RIGID ADJUSTABLE DUAL HINGED KNEE BRACE FOR
THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE
Indications:
• Moderate to severe unicompartment femoral-tibial osteoarthritis of the
knee.
• Unicompartment knee joint degeneration requiring offloading.
• Post-operative offloading of a single compartment (articular or
meniscus cartilage defect or osteochondral defect).
• Knee joint instability after injury or surgery on the cruciate and/or
collateral ligaments (ACL, PCL, LCL, MCL).
Contraindications:
• Do not place the product directly in contact with damaged skin.
• Patients with severe arterial insufficiency.
• Patients with severe varicose veins preventing the regular use of an
offloading brace.
• Allergy to one of the components.
• Severe cognitive and/or psychiatric disability.
• Patients with severe genu recuvatum.
• Patients presenting with significant genu varum or genu valgum.
Adverse effects:
There are no known adverse effects when the product is used correctly.
Healthcare professional instruction guide:
Please read these instructions with the patient when fitting the brace
for the first time and make sure that he/she understands how to
position the knee brace.
How to fit the knee brace:
Step 1: Evaluation of initial pain
Assess the level of pain felt by the patient to be able to assess the
function and efficacy of the knee brace after it is fitted.
Step 2: Positioning the brace on the lege
Loosen all the straps of the knee brace and confirm the LOADSHIFTER
Mechanism above each knee joint are in the factory-set neutral
position (same height on both sides of the thigh shell). Have
the patient sit on the edge of a chair, and have the patient bend
his/her knee to a position of approximately 30-60° of flexion. Place
the knee brace on the bare leg, not on top of clothing (figure 2).
Ensure that the brace size is appropriate by checking that there is no
space between the brace and the leg. If there is any gapping, or if the
brace is too tight, if possible, manipulate the frame of the brace or
retake measurements of the leg and select the appropriate size (see
size table on page 2 of this instruction leaflet).
Step 3: Fitting the knee brace
• Fasten the suspension strap A (figure 1) so it is above the calf muscle,
just below the flexion fold on the back of knee.
• Next fasten the anterior tibia strap B (figure 1). In addition to helping
secure the brace to the tibia, the secondary function of this strap is to
pre-set the anterior-posterior position of the hinges and uprights, so
they align with the midline of the sides of the leg, or just posterior to
midline (2
third of the leg in the sagittal plane).
nd
• The anterior-posterior position of the hinges can be modulated by
adjusting straps A & B. After you pre-set the anterior strap, instruct
the patient to leave it closed when putting on or taking off the brace.
• Next fasten the lower strap C, and then the two straps behind the
thigh D and E, and finish by fastening the anterior thigh strap F.
If one or more of the knee brace straps is too long, each strap can be cut
to the desired length. To do this, remove the Velcro hook tab from the
end of the strap, cut the strap to the desired length, and reattach the
Velcro hook tab to the end of the strap (figure 3). Take care to not cut
any strap too short. The comfort pads fixed inside the straps may need
to be removed for this operation and repositioned after the strap is cut
to avoid any interference when the strap is tightened.
Step 4: Check the fit, suspension and pain level prior to adjusting the
corrective force
Ask the patient to stand and walk, taking normal steps and looking
straight ahead. Confirm the brace fits and suspends properly on the
leg. Ask the patient if the pain level with the brace on (and with the dual
LOADSHIFTER Mechanisms still in the neutral position) is the same or
less than without the brace.
Step 5: Adjusting the corrective force
The dual LOADSHIFTER Mechanisms enables you to change the angle of
the femoral shell of the knee brace to increase the corrective 3-point force
and offload the compromised (degenerated, compressed) medial or
lateral compartment of the knee (figure 4). Both LOADHSHIFTERS are
set during fabrication in a neutral position at mid-height. The optimum
Notice Rebel Reliever International.indd 5
way to adjust the correction is by lengthening the upright on the
affected side. This produces more leverage force. If the patient
is short, you can also increase correction of lowering the upright on
the unaffected side of the knee. For severe OA and/or severe varus
or valgus deformities, you may need to adjust both LOADSHIFTERS.
Collectively, the angle of the Rebel Reliever thigh shell can be adjusted
by up to 18°.
Medial Compartment Femoral-Tibial Osteoarthritis of the Knee:
This brace is effective for the treatment of unicompartment
internal/medial femoral-tibial osteoarthritis of the knee. A thicker
condylar pad should be positioned on the external/lateral hinge (on the
side opposite the affected compartment). To increase corrective force,
the internal/medial upright (affected side) can be lengthened compared
with the external/lateral upright, or the external/lateral upright can be
shortened compared to the internal/medial upright.
Lateral Compartment Femoral-Tibial Osteoarthritis of the Knee:
This brace is also effective for the treatment of unicompartment
external/lateral compartment femoral-tibial osteoarthritis of the knee.
A thicker condylar pad should be positioned on the internal/medial hinge
(on the side opposite the affected compartment). To increase corrective
force, the external/lateral upright (affected side) can be lengthened
compared with the internal/medial upright, or the internal/medial upright
can be shortened compared to the external/lateral upright (figure 5).
• There are lines and numbers on each of the uprights. Beginning
with the LOADSHIFTERS in the neutral position, you can raise
the LOADSHIFTER above the affected compartment, or lower the
LOADSHIFTER on the upright opposite the affected compartment.
The initial adjustment should create a 1-3 number/line difference
between the two sides of the brace, shifting the angle of the femoral
shell to create a corrective force at the top end of the brace on the
same side of the leg of the affected compartment, which will create a
corresponding increase to the corrective force applied by the thicker
condylar pad that should be positioned on the inside of the hinge on
the unaffected side of the knee. To adjust the LOADHSIFTERS, lift the
black plastic SNAP LOCK lever located above the hinge, on the side of
the brace you want to lengthen or shorten (figure 5). After adjusting
the angulation of the upper shell of the brace.
• Ask the patient to walk again and assess his/her pain level.
• Repeat the operation, increasing or reducing the correction until it is
satisfactory and optimal for the patient.
• If the patient feels any discomfort, reduce the angle of the thigh shell
which will reduce the corrective force.
• For conservative treatment, start with a small amount of correction
and let the patient wear the knee brace for one or two weeks. If it is
necessary to increase the correction, see the patient again.
• A bag containing an additional set of condylar pads is provided in the
box with the brace. If necessary, use the set of thicker pads to increase
the compression on the sides of the knee. The pad on the unaffected
side should routinely be thicker than the pad on the affected side.
Both pads may be the same thickness if that provides the ideal
compression.
• Once the adjustment of the knee brace is finalized, it is possible to
trim any excess padding at the lower end of the pads, just above
both hinges. There are a series of serrated depressions in the pads to
indicate where to cut the pads.
• Lines and numbers are printed on the uprights of the knee brace.
There is no correlation between these graduations and specific
degrees of correction. You can record in the patient's chart the initial
setting of the LOADSHIFTERS.
Control of flexion/extension:
During the fabrication of the Rebel Reliever knee brace, the hinges
are set at 0° extension and maximum flexion. To adjust and/or reduce
the range of motion of the hinges, follow these instructions and make
the adjustments to BOTH hinges. The extension and flexion stops are
supplied on a plastic tree in the box (figure 6A, 7A).
Extension stops available: 0°, 5°, 10°, 15°, 20°, 30°, 40°.
Flexion stops available: 0°, 30°, 45°, 60°, 75°, 90°.
Adjustment of the extension stop (do this for BOTH hinges):
1. Select the desired extension stop from the plastic tree (figure 6A).
2. Open the hinge cap using the catch at the rear: push the catch
towards the interior and raise the cap.
3. Flex the hinge slightly and remove the existing extension stop. Take
care to note the direction this stop is facing.
4. Insert the replacement extension stop. Take care to check that the
shape of this part follows the contours of the cap. Straighten the hinge
to full extension to confirm the extension stop is correctly positioned.
5. Close the cap and flex and extend the brace several times to ensure
the stop is locked at the desired angle.
GB
23/01/2018 14:05