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The
Vilex
FUZE
TM
Dual Thread Screw &
Intramedullary Nail in
One Implant
The Ultimate TTC Arthrodesis
Internal Fixator
Introduction
The Vilex FUZETM TTC Arthrodesis Compression Nail combines the attributes of a compression screw and
intramedullary nail. The screw feature achieves compression at the talo-tibial joint. The intramedullary nail
feature allows the distribution of the patient’s weight through four lateral-medial and two anterior-posterior
solid locking screws. The FUZE head is embedded in the calcaneous. In addition, the proximal anterior
hole is slanted 45˚ to allow a locking screw from the heel to the talus through FUZE itself.
STEP-BY-STEP SURGICAL PROCEDURE
PREPARATION AND
INCISIONS
Patient Positioning
Position patient supine on the
operating room fluoroscopy table.
Thigh tourniquet if needed. Place
a roll under the ipsilateral buttocks
to maintain neutral rotation of the
lower extremity. Prep and drape
free the lower extremity up to the
thigh tourniquet. Position either a
standard or mini-fluoroscopy c-arm
unit on the operative side.
1
Incision, Exposure and Joint
Preparation
10-15 cm curvilinear incision over
the distal third of the fibula extending past the sinus tarsi and subtalar
joint. Care to stay away from the
superficial peroneal nerve anteriorly
and sural nerve posteriorly.
Full-thickness dissection.
Osteotomize the fibula to rotate out
of surgical field. The fibula can also
be removed and morselised for use
as bone graft for the fusions.
Prepare the tibiotalar joint and
subtalar joint by removing any
remaining cartilage and subchondral bone.
Make a second small incision
medial to the anterior tibial tendon
to expose the medial ankle joint
and remove cartilage from the
remaining joint surfaces. A laminar
spreader can aid in visualization.
Translate the talus medially by
1-2cm to insure that the talus and
calcaneus are centered with the
tibial canal.
Resect the soft tissue in the sinus
tarsi and remove the cartilage and
subchondral bone from the posterior facet of the subtalar joint.
Once the joints have been
adequately prepared, position
the foot with neutral ankle dorsiplantar flexion, 5 degrees of
external rotation and 5 degrees
of hindfoot valgus. The joints
can be temporarily stabilized in
this position with the temporarily
external fixator included in the
FUZE tray or with large pins.
Plantar incision to expose the
plantar aspect of the calcaneus.
Careful blunt dissection through
the plantar fascia retracting
the neurovascular bundle with
Hohman retractors.
2
Use a power driver to insert
and advance the 2.5 x
300mm Steinman pin through the
plantar aspect of the calcaneus
through the talus and into the distal
tibial medullary canal.
The pin should advance at least
100mm into the tibial canal.
Confirm proper placement of the
Guide Wire using anteroposterior
and lateral fluoroscopy.
Using the cannulated 8mm
drill bit either with power
driver or the FUZE Blue T-Handle,
drill up to the level of the distal
tibial metaphysis. Visualize the
progress of the drill with the aid of
fluoroscopy.
3
Remove the drill and remove the
Guide Wire. Insert the 2.5mm x
500mm ball/rounded end guide
wire into the tibial canal. Verify
on both anteroposterior and lateral
fluoroscopy the central location of
the guide wire.
4
Place the Reamer over the
ball/rounded end guide wire
and advance it through the calcaneus,
talus and into the tibial canal. Increase
the reamer sizes until the reamed hole
is .5mm larger than the minor diameter of the FUZE implant (as noted in
able on next page). Over-reaming the
canal will aid the FUZE in advancing
through the talar and tibial bone.
Ensure that the foot maintains proper
position during reaming so malalignment does not occur.
5
Manually compress the foot
against the tibia to close the
tibiotalar and subtalar gaps. Augment
any bone deficits with either autogenous graft or allograft substitutes.
6
Remove the ball/rounded
end guide wire and insert
the FUZE manually with the attached
5.5mm hex screwdriver. When the
distal thread of the implant engages
the distal tibia and the head engages
the calcaneus, the tibio-talar and
talo-calcaneal joints compress.
Make sure the middle thread clears
the talus and screws into the distal
aspect of the tibial plafond. Verify
this position under fluoroscopy.
NOTE: If using a cannulated
version of the FUZE, it can be
passed over a straight guide
pin. Make sure the ball/bent
wire is exchanged for the
straight guide wire.
If a fracture occurs at the top of
the FUZE upon insertion, remove
the nail, ream slightly larger and
insert a longer FUZE.
See FUZE Assembly Chart below.
FUZE Assembly
FUZE
DRIVER
LOCKING SCREW
ADAPTER
T RATCHET HANDLE
Reamer Chart
Vilex Fuze Nail Sizes
(diameter x length)
Recommended Reaming Size for FUZE Nail
(in order)
Reaming/Drill Depth for FUZE
10mm x 150mm
8mm Drill only - no reaming needed
150mm
10mm x 200mm
8mm Drill only - no reaming needed
200mm
10mm x 250mm
8mm Drill only - no reaming needed
250mm
12mm x 150mm
8mm Drill followed by 10.5mm Reamer
150mm
12mm x 200mm
8mm Drill followed by 10.5mm Reamer
200mm
12mm x 250mm
8mm Drill followed by 10.5mm Reamer
250mm
14mm x 150mm
8mm Drill followed by 10.5mm Reamer,
followed by 12.5mm Reamer
150mm
14mm x 200mm
8mm Drill followed by 10.5mm Reamer,
followed by 12.5mm Reamer
200mm
14mm x 250mm
8mm Drill followed by 10.5mm Reamer,
followed by 12.5mm Reamer
250mm
Attach Targeting Frame
Attach the targeting Frame
to the FUZE head. Align the notch of
the FUZE implant with the protrusion
pin that is located in the middle
support bar of the targeting frame.
The FUZE screwdriver assembly
locks into the targeting frame in
only one position. Tighten the locking
nut to secure the frame to the FUZE
hex screwdriver assembly.
7
Targeting Frame Locked
NOTE: The FUZE screwdriver
assembly locks into the
Targeting Frame in only one
position. Tighten the locking
nut to secure the Targeting
Frame to the FUZE hex
screwdriver assembly.
Nut
Interlocking Screws
Placement
The FUZE Interlocking screws
are solid, fully threaded, 5.0mm
diameter ( lengths from 20mm
to 130mm)
Introduce the interlocking screws.
Insert the drill sleeve into the targeting frame hole (proximal hole must
correspond to the leading tip of the
implant). Use the long Vilex 3.5mm
drill to drill bi-cortical through the
medial aspect of the tibia, FUZE
Nail and lateral aspect of the tibia.
This will provide the pilot hole for the
interlocking screw. Remove the drill
sleeve; place the appropriate length
5.0 solid interlocking screw.
Determine the proper length by
reading the calibration mark off the
drill at the back of the drill sleeve.
Alternatively, a sliding depth gauge
can be used to determine the proper
screw length.
Verify under fluoroscopy the appropriate length measured to determine
the correct screw length.
8
Optional Anterior Tibial
Calcanal Screw
An optional anterior tibial  calcaneal
screw can be placed to achieve additional stability through the fusion sites.
An anterior incision should be made
along the anterior aspect of the distal
tibia corresponding to the site the drill
guide/drill meets the anterior skin.
9
Dissect and protect the anterior tendinous and neurovascular structures and
advance the drill guide until it hits the
bone. This will protect the vital structures
during drill and screw advancement.
10
An end cap is provided to close
the FUZE cannulation.
The Vilex FUZE System
Self Drilling and
Tapping Leading
Tip
INDICATIONS
• Ankle Arthrodesis
• Charcot Foot
• Arthritis
• Foot Deformity
• Trauma
FUZE SPECIFICATIONS
• FUZE Length: 150, 200, 250
• Thread Diameter: 10, 12, 14 mm
• Material: Titanium
• Multi-axial stabilization with up to
6 bicortical locking screws
• 5.0 mm screws in 20-120 mm
lengths
• Radio translucent targeting tool
• Cannulated implant and instruments
Cancellous Tibia Thread
Rearfoot Arthrodesis
Screw Slant ed 45˚
Threaded Head
Cortical
Fax: 866-606-4911
E-mail: [email protected]
Visit us at www.vilex.com
Vilex, Inc. • 111 Moffitt Street
McMinnville, TN 37110 USA
Phone: 800-521-5002
©2013 Vilex, Inc. All rights reserved.
QSD 8.12-15 REV B