Biomet Vision FootRing System · Additional indications for the Biomet® Vision FootRing ... of all...
Transcript of Biomet Vision FootRing System · Additional indications for the Biomet® Vision FootRing ... of all...
Surgical Technique
Biomet® Vision™
FootRing™ System
Fixation In A Snap
Contents
Introduction .................................................... Page 1
Indications and Contraindications ................ Page 1
Product Overview ........................................ Page 1
Product And Implant Description And Use ....... Page 2
Carbon Fiber U-Trak ................................... Page 2
Short And Long Posts ................................. Page 3
Standard Wire Clamp .................................. Page 3
Pins And Wires............................................ Page 4
Bone Screw Clamp ..................................... Page 5
SLM Screw-To-Rod Clamp & Half Pins........ Page 5
Transfixing Pin ............................................ Page 5
Self Drilling, Self-Tapping Bone Screw ........ Page 6
Universal Rod Connector ............................. Page 6
Biomet Vision Rod ...................................... Page 6
Compression/Distraction Assembly ............. Page 7
SLM Rod-To-Rod Clamp ............................. Page 8
Bent U-Bar .................................................. Page 8
Clamps And 3/5 Post .................................. Page 9
Trocar/Drill Sleeve ...................................... Page 10
TS Trocar .................................................... Page 11
Split Tissue Guide ....................................... Page 12
Long Drill .................................................... Page 12
Universal Clamps ........................................ Page 13
Universal Rails ............................................ Page 15
Tensioners .................................................. Page 16
Walker Pad ................................................. Page 16
System Component Sets ............................. Page 17
Half Pin Insertion Technique ........................... Page 21
Thin Wire Insertion Technique ........................ Page 21
Tensioning Wire .............................................. Page 22
Standard Basic Protocol .................................. Page 23
Ankle Spanning Construct ............................... Page 27
Pan-Talar Fusion Construct............................. Page 29
Foot And Ankle Construct ............................... Page 30
Triple Arthrodesis Protocol .............................. Page 31
Further Information ......................................... Page 34
Indications
The DynaFix Vision Unilateral System and the DynaFix Vision
External Fixation System are external fixation device intended
for use in the treatment of bone conditions including leg
lengthening, osteotomies, arthrodesis, fracture fixation, and other
bone conditions amenable to treatment by use of the external
fixation modality.
Additional indications for the Biomet® Vision FootRing System, a
sub system of the DynaFix Vision External Fixation System include:
• Correction of deformity
• Revision procedures where other treatments or devices
have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot reconstruction and Lisfranc dislocations
• Ankle distraction (arthrodiastasis)
Contraindications
Patients with mental or neurologic conditions who are unwilling
or incapable of following postoperative care instructions.
Product Overview
The Biomet Vision FootRing System uses Biomet Vision
technology, which enables simplified application of all fixation
components to the carbon fiber U-Track, for one snap fixation.
The system is composed of anodized aluminum alloy, titanium,
carbon reinforced epoxy and stainless steel. All bone screws are
made of 316L stainless steel. Select sizes are available with HA
coating. Each carbon fiber U-Trak is made of lightweight carbon
fiber material that is ideally suited for patient comfort and is
radiolucent. Spanning fixator placement can easily be converted
to the Biomet Vision FootRing System configuration by simply
adding a carbon fiber U-Track with tensioned wires to the
articular fragment. This assembly then connects to the previously
placed pins, clamps and rods. Adaptation to the carbon fiber
U-Trak can be performed with the included components.
1
Introduction
The Biomet Vision FootRing System is a comprehensive
external fixation device intended for use in the treatment of bone
conditions including osteotomies, arthrodesis, fracture fixation,
and other bone conditions amenable to treatment by use of the
external fixation modality. The Biomet Vision FootRing System
(PN’s 421471, 421476 and 14-400076) can be configured in a
multitude of constructs ranging from simple fractures to complex
reconstruction to meet clinical needs.
The simplicity and ease of use make this fixator friendly in
the operating room for quick applications. The Biomet Vision
FootRing System functions as an excellent means of “portable
traction”. This allows the patient the benefit of soft tissue healing
while having the option of being at home and waiting for their
elective procedures. It allows the surgeon the benefits of getting
the patient out of the hospital quickly and re-admitting for well-
planned surgery or for transfer to the appropriate physician.
Product And Implant Description And Use
Carbon Fiber U-Trak
Catalog # Description
21202 150mm, Short
21207 180mm, Short
21212 210mm, Short
Carbon Fiber U-Trak
Catalog # Description
21200 150mm, Long
21205 1 80mm, Long
21210 210mm, Long
Prior to positioning the carbon fiber U-Trak (PN’s 21202, 21207,
21212, 21200, 21205 or 21210) on the patient, attach proper
size Standard Post (PN 21243 or 21242)
to lobe located on carbon fiber U-Trak.
Magnified View Of Tri-Lobe
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Standard Short Post
Catalog # Description
21243 Short Post, 15mm
21354 Open-Ended Combo Wrench
Standard Long Post
Catalog # Description
21242 Long Post, 30mm
21354 Open-Ended Combo Wrench
After the carbon fiber U-Trak has been positioned, wires are
positioned free hand. The proper size Standard Post (PN 21242
or 21243) connects the wires via the Standard Wire Clamp
(PN 21244) to the carbon fiber U-Trak (PN 21200, 21202,
21205, 21207, 21210 or 21212) and the wires are tensioned to
establish the appropriate fixation required for the procedure. The
Open-Ended Combo Wrench (PN 21354) is used for both sizes
of the Standard Post to allow for counter-rotational torque when
tightening the post, and tensioning if needed.
NOTE: Standard Posts must be attached to the outside lobes of
the carbon fiber U-Trak when utilizing tensioned wires.
Standard Wire Clamp
Catalog # Description
21244 Standard 2.0mm Wire Clamp
The Standard Wire Clamp is used in conjunction with the
Standard Long or Short Post (PN 21242 or 21243). The Standard
Wire Clamp attaches to a 2.0mm straight wire
or olive wire. The clamp holds position and tension
(if desired).
2.0mm Straight Or Olive Wire
15mm
30mm
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Product And Implant Description And Use (Continued)
Smooth Pin
Catalog # Description
21395 2.7mm x 350mm Pin, Smooth
Straight Wire
Catalog # Description
13165 2.0mm x 400mm Straight Wire
21430 2.0mm x 550mm Straight Wire (Packaged Sterile)
Olive Wire
Catalog # Description
13135 2.0mm x 400mm Olive Wire
21425 2.0mm x 550mm Olive Wire (Packaged Sterile)
The straight wires and olive wires (PN 13165, 21430, 13135 and
21425) are used with the Standard Wire Clamps (PN 21244). The
Standard Wire Clamp attaches to a 2.0mm straight wire or olive
wire. The clamp holds position and tension (if desired).New Spade Tip
Standard Bone Screw Clamp
Catalog # Description
21256 Standard 4.0mm Bone Screw Clamp
21258 Standard 6.0mm Bone Screw Clamp
The Standard Bone Screw Clamp (PN 21256 or 21258) is used in
conjunction with the Standard Long or Short Post (PN 21242 or
21243). The Standard Bone Screw Clamp attaches to a 4.0mm
or 6.0mm bone screw shaft.
SLM 4.0-6.0mm Screw-To-Rod Clamp
Catalog # Description
14-400070 SLM 4.0-6.0mm Screw-To-Rod Clamp Connects A Carbon Fiber U-Trak To: 4.0, 5.0,
6.0mm Self Drilling Bone Screw
14280 4.0mm x 350mm Transfixing Screw
14186 5.0mm x 350mm Transfixing Screw
14285 6.0mm x 350mm Transfixing Screw
The SLM Screw-To-Rod Clamp (PN 14-400070) was designed
for ease of use and rapid locking. A single step serrated lock
allows for speed of application and secure purchase on rods,
4.0, 5.0, 6.0mm bone screws and 4.0, 5.0, 6.0mm transfixing
screw. This clamp is locked with a 5.0mm Allen Wrench (PN
03110). The key feature of the SLM Screw-To-Rod Clamp is
the ability to snap on to both the rod and the shank of 4.0, 5.0,
6.0mm screws and transfixing screws. This clamp also has the
ability to lock to the shank of 4.0, 5.0, 6.0mm diameter screws.
Threaded Transfixing Pin
Catalog # Description
21400 2.7mm x 350mm Transfixing Pin
14280 4.0mm x 350mm Transfixing Pin
14186 5.0mm x 350mm Transfixing Pin
14285 6.0mm x 350mm Transfixing Pin
Will Accept 4.0, 5.0, 6.0mm Pin/Screw
MRI Safe
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Product And Implant Description And Use (Continued)
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Carbon Fiber Rod Or C/D Strut
Pivot Articulates 360°
Self-Drilling, Self-Tapping Bone Screw
Catalog # Description
A60-11030 Cortical – 110/30 (Packaged Sterile)
SD60-15050 Cortical – 150/50 (Packaged Sterile)
SD40-10030 Cortical – 100/30 (Packaged Sterile)
SD40-12040 Cortical – 120/40 (Packaged Sterile)
A60-18040 Cortical – 180/40 (Packaged Sterile)
NOTE: The bone screws will need to be ordered separately.
Catalog # Description
21245 Universal Rod Connector (AKA Schnoopy Clamp)
The Universal Rod Connector (PN 21245) allows attachment of a
multitude of Biomet Vision components, including carbon rods,
C/D Assembly, 2-Clamp 3/5 Post. The versatility comes from the
ability of the clamps to rotate and angulate in any direction.
Biomet Vision Rod
Catalog # Description
14160 Carbon Fiber Rod, 9.5mm Dia. x 150mm
14165 Carbon Fiber Rod, 9.5mm Dia. x 200mm
14170 Carbon Fiber Rod, 9.5mm Dia. x 250mm
14176 Carbon Fiber Rod, 9.5mm Dia. x 300mm
14180 Carbon Fiber Rod, 9.5mm Dia. x 350mm
14185 Carbon Fiber Rod, 9.5mm Dia. x 400mm
14650 Carbon Fiber Rod, 9.5mm Dia. x 500mm
14660 Carbon Fiber Rod, 9.5mm Dia. x 600mm
The Biomet Vision Rods are offered in a 9.5mm diameter.
Carbon Fiber Rods have the added benefit of being radiolucent
and extremely lightweight.
Biomet Vision Rod
Standard Long Post
Universal Rod Connector
Standard Wire Clamp
Standard Bone Screw Clamp
Source: Stephen Conti, M.D.
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Compression/Distraction Assembly
Catalog # Description
21252 C/D Assembly, 30mm
21420 C/D Wrench
The Compression/Distraction Assembly (PN 21252) connects
to the Universal Rod Connector (PN 21245) or SLM 4.0-6.0mm
Screw-To-Rod Clamp (PN 14-400070) or SLM Rapid Rod-
To-Rod Clamp (PN 14600) to carbon fiber U-Trak (PN 21200,
21202, 21205, 21207, 21210 or 21212) to the proximal support
frame. This is to provide support and compression/distraction
adjustment to the fracture/fusion site. A set-screw is provided to
ensure locking of the strut.
One Complete Revolution = 1.0mm Compression Or Distraction
Posts Are Same Size As Biomet Vision Bar
Set-Screw Ensures Locking MechanismUp To 30mm
Compression Or Distraction
Product And Implant Description And Use (Continued)
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SLM Rapid Rod-To-Rod Clamp
Catalog # Description
14600 SLM Rapid Rod-To-Rod Clamp Connects A Carbon Fiber U-Trak To:
14160 Carbon Rod, 150mm
14170 Carbon Rod, 250mm
14180 Carbon Rod, 350mm
21252 C/D Assembly, 30mm
The SLM Rapid Rod-To-Rod Clamp (PN 14600) allows
attachment of a smaller range of Biomet Vision components.
Because of the clamps design, adjustment is only in one plane.
The Universal Rod Connector also known as the schnoopy clamp
(PN 21245) is capable of adjusting in two planes.
Bent U-Bar
Catalog # Description
21280 Bent U-Bar, 190mm
21285 Bent U-Bar, 220mm
21290 Bent U-Bar, 250mm
Bent U-Bar, 190mm used with carbon fiber U-Trak, 150mm
Bent U-Bar, 220mm used with carbon fiber U-Trak, 180mm
Bent U-Bar, 250mm used with carbon fiber U-Trak, 210mm
The Bent U-Bar (PN’s 21280, 21285, or 21290) is used in
conjunction with the carbon fiber U-Trak (PN’s 21200, 21202,
21205, 21207, 21210, or 21212) via SLM Rapid Rod-To-Rod
Clamps (PN 14600) or Universal Rod Connector (PN 21245). This
allows placement of bone screws more anterior to the carbon
fiber U-Trak. The Bent U-Bar can be used as a replacement to a
carbon fiber U-Trak proximally.
NOTE: Tensioned wires cannot be used with the Bent U-Bars.
MRI Safe
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3 And 5-Hole Clamps
Catalog # Description
14060 3-Hole Clamp
14090 5-Hole Clamp
The 3 and 5-Hole Clamps (PN 14060 or 14090) were designed
for multi-pin fixation, which increases frame stiffness. The clamp
cover bolts are locked down with the 5mm Allen Wrench (PN
03110) to secure bone screws within the clamp. The 3/5 Post
can be attached to both sides of the clamp for rod or bone screw
attachment. The 3/5 Post is secured to the 3 or 5-Hole Clamps
with the Ratcheting T-Handle (PN 03122 + PN 03121).
Biomet Vision 2-Clamp 3/5 Post
Catalog # Description
14-400065 2-Clamp 3/5 Post
The 3/5 Post (PN 14240) is utilized with the 3-Hole and 5-Hole
Clamps (PN 14060 or 14090) primarily for rod attachment, but
can also be used for bone screw clamp attachment. The 3/5 Post
is secured to either the 3-Hole Clamp or the 5-Hole Clamp with
a Ratcheting T-Handle (PN 03122 + PN 03121) or Biomet Vision
9.0mm wrench (PN 14245).
Product And Implant Description And Use (Continued)
10
Trocar/Drill Sleeve
Catalog # Description
21370 Use 3.2mm Drill/4.0mm Pin
21365 Use 4.8mm Drill/6.0mm Pin
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TS Trocar
Catalog # Description
14-400040 TS Trocar for 3.2mm Drill (60mm Length)
14-400042 TS Trocar 3.2mm Drill (100mm Length)
14-400044 TS Trocar for 4.8mm Drill (60mm Length)
14-400046 TS Trocar for 4.8mm Drill (100mm Length)
14-400030 TS 3.2mm Drill Sleeve (60mm Length)
14-400032 TS 3.2mm Drill Sleeve (100mm Length)
14-400034 TS 4.8mm Drill Sleeve (60mm Length)
14-400036 TS 4.8mm Drill Sleeve (100mm Length)
14-400047 TS Trocar for 4.8mm Drill (125mm Length)
14-400037 TS 4.8mm Drill Sleeve (125mm Length)
14-400027 TS Soft Tissue Sleeve (125mm Length)
14-400020 TS Soft Tissue Sleeve (60mm Length)
14-400025 TS Soft Tissue Sleeve (100mm Length)
The TS Trocar can be used to protect soft tissue and blunt skin
prior to drilling. The teeth of the TS Trocar is designed to blunt
skin effortlessly.
The design rationale behind the new Triple Stack (TS) comes
from the need to maximize speed of pin insertion, while
minimizing soft tissue damage. The TS contains a friction lock
between the soft tissue and drill sleeve. The TS allows the two
components to remain engaged after the trocar has dimpled the
bone and then been removed. Once the trocar is slid out, the
bone can be drilled, and the drill guide can then be removed.
With the serrated teeth on the soft tissue sleeve, the placement
of the drill hole can be kept while transitioning to inserting the
bone screw. The TS can be used free-hand or through bone
screw clamps.
Product And Implant Description And Use (Continued)
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Split Tissue Guide 4.8mm
Catalog # Description
21460 Use 4.8mm Drill/6.0mm Pin
Split Tissue Guide 3.2mm
Catalog # Description
21462 Use 3.2mm Drill/4.0mm Pin
4.8mm Long Drill
Catalog # Description
03015 4.8mm x 240mm Long Drill (A/O Connect)
3.2mm Long Drill
Catalog # Description
03036 3.2mm x 240mm Long Drill (A/O Connect)
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Universal Clamp With Compression/Distraction
Catalog # Description
21260 Universal Clamp With C/D
The Universal Clamp With C/D (PN 21260) allows compression/
distraction to the bone fragment/fusion site to achieve the
desired position or alignment using the Universal Pin Clamp With
Compression/Distraction (PN 21405). These posts allow for a
vertical motion of any of the selected clamps chosen. The post is
threaded, and when combined with a Universal Pin Clamp with
C/D, a gradual compression/distraction force can be applied to
fixation of choice.
Universal Clamp With Compression/Distraction And Pivot
Catalog # Description
21270 Universal Clamp With C/D And Pivot
After carbon fiber U-Trak (PN 21200, 21202, 21205, 21207 or
21210) has been positioned on the patient, wires are positioned
free hand. The bone fragment/fusion site can be compressed or
distracted to achieve the desired position or alignment utilizing
the Universal Clamps With C/D And Pivot (PN 21270) used for
charcot reconstruction. The Universal Clamp With C/D and Pivot
can compress or distract up to 30mm by using the Universal Pin
Clamp With Compression/Distraction (PN 21405) to allow C/D
between a number of different anatomic segments of the ankle
and foot, i.e. between the talus and calcaneous.
These posts allow for a gradual compressive/distractive force in
multiple directions, due to the pivot and the capability to rotate
the post 360° when combined with a Universal Pin Clamp With
C/D.
Rotates 360°
30mm Threaded Post
Will Angulate Up To 250°
Rotates 360°
25mm Threaded Post
Product And Implant Description And Use (Continued)
14
Universal Pin Clamp With Compression/Distraction
Catalog # Description
21405 Universal Pin Clamp With C/D
After carbon fiber U-Trak (PN 21200, 21202, 21205, 21207,
21210 or 21212) has been positioned on the patient, wires are
positioned free hand. The clamp connects the wires or pins
to the carbon fiber U-Trak. The trajectory of the compression/
distraction can be adjusted by pivoting the C/D axis. The bone
fragment/fusion site can be compressed or distracted to achieve
the desired position or alignment. This Universal Pin Clamp With
Compression/Distraction is designed to be utilized with either
of the Universal Post Clamps (PN 21260 or 21270) or Universal
Rails (PN 21440, 21242, 21244 or 21246). It is capable of
accepting a 2.7mm pin up to a 6.0mm pin.
NOTE: The 2.7mm Transfixing Pin (PN 21395 or 21400) cannot
be tensioned.
Universal Pin Clamp
Catalog # Description
21415 Universal Pin Clamp
After carbon fiber U-Trak (PN 21200, 21202, 21205, 21207,
21210 or 21212) has been positioned on the patient, wires are
positioned free hand. The clamp connects the wires or pins
accepting sizes ranging from a 2.7mm to 6.0mm to the carbon
fiber U-Trak. The Universal Pin Clamp is designed to be utilized
with either of the Universal Clamps (PN 21260 or 21270) or
Universal Rails (PN 21440, 21242, 21244 or 21246). It is capable
of accepting a 2.7mm pin up to a 6.0mm pin. It is important to
note that this clamp is purely for fixation, and does not allow
compression or distraction.
NOTE: The 2.7mm Transfixing Pin (PN 21395 or 21400) cannot
be tensioned.
C/D Nut
15
Universal Rails
Catalog # Description
21440 Universal Rail, 75mm
21442 Universal Rail, 100mm
21444 Universal Rail, 125mm
21446 Universal Rail, 150mm
The Universal Rails (PN 21440, 21442, 21444 or 21446) can be
used for Triple Arthrodesis in conjunction with the carbon fiber
U-Trak application.
Universal Multi–4.0mm Pin Clamp
Catalog # Description
21410 Universal Multi–4.0mm Pin Clamp
The Universal Multi Pin Clamp (PN 21410) will accept two 4.0mm
pins to be secured linearly. The Universal Multi Pin Clamp can be
used with both the Universal Clamps (PN 21260 or 21270) or the
Universal Rails (PN 21440, 21242, 21244 or 21246).
Product And Implant Description And Use (Continued)
16
Pistol Grip Tensioner
Catalog # Description
21435 Pistol Grip Tensioner
The new Pistol Grip Tensioner (PN 21435) automatically grips on
wire regardless of wire diameter. It has a quick release, which
releases tension and capture of the wire. To use, simply slip the
tensioner over the wire to be tensioned, and slide the tensioner
down until it presses against the clamp to be tensioned. After
confirming that the opposing clamp is completely locked down,
and the clamp you are attached to is locked only to the carbon
fiber U-Trak (PN’s 21200, 21202, 21205, 21207, 21210 or
21212) and the wire carriage is open, you can begin to tension
on the wire. Once an acceptable amount of tension is on the
wire, lock the wire clamp fully, and hit the release switch on the
tensioner depicted below. Once the tensioner is removed, the
wire should be clipped, and twisted to eliminate the sharp wire
point from sticking out. Then repeat with each wire construct as
needed.
Biomet Wire Tensioner
Catalog # Description
13190 Wire Tensioner Please see thin wire insertion technique on page 21
Walker Pad
Catalog # Description
21235 Walker Pad
Apply an appropriate sized Walker Pad to patient’s foot. Wrap
each strap around carbon fiber U-Trak (PN 21200, 21202,
21205, 21207, 21210, or 21212). Slide thru the buckle and
double back to secure the strap. Excess strap material may
be cut to proper length after application. The Walker Pad (PN
21235) comes with 16” velcro straps that are adjustable for
flexible positioning.
Top Level
Base Level
Biomet Vision FootRing System Component Set
Catalog # Description
421471 Biomet Vision FootRing System Component Set (Loaner Set)
21470 Sterilization Tray
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Top Level
Base Level
Biomet Vision FootRing System U-Trak Set
Catalog # Description
421476 Biomet Vision FootRing System U-Trak Set (Loaner Set)
21475 Sterilization Tray
Product And Implant Description And Use (Continued)
Biomet Vision Pin-To-Bar System
Catalog # Description
14-400076 Biomet Vision Pin-To-Bar Set (Loaner Set)
14-400075 Sterilization Tray
The Biomet Vision Pin-To-Bar System is a supplemental system
to the Biomet Vision FootRing System and can also be used
on its own. The Biomet Vision Pin-To-Bar is a modular system
intended for use in treatment of bone conditions including leg
lengthening, osteotomies, arthrodesis, fracture fixation and
other bone conditions amenable to treatment by use of external
fixation modality.
Top Level
Bottom Level
19
Product And Implant Description And Use (Continued)
20
Base Level
Biomet Vision Pin-To-Bar System (Continued)
Half Pin Insertion Technique Thin Wire Insertion Technique
Using the screw clamp, locate where you want the screw to
be placed. Make a small stab incision into the skin and spread
through the soft tissue carefully. Place a drill sleeve and trocar
either through the screw clamp, or independently through the
skin incision and soft tissue to the bone cortex.
Lightly tap on the trocar dimpling the bone to prevent the drill
from walking. Remove the trocar and insert the appropriate drill
through the drill sleeve to prevent soft tissue damage. Pre drill
the screw hole.
The drill guide is then removed and the appropriate length
screw is inserted. The screw is inserted by hand using the bone
screw t-wrench. This will help to prevent thermal necrosis at the
screw site. To obtain optimal purchase, all bone screws must
be bi-cortical with no less than 2.0mm or two thread lengths
protruding from the far cortex and about 5.0mm remaining
outside the near cortex.
NOTE: When using tapered screws care must be taken to avoid
over-penetration of the far cortex. Tapered screws cannot be
backed out without losing purchase.
A Biomet self-drilling self-tapping bone screw could be used if
the physician elects to do so. The aforementioned technique is
recommended for the use of this screw.
1. Make a small incision and insert the wire (through a safe
zone) until it reaches bone. Be sure to have good contact.
Start the drill and lightly press on the wire until it starts going
through bone on the near cortex. Be sure to avoid thermal
necrosis. You can avoid this by either irrigating with saline
while drilling on the wire or stopping every few seconds to
reduce heat build-up.
2. When the wire has been drilled through the far cortex, stop
advancement of the wire and remove from the drill. Continue
advancement of the wire by using a mallet and pliers through
the rest of the soft tissue.
3. Once the wire reaches the far skin edge, make a small
incision over the tip of the wire and pass the wire through the
skin.
4. Be aware to relieve any tension on the skin that wire
insertion may have caused. This will help reduce soft tissue
complications.
5. Check wire position under fluoroscopy.
21
Tensioning Wire
1. All clamps need to be securely tightened.
2. Before tensioning, make certain the opposite end of the wire
is locked onto the Standard Wire Clamp (wire carriage) and
the carriage is secured firmly on the U-Trak. Watch for wire
bending while securing the wire into the carriage and onto the
carbon fiber U-Trak.
3. Slide the wire through the tensioner until the tensioner
reaches the near wire carriage. Lock the wire onto the
tensioner. The near wire carriage lock nut should be finger
tight to ensure anterior rotation teeth engagement.
4. Once the wire is locked into the tensioner, begin tensioning
by turning the back nut of the tensioner clockwise until
the desired tension is achieved. (Approx. 100-120kg is
recommended). Note: when using olive tip wires you must
tension from the opposite side of the olive tip (mark the wire
carriage on the side of the olive).
5. When the proper tension is achieved lock the near wire
carriage to retain the tension on the wire.
22
23
Standard Basic Protocol
Step 1
Position the patient supine with the affected foot at the very end
of the operating table. A bump should be placed beneath the
ipsilateral buttock to ensure that the foot is pointing straight up.
Step 2
Prior to positioning carbon fiber U-Trak, attach Standard Short or
Long Post to the outside of lobe.
Step 3 (Standard Post)
Position proper size carbon fiber U-Trak with proper size
Standard Post on medial side of foot. The carbon fiber U-Trak
should be adjusted to lie PERPENDICULAR to the TIBIA and
parallel to the weight-bearing surface of the foot. A 150mm long
U-Trak is recommended to use for the average size foot.
To span the ankle by utilizing dissipated forces through the
hindfoot continue to Step 4. To span the ankle by utilizing only
smooth wires through the talus proceed to Step 8.
Step 4 (Calcaneal Pin)
Place a 4.0mm or 6.0mm Transfixing Pin, lateral/medial into
the calcaneous, perpendicular to the long axis of the foot in the
coronal and transverse plane. Pin placement should be below the
carbon fiber U-Trak. Careful soft tissue dissection on the medial
side of the heel will avoid damage to the medial calcaneal nerve.
If the pin is placed in the posterior tuberosity of the calcaneus,
neurovascular damage will be avoided. Pin placement should be
below the anticipated final position of the U-Trak. The carbon
fiber U-Trak frame should be adjusted to lie PERPENDICULAR to
the tibia and, if possible, parallel to the weight-bearing surface
of the foot. Confirmation of pin placement with C-arm may be
desired.
Step 10 (Talar Pin 2)
Place wire, olive or smooth k-wire (olive wire is recommended
to prevent foot from sliding in the frame), anteromedial to
posterolateral to avoid damage to medial neurovascular bundle.
The anterior clamp is above the U-Trak and the posterior clamp
is below the U-Trak. Secure wire assembly to frame. Do not
tension wire at this time. Confirmation of wire placement with
C-arm may be performed at this time.
Source: Stephen Conti, M.D.
Step 11 (Standard Wire Clamp)
Place Standard Wire Clamp over Standard Post. The Standard
Wire Clamp and Standard Post is used to attach a 2.0mm
smooth k-wire or olive wire. Secure frame with Standard Wire
Clamp. Do not tension wire at this time.
Step 12 (Tension)
Tension all wires to between 100-120kg using the manual
tensioning device. Be sure that Standard Wire Clamps are
tightened on the opposite side of the tensioner, which is always
the side of the olive, if present. All pin assemblies must be
attached to the lateral side of the U-Trak.
Standard Basic Protocol (Continued)
24
Step 5 (Standard Bone Screw Clamp)
Place the Standard Bone Screw Clamp over the Standard
Post. The Standard Bone Screw Clamp is used to attach a
4.0mm/6.0mm Transfixing Pin. Secure the frame with the
Standard Bone Screw Clamp. Do not tighten the screw assembly
over pin at this time.
Step 6 (Navicular Pin)
Place an olive or smooth k-wire (2.0mm olive is recommended
to prevent foot from sliding medial/lateral in the frame), medial
to lateral into the navicular above the U-Trak. Secure to wire
to the Standard Wire Clamp. Do not tension wire at this time.
Confirmation of wire placement with C-arm may be done at this
time.
Step 7 (Standard Wire Clamp)
Place Standard Wire Clamp over the Standard Post. This is used
to attach a 2.0mm smooth k-wire or olive wire. Secure frame
with Standard Wire Clamp. Do not tension wire at this time.
Step 8 (Talar Pin 1)
Place a wire, olive or smooth k-wire (olive wire is recommended
to prevent foot from sliding medial/lateral in the frame),
directly medial to lateral into the talar neck below the U-Trak.
Confirmation of wire placement with C-arm may be desired.
Step 9 (Standard Wire Clamp)
Place Standard Wire Clamp over the Standard Post. This is used
to attach a 2.0mm smooth k-wire or olive wire. Secure Standard
Wire Clamp to frame. Do not tension wire at this time.
Shown here is the insertion of olive wires to prevent foot from sliding in the frame.
25
Step 13 (Universal Rod Connector)
Attach Universal Rod Connector to each lateral side of the
U-Trak. Use Carbon Fiber Rods (150mm, 250mm) to stabilize
the U-Trak to the proximal tibial. Both Carbon Fiber Rods should
be positioned parallel to the tibia and half pins placed mid-shaft
proximal to any anticipated anterior surgical incision. Secure
Universal Rod Connectors and to Carbon Fiber Rods finger tight.
Step 14 (Mid-Shaft Half Pins)
Prior to half pin insertion follow the aforementioned half pin
insertion technique described on page 21. Insert half pins placed
mid-shaft perpendicular to each side. Use appropriate thread
length and overall pin length (generally 110/30). Secure carbon
fiber U-Trak to Universal Rod Connector to Carbon Fiber Rods
with pin to rod clamps (Biomet Vision Clamps), careful to leave
enough room to distract and not to pull the rod through the clamp.
Step 15
Place foot in the desired position, generally perpendicular to leg
and tighten all clamps except for the pin to rod clamp on mid-
shaft Tibia.
Step 16
Manually distract pulling the U-Trak distally with equal force on
lateral and medial side of the U-Trak.
Step 17
Tighten pin to rod clamps on mid-shaft tibia.
Mid-Shaft Half Pin Insertion
Anteriorly Medial
Anteriorly Lateral
Source: Stephen Conti, M.D.
Standard Basic Protocol (Continued)
Step 18 (Foot Pad Application)
Apply an appropriate size Walker Pad to patient’s foot. Wrap
each buckle around U-Trak leaving an inch of the buckle so it
can wrap around the U-Trak.
26
Source: Stephen Conti, M.D.
27
Ankle Spanning Construct
This frame could be used for:
1. Ankle Arthrodesis
2. Ankle Spanning
3. Distal Tibial Fracture
This system will allow for soft tissue management
and fracture stabilization.
Ankle Spanning Construct
Catalog # Description Qty
21200 Carbon Fiber U-Trak 150mm
21205 Carbon Fiber U-Trak 180mm 1
21210 Carbon Fiber U-Trak 210mm
A60-18040 Bone Screw 180/40 2
14060 3-Hole Clamp 1
14240 3.5 Biomet Vision Post 2
14175 300mm Carbon Rods 2
21242 Standard Long Post 6
21243 Standard Short Post
21244 Standard Wire Clamp 6
13165 2.0mm x 400mm Straight Wire
21430 2.0mm x 550mm Straight Wire 3
13135 2.0mm x 400mm Olive Wire
21425 2.0mm x 550mm Olive Wire
14600 SLM Rapid Rod-To-Rod Clamp 2
21245 Universal Rod Connector 2
Ankle Spanning Construct (Continued)
A. Select the appropriate size carbon fiber U-Trak to be placed
at the level of the foot.
B. Using a carbon fiber U-Trak at the level of the distal
calcaneus secure fixation points using k-wire, half pins, or
transfixation screws. Wires should be parallel and 5.0 to
10mm from a joint surface.
C. A 3 or 5-Hole Clamp and MRI safe Rapid Rod-To-Rod Clamps
or independent pin placement may be used at mid tibia using
haft pin to affix the proximal end of the frame. Carbon rods
would then extend distal to the carbon fiber U-Track and
attach with MRI safe Rapid Rod-To-Rod Clamps.
28
29
Pan-Talar Fusion Construct
This frame could be used for:
1. Ankle Spanning
2. Ankle Arthrodesis
3. Pilon Fractures
4. Ankle Arthrodesis Over A Nail
For Weight Bearing Patients
This system will allow for soft tissue management
and fracture stabilization.
Catalog # Description Qty
21200 Carbon Fiber U-Trak, 150mm
21205 Carbon Fiber U-Trak, 180mm 1
21210 Carbon Fiber U-Trak, 210mm
21202 Carbon Fiber U-Trak, 150mm (Short)
21207 Carbon Fiber U-Trak, 180mm (Short) 1
21212 Carbon Fiber U-Trak, 210mm (Short)
A60-18030 Bone Screw, 180/30
A60-15040 Bone Screw, 150/40 2
A60-18040 Bone Screw, 180/40
13165 2.0mm x 400mm Straight Wire
21430 2.0mm x 550mm Straight Wire
13130 2.0mm x 350mm Olive Wire 1
13135 2.0mm x 400mm Olive Wire
21425 2.0mm x 550mm Olive Wire
14280 Transfixing Pin, 4.0mm 2
14285 Transfixing Pin, 6.0mm
Catalog # Description Qty
21242 Standard Long Post 8
21243 Standard Short Post
21244 Standard Wire Clamp 2
21256 Standard 4.0mm Bone Screw Clamp 6
21258 Standard 6.0mm Bone Screw Clamp
21252 C/D Assembly 3
21245 Universal Rod Connector 6
30
Foot And Ankle Construct
This frame could be used for:
1. Ankle Arthrodesis
2. Triple Arthrodesis
3. Ankle Spanning
4. Pan Talar Arthrodesis For All Midfoot, Hindfoot,
And Ankle Considerations
This system will allow for soft tissue management
and fracture stabilization.
Foot And Ankle Construct
Catalog # Description Qty
21200 Carbon Fiber U-Trak, 150mm
21205 Carbon Fiber U-Trak, 180mm 2
21210 Carbon Fiber U-Trak, 210mm
21202 Carbon Fiber U-Trak, 150mm (Short)
21207 Carbon Fiber U-Trak, 180mm (Short) 1
21212 Carbon Fiber U-Trak, 210mm (Short)
A60-18030 Bone Screw 180/30
A60-15040 Bone Screw 150/40 3
A60-18040 Bone Screw 180/40
14160 150mm Carbon Rod 3
13165 Wires 1
14285 Transfixing Pin, 6.0mm 2
14280 Transfixing Pin, 4.0mm
21242 Standard Post (Long) 9
21243 Standard Post (Short)
21244 Standard Wire Clamp 2
21270 Universal Clamp with C/D and Pivot 2
21258 Standard 6.0mm Bone Screw Clamp 7
21256 Standard 4.0mm Bone Screw Clamp
21395 2.7mm x 350mm Smooth Pin 1
21405 Universal Pin Clamp With C/D 2
14600 SLM Rod-To-Rod Clamp 8
31
Triple Arthrodesis Protocol
Step 1
Position the patient supine with the affected foot at the end
of the operating table. A bump should be placed beneath the
ipsilateral buttock to ensure that the foot is pointing straight up.
Step 2
Prior to positioning carbon fiber U-Trak, attach Standard Short or
Long Post to the outside of lobe.
Step 3 (Standard Post)
Position proper size carbon fiber U-Trak with proper size
Standard Post on medial side of foot. The carbon fiber U-Trak
should be adjusted to lie PERPENDICULAR to the ankle joint
(TIBIA) or Standard Long Post to the outside lobe of the carbon
fiber U-Trak and parallel to the weight-bearing surface of the
foot. A 150mm, long carbon fiber U-Trak is recommended to use
for the average size foot.
Step 4 (Calcaneal Pin)
Place a 4.0mm or 6.0mm Transfixing Pin, lateral/medial into
the calcaneous, perpendicular to the long axis of the foot in
the coronal and transverse plane. Two crossing smooth or
olive wires may be used in the posterior calcaneous instead of
a 4.0mm or 6.0mm Transfixing Pin. Pin placement should be
below the carbon fiber U-Trak. Careful soft tissue dissection
on the medial side of the heel will avoid damage to the medial
calcaneal nerve. If the pin is placed in the posterior tuberosity
of the calcaneus, neurovascular damage will be avoided. Pin
placement should be below the anticipated final position of the
carbon fiber U-Trak. The carbon fiber U-Trak frame should be
adjusted to lie PERPENDICULAR to the tibia and, if possible,
parallel to the weight-bearing surface of the foot. Confirmation of
pin placement with C-arm may be desired.
32
Step 5 (Standard Bone Screw Clamp)
Place a Standard Bone Screw Clamp over the Standard Post. The
Standard Bone Screw Clamp is used to attach a 4.0mm/6.0mm
Transfixing Pin or Half Pin. If olive or smooth wires are used,
place Standard Wire Clamp over the Standard Post. The Standard
Wire Clamp is used to attach a 2.0mm smooth k-wire or
olive wire. Secure frame with Standard Bone Screw Clamp or
Standard Wire Clamp. Do not tighten screw assembly over pin at
this time.
Step 6 (Navicular Pin)
Place an olive or smooth k-wire (2.0mm olive wire is
recommended to prevent foot from sliding medial/lateral in the
frame), medial to lateral into the navicular above the carbon fiber
U-Trak. Secure the wire to the frame with Standard Wire Clamp.
Do not tension wire at this time. Confirmation of wire placement
with C-arm may be done at this time.
Step 7 (Standard Wire Clamp)
Place a Standard Wire Clamp over the Standard Post. The
Standard Wire Clamp is used to attach a 2.0mm smooth k-wire
or olive wire. Secure frame with Standard Wire Clamp. Do not
tension wire at this time.
Step 8 (Talar Pin 1)
Place a wire, olive or smooth k-wire (olive wire is recommended
to prevent foot from sliding medial/lateral in the frame), directly
medial to lateral into the talar neck below the carbon fiber
U-Trak. Confirmation of wire placement with C-arm may be
desired.
Step 9 (Standard Wire Clamp)
Place Standard Wire Clamp over the Standard Post. The Standard
Wire Clamp is used to attach a 2.0mm smooth k-wire or olive
wire. Secure Standard Wire Clamp to frame. Do not tension wire
at this time.
Step 10 (Talar Pin 2)
Place wire, olive or smooth k-wire (olive wire is recommended
to prevent foot from sliding in the frame), anteromedial to
posterolateral to avoid damage to medial neurovascular bundle.
The anterior clamp is above the carbon fiber U-Trak and the
posterior clamp is below the carbon fiber U-Trak. Secure wire
assembly to frame. Do not tension wire at this time. Confirmation
of wire placement with C-arm may be performed at this time.
Step 11 (Standard Wire Clamp)
Place a Standard Wire Clamp over a Standard Post. The Standard
Wire Clamp is used to attach a 2.0mm smooth k-wire or olive
wire. Secure frame with Standard Wire Clamp. Do not tension
wire at this time.
Step 12 (Cuboid Pin Or Wire)
Place a half pin, olive wire or smooth wire into the cuboid (lateral
to medial into the cuboid below the carbon fiber U-Trak). Secure
to frame with appropriate clamp. Do not tension at this time.
Confirmation of wire placement with C-Arm may be done at this
time.
Step 13 (Tension)
Tension all wires to between 100-120kg using the manual
tensioning device. Be sure that Standard Wire Clamps are
tightened on the opposite side of the tensioner, which is always
the side of the olive, if present. All pin assemblies must be
attached to the lateral side of the carbon fiber U-Trak.
Step 14 (Calcaneocuboid Pin)
Apply Universal Rail to lateral calcaneal pin and connect to
the cuboid pin with a Universal Pin Clamp With C/D and static
Universal Pin Clamp.
Triple Arthrodesis Protocol (Continued)
33
Step 15 (Talocalcaneal Pin)
Apply a second Universal Rail to the calcaneal pin and connect
to the talar pin with a Universal Pin Clamp With C/D and static
Universal Pin Clamp.
Step 16 (Talonavicular Pin)
Apply a Universal Rail to medial calcaneal pin and connect to
the navicular pin with a Universal Pin Clamp With C/D and static
Universal Pin Clamp. Apply another Universal Rail from the talar
pin and connect to the navicular pin with a Universal Pin Clamp
With C/D and static Universal Pin Clamp.
Step 17 (Universal Rail)
Tighten all Universal Rails uniformly until appropriate reduction
and compression is achieved.
Step 18 (Walker Pad Application)
Apply Walker Pad to patient’s foot. Wrap each strap around
carbon fiber U-Trak, slide through the buckle and double back
to secure the strap. Excess strap material may be cut to proper
length after application.
34
Further Information
This brochure is presented to demonstrate the surgical technique
utilized by Stephen Conti, M.D. and Marc Conner, D.P.M.
Biomet, as the manufacturer of this device, does not practice
medicine and does not recommend this product or any specific
surgical technique for use on any individual patient. The
surgeon who performs any implant procedure is responsible
for determining the appropriate product(s) and utilizing the
appropriate technique(s) for said implantation in each
individual patient.
For further information, please contact the Customer Service
Department at:
Biomet Trauma
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0587
800.348.9500 x 1501
www.biomet.com
Notes:
35
Notes:
36
©2013 Biomet Orthopedics • Form No. BMET0355.0 • REV011513
All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated.
This material is intended for the sole use and benefit of the Biomet sales force and health care professionals. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet.
For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet’s website.
Responsible ManufacturerBiomet, Inc. P.O. Box 58756 E. Bell DriveWarsaw, Indiana 46581-0587 USA
www.biomet.com
Rx only.