t2 Alpha Femur Retrograde Operativetechnique
t2 Alpha Femur Retrograde Operativetechnique
Femur Retrograde
Nailing System
Operative technique
T2 Alpha
Femur Retrograde Nailing System
Contents
1. Indications and contraindications...........3 Follow the instructions provided in our cleaning
and sterilization guide (OT-RG-1). All non-strile
2. MRI Safety information..............................4 devices must be cleaned and sterilized before use.
2. Additional information...............................5
3. Operative technique..................................10 Consult Instructions for Use (www.ifu.stryker.com)
for a complete list of potential adverse effects and
Patient positioning........................................ 10 adverse events, contraindications, warnings and
Entry point.....................................................11 precautions.
Reaming........................................................ 14
Nail selection................................................. 15
Multi-component instruments must
Nail insertion................................................ 16 be disassembled for cleaning.
Guided distal locking.................................... 18 Please refer to the corresponding assembly /
disassembly instructions.
Compression.................................................. 24
Guided proximal locking.............................. 26
The surgeon must discuss all relevant risks including
Freehand proximal locking.......................... 32 the finite lifetime of the device with the patient when
necessary.
Advanced locking screws............................. 33
Condyle screw insertion............................... 36
End cap insertion.......................................... 40 The surgeon must advise patients of surgical
risks, and make them aware of adverse effects
Nail removal.................................................. 41
and alternative treatments.
This publication sets forth detailed recommended
procedures for using Stryker devices and instruments.
It offers guidance that you should heed, but, as The patient should be advised that the device
with any such technical guide, each surgeon must cannot and does not replicate a normal healthy
consider the particular needs of each patient and bone, that the device can break or become
make appropriate adjustments when and as required. damaged as a result of strenuous activity or
A workshop training is recommended prior to trauma and that the device has a finite expected
performing your first surgery. service life.
Please remember that the compatibility* of different Removal or revision of the device may be
product systems has not been tested unless specified required sometime in the future due to
otherwise in the product labeling. medical reasons.
•
*The terms "all Stryker IM Systems" / "all titanium-made Use instruments / implants as described in
Stryker IM Nailing Systems" are defined as T2 Alpha this operative technique to avoid damage to
Femur Retrograde Nailing Systems.
instruments / implants or bone and soft tissue.
2
Indications and
contraindications
The indications for use of these internal • Implant utilization that would interfere
fixation devices include: with anatomical structures or physiological
performance.
• Open and closed femoral fractures.
• Pseudoarthrosis and correction osteotomy. • Any mental or neuromuscular disorder which
would create an unacceptable risk of fixation
• Pathologic fractures, impending pathologic
failure or complications in postoperative care.
fractures and tumor resections.
• Supracondylar fractures, including • Other medical or surgical conditions which
those with intra-articular extension. would preclude the potential benefit of surgery.
• Fractures involving osteopenic
IMN Screws System Intended Use
and osteoporotic bone.
• Fractures distal to a total hip prosthesis. The IMN screws system is intended to stabilize the
intramedullary nail-bone construct for temporary
• Periprosthetic fractures.
stabilization.
• Nonunions and malunions.
IMN Instruments System Intended Use
Contraindications The IMN instruments system is intended to enable
The physician’s education, training and the implantation and extraction of intramedullary
professional judgement must be relied upon to nail and screw.
choose the most appropriate device and treatment.
Conditions presenting an increased risk of failure The T2 Alpha Femoral Nail Retrograde is not
include: intended for full weight bearing in patients
with complex unstable fractures until bone
• Any active or suspected latent infection or
consolidation is confirmed in the follow-up
marked local inflammation in or about the
X-rays.
affected area.
•
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 Femur Retrograde Nailing
System and IMN Screws System, this could
result in additional MRI effects and the
information provided above may not apply.
*∆1°C = 1.8° F
∆2.1° C = 3.78° F
4
Additional Information
T2 Alpha Femur
Retrograde Nailing System
Nail diameter
Ø9mm–Ø14mm1
Driving end diameter
Driving end diameter of the 9–11mm nails is Ø11.5mm;
nail sizes 12–14mm have a constant diameter
Nail length
Femoral Nail Retrograde, Short: 170mm and 200mm
Femoral Nail Retrograde: 220mm– 480mm in 20mm increments
Locking Screw2,3
Ø5mm, 25mm–120mm length
25mm–60mm in 2.5mm increments
60mm–120mm in 5mm increments
5
Additional Information
T2 Alpha Femur Retrograde
Nailing Length
0mm 0mm
10mm
15mm
25mm
35mm
45mm
0mm
RoC:
10mm 700mm-1350mm
30mm
Distal posterior
bend 1-5°
70mm
6
Additional Information
T2 Alpha Femur Retrograde
Nailing System Locking Options
Note: Distal locking option is patient and fracture dependent. Surgeon my choose to utilize any combination of the distal locking options.
7
Additional information
Packaging
Fig. 2
Fig. 3
8
Additional Information
Packaging
Fig. 5
Fig. 6
Fig. 7
9
Operative technique
Pre-operative planning
Patient positioning
and reduction
Retrograde nail insertion is
performed with the patient supine
on a radiolucent table. The affected
lower extremity and hip region
are freely draped, and the knee
is placed over a sterile bolster
to allow for knee flexion (fig.8).
Manual traction through a flexed
knee or a distraction device may
be used to facilitate reduction for
most femoral fractures. Fig. 8
Incision
Make a longitudinal 5cm, or an
appropriate sized incision, just
distal to the inferior pole, over
the midline of the patellar tendon
(fig. 9). Spread the tissues medial
to the patellar tendon and retract
the patellar tendon gently to
allow for guide-wire insertion.
Alternatively, a patellar tendon
split may be performed. In some
instances (e.g. fractures with
intra-articular extensions
requiring fixation of the condyles) Fig. 9
larger incision may be necessary.
Distal femoral fractures are often
complicated by intra-articular
fracture line extension. These
fractures should be anatomically
reduced and secured. Titanium
Asnis III cannulated screws may
be used with a combination of
bone holding clamps to secure An alternative is to reduce
the intracondylar region for nail and maintain reduction of the
insertion. Consider placement of femoral condyles with pointed
the cannulated screws to avoid reduction forceps and only
interference with the nail during utilize the cross locking
nail insertion. screws for definitive fixation.
10
Operative technique
Entry point
11
Operative technique
Entry point
12
Operative technique
Length
Determine appropriate nail length
by measuring the remaining length
of the Ball Tip Guide Wire (fig. 17).
Place the Guide Wire Ruler on the
Ball Tip Guide Wire and read the
correct nail length at the end of the
Ball Tip Guide Wire on the Guide
Wire Ruler (fig 18). Ensure that
the tip of the Guide Wire Ruler
is fully seated on the bone prior
to determining measurement. Fig. 17
•
Use fluoroscopy to ensure that The end of the Guide Wire Ruler
the Ball Tip Guide Wire and should align with the distal end
Guide Wire Ruler are correctly of the nail once inserted.
positioned and verify nail
length measurement prior
to nail insertion. •
The Guide Wire Ruler is
calibrated for 800mm and
• 1000mm guide wires.
If the fracture is suitable
for apposition / compression
the implant selected should
be at least 10mm shorter
than measured to help avoid
migration of the nail beyond
the insertion site.
15
Operative technique
Nail insertion
17
Operative technique
Guided distal locking
Fig. 26
5.0mm Locking Screws and
Advanced Locking Screws
require the 4.2mm drill
(green color-coded drill).
18
Operative technique
Guided distal locking
20
Operative technique
Guided distal locking
•
Applying excessive force
may result in breakage
of the drill which could
require recovery. Recovery
could result in an iatrogenic Fig. 35
fracture and/or bone damage
may occur.
21
Operative technique
Guided distal locking
23
Operative technique
Compression
Internal apposition
/ compression mode
(long nail only)
In transverse, axially stable
fracture patterns, active
mechanical apposition /
compression may be desired.
• •
Apposition / compression must The Compression Screw Femur
Once initial signs of bending
be carried out under X-ray must be screwed in correctly
of the Locking Screw is
control. Over-compression and with reasonable forces to
observed, further compression
may cause the nail or screw provide desired function and
should be limited to one
to fail. to avoid damage of implants
additional turn of the
/ instruments. Excessive
Compression Screw Femur.
deformation of the Locking
Screw may indicate unreasonable
24 force.
Operative technique
Compression
External apposition
/ compression mode
(long nail only)
As an alternative to internal
compression, the External
Compression Device Femur
(fig. 41) can be used to apply
apposition / compression. Fig. 41
When compressing the nail,
the implant must be inserted
at a safe distance from the entry
point to accommodate for the
10mm of active compression.
The three grooves on the
insertion post help attain
accurate insertion depth of the
implant. After insertion of two
proximal Locking Screws, insert
a Locking Screw in the dynamic
position of the distal oblong hole.
To apply compression, attach the
External Compression Device to
the Quick-Lock Delta Handle and
insert the External Compression
Device through the Nail Holding
Screw Femur Retrograde to
engage the internal threads
of the nail. Rotate to apply Fig. 42
compression (fig. 42,43).
Once apposition / compression
has been applied, insert the most
proximal of the distal ML
screws. Once the second screw
has been inserted, the External
Compression Device Femur can
be detached.
25
Operative technique
Guided proximal locking
Fig. 45
26
Operative technique
Guided proximal locking
28 Fig. 51
Operative technique
Guided proximal locking
Sleeve adjustment
to the nail position
Once the C-arm has been Fig. 52
adjusted so that nail and sleeve
are shown in parallel (fig. 50),
the deviated image will show
the sleeve either medial or
lateral to the nail. If the sleeve
and the nail are shown parallel
and collinear (fig. 54), no further
adjustment of the sleeve is
needed.
Fig. 54
29
Operative technique
Guided proximal locking
Proximal drilling
and locking
Once the correct nail and sleeve
adjustment has been obtained,
make a small skin incision at the
sleeve entry point. Ensure that
the incision is straight to avoid
forces on the sleeve.
Advance the Locking Tissue
Protection Sleeve, Long, Locking
Drill Sleeve, long, and Locking
Trocar, Long, assembly through
the incision until the sleeve tip Fig. 55
is close to the cortex. Do not
force the chamfers of the sleeve •
into the bone as this could cause To prevent skiving of the Patient anatomy, entry point
deviations. Take an X-ray to sleeve while ensuring bone or other factors may result in
confirm correct position of the contact for correct screw excessive nail bending that
sleeve as sleeve alignment could measurement, gently seat cannot be compensated by
be compromised by soft tissue the sleeve on the bone. Do design or with the adjustment
or slippage on the bone. Adjust not apply excessive forces function. In these instances,
sleeve position if needed. to the sleeve. freehand proximal locking
Once sleeve position has been must be performed.
confirmed, commence distal
drilling (fig. 55) and screw •
insertion as outlined in the Avoid applying soft tissue
distal locking section. Repeat pressure to the sleeve
these steps for the insertion assembly. Do not make
of a second AP screw. skin incision until correct
alignment of screw trajectory
is confirmed.
30
Operative technique
Guided proximal locking
Fig. 58
31
Operative technique
Freehand proximal locking
•
Take care to avoid capturing
soft tissue during freehand
drilling.
32
Operative technique
Advanced locking screws
34
Operative technique
Advanced locking screws
•
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 attempt to insert
the screw. If unreasonable Fig. 70
insertion torque is still noticed,
remove the screw and proceed
with a Locking Screw. 35
Operative technique
Condyle screw insertion
36
Operative technique
Condyle screw insertion
Fig. 75
Fig. 76
38
Operative technique
Condyle screw insertion
Fig. 77
Fig. 78
39
Operative technique
Fig. 80
Fig. 81
40
Operative technique
Nail removal
41
System components
42
System components
43
System components
End Cap
Ref # Diameter (mm)
1826-0003S Ø8.0
Condyle Screws
Ref# Diameter (mm) Length (mm)
1895-5040S Ø5.0 40
1895-5045S Ø5.0 45
1895-5050S Ø5.0 50
1895-5055S Ø5.0 55
1895-5060S Ø5.0 60
1895-5065S Ø5.0 65
1895-5070S Ø5.0 70
1895-5075S Ø5.0 75
1895-5080S Ø5.0 80
1895-5085S Ø5.0 85
1895-5090S Ø5.0 90
1895-5095S Ø5.0 95
1895-5100S Ø5.0 100
1895-5105S Ø5.0 105
1895-5110S Ø5.0 110
1895-5115S Ø5.0 115
1895-5120S Ø5.0 120
1895-5001S Ø5.0
44
System components
Locking Screws
Ref # Diameter (mm) Length (mm)
2360-5025S Ø5.0 25.0
2360-5027S Ø5.0 27.5
2360-5030S Ø5.0 30.0
2360-5032S Ø5.0 32.5
2360-5035S Ø5.0 35.0
2360-5037S Ø5.0 37.5
2360-5040S Ø5.0 40.0
2360-5042S Ø5.0 42.5
2360-5045S Ø5.0 45.0
2360-5047S Ø5.0 47.5
2360-5050S Ø5.0 50.0
2360-5052S Ø5.0 52.5
2360-5055S Ø5.0 55.0
2360-5057S Ø5.0 57.5
2360-5060S Ø5.0 60.0
2360-5065S Ø5.0 65.0
2360-5070S Ø5.0 70.0
2360-5075S Ø5.0 75.0
2360-5080S Ø5.0 80.0
2360-5085S Ø5.0 85.0
2360-5090S Ø5.0 90.0
2360-5095S Ø5.0 95.0
2360-5100S Ø5.0 100.0
2360-5105S Ø5.0 105.0
2360-5110S Ø5.0 110.0
2360-5115S Ø5.0 115.0
2360-5120S Ø5.0 120.0
45
System components
46
System components
Optional Instruments*
Ref # Description
48
System components
Disposables*
Ref # Description
2351-3028S K-Wire, Ø3.0 × 285mm
0152-0218S K-Wire, Ø1.8 × 310mm
2351-4236S Locking Drill, Ø4.2 × 360mm
2351-4213S Freehand Drill, Ø4.2 × 130mm
2351-4218S Freehand Drill, Ø4.2 × 185mm
1806-0085S Guide-Wire, Ball Tip, Ø3.0 × 1000mm
2351-5500 Counterbore Drill, Short, Ø5.5 × 185mm
2351-5500S Counterbore Drill, Short, Ø5.5 × 185mm, Sterile
2351-5510 Counterbore Drill, Long, Ø5.5 × 255mm
2351-5510S Counterbore Drill, Long, Ø5.5 × 255mm, Sterile
2351-5515 Counterbore Drill, Manual, Ø5.5 × 280mm
2351-5515S Counterbore Drill, Manual, Ø5.5 × 280mm, Sterile
2351-0335S Countersink Bit For Condyles, Sterile
The information in the section is not intended to be used for sales and/or promotional purposes. This information is solely intended to be used
as a reference for clinical usage.
49
Notes
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 Manufacturer:
clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense
Stryker GmbH
medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.
Bohnackerweg 1
The information presented is intended to demonstrate a Stryker product. A surgeon must always refer to the product label and/or 2545 Selzach, Switzerland
Instructions for Use, including the instructions for Cleaning and Sterilization (if applicable), before using any Stryker product. Products
stryker.com
may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual
markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.
The Instructions for Use, Operative Techniques, Cleaning instructions, patient information leaflets and other associated labeling may
be requested online at www.ifu.stryker.com or www.stryker.com. If saving the Instructions for Use, Operative Techniques, Cleaning
instructions from the above mentioned websites, please make sure you always have the most up to date version prior to use.
Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or
service marks: Stryker, T2, T2 Alpha. All other trademarks are trademarks of their respective owners or holders.