancing. This is a truly unique systems that we’ve developed with various
positive effects. Dynamic 4 Point Balancing is a system in which the straps of the brace just above and just below the knee are connected to
each other by means of a smart cable. This cable runs posteriorly of (behind) the centre of
rotation of the knee joint. As a result the cable allows the straps to become loose in flexion,
but to tighten in extension. The positive effects of this system are subsequently described below:
Extension Preloading
When the knee extends, the straps of the interface just above the knee and just below
the knee tighten themselves because the cable, that connects these two straps and
that runs behind the centre of rotation of the knee joint gets tightened. With this
tightening of these two straps the soft tissues of the leg at all 4 interface locations of
the brace are compressed/tensioned, gradually ‘gripping’ the brace tightly to the leg.
When the leg reaches full extension brace and leg form a rigid combination with a
direct transfer of the stabilising forces from the brace to the leg.
This is (and feels!) much more stable because you prevent that the brace, once you
start loading the leg by standing on it is first pressed into the soft tissues, before it
actually does anything, allowing the leg to give way a little.
Extension Triggering
Patients that need to control a hyperextension feel the built up of the correction
forces of the straps just below and just above the knee increasing before their foot
is on the floor and the leg gets loaded by body weight. That triggering reduces the
active component of pushing the knee in hyperextension that patients often have. They do actively push their knee into
(hyper)extension, because the body needs to feel that the knee is stable enough to start loading the leg. There are no sensors in the
leg that accurately tell the brain the alignment of the leg, so feeling the ‘end’ of extension (even if that’s in hyperextension) is the
only trigger left. With the extension triggering the brace gives that signal a lot earlier, combined with a more rigid grip of the brace
to the leg leading to a reduction of the excessive extension forces.
Force Balancing
Because of the cable that connects the straps around the knee, the force in these straps need to be equal. If not, the cable is pulling
the strap with the lower force until the forces are equal again. This balancing of these two forces ensures that not one is taking most
of the load, whereas the other does little to nothing. Furthermore, since the lever arms of the lower leg are made equal to that of
the upper leg, the forces on the pelottes (interfaces) at the top and bottom of the brace are equal as well and equal to the balanced
strap force. This is a very nice feature, because we now never have the situation in which one interface doing a lot more than another.
This prevents excessive interface forces that can be uncomfortable. But it also means that we know a lot more precise what the
maximum loading on the system will be and that allows for a huge step in optimization of the weight of the orthosis.
Sitting Comfort
A very tight, snug fitting of the brace is nice in having a direct action of the brace to what the leg is doing. However it’s not so nice
in sitting, particularly if we realise that the shape of the leg (due to a different alignment of muscles and tendons in a 90° flexed
position, compared to a straight leg) is somewhat different. For instance, the upper leg just above the knee is narrower but somewhat
higher (in front side to back side of the leg) in sitting than in stance. The coupling of the straps just around the knee loosens these
straps in bending the knee. This allows for a great increase in comfort during sitting.
Anti slipping
In the earlier model (the GENUX I) we’ve proven the need for skin migration underneath the brace just above the knee at the front
side of the leg in flexing the knee to prevent the skin from pulling the brace downwards (see https://www.ambroise.nl/en/leg-
Figure 3: When the knee extends the cable of the
Dynamic 4 Point Balancing System pulls the straps just
above and just below the knee tighter to the leg. When
the knee flexes, the opposite happens: the straps are
loosened.

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orthoses/GENUX-knee-orthosis/). In the GENUX 2 we’ve realised the freedom to migrate the skin underneath the brace by loosening
the strap of the interface just above the knee (as well as the one just below the knee). As a result of that the contact force of the
interface at that location drops to (almost) zero in flexing. This logically results in a drop in the contact-friction forces and thus in the
skin trying to pull the brace downwards in flexion. Combined with a very smooth non-stick surface of the interfaces this ensures that
the GENUX 2 stays in place on the leg.
THE GENUX 2 –ADJUSTABLE KNEE JOINT
The GENUX 2 knee joint has an adjustable extension stop. With that adjustment you can change the alignment in flexion with 15 ° This is
important because for many patients a slightly more flexed alignment can be less painful. However, too much flexion is more tiring, because
you require more muscle activity to stabilise the knee. And this increased muscle activity also leads to an undesired increase in forces in the
knee. Also for patients with a knee hyperextension it can be very meaningful to be able to adjust the extension stop in the brace.
THE GENUX 2 –CUSTOM MADE BASED ON PHOTO MEASUREMENT
The GENUX 2 is a custom made brace, based on our unique photo measurement system. With this quick, clean and easy system we are able
to make a brace the is specially shaped to your leg. A proper fitting for a knee brace is important, because in general such a device needs to
be worn for many hours a day. Both OA as hyperextension (the two main indications for the GENUX 2) are incurable conditions. This means
that if you need an orthosis because of this condition, it is very likely that you will need that orthosis permanently (or at least until your
condition has deteriorated even further). A brace that gives you support needs to be comfortable, because you’ll need to wear it most of the
day, every day.
We advise that you consult your local orthotist to ensure that with the proper fine-tuning done by him your brace is optimally adjusted to
your needs.
Advantages of the GENUX 2
Active and dynamic correction of the leg.
Dynamic 4 Point Balancing
Adjustable knee joint
No limitation of the normal gait.
Light weight & High comfort of wearing.
Custom made and therefore great fitting.
WHAT DOES THE DELIVERY PROCESS OF THE GENUX 2 LOOK LIKE?
The GENUX 2 is an individually custom made orthopaedic device. Your doctor (physiatrist or orthopaedic surgeon) will decide together with
you and the orthotist if a GENUX 2 will benefit you. They can also assess which type of GENUX 2 is best for you. After choosing a GENUX
2, your orthotist can start preparing for your individual GENUX 2. Depending on your insurance situation, he will ask for an authorization
from your insurance company as a first step. If your insurer agrees, your orthotist will call you for the intake. At this appointment, the orthotist
will take pictures of your leg against a special background. These photos are used to collect the correct shape and size information about your
leg. The orthotist also collects all the information needed for a correct order, for example, the required type and your personal information.
With this information, the orthotist can order a GENUX 2 at Ambroise. At Ambroise in Enschede, your GENUX 2 is then manufactured for
you, based on the data provided by the orthotist. First of all, using the specially developed software, a technical drawing is made of your
Figure 4: The Genux 2

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GENUX. This drawing is used during the production process to choose the right sizes and shapes. When the GENUX 2 is complete, Ambroise
sends the orthosis to the orthotist. Your orthotist will then invite you to an appointment where you can fit the knee orthosis. During this
appointment, the orthotist will also need to adjust some elements of your GENUX 2. For example, setting the lengths of the straps, but the
orthotist also looks at the level of correction achieved with the GENUX 2. If all settings are right, you can take the GENUX 2 home so you
can practice using it.
DONNING THE GENUX
The GENUX 2 can be worn either underneath clothing or on top of clothing. When worn underneath clothing we advise to wear a sleeve
under the brace. There needs to be migration underneath the GENUX at the front side of the upper leg (see Anti-Slipping above). The human
skin can have a relatively high coefficient of friction, making slipping of the interfaces with respect to the skin more difficult. The sleeve can
ensure a low coefficient of friction between sleeve and pelottes. Furthermore the sleeve is an extra protective cover for sensitive skin. If you
order a GENUX 2 a sleeve will be supplied. You can order spare sleeves in various designs on our web shop.
When donning a GENUX 2 please follow the steps as described below
Step 1 Put on the calf strap
A) First, the GENUX 2 calf strap must be donned. Step with the foot through this circular strap.
B) Make sure that the clip is on the front of the calf strap and facing down.
C) Secure the calf strap just above the widest part of the calf and just below the knee
D) Evenly tighten the two ends of the strap. (see Figure 5)
Step 2 Put the GENUX 2 on the leg
A) Donning the GENUX 2 is best done in sitting position, with the knee bent in 90°.
B) Now also bend the GENUX 2 with your hands till 90°.
C) Now push the GENUX 2 frame on your leg.
Step 3 Attach the GENUX 2 to the calf strap
A) The calf strap and GENUX 2 are connected by means of a plastic clip. Click the two ends of the clip
together (see Figure 6).
B) The elastic of the calf strap will now pull the GENUX 2 upwards.
Step 4 Push the GENUX 2 down
A) Push the GENUX 2 against the tension of the elastic down until the interface just above the knee t
ouches the upper leg.
Step 5 Attach the strap just below the knee
A) The first strap that is attached is the strap that is just under the knee.
B) Hook the clip into the connector.
C) Close the clip. (See photo series ‘closing the clips’ on the next page)
Step 6 Attach the lower strap
A) Attach the lower strap in the same way as the strap just below the knee
Step 7 Attach the upper leg straps
A) Attach the upper leg straps in the same way as the strap just below the knee.
Step 8 Adjust strap tension (B1 and B4, top and bottom strap)
Figure 5: Putting on the calf strap
Figure 6: Attach GENUX 2 to calf strap

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A) The straps can be adjusted by means of the Velcro closure.
B) The double backing hook-to-hook piece can be shifted to a new location at your liking, to ensure that the end of the strap is
fully gripping.
Step 9 Adjust strap tension (B2 and B3, strap just above and just below the knee)
A) The straps B2 (the one just above the knee) and B3 (The one just below the knee) should be adjusted with the knee fully
extended, for instance while standing
B) Because these straps are connected to each other they need to be adjusted the same amount for each strap.
C) Make sure the marker on the connecting cable is always at the level of the knee centre.
D) The strap are loosened when flexing the knee. Adjusting them in full extending / standing ensures you feel what the maximum
tension of the straps will be
E) When fully tensioned in flexed position, the straps can increase in tension on the leg considerably when the brace is stretched.
This might cause discomfort or worse. Please therefore do not tension the straps in sitting position.
F) If all steps are at the appropriate tension, you can walk with the GENUX 2.
On our YouTube channel you can find a tutorial how the GENUX 2 can be donned and doffed.
www.youtbube.com/AmbroiseHolland
It will require practice to become skilful in donning and doffing the orthosis.
DOFFING THE GENUX 2
When doffing a GENUX 2, the sequence is less important. For most people, it’s easy to start with the upper strap. The GENUX 2 straps can
be loosened by turning them out of the connector (see photo series ‘opening the clips’ on the following page).
The clip that attaches the GENUX 2 to the calf strap is easy to loosen by pressing the two pins from both ends inwards

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CLOSING THE CLIPS -when brace is on the leg.
OPENING THE CLIPS - when brace is on the leg.
1. Hold the clip between thumb and index finger and bring it
towards the connector. Beware of any skin entrapment.
2. Connect the clip with the connector with a twisting motion.
Make sure the clip is well connected.
3. Close the clip with your thumb. Beware of skin entrapment.
4. When you hear the ‘click’ it means the clip is closed correctly.
1. Place the top of your finger behind the flap of the clip.
2. Open the clip entirely until it is in line with the rest.

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FIRST USE OF THE GENUX 2
If you get home with your GENUX 2, you can use the orthosis during your daily activities. Take into account that you have to get used to
wearing a GENUX 2 at first use. To function properly, the orthosis should push against your leg on various spots. At these pressure points your
skin must get used to the load of the brace.
It is therefore wise to slowly build up the use of the GENUX 2. Although most users in the end wear the GENUX 2 all day, it’s advisable to
build up the usage time slowly in the first few days.
Your orthotist has set up the GENUX 2 during the fitting phase. The chosen settings were at that moment carefully selected by your orthotist
to best fit your situation. However, some of these settings may need to be modified later on.
In the end, only you can really judge whether the GENUX 2 is comfortable, by wearing it for hours. Therefore, it’s a good idea to register your
first-day experiences for yourself, for example, by writing them down. If, after a few days, you find that there is still some improvement needed
in the setting of your GENUX 2, your orthotist will get a good idea of your experiences and know how to customize the GENUX 2 to meet
your needs. Setting up the GENUX 2 requires a good insight into the clinical situation of your knee and the possibilities and impossibilities of
the GENUX 2. Your orthotist is trained for that. Therefore, contact him if something needs to be changed and do not change settings yourself.
ACTIVE USE OF THE GENUX 2
The GENUX 2 does its job when the leg is stretched and loaded, especially during standing and walking. If the GENUX 2 is bent and/or the leg
is not loaded, the corrective action of the GENUX 2 is low. Some people choose not to wear the GENUX 2 on days or dayparts that they are
mostly sitting. For other people, even the few steps they make during such a day(parts) are too unstable and/or painful to do without the
GENUX 2. You can ultimately judge best for which activities you most benefit from wearing your orthosis.
Keep in mind that sometimes the reaction to overloading your knee (by not wearing your GENUX 2) will come later, for example, at night.
Most people therefore choose to wear the GENUX 2 throughout the day.
The GENUX 2 can be used for sporting activities. Exercising is healthy. If you are able to exercise again, using the GENUX 2, we advise you do
that. However, the GENUX 2 is not a sports brace. The GENUX will especially benefit from sports activities where you can make steps, such
as walking. For sports where the knees remain mainly bent, such as cycling, skating or skiing, the GENUX 2 relieving effect is significantly less.
Keep in mind that if you’re going to walk more and faster, the GENUX 2 pushes more to your leg. This may overload the skin on the contact
points with the GENUX 2. Slowly building up activities is therefore advisable.
PHOTO MEASUREMENT
Ambroise not only pays attention to the innovation of its products, but also to the way they are individually measured. Every GENUX 2 is
custom made based on two digital photos using the Ambroise Photo Measurement Technique. (See Figure 7).
3. Grab the clip between thumb and index finger and twist the
clip to disconnect.