Synthes Expert Tibial Nail User manual

Expert
Nailing System
Expert Tibial Nail.
Technique Guide
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Synthes 1
Table of Contents
Image intensifier control
Introduction
Surgical technique
Product information
Features 2
AO/ASIF Principles of internal fixation 4
Indications 5
Cases 6
Preoperative planning 8
Opening the tibia 9
Insert the nail 20
Distal locking 28
Proximal locking 35
Insert the end cap 55
Weight-bearing 57
Implant removal 58
Implant specifications 61
Implants 62
Instruments 69
Warning
This description is not sufficient for immediate application of
the instrumentation. Instruction by a surgeon experienced in
handling this instrumentation is highly recommended.
Cleaning of instruments:
For detailed information please refer to “Reprocessing,
Care and Maintenance of Synthes Instruments”,
Article No. 035.000.090.
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Stardrive
®
T40
2Synthes Expert Tibial Nail
Improved stability
Expert Tibial Nail
Advanced solutions
End caps:
– Securely lock the most proximal
oblique locking screw to create a
fixed-angle construct
– End cap prevents ingrowth of tissue
and facilitates nail extraction
– Self-retaining Stardrive T40 recess for
effortless end cap pick-up and ease
of insertion
– Cannulated
– 0 mm end cap sits flush with nail.
– 5, 10 and 15 mm end caps extend
nail height if nail is over inserted.
Advanced proximal locking options:
– Three unique and innovative locking
options, in combination with cancel-
lous bone locking screws, increase
the stability of the proximal fragment
for proximal third fractures.
– Two state of the art medio-lateral
(ML) locking options enable primary
compression or secondary controlled
dynamization
0 mm 5 mm 10 mm 15 mm
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Stardrive
®
T25
Multidirectional locking options for improved stability
Synthes 3
Advanced nail design:
– New anatomic bend for ease of nail
insertion
– Titanium alloy TAN* for improved
mechanical and fatigue properties
– Cannulated nails (from 8 mm to
13 mm) for reamed or unreamed
techniques, enabling nail insertion
over guide wire
– The 2.5 mm or 3.0 mm ball tipped
guide wires may be removed through
the nail and insertion handle assem-
bly (no exchange tube required).
– Solid nails (from 8 mm to
10 mm) for unreamed technique
Advanced distal locking options:
– Distal oblique locking option to pre-
vent soft tissue damage and increase
stability of the distal fragment
– Two ML and one antero-posterior
(AP) locking options for stability of
the distal fragment
All locking screws:
– Double lead thread for more contact
points for enhanced stability and
ease of insertion
– Thread closer to screw head provid-
ing better bone purchase in the near
cortex and improved stability
– Titanium alloy TAN* for improved
mechanical and fatigue properties
– Self-tapping blunt tip
– Self-retaining Stardrive T25 recess
allows improved torque transmission
and increased resistance to stripping
relative to a hex recess and secure
locking screw pick-up.
Cancellous bone locking screws:
– Indicated for the three unique proxi-
mal locking options of all tibial nails
diameters
– Dual core design for optimized pur-
chase in cancellous bone
– Unicortical
– Lengths: 30 mm – 90 mm
Standard locking screws:
– Larger cross section for improved
mechanical resistance
–4.0 mm for 8 mm and 9 mm
tibial nails, lengths: 18 mm – 80 mm
–5.0 mm for 10 mm to
13 mm tibial nails,
lengths: 26 mm – 100 mm
* Titanium-6% aluminum-7% niobium
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4Synthes Expert Tibial Nail
AO/ASIF Principles of
internal fixation
1M.E. Müller, M. Allgöwer, R. Schneider y R. Willenegger:
Manual de osteosíntesis, 3ª edición. Barcelona: Springer-Verlag Ibérica. 1991
* Titanio, 6%; aluminio, 7%; niobio
In 1958, the AO/ASIF (Association for the Study of Internal
Fixation) formulated four basic principles1, which have
become the guidelines for internal fixation in general, and in-
tramedullary nailing in particular:
The Expert Tibial Nail permits an intramedullary approach for
the fixation of proximal, shaft and distal fractures of the
tibia. The system consists of a series of cannulated nails, can-
nulated end caps, dual core locking screws and standard
locking screws. All of the implants are made of titanium alloy
(TAN*).
Anatomic Reduction
The Expert Tibial Nail is designed to fit anatomically in the
medullary canal, allowing indirect reduction of proximal,
distal and shaft fractures of the tibia.
Stable Fixation
The Expert Tibial Nail provides stable fixation of fractures by
incorporating oblique locking holes in the proximal and distal
portions of the nail.
Cancellous bone locking screws are used proximally for
better purchase in the cancellous bone. The most proximal
locking screw, when used with an end cap, provides a
locked, fixed-angle construct. Locking screws in the distal
oblique hole and ML hole provide stable fixation of distal
fractures.
Preservation of Blood Supply
The instruments and implants in the Expert Tibial Nail permit
a more percutaneous technique and less tissue stripping
than other treatment methods. An intramedullary approach
results in decreased blood loss compared to plate fixation.
Early, Active Mobilization
The Expert Tibial Nail provides secure fixation which permits
controlled, early, active rehabilitation conducive to optimal
recovery.
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Synthes 5
Indications
The Expert Tibial Nail is indicated for fractures in the tibial
shaft as well as for metaphyseal and certain intraarticular
fractures of the tibial head and the pilon tibiale:
– 41-A2/A3
– All shaft fractures
– 43-A1/A2/A3
– Combinations of these fractures
For these indications the Expert Tibial Nail should be used in
combination with other implants (not shown in the illustra-
tions):
– 41-C1/C2
– 43-C1/C2
Note: The use of a cannulated Expert Tibial Nail with a large
diameter offering more stability associated with the reamed
technique is generally recommended for pseudarthroses,
tumours, mal-unions and non-unions.
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6Synthes Expert Tibial Nail
Cases
Fracture involving the proximal component
Case 1
The use of the three locking screws in the proximal oblique
locking options ensures optimal stabilization of the proximal
fragment. The distal segment can be stabilized by using
two ML locking options. Stability of the distal fragment can
be enhanced by the use of a third locking screw in the AP
hole.
Shaft fracture
Case 2
For simple shaft fractures, two proximal ML and two distal
ML locking screws are normally sufficient to stabilize the
fracture. Secondary dynaminization is achieved by removing
the proximal static locking screw.
Fracture involving the distal component
Case 3
The use of four distal locking screws is sometimes necessary
to achieve stabilization of the distal fragment. In many
cases though, three locking screws placed in the most distal
locking options are sufficient to stabilize the distal fragment.
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Synthes 7
postoperative follow-up (3 weeks after surgery)
preoperative postoperative follow-up (1 month after surgery)
preoperative postoperative follow-up (4 months after surgery)
preoperative
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EXPERTTM Tibial Nail
For use only with the Original AO/ASIF System of
Instruments and Implants
0 10 20 30 40 50 60 70 80 90 100 mm
1.10 Magnification
034.000.015 © Stratec Medical 2005 Printed in Switzerland SEK Subject to modifications.
for Ø 8, 9, 10, 11, 12, 13 mm nails
04.004.003
04.004.002
04.004.001
255 mm
270 mm
285 mm
300 mm
315 mm
330 mm
345 mm
360 mm
375 mm
390 mm
405 mm
420 mm
435 mm
450 mm
465 mm
dynamic
static
0 mm
5
13
22
37
151050mm
Ø 8
AP View Lateral View
Cancellous Bone Locking Screw Ø 5.0 mm (golden) 04.015.5XX
0 mm 30 40 50 60 70 80 90
Locking Screw Ø 5.0 mm (light green) 04.005.5XX
0 mm 26 30 40 50 60 80 10070
Locking Screw Ø 4.0 mm (dark blue) 04.005.4XX
0 mm 18 30 40 50 60 70 80
04.004.000
(04.004.004)
7 mm
Ø 9 mm
Ø 10 mm
Ø 11 mm
Ø 12 mm
Ø 13 mm
Manufacturer: Stratec Medical
Eimattstrasse 3
CH-4436 Oberdorf
www.synthes.com
8Synthes Expert Tibial Nail
Use the AO ASIF Preoperative Planner Template for the
Expert Tibial Nail to estimate nail diameter and nail length. To
estimate nail diameter, place the template on the AP or
lateral X-ray of the uninjured tibia and measure the diameter
of the medullary canal at the narrowest part that will contain
the nail.
To estimate nail length, place the template on the AP X-ray
of the uninjured tibia and select the appropriate nail length
based on patient anatomy. When selecting nail size, consider
canal diameter, fracture pattern, patient anatomy and post-
operative protocol.
Preoperative planning
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Synthes 9
Opening the tiba
1
Position patient
Position the patient supine on the radiolucent table. Ensure
that the knee of the injured leg can be flexed at least 90°.
Position the image intensifier such that visualisation of the
tibia including the articular surface proximally and distally is
possible in AP and lateral views.
Optionally, the procedure can be performed on a fracture
table with the leg placed in traction.
Note: The knee roller can be placed under the lower part
of the thigh if it obstructs the view of the tibia plateau in AP
view.
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10 Synthes Expert Tibial Nail
2
Reduce fracture
Perform closed reduction manually by axial traction under
image intensifier. The use of the Large Distractor (394.350)
or Pinless Fixator (186.310) may be appropriate in certain
circumstances.
Note: The reduction can be temporarily fixed with reduction
clamps. In epiphyseal fractures the condyles or the pilon
tibiale are fixed first in order to enable the nail insertion.
Opening the tiba
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Synthes 11
3
Confirm nail length and diameter
Instrument
03.010.021 Radiographic Ruler for Tibial Nails,
length 450 mm
The required nail length must be determined after reduction
of the lower leg fracture.
Position the C-arm for an AP view of the distal tibia. With
long forceps, hold the ruler along the leg, parallel to and at
the same level as the tibia. Adjust the ruler until the distal tip
is at the level of the physeal scar or the desired nail insertion
depth. Mark the skin at that site.
Move the C-arm to the proximal tibia, replace the distal end
of the ruler at the skin mark, and take an AP image of the
proximal tibia. Read nail length directly from the ruler image,
selecting the measurement at or just below the level of the
anterior edge of the tibial plateau.
When using the large distractor, measure the distance from
the inferior border of the distal pin to the superior border of
the proximal pin to determine optimal nail length.
Position the C-arm for an AP or lateral view of the tibia at
the level of the isthmus. Hold the ruler over the tibia so that
the diameter gauge is centered over the narrowest part of
the medullary canal. Read the diameter measurement on the
circular indicator that fills the canal.
Note: Compression or dynaminization must be taken into
account when determining the nail length. A shorter nail
should be chosen when active compression is planned for
the procedure. The dynamic locking option allows for 7 mm
of travel.
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12 Synthes Expert Tibial Nail
4
Approach
Make an incision in line with the central axis of the intra-
medullary canal. Depending on the anatomy of the patient,
this incision can be transpatellar, medial or even lateral
parapatellar.
The incision starts proximally at the distal third of the patella
along the patellar ligament down to the tibial tuberosity.
Mobilise the infrapatellar corpus adiposum laterally and dor-
sally without opening the synovia. A free access of the nail to
the insertion point must be guaranteed.
Prepare the entry site of the nail on the ventral edge of the
tibial plateau.
Alternatives
Determine the nail length by the above procedure on the un-
injured leg or before draping (unsterile) or compare the
length of two identical SynReam Reaming Rods 2.5 mm
(352.032).
Place the radiographic ruler over the tibia so that the measur-
ing edge is located over the isthmus. Select the nail diameter
shown when the medullary canal/cortex transition is still visi-
ble on both sides of the marking.
If the reamed technique is used, the diameter of the largest
medullary reamer applied must be 0.5 mm to 1.5 mm larger
than the nail diameter.
Opening the tiba
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Synthes 13
5
Determine entry point
The entry point defines the optimal position of the Expert
Tibial Nail in the intramedullary canal. This is more important
for proximal and distal third fractures to prevent fragment
displacement.
In AP view the entry point is in line with the axis of the intra-
medullary canal and with the lateral tubercle of the inter-
condylar eminence.
In lateral view the entry point is at the ventral edge of the
tibial plateau.
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14 Synthes Expert Tibial Nail
6
Insert guide wire
Instruments
357.399 Guide Wire 3.2 mm
393.100 Universal Chuck with T-Handle
Secure the guide wire in the universal chuck. Slightly punch
mark the insertion point at a 10° angle to the shaft axis in
the lateral view. Hold a sterile Expert Tibial Nail on the side of
the lower leg with its distal end parallel to the tibia shaft.
The curved proximal nail end determines the definitive angle
of insertion for the guide wire.
Insert the guide wire for approx. 8–10 cm and check the po-
sition under the image intensification in the AP and lateral
views.
Opening the tiba
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Synthes 15
7
Open medullary canal – cutter
Instruments
357.399 Guide Wire 3.2 mm
03.010.008 Cutter for Tibial Nails, 12.0 mm,
length 350 mm
03.010.035 Protection Sleeve 14.0/12.0,
length 161 mm
Push the protection sleeve and the cutter over the guide wire
and open the medullary canal to a depth of 8–10 cm. The
guide wire and the cutter should not touch the posterior cor-
tex.
Remove guide wire, cutter and protection sleeve.
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16 Synthes Expert Tibial Nail
7a
Open medullary canal – drill bit
Alternative instruments
357.399 Guide Wire 3.2 mm
03.010.036 Drill Bit 12.0 mm, cannulated,
length 300 mm, for No. 532.015
03.010.035 Protection Sleeve 14.0/12.0,
length 161 mm
Place the protection sleeve and the drill bit over the guide
wire and down to the bone. Drill to a depth of approx. 8–
10 cm. The guide wire and the drill bit should not touch the
posterior cortex.
Remove guide wire, drill bit and protection sleeve.
Opening the tiba
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Synthes 17
7b
Open medullary canal – awl
Alternative instruments
357.399 Guide Wire 3.2 mm
03.010.040 Awl 12.0 mm, cannulated,
length 243 mm
Place the cannulated awl over the guide wire and open the
medullary canal. Use a twisting motion to advance the awl to
a depth of approx. 8–10 cm.
The awl should not touch the posterior cortex.
Remove guide wire and awl.
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18 Synthes Expert Tibial Nail
8
Reaming medullary canal (optional)
Instruments
189.060 SynReam Intramedullary Reaming System
03.010.093 Rod Pusher for Reaming Rod with
Hexagonal Screwdriver 8.0 mm
If necessary enlarge the tibia canal with the medullary
reamer up to the desired diameter.
Check fracture reduction under the image intensification.
Inserting the reaming rod
Insert the SynReam Reaming Rod 2.5 mm (352.032) into
the medullary canal to the desired insertion depth.
Reaming
Starting with the  8.5 mm reaming head, ream to a diame-
ter of 0.5–1.5 mm greater than the nail diameter. Ream
in 0.5 mm increments and advance the reamer with steady,
moderate pressure. Do not force the reamer. Partially retract
the reamer often to clear debris from the medullary canal.
Note: All cannulated Expert Tibial Nails can be inserted over
the reaming rod. Reaming rod exchange is not required.
In case of solid Expert Tibial Nails, remove the reaming rod
before nail insertion.
Opening the tiba
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