WRIGHT SIDEKICK EZ FRAME User manual

SIDEKICK® EZ FRAME
External Fixator System
SURGICAL TECHNIQUE
™

1
Introduction
Intended Use
Device Description
Surgical Technique
Preoperative Planning
Surgical Procedure
System Compatibility
Explant Information
Postoperative Care
Catalog Information
Chapter 1 2
2
Chapter 2 3
Chapter 3 4
4
4
Chapter 4 12
Chapter 5 13
Chapter 6 14
Chapter 7 15
Contents
Proper surgical procedures and techniques are the responsibility of the medical
professional. The following guidelines are furnished for information purposes only.
Each surgeon must evaluate the appropriateness of the procedures based on his or her
personal medical training and experience. Prior to use of the system, the surgeon should
refer to the product package insert for complete warnings, precautions, indications,
contraindications and adverse eects. Package inserts are also available by contacting
the manufacturer. Contact information can be found on the back of this surgical
technique and the package insert is available on the website listed.
For information on product availability in your area, please contact your local sales
representative.

2
Introduction
Chapter 1 Introduction
The SIDEKICK® EZ FRAME™ External Fixation System utilizes transosseous thin
wires and is based on the concepts of minimally invasive external fixation.
The system simplifies frame application when compared to traditional ring
fixators by eliminating the need for pins and wires to be placed into the tibia.
A boot is stabilized on the distal leg (tibia) and further stabilized to a distal ring
about the foot with carbon fiber reinforced composite rods that are connected
to the boot and ring respectively. Thin wires are placed into the foot to address
indications, while a frame-boot combination provides stability and support.
1
chapter
Intended Use
Indications for Use
» Triple Arthrodesis
» Isolated Rearfoot Arthrodesis
» Midfoot Arthrodesis
» Comminuted Trauma
» Diabetic Charcot Reconstruction
» Most foot pathology not requiring fixation above the ankle
Contraindications
» Talo-tibial or tibio-calcaneal arthrodesis
» Any pathology requiring absolute rigidity at or above the ankle
» Mentally unt patients
» Poorly vascularized patients
Prior to use of the system, the surgeon should refer to the product package
insert for complete warnings, precautions, indications, contraindications
and adverse effects. Package inserts are also available by contacting the
manufacturer. Contact information can be found on the back of this surgical
technique and the package insert is available on the website listed.

3
Device
Description
Chapter 2 Design Description
The SIDEKICK® EZ FRAME™ was designed to address the need for a simplied
approach to external xation. The system allows for the management of diabetic
Charcot reconstruction, triple arthrodesis, fusion of the midfoot and rearfoot,
challenging comminuted trauma, and most foot pathology not requiring xation
above the ankle. It is a viable tool for ooading and/or immobilizing wounds
associated with diabetic Charcot disease.
The system features transosseous thin wire xation, taking advantage of the
proven benets of minimally invasive external xator concepts. Bone segments
are easily and eectively manipulated for the purposes of midfoot and rearfoot
joint arthrodesis and for fusion of midfoot and rearfoot osteotomies. As with
other external xators, the frame may be applied with or without adjunct internal
xation.
By utilizing a unique combination of total contact casting concepts for the tibia
and thin wire xation in the foot, tibial wires or pins are not needed. By requiring
no pins or wires in the tibia, the SIDEKICK® EZ FRAME™ eliminates complications
associated with tibial xation elements and the time it takes to place these pins
and wires. The tibial boot portion of the frame helps facilitate positioning and
centering of the leg and foot, and the rocker plate helps to align the foot in a
neutral position. This simplies frame application compared to traditional circular
frames.
A rocker-bottom sole and rocker plate is attached to the foot ring. This rocker
plate features a cushioned surface insole upon which the foot can rest during
the healing process after the surgery. This insole (foot pad) may be modied
to accommodate compromised soft tissue as needed, by cutting it to relieve
pressure on compromised soft tissue. The position of the rocker plate can be
adjusted using optional spacers so that the foot is suspended, with no contact or
weight on the plantar surface of the foot. This can be particularly useful following
a ap or skin grafting procedure associated with diabetic Charcot reconstruction.
Spacers are available in two (2) thicknesses (5mm and 10mm).
The sterile boot liner allows for a custom tibial t and is designed to enhance
patient comfort.
The SIDEKICK® EZ FRAME™ is available in Standard and Large size kits.
The SIDEKICK® FREEDOM™ Circular Instrument Kit (RNRCKIT1) should be used
with the SIDEKICK® EZ FRAME™ System.
Replacement Boot Liners (Standard and Large), rocker-bottom soles, and foot
pads are available. The SIDEKICK® EZ FRAME™, and all frame components
(excluding instruments) are intended for single-use only.
2
chapter

4 Chapter 3 Surgical Technique
Preoperative Planning
The proper size xator should be ordered after considering patient anatomy.
Prior to surgery, the surgeon should consider the following while planning:
» Diameter of the distal leg
» Foot width and length
» Tibial length
Surgical Procedure
Example Procedure for Triple Arthrodesis
The leg should be prepared to above the knee and wrapped. Cast padding or
Kerlix with an Ace Bandage may be used to prepare the leg as shown.
After the completion of triple arthrodesis with provisional K-wire or screw
xation (surgeon’s preference), closure of all wounds, and application of all drains
as indicated, the foot and leg are placed within the SIDEKICK® EZ FRAME™ Fixator.
The foot should be placed in the center of the rocker plate, and the calf placed
within the boot. The insole may be placed between the foot and the rocker plate.
Surgical
Technique 3
chapter

5Chapter 3 Surgical Technique
Once adjustments are made to best t patient anatomy, the bolts should
be tightened with the 10mm wrench, locking the frame/boot position.
Subsequently, the surgeon is ready to insert the 2mm Titanium Nitride (TiN)
Tip Wires (#EF002400) across the foot to eventually achieve transosseous
compression of the arthrodesis sites. The 2mm Titanium Nitride (TiN) Tip Wires
(#EF002450) with olive and SIDEKICK® FREEDOM™ 1.8mm wires (#RR18400 and
#RR180400) are also available for use with the system.
When placing transosseous wires, they can be inserted directly through the skin
in a percutaneous manner. When using an olive (stopper) wire, a small 3mm
incision is made in the skin to allow the olive to rest directly against the bone.
Wires are inserted under power, and it is recommended to use a start/stop
technique to minimize potential thermal damage. Once the wire is through both
cortices, the wire can be tapped through the skin on the opposite side manually,
or advanced using the oscillating feature of the hand-held power equipment.
Tapping the wire manually or oscillating the wire may help prevent “wrapping”
soft tissue as the wire penetrates the soft tissue. When placing any percutaneous
xation, be mindful of anatomic safe zones. If a wire causes tension or tenting of
the skin, this tension should be released with a small incision. Utilization of the
uoroscope may be helpful in determining the exact anatomic position.
The boot position of the xator can be adjusted. Loosen the four vertical
adjustment locking bolts, the two carbon ber reinforced composite rod clamp
bolts, and the two carbon ber reinforced composite rod connector bolts using
the 10mm wrench (RR301090B SIDEKICK® SLOTTED WRENCH 10mm or the
RR3010 WRENCH 10mm) prior to adjusting the height of the boot assembly.
Once loosened, the boot assembly can be adjusted up or down by sliding the
boot assembly on the carbon ber reinforced rods.
Wrench 10mm
RR3010
SIDEKICK® Slotted Wrench 10mm
RR301090B

6 Chapter 3 Surgical Technique
Three essential 2mm TiN Tip Wires need to be placed in order to achieve the goal
of compressing fusion sites of the triple arthrodesis.
The rst wire crosses the calcaneus from medial to lateral avoiding the
neurovascular bundle. An olive wire may be used in this position to limit medial
migration of the foot on the frame after surgery.
Attach a post to the foot ring on either side of the foot, next to the wire that was
placed. Tighten the nuts on these posts to the ring using the 10mm wrench.
Attach the wire to the posts on either side using a wire bolt and a wire nut for
each end of the wire. The wire can be attached using the cannulation of the bolt,
or using the slot feature built into the nut.
Please note that the system features 6-hole male posts. Male and female posts
are also available with 1 through 4 holes. Select the aperture closest to the
location of the wire exiting the foot to determine placement of the wire bolt.
Use the longer 6-hole posts for wires further away from the foot plate, and use
shorter posts for wires that are closer to the foot plate. Calcaneal wires should
not be bent up or down when attaching them to the posts. Bending wires up
or down could result in elevating the heel away from the rocker bottom insole
or overly compressing it into the rocker bottom insole when the wires are
tensioned. Tighten the wire bolts and wire nuts using the 10mm wrench.
Wire attached using the
EZ FRAME™ wire bolt
Wire attached using the
EZ FRAME™ wire nut

7Chapter 3 Surgical Technique
The second wire crosses the talus from medial to lateral and should ideally be an
olive wire to limit lateral foot migration. If necessary, utilize the uoroscope to
ensure the correct placement of this 2mm wire across the talus.
Attach a post to the foot ring on either side of the foot, next to the wire that was
placed. Tighten the nut on the post to the ring using the 10mm wrench. Attach
the wire to the posts on either side using a wire bolt and a wire nut for each end
of the wire. Select the aperture closest to the location of the wire exiting the foot
to determine placement of the wire bolt. The ends of the talar wire should be
bent slightly down when attaching them to the male posts. This downward bend
will help provide better compression across the subtalar joint when tensioned.
Tighten the wire bolts and wire nuts using the 10mm wrench.
The third wire can be placed across the foot from either side. This wire can cross
the navicular and cuboid or alternatively cross from the medial cuneiform and
exit the cuboid. Once again, utilization of the uoroscope may be helpful in
determining the exact anatomic position.
Attach a post to the foot ring on either side of the foot next to the wire that was
placed. Tighten the nut on the post to the ring using the 10mm wrench. Attach
the wire to the posts on either side using a wire bolt and a wire nut for each end
of the wire. Select the aperture closest to the location of the wire exiting the
foot to determine placement of the wire bolt. Do not bend the wires up or down
when attaching them to the male posts. Tighten the wire bolts and wire nuts
using the 10mm wrench.
At least one additional transosseous 2mm wire is recommended to supplement
these three essential wires. It can be placed either across the calcaneus or
the midfoot. The exact location of this additional wire can be determined by
surgeon’s preference intraoperatively. This wire should be attached to the foot
ring via the same parameters as the rst three wires.

8 Chapter 3 Surgical Technique
Tensioner
RR3028
Once all wires are placed, the posts can be disconnected from their original
positions and realigned on the foot ring. This bends the 2mm wires in
anticipation of tensioning them to compress the arthrodesis sites. For a triple
arthrodesis the three essential wires, which have been described, are moved as
follows:
1. Move the two posts holding the transosseous calcaneal wire 1 or 2 holes
on the foot ring forward (towards the toes) and then reattach the posts
to the foot ring.
2. Move the two posts holding the transosseous talar wire 1 or 2 holes on
the foot ring back (towards the heel) and then reattach the posts to the
foot ring.
3. Move the two posts holding the transosseous midfoot wire 1 or 2 holes
on the foot ring back (towards the heel) and then reattach the posts to
the foot ring.
The fourth, additional wire should be moved in the same manner as the wires
described above. If the wire was placed in the calcaneus, the posts should be
moved forward and reattached. If the wire is placed in the midfoot, then the
posts should be moved back and reattached.
TENSIONING THE WIRES:
Tensioning of transosseous thin wires increases frame rigidity. By utilizing arched
wire concepts, bone segments can be manipulated to apply compression across
arthrodesis sites. When utilizing olive (stopper) wires, tension should be pulled
from the opposite side of the olive.
The calcaneal wire is the rst to be tensioned. Before tensioning this wire,
the posts should be rmly tightened to the footplate using the 10mm wrench.
The wire bolts and wire nuts on one side of the 2mm wire need to be rmly
tightened next. With the olive (stopper) wires, it should specically be noted that
the wire nut or post on the same side as the olive needs to be tightened rst.
Once the wire nut on one side of the foot has been rmly tightened, the
tensioner (RR3028 TENSIONER) is applied over the wire on the opposite side of
the foot, and moved down to contact the wire bolt.

9Chapter 3 Surgical Technique
Tension is the applied to the wire by squeezing the tensioner handles. The wire
should be pulled from 70kg to 110kg, and this measure is taken by reading
where the force markings line up with the housing of the tensioner.
The tensioner should be held in place, maintaining tension, until the second
wire nut is tightened to the wire bolt. This will lock the wire under tension.
The tensioning device is then released. Tensioning the calcaneus wire stabilizes
the calcaneus while pushing it forward and compressing the posterior facet of
the calcaneus against the talus.
Next, the talar wire will be tensioned. Before tensioning this wire, the posts
should be rmly tightened to the foot ring using the 10mm wrench. The wire
bolts and wire nuts on one side of the 2mm wire need to be rmly tightened
next. With the olive (stopper) wires it should specically be noted that the
wire nut on the same side of the foot as the olive needs to be the one which is
tightened rst.
Once the wire nut or post on one side of the foot has been rmly tightened,
the tensioner is applied over the wire on the opposite side of the foot, and
moved down to contact the wire bolt. Tension is applied to the wire by squeezing
the tensioner handles. The wire should be pulled from 70kg to 110kg, and this
measure is taken by reading where the markings line up with the housing of
the tensioner. The tensioner should be held in place, maintaining tension, until
the second wire nut is tightened to the wire bolt. This will lock the wire under
tension. The tensioning device is then released. Tensioning the talar wire pushes
the talus backwards towards the posterior facet of the calcaneus, applying
compression from the opposite direction as the rst wire.
The midfoot wire is the last wire to be tensioned. Before tensioning this wire,
the posts should be rmly tightened to the footplate using the 10mm wrench.
The wire bolts and wire nuts on one side of the 2mm wire need to be rmly
tightened next. With the olive (stopper) wires it should specically be noted that
the wire nut on the same side of the foot as the olive needs to be tightened rst.
Once the wire nut on one side of the foot has been rmly tightened, the
tensioner is applied over the wire on the opposite side of the foot, and moved
down to contact the wire bolt. Tension is applied to the wire by squeezing the
tensioner handles. The wire should be pulled from 70kg to 110kg, and this
measure is taken by reading where the force markings line up with the housing
of the tensioner. The tensioner should be held in place, maintaining tension,
until the second wire nut is tightened to the wire bolt. This will lock the wire
under tension. The tensioning device is then released. Tensioning the midfoot
wire results in compression across the talaonavicular and calcaneocuboid joints.