Synthes The Titanium Femoral Nail System User manual

R
Standard Locking 130˙ Antegrade Locking
Spiral Blade Locking Miss-A-Nail Locking
The Titanium
Femoral Nail System
Solid and Cannulated Nails
TECHNIQUE GUIDE

Implant Specifications ......................2
Implant Chart .............................7
Indications................................8
Preoperative Implant Selection...............13
Opening the Femur ........................14
Standard Locking..........................19
130° Antegrade Locking.....................29
Spiral Blade Locking .......................39
Miss-A-Nail Locking ........................53
Distal Locking ............................64
Implant Removal ..........................66
Product Information .......................68
Table of Contents
TECHNIQUES

Implant Specifications
Titanium Femoral Nails (green)
9 mm – 12 mm solid nails
10 mm – 15 mm cannulated nails
1.5 m radius
of curvature
Locking holes accept
4.9 mm locking bolts or
5.0 mm locking screws
50 mm from
end of nail
20 mm from
end of nail 12 mm proximal end accepts locking
sleeves for 13 mm –15 mm nails.
2
Universal design
for the right and
left femur
12 mm diameter
proximal end
Proximal flats
orient the specialty
locking sleeves
Material:
Titanium - 6% aluminum - 7% niobium
alloy implant material
Lengths:
300 mm – 480 mm, in 20 mm increments
Diameters:
9 mm and 10 mm diameters:
round cross section
11 mm – 15 mm diameters:
fluted cross section
Dynamic slot accepts 4.9 mm
locking bolt, 5.0 mm locking
screw, Spiral Blade, or 5.0 mm
shaft screw. Permits up to 8 mm
controlled, axial dynamization
with transverse locking bolt or
locking screw.
13 mm–15 mm
cannulated nails

15 mm Titanium End Caps, for standard locking sleeve
Protect proximal nail threads from tissue ingrowth
Secure locking sleeve to nail
•
0 mm extension
•
10 and 20 mm extensions
extend proximal nail end to
level of greater trochanter
Standard Locking Implants (green)
For 9 mm–12 mm solid nails
and 10 mm–12 mm cannulated nails
4.9 mm Titanium Locking
Bolts and 5.0 mm
Titanium Locking Screws
•
Lengths:
26 –100 mm, in 2 –5 mm
increments
•
4.3 mm core diameter
•
Self-cutting trocar tip
•
3.5 mm hex drive
For 13 mm –15 mm cannulated nails
Standard Locking Sleeve
For use with 13 mm –15 mm diameter nails
•
15 mm diameter sleeve matches proximal profile
of 13 mm –15 mm nails to provide smooth
transition on nail
•
Flats key onto proximal nail end in one
of two positions for right or left femur
12 mm Titanium End Caps
Protect proximal nail threads
from tissue ingrowth
•
0 mm extension
•
10 and 20 mm extensions:
extend proximal nail end to
level of greater trochanter
IMPLANT SPECIFICATIONS
3
0mm
10 mm
20 mm
0mm
10 mm
20 mm
For all nails
459.012 459.013 459.014
459.26–.100
458.926–.999
474.920 474.921 474.922
474.900

Implant Specifications (continued)
130 ° Locking Implants (pink)
For 9 mm–12 mm solid nails
and 10 mm–12 mm cannulated nails
130
° Locking Sleeve
•
15 mm diameter sleeve adapts dynamic
slot to a 130
° antegrade locking hole
•
Flats key onto proximal nail end in one
of two positions for right or left femur
0mm
10 mm
20 mm
130
°
For 13 mm–15 mm cannulated nails
130
° Locking Sleeve
for use with 13 mm–15 mm diameter nails
•
15 mm diameter sleeve adapts dynamic slot
to a 130
° antegrade locking hole
•
15 mm diameter sleeve matches proximal
profile of 13 mm–15 mm nails to provide
smooth transition on nail
•
Flats key onto proximal nail end in one
of two positions for right or left femur
15 mm Titanium End Caps
for 130
° locking sleeves
Protect proximal nail threads
from tissue ingrowth
Secure locking sleeve to nail
•
0 mm extension
•
10 and 20 mm extensions:
extend proximal nail end to
level of greater trochanter
For all nails
4
456.013
457.210 457.211 457.212
474.913

Spiral Blade Locking Implants (blue)
For 9 mm–12 mm solid nails
and 10 mm–12 mm cannulated nails
Spiral Blades
•
Lengths: 70 –120 mm,
in 5 mm increments
•
Cannulated for insertion
over 3.2 mm guide wire
•
Front-cutting end
•
Spiral rotates counterclockwise
90
° between nail and front tip
•
Width: 12.5 mm
Locking Sleeves for Spiral Blade
•
100 ° , 110 ° , 120 ° angles adapt nail
slot for Spiral Blade
•
15 mm diameter
•
Flats key onto proximal nail end in
one of two positions for right or left femur
•
Etching identifies the lateral side
90 ° Spiral
Cannulated
Front-cutting end
0mm
10 mm
20 mm
*Ultra High Molecular Weight Polyethylene implant material.
For all nails
15 mm Titanium End Caps,
for Spiral Blade locking sleeves
Protect proximal nail threads from tissue
ingrowth
Secure Spiral Blade locking sleeve to nail
•
0 mm extension
•
10 and 20 mm extensions:
extend proximal nail end to level
of greater trochanter
IMPLANT SPECIFICATIONS
5
456.010 456.011 456.012
•
15 mm diameter Locking Sleeves match
proximal profile of 13 mm–15 mm nails
to provide smooth transition on nail
474.910 474.911 474.912
456.70 –.120
457.010 457.011 457.012
For 13 mm –15 mm cannulated nails
UHMWPE* tip deforms
over blade for secure
locking of blade in
initial postoperative
period
100 ° 110 °
120 °
100 ° 110 °
120 °

Miss-A-Nail Locking Implants (gold)
7.3 mm Titanium
Cannulated Screws
•
16 mm cancellous thread
length for interfragmentary
compression
•
Lengths: 70 –125 mm,
in 5 mm increments
•
Accept 2.8 mm guide wire
•
Self-drilling/self-tapping
•
Reverse-cutting flute
for removal
5.0 mm Titanium
Shaft Screws
•
16 mm cancellous thread
length for interfragmentary
compression
•
Lengths: 70 –125 mm,
in 5 mm increments
•
5.0 mm diameter for insertion
through nail slot, as a third
point of femoral neck
fracture fixation
•
Self-tapping
•
Front-cutting flutes permit
insertion of 5.0 mm shaft screw
into 3.2 mm drilled hole
7.3 mm Titanium Cannulated Screws
5.0 mm Titanium Shaft Screws
13.0 mm Titanium Washers
(optional)
6
Implant Specifications (continued)

IMPLANT CHART
7
9–12 mm Solid Femoral Nails and 13–15 mm Cannulated
10–12 mm Cannulated Femoral Nails Femoral Nails
Locking Sleeve
not needed
12 mm End Caps
459.012–.014
15 mm End Caps
474.920 –.922
Standard Locking
Sleeve
474.900
15 mm End Caps
457.210 –.212
15 mm End Caps
457.210 –.212
130 ° Locking Sleeve
474.913
130 ° Locking Sleeve
456.013
15 mm End Caps
457.010 –.012
12 mm End Caps
459.012–.014
Spiral Blades
456.70 –.120
15 mm End Caps
457.010 –.012
Spiral Blades
456.70 –.120
Locking Sleeves
for Spiral Blade
474.910 –.912
Locking Sleeves
for Spiral Blade
456.010 –.012
7.3 mm Cannulated Screws
408.870–.925
Not
Recommended
MISS-A-NAIL SPIRAL BLADE LOCKING 130° LOCKING STANDARD LOCKING

Indications for the
Titanium Femoral Nail
System include:
•
Femoral shaft fractures
•
Subtrochanteric fractures
•
Ipsilateral femoral
neck/shaft fractures
•
Impending pathologic
fractures
•
Nonunions
Femoral shaft
fractures
For the femoral shaft fracture,
two standard locking
configurations are possible:
•
Static transverse locking
•
Dynamic transverse locking
8
Static locking Dynamic locking
Indications
STANDARD STANDARD

INDICATIONS
9
CASE 2
CASE 1

Indications (continued)
Femoral shaft or
stable* subtrochanteric fractures
For the femoral shaft or the stable subtrochanteric
fracture, 130
° antegrade locking is possible.
10
130 ° ANTEGRADE
*Lesser trochanter and medial buttress intact/attached
to the proximal fragment
CASE 3

11
Subtrochanteric fractures
For the subtrochanteric fracture with a detached lesser trochanter,
the Spiral Blade provides secure fixation of the proximal fragment.
The Spiral Blade is not indicated for intertrochanteric fractures.
SPIRAL BLADE
CASE 4
INDICATIONS

Indications (continued)
Ipsilateral femoral neck/
shaft fractures
For the ipsilateral femoral neck/shaft fracture, the Miss-A-Nail
instruments permit insertion of titanium cannulated screws into
the femoral head, anterior to the nail path, for fixation of the
neck fracture prior to intramedullary fixation of the shaft fracture.
The Miss-A-Nail instruments also permit screw insertion into the
femoral head after nail insertion, for the occult neck fracture.
CASE 5
12
MISS-A-NAIL

Preoperative Implant Selection
Use the AO Preoperative
Planner rulers to determine
the following measurements:
•
Nail length
•
Nail diameter
•
Spiral Blade angle
(if indicated)
For Spiral Blade
locking procedures
Determine Spiral
Blade angle
Select Spiral Blade angle
based on anatomy and
fracture location.
Ideally, the blade tip should lie
just inferior to the intersection
of the compression and
tension trabeculae in the AP
view of the femoral head, and
the midsection of the blade
should lie in the inferior
aspect of the femoral neck.
Because the trabecular
intersection is the densest
area of bone in the femoral
head, this blade placement
maximizes purchase and
cutout resistance.
The Spiral Blade should be
in the proximal fragment and
should not cross the fracture.
For high subtrochanteric
fractures, a lower angled
Spiral Blade is often needed.
For all locking procedures
Note that all ruler images are enlarged 15% to account
for average radiograph magnification; however, deviations
in magnification levels are common.
When selecting nail diameter, consider anatomic
isthmus diameter, fracture pattern, and postoperative
protocol/expectations.
PREOPERATIVE IMPLANT SELECTION
13
Plan for Spiral Blade angle
Example showing ruler placed over the preoperative x-ray.
The 100 ° angle will place the Spiral Blade inferior to the
trabecular intersection and fully in the proximal fragment.

14
Instruments for Opening the Femur
3.2 mm Calibrated Guide Wire
292.69
Additional Instruments
Broach
351.89
(for specialty locking
and 13–15 mm nails)
2.5 mm Reaming Rod with ball tip
950 mm, sterile
351.706S
(for cannulated nails)
Large Reverse Awl
351.11
13.0 mm Cannulated Drill Bit
351.27
Universal Chuck
393.10
Battery Casing
for 14.4 V Battery
532.032
Large Quick Coupling
532.015
Small Battery Drive
532.010
14.4 V Battery
532.033
Small Battery Drive with 14.4 V Battery Pack Set [105.954], specifically:
Radiographic Ruler
357.59
Tissue Protector
351.05
Quick Coupling
for K-Wires
532.022

Read nail length
Position the ruler
Opening the Femur
Position the patient
Position the patient in the lateral decubitus or supine position,
on a fracture or radiolucent operating table. Use of the Large
Distractor is optional.
Position the C-arm so true AP and lateral views are possible.
Reduce the fracture.
1
Confirm nail length
Position the image intensifier for an AP view of the proximal
femur. With a long forceps, hold the ruler alongside the lateral
aspect of the thigh parallel to and at the same level as the femur.
Adjust the C-arm so the beam is centered between the femur and
ruler; this will prevent magnification errors. Adjust the ruler until
the top is level with the tip of the greater trochanter. Mark the
skin at the top of the ruler.
Move the image intensifier to the distal femur, replace the proximal
end of the 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 at or just
proximal to the physeal scar, or at the chosen insertion depth.
2
OPENING THE FEMUR
15
Identify nail entry point
The entry point for the nail is in line with the medullary
canal in the AP and lateral views. This point is posterior
in the proximal femur, in the piriformis fossa, but varies
with patient anatomy.
Make a longitudinal incision proximal to the greater
trochanter, through the gluteus medius and maximus
interval. Insert the 3.2 mm guide wire through the
incision to the piriformis fossa. Under an AP image
intensification view, center the pin in line with the
medullary canal.
Perform the same procedure under a lateral view.
3
Center the pin in
theAPview
Center the pin in
the lateral view

16
Opening the Femur (continued)
Open the canal
With a power drill or hand
chuck, insert the 3.2 mm guide
wire into the entry point.
Pass the guide wire into the
medullary canal to a depth of
100 mm, confirming direction
and depth with the image
intensifier.
Using the tissue protector, drill
over the guide wire with the
13 mm cannulated drill bit to
a minimum depth of 100 mm,
approximately the level of
the lesser trochanter. This
opening will accommodate the
9 mm –12 mm nails, which are
12 mm in diameter for a length
of 90 mm from the proximal
end. Remove the drill bit.
4
Do not use the 15 mm/13 mm Protection Sleeve with the
Cannulated Drill Bit. This sleeve prevents adequate drill
bit penetration into the insertion site and is used only
for Spiral Blade technique.
Insert the guide wire Drill over the guide wire
AP view Lateral view
Note: The surgeon may also use
the awl to identify the nail entry
point and open the canal.
For specialty locking and for 13 mm –15 mm
diameter nails, use the broach (from the Specialty
Locking Set) to enlarge the femoral opening to
accommodate a 15 mm sleeve. Fully insert the
broach into the femoral opening using a twisting
hand motion. Remove the 3.2 mm guide wire.

OPENING THE FEMUR
17
Reaming guidelines
(optional technique)
Under image intensification, reduce the fracture and
insert the appropriate reaming rod into the canal as
far as the distal metaphysis.
Ream to desired diameter in 0.5 mm increments.
Advance the reamer with a steady, moderate pressure.
Do not force the reamer. Partially retract the reamer
often to clear debris from the medullary canal.
For: Ream:
9 mm or 10 mm nails 0.5 mm > nail diameter
11 mm or 12 mm nails 1.0 mm > nail diameter
13 mm –15 mm nails 1.5 mm –2.0 mm > nail diameter
After reaming, withdraw the reamer shaft from the
canal until the reamer head is visible. To prevent loss
of reduction, grasp the reaming rod at the canal entry
point and hold the reaming rod in place using the
Holding Forceps [351.782].
Leave the 2.5 mm reaming rod in position for insertion
of the cannulated nail.

The Titanium Femoral Nails allow two
standard locking configurations (static
transverse and dynamic transverse locking)
for fixation of the femoral shaft fracture.
Steps of the procedure:
•Fracture reduction
•Insertion of the nail
•Insertion of proximal and distal
locking bolts or locking screws
•Insertion of end cap
Follow standard technique for opening the femur,
pages 14 –16.
STANDARD LOCKING
19
Standard Locking