Synthes Titanium Trochanteric FixationNail System User manual

Titanium Trochanteric Fixation
Nail System—Screw Option.
For intramedullary fixation of proximal
femur fractures.
Technique Guide

Introduction
Surgical Technique
Product Information
Table of Contents
Titanium Trochanteric Fixation Nail System— 2
Screw Option
AO Principles 4
Indications 5
Preoperative Implant Selection 6
Open Proximal Femur 7
Insert Nail 14
Proximal Locking 18
Distal Locking—Short Nails 31
SureLock Distal Targeting Device—Long Nails 34
Freehand Distal Locking—Long Nails 35
Insert End Cap 39
Implant Removal 40
Instrument Cleaning 45
Locking Mechanism Assembly 46
Implants 47
Instruments 53
Set Lists 62
Image intensifier control
Synthes
Important: These devices have not been evaluated for safety
and compatibility in the MR environment. These devices
have not been tested for heating or migration in the MR
environment.

End caps
– Prevent ingrowth of tissue and
facilitate nail extraction
– Cannulated for insertion over a guide
wire
– 0 mm end cap sits flush with nail
– 5 mm, and 10 mm end caps extend
nail height if nail is overinserted
– Titanium alloy*
Instrumentation
– Easy-to-use instrumentation facilitates
the surgical procedure
– Ball-tip reaming rod can be removed
through the nail and insertion instru-
ments, eliminating the need for an
exchange tube
2 Synthes Titanium Trochanteric Fixation Nail System—Screw Option Technique Guide
Titanium Trochanteric Fixation Nail System—Screw Option.
For intramedullary fixation of proximal femur fractures.
Nail features
– 6° lateral angle accommodates entry
site through the greater trochanter
– Cannulated nails with 17 mm proxi-
mal diameter
– Distal diameters of 10 mm–12 mm
(14 mm option for long nails) for
reamed or unreamed techniques
– Lengths: 170 mm, 235 mm,
300 mm–460 mm in 20 mm
increments
– Preassembled locking mechanism
for controlling screw rotation and
amount of screw travel
– Femoral neck angles of 125°, 130°,
135°
– Long nails with anatomic 1.5 m
radius of curvature
– Titanium alloy*

11.0 mm screw features
– 11.0 mm diameter
– Inverse-angle threads
– Self-tapping
– 70 mm– 130 mm lengths
– Titanium alloy*
Distal locking
– 4.9 mm locking bolts or 5.0 mm
locking screws
– Titanium alloy* for improved
mechanical and fatigue properties
– Self-cutting trocar tip
Synthes 3
*Titanium-6% aluminum-7% niobium
4.9 mm locking bolt
5.0 mm locking screw

AO Principles
In 1958, the AO formulated four basic principles, which have
become the guidelines for internal fixation.1They are:
Anatomic reduction
Precontoured plate assists in reduction of metaphysis to
diaphysis and facilitates restoration of length and rotation.
Stable fixation
Locking screws create a fixed-angle construct providing
angular stability.
Preservation of blood supply
Tapered end facilitates submuscular plate insertion. Submus-
cular insertion may help to preserve tissue viability.
Early, active mobilization
Early mobilization per standard AO technique creates an
environment for bone healing, expediting a return to optimal
function.
4 Synthes Titanium Trochanteric Fixation Nail System—Screw Option Technique Guide
1. M.E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger, Manual of
Internal Fixation, 3rd Edition. Berlin: Springer-Verlag, 1991.
2. M. Baumgaertner, S. Curtin, D. Lindskog. “Intramedullary Versus
Extramedullary Fixation for the Treatment of Intertrochanteric Hip Fractures.”
Clinical Orthopaedics and Related Research, 348, pp 87-94, 1998.
3. D. Hardy, P. Descamps, P. Krallis, et al. “Use of an Intramedullary Hip-Screw
Compared with a Compression Hip-Screw with a Plate for Intertrochanteric
Femoral Fractures.” The Journal of Bone and Joint Surgery, 80-A(5),
pp 618-630, 1998.

Indications
Synthes 5
The Synthes Titanium Trochanteric
Fixation Nail (TFN) is intended to treat
stable and unstable pertrochanteric
fractures, intertrochanteric fractures,
basal neck fractures, and combinations
thereof. The long TFN is additionally
indicated for subtrochanteric fractures,
pertrochanteric fractures associated
with shaft fractures, pathologic
fractures of osteoporotic bone
(including prophylactic use) in both
trochanteric and diaphyseal regions,
long subtrochanteric fractures,
proximal or distal nonunions,
malunions, and revisions.
Short (170 mm and 235 mm)
Trochanteric Fixation Nails
Long (300 mm–460 mm)
Trochanteric Fixation Nails

Preoperative Implant Selection
6 Synthes Titanium Trochanteric Fixation Nail System—Screw Option Technique Guide
Use the AO preoperative planner rulers for the Titanium
Trochanteric Fixation Nail System to determine nail length,
nail diameter, and femoral neck angle.
Note: Check the magnification on the specific preoperative
planner ruler. Magnification levels are either 0% or 15%.
Determine the typical magnification factor at your institution
and then adjust measurements accordingly. To do this, divide
the measured length by the magnification factor and choose
the nearest nail length. Note that this will provide an esti-
mated nail length and implant size.
Example (for 0% magnification planner ruler):
– Measured nail length is 420 mm
– Typical femoral x-ray image is enlarged by 5%
(magnification factor 1.05)*
– 420/1.05 = 400
– Estimated nail length is 400 mm
When selecting nail size, consider canal diameter, fracture
pattern, patient anatomy, and postoperative protocol.
* Magnification factor may vary
Titanium Trochanteric Fixation Nail Ruler
For use with the Original AO/ASIF System of Instruments and Implants. ASIF is a registered trademark of SYNTHES (USA) and SYNTHES AG Chur.
170 mm and 235 mm Lengths, for 10 mm, 11 mm and 12 mm Cannulated Nails
80
85
90
95
100
105
110
115
120
125°130°
135°
10 mm 11 mm
12mm
170 mm 170 mm 235 mm
235 mm
10 mm 11 mm 12 mm
10 mm
5 mm
0mm
END CAP EXTENSIONS
mm 0
Titanium Helical Blade
80 mm – 120 mm
(5 mm increments)
Lateral View A-P View
For distal locking use
4.9 mm Titanium Locking Bolts or
5.0 mm Titanium Locking Screws
AO ASIF
GP2028-A 1/02 J3898A
Millimeters Illustrations (1.15 Magnification)

Synthes 7
Open Proximal Femur
1
Position patient
Instrument
394.35* Large Distractor
Position the patient in the lateral decubitus or supine
position on a fracture or radiolucent table. Position the
image intensifier to enable visualization of the proximal
femur in both the AP and lateral planes.
For unimpeded access to the medullary canal, abduct
the upper part of the body approximately 10–15° to the
contralateral side (or adduct the affected leg by 10–15°).
Reduce the fracture. The universal large distractor may
be useful when not using a fracture table.
2
Determine femoral neck angle
Instruments
357.391 Radiographic Ruler
357.399 3.2 mm Guide Wire, 400 mm
The three oblique slots at the proximal end of the radiographic
ruler can be used to determine the femoral neck angle. Select
a 3.2 mm guide wire and clamp the guide wire into one of
the grooves marked 125°, 130°, or 135°. Position the ruler
over the proximal femur and take an AP image. Select the an-
gle that most closely matches the angle of the femoral neck.
10°–15°
Affected leg
* Also available

8 Synthes Titanium Trochanteric Fixation Nail System—Screw Option Technique Guide
Open Proximal Femur
3
Determine nail length
(for nails 300 mm–460 mm)
Instrument
357.391 Radiographic Ruler
Position the image intensifier for an AP view of the proximal
femur. With long forceps, clamp the guide wire in the
appropriate neck angle position as previously determined.
Place the radiographic ruler over the femur. Adjust the
radiographic ruler until the guide wire is centered in the
femoral head. Mark the skin at the proximal end of the ruler.
Move the image intensifier to the distal femur, replace the
proximal end of the radiographic ruler at the skin mark,
and take an AP image of the distal femur. Verify fracture
reduction. Read nail length directly from the ruler image,
selecting the measurement that places the distal end of the
nail at, or just proximal to, the physeal scar, or the chosen
insertion depth.
Alternative technique
Instrument
360.255 Reaming Rod Measuring Device
Nail length may also be determined by using the reaming rod
measuring device and a 950 mm reaming rod or guide rod.
Insert the reaming rod to hold fracture reduction. Position
the image intensifier over the distal femur and take an image
to confirm reaming rod insertion depth. Pass the reaming
rod measuring device over the proximal end of the reaming
rod and through the incision to the bone. Read nail length
directly from the measuring device.

Synthes 9
4
Determine nail diameter
To determine nail diameter, position the image intensifier
for an AP view of the femur at the level of the isthmus.
Hold the radiographic ruler perpendicular to the femur
and position the diameter tabs over the isthmus. Read the
diameter measurement on the tab that fills the canal.
Note: Take into consideration that the ruler is not at the
same level as the femur. This will affect the accuracy of
the measurement.

Open Proximal Femur
10 Synthes Titanium Trochanteric Fixation Nail System—Screw Option Technique Guide
5
Identify nail entry point
Instruments
357.392 17.0 mm/3.2 mm Wire Guide
357.393 3.2 mm Trocar
357.399 3.2 mm Guide Wire, 400 mm
357.410 22.0 mm/17.0 mm Protection Sleeve
393.10 Universal Chuck with T-Handle
The entry point for the nail is in line with the medullary canal
in the lateral view. In the AP view, the nail insertion point
is slightly lateral to the tip of the greater trochanter, in the
curved extension of the medullary cavity.
Make a longitudinal incision proximal to the greater trochanter.
Carry the dissection down to the gluteus maximus fascia longi-
tudinally in the direction of the wound. Separate the underlying
muscle fibers and palpate the tip of the greater trochanter.
Insert the 22.0 mm/17.0 mm protection sleeve, the 17.0 mm/
3.2 mm wire guide, and the 3.2 mm trocar assembly into the
incision site and down to the bone. Remove the trocar.
The lateral angle of the nail is 6°; therefore, the 3.2 mm
guide wire must be inserted at an angle 6° lateral to the
shaft of the femur, and intersect the centerline of the canal,
just distal to the lesser trochanter. The guide wire will be
centered in the canal in the lateral view. The guide wire
can be inserted either manually with the universal chuck
with T-handle or with a power drill.
Axial and AP view
of insertion site
6°
Anatomic
axis
Guide wire
entry path

Synthes 11
Insert the guide wire through the protection sleeve and wire
guide. Confirm guide wire placement in both the AP and
lateral planes. Insert to a depth of approximately 15 cm.
Remove the wire guide.

Open Proximal Femur
12 Synthes Titanium Trochanteric Fixation Nail System—Screw Option Technique Guide
6
Open canal
Instruments
351.05 Tissue Protector
357.394 17.0 mm Cannulated Drill Bit
357.399 3.2 mm Guide Wire, 400 mm
357.412 Cannulated Reverse Awl
Place the 17.0 mm cannulated drill bit into a power drill. Pass
the drill bit over the guide wire and through the protection
sleeve to the bone. Drill to the stop.
Note: If the fracture line runs through the entry point for
the nail, care must be taken to remove the bone on the
medial fragment to create a path for the nail. Do not plunge
the drill bit through the fracture as this may displace the frac-
ture and cause the fracture to be fixed in varus. Take care to
remove the bone on the medial segment of the fracture to
prepare an adequate opening for the proximal end of
the nail.
When the 17.0 mm drill bit is removed, the 3.2 mm guide
wire may be captured and removed simultaneously. If the
guide wire remains in the bone, remove it by hand.
Dispose of the guide wire. Do not reuse.
Note: The cannulated reverse awl may also be used to open
the canal or expand the opening created by the 17.0 mm
drill bit. Use the tissue protector to spare the soft tissues.
Place the awl over the guide wire and to the bone. Use a
twisting motion to advance the awl. As with the cannulated
drill, take care not to plunge the awl into the fracture site be-
cause this may displace the fracture and cause the fracture to
be fixed in varus. Take care to remove the bone on the me-
dial segment of the fracture to prepare an adequate opening
for the proximal end of the nail.

Synthes 13
7
Reaming guidelines (optional)
Instruments
351.706S* 2.5 mm Reaming Rod with ball tip,
950 mm, sterile
360.255 Reaming Rod Measuring Device
Using image intensification, ensure that fracture reduction
has been maintained. Insert the 2.5 mm reaming rod
with ball tip into the medullary canal to the desired
insertion depth.
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.
Ream to a diameter at least 1.0 mm greater than the nail
diameter as determined by surgeon preference.
After reaming, remove the reaming assembly, leaving the
reaming rod in place.
Note: The trochanteric fixation nail can be passed over
the 3.0 mm reaming rod, with straight ball tip, if used.
No reaming rod exchange is required.
Nail length may be determined by using the reaming rod
measuring device and a 950 mm reaming rod or guide rod.
Insert the reaming rod to hold fracture reduction. Position
the image intensifier over the distal femur and take an image
to confirm reaming rod insertion depth. Pass the reaming
rod measuring device over the proximal end of the reaming
rod and through the incision to the bone. Read nail length
directly from the measuring device.
* Also available

Insert Nail
14 Synthes Titanium Trochanteric Fixation Nail System—Screw Option Technique Guide
1
Assemble insertion instruments
Instruments
357.397 Cannulated Connecting Screw
357.406 5.0 mm Flexible Hexagonal Screwdriver
357.411 Insertion Handle
357.515 Ball Hexagonal Screwdriver, 8 mm
Optional instruments
357.418 Percutaneous Insertion Handle
357.419 Percutaneous Cannulated Connecting
Screw
The sterile nail is packaged with a protective plug in
the proximal end of the nail. Remove and dispose of
the plug.
Orient the insertion handle laterally and match the geometry
of the handle to the nail.
Note: For long (300 mm to 460 mm) nails, the bow of the
nail must be aligned with the anterior bow of the femur.
Also confirm left or right nail is being assembled for correct
affected limb.
Pass the cannulated connecting screw through the insertion
handle and into the nail. Secure using the ball hexagonal
screwdriver.
To verify the appropriate position of the locking mechanism
for the screw, pass the 5.0 mm flexible hexagonal screw-
driver through the cannulated connecting screw and turn
counterclockwise until it stops.
Important: Ensure that the connecting screw is tight to
avoid misalignment when inserting the screw through the
aiming arm. Do not attach the aiming arm to the handle
until after the nail is fully inserted.

Synthes 15
2
Insert nail
Instrument
357.411 Insertion Handle
For short nails (170 mm and 235 mm), orient the insertion
handle laterally, taking into consideration the anteversion
of the femoral head and neck. Manually insert the nail into
the femoral opening. When using a reaming rod, pass
the cannulated nail over the reaming rod and into the
femoral opening.
Optional technique
Ensure correct anteversion of the nail by placing a guide wire
ventral to the femoral neck and into the femoral head.
Under image intensification, verify fracture reduction and
insert the nail as far as possible by hand. Use the insertion
assembly to manipulate the nail across the fracture.
When inserting a short nail, no hammer blows
should be required.

Insert Nail
16 Synthes Titanium Trochanteric Fixation Nail System—Screw Option Technique Guide
2. Insert nail continued
To aid with the insertion of long nails,
orient the insertion handle anteriorly
until the nail reaches the isthmus. As
the nail is advanced, rotate the handle
so it is positioned laterally for final
seating. This will allow the bow of the
long nails to aid nail passage through
the 6° laterally angled entry point.
For long nails, insertion can be aided
by light hammer blows. When using
a hammer, monitor the tip of the
nail using image intensification.
Verify that there is no evidence of
impingement distally.

Synthes 17
Instruments
321.20 Ratchet Wrench, 11 mm width across flats
321.25 Spanner Wrench
357.22 Hammer Guide
357.25 Slide Hammer
357.395 Driving Cap
357.398 Cannulated Shaft with 8 mm hex
To use a hammer, slide the driving cap into the grooves on
the insertion handle and secure it in place using the 11 mm
ratchet wrench or spanner wrench. A free hammer can be
used to strike the driving cap directly. Alternatively, the slide
hammer and hammer guide can be threaded into the driving
cap. Light blows can be used to seat the nail. Remove the
driving cap once the nail has been seated.
Important: Confirm that the nail is tightly connected to the
insertion handle, especially after hammering. The cannulated
shaft with 8 mm hex and 11 mm ratchet wrench may be
used to retighten the connecting screw over the reaming rod
as needed.
If a reaming rod has been used, it should be removed once
the nail has crossed the fracture site.

Proximal Locking
18 Synthes Titanium Trochanteric Fixation Nail System—Screw Option Technique Guide
1
Verify nail insertion depth and anteversion
Instruments
357.365 125° Aiming Arm
357.366 130° Aiming Arm
357.367 135° Aiming Arm
357.399 3.2 mm Guide Wire, 400 mm
Ensure that the nail is tightly connected to the
insertion handle.
Securely attach the appropriate aiming arm to the
insertion handle.
Nail insertion depth can be confirmed by inserting a 3.2 mm
guide wire through the aiming arm. To ensure the correct
anteversion of the nail, an additional guide wire can be
inserted ventral to the femoral neck and into the femoral
head. Take a lateral image of the proximal femur to verify
nail rotation and ensure that the screw will be aimed toward
the center of the femoral head.