Tibia Nailing System: T2 Alpha
Tibia Nailing System: T2 Alpha
Tibia Nailing System: T2 Alpha
Operative technique
T2 Alpha
T2 Alpha Tibia Nailing System,
IMN Screws System and IMN Instruments System
Contents
Indications and contraindications . . . . . . . . . . . . 3 Reaming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
This publication sets forth detailed recommended Please remember that the compatibility of different
procedures for using Stryker devices and instruments. product systems has not been tested unless specified
It offers guidance that you should heed, but, as with in the product labeling.
any such technical guide, each surgeon must consider See package insert (Instructions for Use) (L22000035,
the particular needs of each patient and make L22000044, L22000045, L22000007) for a complete
appropriate adjustments when and as required. list of potential adverse effects, contraindications,
A workshop training is recommended prior to warnings and precautions.
performing your first surgery. All nonsterile devices The surgeon must discuss all relevant risks including
must be cleaned and sterilized before use. the finite lifetime of the device with the patient
when necessary.
Follow the instructions provided in our cleaning
and sterilization guide (OT-RG-1). Multi-component
instruments must be disassembled for cleaning. CAUTION
Please refer to the corresponding assembly/
Use instruments/implants only as described
disassembly instructions.
in this operative technique to avoid damage
to instruments/implants, bone or soft tissue.
CAUTION
The MRI safety information provided
is based on testing which did not include supplementary devices. If there are
supplementary devices (i.e. plates, screws, wires, etc.) present in proximity to the T2
Alpha Tibia Nailing System and IMN Screws System, this could result in additional MRI
effects and the information provided above may not apply.
4
0mm
A / P slope 10º
Additional Information 12
19
27
Compression
Slot
Range**
34
46
T2 Alpha Tibia Nail
Herzog Bend, 10 °
• Nail diameters 50mm
Ø8mm – Ø15mm*
• Nail length
240mm – 420mm in 15mm increments
IMN Screws
• Locking Screw
Ø5mm, 25mm –120mm
04mm, 20mm - 60mm for 8mm nails (distal screws only)
20mm - 60mm in 2.5mm increments
60mm - 120mm in 5mm increments
Drills
4.2mm - green 21
5.5mm - green (counterbore drill) 13
5
3.5mm - orange 0mm
4.5mm - orange (counterbore drill)
* Check with local representative regarding availability of implant sizes.
** Compression range Note: Screw length is measured from top of head to tip
Note: The suprapatellar instrumentation can only be used with nails with a
Total length of slot 12mm diameter of up to 13mm
Less screw diameter 5mm Note: 8mm nails require 4mm IMN Locking Screws or 4mm IMN Advanced
5 Locking Screws for distal locking. 5
Max movement of screw 7mm
Additional Information
Packaging
Fig. 2
Fig. 3
6
Additional Information
Packaging
Fig. 4
Fig. 5
Fig. 6
Fig. 7
7
Operative technique
Infrapatellar approach
Patient positioning
and reduction
There are two options for patient
positioning.
1. The patient is placed in the
supine position on a radiolucent
table and the knee of the injured
leg is flexed.
2. The patient is placed in the
supine position on a radiolucent
fracture table and the leg is
hyperflexed on the table with
the aid of a leg holder (fig. 8).
Fig. 8
The knee is flexed to >90°.
A triangle may be used under the
knee to accommodate flexion
intra-operatively. It is important
that the knee rest is placed under
the posterior aspect of the lower
thigh in order to reduce the risk
of vascular compression and of
pushing the proximal fragment
of the tibia anteriorly.
Anatomical reduction can be
achieved by internal or external
rotation of the fracture and by
traction, adduction or abduction,
and must be confirmed under
image intensification. Draping
Fig. 9
must leave the knee and the
distal end of the leg exposed.
Incision
Based on radiological image, at the junction of the medial
a paratendenous incision is made third, and lateral two-thirds
from the patella extending down of the patellar ligament. This
approximately 1.5 – 4cm determines the entry point (fig. 9).
in preparation for nail insertion.
The patellar tendon may be
retracted laterally or split
8
Operative technique
Infrapatellar approach
Entry point
The medullary canal is opened
through a superolateral plateau
entry portal. The center point
of the portal is located slightly
medial to the lateral tibia spine
as visualized on the A / P
radiograph and immediately
adjacent and anterior to the
anterior articular margin as
visualized on the true lateral
radiograph. It is located lateral
to the midline of the tibia by an
average of 6 percent of the tibia
plateau width.
Radiographic confirmation of this
area is essential to prevent damage
to the intra-articular structure
during portal placement and nail
Fig. 10
insertion (fig. 10, 11).
Fig. 11
9
Operative technique
Infrapatellar approach
Opening Opening
Trocar
The opening should be directed
with a central orientation in
relation to the medullary canal.
Insert the 3x285mm K-wire at
the identified entry point and
into the medullary canal.
Assemble the Opening Reamer
Handle and Opening Reamer
Sleeve, 11.5, and together with Opening
the Opening Trocar, 11.5 (fig. 12), Reamer Sleeve
Opening
guide the assembly over the Reamer
K-wire until the Opening Trocar Handle
is fully seated on the bone. It is
recommended to orient the sleeve
so that the convex tips are Fig. 12
positioned anteriorly/posteriorly
and the concave ends are
positioned medially/laterally.
If the initial K-wire is not
optimally positioned, the off-
center holes of the Opening
Trocar can be used to correct the
entry point by inserting a second
K-wire. To utilize, rotate the
trocar into the desired position
and place a second K-wire
through one of the off-center
holes. The distance from the
center hole is 4mm (fig. 13). Once
the second K-wire is positioned
as desired, remove the initial
K-wire and the Opening Trocar.
As an alternative to the
standard 3x285mm K-wire,
the 3x285mm Fixation K-wire Fig. 13
can be utilized as an entry 4mm
point guide wire. 4mm
10
Operative technique
Infrapatellar approach
11
Operative technique
Suprapatellar approach
Patient positioning
options and reduction
The patient is placed in the supine
position on a radiolucent table and
the leg is flexed approximately 15°.
To create this necessary flexion in
the knee, a cushion can be placed
underneath the tibia to create the Fig. 15a
Fig. 15b
Increasing the knee flexion
may limit the available space
within the joint and the
opportunity to maneuver
the sleeves during insertion.
12
Operative technique
Suprapatellar approach
Incision
A longitudinal incision is made
directly proximal to the patella,
measuring approximately 2-3cm
(fig. 16).
Then, a longitudinal split of the
quadriceps tendon is performed
along its midline.
CAUTION
Surgeons must evaluate
the available joint space.
Switching to a parapatellar
approach is recommended if
space within the joint is too Fig. 16
limited to permit smooth
sleeve insertion.
13
Operative technique
Suprapatellar approach
Trigger Modular Handle
It is recommended to visibly
inspect the Drill Sleeve
Fig. 17b
before use, as it may become
damaged over time.
Drill Sleeve
CAUTION
Due to the sleeve sizes the
suprapatellar approach can
only be performed with T2
Alpha Tibial Nails up to a
diameter of 13mm.
Fig. 17c
Final position of
assembled
Modular Handle
and Drill Sleeve.
The Modular Handle, Drill Sleeves, Trocars, Plug and Elastic Nail Insertion Sleeves are existing components
of the T2 System.
14
Operative technique
Suprapatellar approach
Fig. 18
15
Operative technique
Suprapatellar approach
16
Operative technique
Suprapatellar approach
CAUTION
Proceed with caution
to not cause harm to the
patella, intercondylar notch,
and surrounding tissues.
Fig. 20b
Fig. 20c
17
Operative technique
Suprapatellar approach
Entry point
The medullary canal is opened In an additional M / L radiograph
through a superolateral plateau (fig. 16), the correct positioning
entry portal. of the entry point in the sagittal
plane should be confirmed.
The center point of the portal
is located slightly medial to the The opening should be directed
lateral tibia spine as visualized on with a central orientation in
the A / P radiograph (fig. 21a) and relation to the medullary canal
immediately adjacent and anterior in both (A / P and M / L) views.
to the anterior articular margin
as visualized on the true lateral
radiograph (fig. 21b). Fig. 21a
Do not use a bent K-wire
The entry point is located lateral for entry point definition.
to the midline of the tibia by an
average of 6 percent of the tibia
plateau width. Radiographic
confirmation of this area is
essential to prevent damage
to the intra-articular structure
during portal placement and
nail insertion.
The off-center hole of the Trocar
can be used either for guide wire Fig. 21b
placement or to correct an initially
misplaced entry point through the
center hole. The distance between
the center and the off-center hole
is 4.5mm.
To utilize the off-center hole,
rotate the Trocar into the desired
position and place either an
initial or second 3x285mm K-wire
through the off-center hole of the
Trocar (fig. 22). If an initial K-wire
was used in the center hole,
remove at this time. Fig. 22
4.5mm
18
Operative technique
Suprapatellar approach
Fig. 23
3x285mm
Fixation K-wire
Fig. 24
19
Operative technique
Suprapatellar approach
Opening
Remove the Trocar prior to
opening of the tibia. The Opening
Drill Ø12 is used to access the
medullary canal (fig. 25a).
Reamed technique
The Drill Sleeve and the 3x285mm
Fixation K-wires are not removed
prior to reaming. The Elastic Nail
Insertion Sleeve also remains
in place.
Fig. 25a Fig. 25b
The remaining operative steps
for both the infrapatellar and
suprapatellar approach are the
same unless otherwise
indicated. All of the following
pictures are shown using the
infrapatellar approach unless
otherwise indicated.
CAUTION
Use of the suprapatellar
instrumentation decreases
the working length and may
require longer reamer and
guide wire lengths than those
used with the infrapatellar Fig. 26
approach. Please plan
accordingly.
CAUTION
Opening drilling should be
performed through the drill
sleeve with the Elastic Nail
Insertion Sleeve or the Nail
Insertion Sleeve SPI remaining
in place. Advance the opening
drill until it stops.
20
Operative technique Adjustment wheel
Guide wire insertion
Fixation lever
Insert the Ball Tip Guide Wire
3x800mm through the Guide
Wire Handle (fig. 27a). Adjust the
Release lever
handle as desired and lock the
assembly by closing the fixation
lever.
The Guide Wire Handle can
accommodate guide wires and
K-wires with diameters from
1.8mm – 4mm. If necessary,
loosen or tighten the adjustment
wheel to increase or decrease the
diameter of the insertion hole.
Advance the Ball Tip Guide Wire
through the fracture site and
to the desired insertion depth. Fig. 27a
The guide wire should lie in the
center of the metaphysis and
the diaphysis in both the AP and
Lateral views to avoid offset
positioning of nail.
The Reduction Rod and Quick-
Lock Delta Handle Assembly may
be used as a fracture reduction tool
to facilitate guide wire insertion
through the fracture site (fig. 27b).
CAUTION
Confirm correct position of
Ball Tip Guide Wire prior to
reaming.
21
Operative technique
Reaming
CAUTION CAUTION
If the fracture is suitable Use fluoroscopy to ensure
for apposition / compression that the Ball Tip Guide
the implant selected should Wire and Guide Wire Ruler
be at least 7-12mm shorter are correctly positioned
than measured to help avoid and verify nail length
migration of the nail beyond measurement prior to nail
the insertion site. insertion.
CAUTION
The Guide Wire Ruler is
calibrated for 800mm and
1000mm Guide Wires.
23
Operative technique
Nail insertion
24
Operative technique
Nail insertion
4 3
Proximal locking hole options - top view
Numeric markings are for
illustration only. The
targeting device is not
marked with numbers.
All circles marked on
targeting device indicate
static locking. Dynamic/
compression locking
options are marked
accordingly.
5
3
1
4 2
1
2
5
3
4
Option 1
Static locking mode
All four indicated holes
may be used.
1 Oblique static
2 Oblique static
3 ML static
4 ML static
Option 2:
Controlled dynamization
or appostion / compression
mode
The dynamic hole is used to
lock the nail in the controlled
dynamization or apposition/
compression modes.
The dynamic hole is indicated on
the targeting arm.
Dynamic
5
CAUTION
Dynamic locking might be
associated with bone
shortening during the healing
period.
28
Operative technique
Guided proximal locking
Option 3:
Internal apposition/
compression
In the internal apposition/
compression mode, use of the
dynamic hole is required.
Use of an additional ML static
screw and/or the most proximal
oblique screw is recommended.
In the internal apposition/
compression mode, the more
distal oblique screw cannot be
used as the compression screw
blocks this hole in the nail.
Dynamic
5
4 ML static (recommended)
1 Oblique static (optional)
Option 4:
External apposition/
compression
In the external apposition/
compression mode, use of the
dynamic hole is required.
Use of an additional ML static
screw is recommended.
Dynamic
5
4 ML static (recommended)
1 Oblique static (optional)
2 Oblique static (optional)
29
Operative technique
Static locking mode
CAUTION
Ensure sleeve assembly is
seated on bone prior to
drilling and screw length Fig. 39
measuring. Verify correct
position of sleeve under
imaging prior to drilling. The CAUTION
gray friction lock mechanism
is designed to maintain the Applying excessive force may Drilling past the far cortex
position of the drill sleeves. result in breakage of the drill may damage soft tissue.
To remove the sleeve assembly which could require recovery.
from the Targeting Arm Tibia, Recovery could result in an
press the gray mechanism iatrogenic fracture and/or
while pulling the sleeves and bone damage may occur.
trocar.
30
Operative technique
Static locking mode
Fig. 42
31
Operative technique
Static locking mode
33
Operative technique
External apposition/compression mode
As an alternative to internal
compression, the External
Compression Device Tibia can
be used to apply apposition /
compression.
After two static screws have
been inserted distally, insert a
Locking Screw proximally in
Fig. 49
the dynamic position of the
oblong hole.
To apply compression, attach
the External Compression
Device Tibia to the Quick-Lock
Delta Handle (fig. 49) and insert
the External Compression Device
Tibia through the Nail Holing
Screw Tibia / Femur PF or Nail
Holding Screw Tibia SPI to
engage the internal threads of
the nail. Rotate to apply
compression (fig. 50, 51).
When compressing the fragments,
the implant must be inserted at
a safe distance from the entry
point to accommodate up to
7mm of active compression. The
three grooves on the insertion Fig. 50 Fig. 51
post help attain accurate
insertion depth of the implant.
The lines marked on the shaft of Once the second black line is at
the External Compression the same height as the Nail
Device, Tibia are designed to aid Holding Screw, 7mm of
in determining the amount of compression has been achieved
compression that has been and no additional forces should
achieved. The two distal lines be applied.
are used in the infrapatellar
Once apposition / compression
approach, and the two proximal
has been applied, insertion
lines are used for the suprapatellar
of a second proximal ML screw
approach. When the first black
is recommended. Once the
line passes the proximal end of
second screw has been inserted,
the nail holding screw,
the External Compression
compression is being applied.
Device Tibia can be detached.
Fig. 52
34
Operative technique
Guided distal locking
Distal Targeting
Arm Tibia
Adjusting
Device Tibia
Fig. 53
35
Operative technique
Assembly
Pre-operative assembly is
recommended prior to nail
insertion. Assembly steps
are as follows:
Fig. 55
2. Attach Adjusting
Device, Tibia to the Distal
Targeting Arm, Tibia
Insert the center pin of the
Adjusting Device Tibia through
the appropriate hole of the Distal
Targeting Arm Tibia. Left/Right
markings on the targeter
indicate which hole should be
used (fig. 56, 57). Once inserted,
turn knob to secure.
Fig. 56 Fig. 57
36
Operative technique
Pre-operative assembly
Fig. 59
37
Operative technique
Distal drilling and locking
Proceed with nail and screw The following three steps must
insertion as described in this be taken prior to drilling:
operative technique. Once the
nail insertion has been 1. Oblique positioning of C-arm
performed, re-attach the Distal 2. Height and orbital rotation
Targeting Arm Tibia to the Nail adjustment of the C-arm
Adapter Tibia or Nail Adapter
Tibia SPI as described in the 3. Sleeve adjustment to the
preassembly steps. Depending nail position
on the preferred locking
configuration, proximal screw
insertion may be performed prior
to distal locking.
Fig. 60
38
Operative technique
Distal drilling and locking
1. O
blique positioning
of the C-arm
To perform guided distal
locking, it is essential to place
the X-ray beam of a C-arm
approximately 30º oblique to the
axis of the drill sleeve assembly.
30º
Fig. 61
39
Operative technique
Distal drilling and locking
2. H
eight and orbital
rotation of the C-arm
In this step, it is important to
position the C-arm so that the
nail tip and the sleeve tip are
seen parallel on the fluoroscopic
image. 1
After oblique C-arm positioning,
adjust the height and orbital
rotation of the X-ray beam at the
2
same plane as the Drill Sleeve
assembly (fig. 62). Take an X-ray.
Fig. 62
If the sleeve and nail tip are
parallel (fig. 63a) or colinear
(fig. 63b) in the X-ray image, the
C-arm is correctly positioned
and no adjustments to the C-arm
position are necessary (fig. 63).
If the sleeve and nail are not
parallel or colinear, the C-arm is
incorrectly positioned.
Adjust the C-arm rotation as per
the following instructions until Fig. 63a Fig. 63b
the correct position is achieved.
This step requires appropriate
C-arm positioning only. Do not
turn the Adjusting Device Tibia
before the nail and the sleeve are
parallel.
40
Operative technique
Examples of incorrect C-arm positioning
41
Operative technique
Distal drilling and locking
3. Sleeve adjustment
to the nail position
Once the C-arm has been
adjusted so that nail and sleeve
are shown parallel, the deviated
image may show the sleeve
either above or below the nail
(fig. 66a and fig. 66b). If the
sleeve and the nail tip are shown
colinear, (fig. 66c) no further Nail tip and sleeve parallel but not in Nail tip and sleeve parallel but not in
adjustment of the Adjusting the same axis. Turn the knob of the the same axis. Turn the knob of the
adjusting device counterclockwise to adjusting device clockwise to move
Device Tibia is needed. move the sleeve up. the sleeve down.
If the sleeve and nail tip Fig. 66a Fig. 66b
are not colinear on the same axis
(fig. 66a, 66b) sleeve adjustment
is required by turning the
adjusting screw of the Adjusting
Device, Tibia (fig. 67). By turning
the adjusting screw, the sleeve
moves anteriorly or posteriorly.
42
Operative technique
Distal drilling and locking
43
Operative technique
Freehand distal locking
Fig. 72
44
Operative technique
Freehand distal locking
Fig. 74
45
Operative technique
Advanced locking screws
46
Operative technique
Advanced locking screws
confirm.
CAUTION
The Advanced Locking
Screw must be inserted
using reasonable force.
to provide desired function
and to avoid damaging the
screw. If unreasonable
insertion torque is noticed,
stop insertion, turn the screw
counterclockwise and then
Fig. 82
attempt to insert the screw. If
unreasonable insertion torque
is still noticed, remove the
screw and proceed with a
Locking Screw.
48
Operative technique
End cap insertion
Fig. 84
49
Operative technique
Nail removal
50
Notes
51
This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical 0123
judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice
and recommends that surgeons be trained in the use of any particular product before using it in surgery. Manufacturer:
The information presented is intended to demonstrate a Stryker product. A surgeon must always refer to the package insert, product label Stryker Trauma GmbH
and/or instructions for use, including the instructions for cleaning and sterilization (if applicable), before using any Stryker product. Products Prof.-Küntscher-Str. 1-5
may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. 24232 Schönkirchen
Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.
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