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PHILOS - With Augmentation. Surgical Technique - DSEMTRM061400876

Surgical technique for Umerus Proximal Plate by Synthes.

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Ederson Vieira
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0% found this document useful (0 votes)
700 views48 pages

PHILOS - With Augmentation. Surgical Technique - DSEMTRM061400876

Surgical technique for Umerus Proximal Plate by Synthes.

Uploaded by

Ederson Vieira
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 48

PHILOS™

with Augmentation
Surgical Technique
Image intensifier control

This description alone does not provide sufficient background for direct use
of DePuy Synthes products. Instruction by a surgeon experienced in handling
these products is highly recommended.

Processing, Reprocessing, Care and Maintenance


For general guidelines, function control and dismantling of ­multi-part
instruments, as well as processing guidelines for ­implants, please contact your
local sales representative or refer to:
http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance
For general information about reprocessing, care and maintenance of Synthes
reusable devices, instrument trays and cases, as well as processing of Synthes
non-sterile implants, please consult the Important Information leaflet
(SE_023827) or refer to:
http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance
Table of Contents

Introduction PHILOS™ Augmentation 2

AO Principles 4

Indications5

Surgical Technique Patient Positioning and Approach 6

Implantation8

Augmentation of Screw Tips


with TRAUMACEM™ V+ Injectable Bone Cement 27

Implant Removal 36

Product Information Implants37

Instruments39

Sets43

Bibliography 44

MRI Information 45

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    1


Continued Trust in Stable Fixation

PHILOS™
Trust that is based on more than 10 years of
experience, over 500’000 implantations and the
results of over 50 journal articles.
Trust that continues: Worldwide every seven
minutes a surgeon decides to implant a PHILOS™
plate and every seven minutes a patient trusts their
decision.

2    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


PHILOS™ Augmentation
In osteoporotic bone, failure of the bony structure
around the implant can result in fixation failure and
secondary screw perforation.1,3
Augmentation increases the stability of the PHILOS
fixation, when needed. Biomechanical studies show
that PHILOS Augmentation offers enhanced
anchorage in low-density bone.4,5
The PHILOS Augmentation system follows the
routine reduction and fixation procedure. In a final
step, the screw tips are augmented with a simple
add-on.

10.000 PHILOS Standard


PHILOS Augmentation
Correlation of cycles to failure
in varus bending with
BMD values. Data received
6.000
Cycles to failure

and reprinted with permission


of the Laboratory for Biome-
chanics, Clinic for Trauma
Surgery, Innsbruck Medical
University, Austria.
2.000
low high

Bone Mineral Density mg/cm3

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    3


AO Principles

In 1958, the AO formulated four basic principles, which


have become the guidelines for internal fixation1,2.

4_Priciples_03.pdf 1 05.07.12 12:08

Anatomic reduction Stable fixation


Fracture reduction and fixation Fracture fixation providing abso-
to restore anatomical relation- lute or relative stability, as re-
ships. quired by the patient, the injury,
1 2 and the personality of the frac-
ture.

Early, active mobilization Preservation of blood supply


Early and safe mobilization and 4 3 Preservation of the blood supply
rehabilitation of the injured part to soft tissues and bone by gentle
and the patient as a whole. reduction techniques and careful
handling.

1 M üllerME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal


Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer. 1991.
2 Rüedi TP, Buckley RE, Moran CG. AO Principles of Fracture Management. ­­

2nd ed. Stuttgart, New York: Thieme. 2007.

4    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


Indications

PHILOS indications
• Dislocated two-, three-, and four-fragment fractures of
the proximal humerus, including fractures involving
osteo­penic bone
• Pseudarthroses in the proximal humerus
• Osteotomies in the proximal humerus

PHILOS long indications


• As for PHILOS, but for fractures extending to the shaft
or without medial support

PHILOS Augmentation indications

Augmentation
• As for PHILOS and PHILOS long, but exclusively in
conjunction with osteoporotic bone
• The perforated screws may also be used without
cement augmentation (see page 15)

PHILOS Augmentation contraindications


• In case of potential risk of cement leakage into the
fracture gap, the articulation or vascular structures
(e.g. via fractures which open into the articulation)

Notes:
• Consult the “instructions for use” for indications/
contraindications of the “TRAUMACEM™ V+
­Injectable Bone Cement”.
• Consult the “instructions for use” for the intended
use of the “TRAUMACEM V+ Syringe Kit, 4 × 1 mL,
2.3 mm Adapter, sterile”.
• Consult the manufacturer’s directions on
indications/contraindications of the radiographic
contrast agent.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    5


Patient Positioning and Approach

Note: For information on fixation principles using


conventional and locked plating techniques, please
refer to the LCP Locking Compression Plate surgical
technique (DSEM/TRM/0115/0278).

1. Position the patient


Place the patient in the beach chair position or supine
­position on a radiolucent table.

Ensure the fluoroscope is positioned in a way that


allows ­visualization of the proximal humerus in two axes
(AP and lateral/axial).

Prepare the patient’s arm so that it can be mobilized


­intraoperatively.

6    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


2. Approach
A deltopectoral or transdeltoid approach is
recommended.

If the transdeltoid approach is performed, the use of the


LCP Percutaneous Aiming System 3.5 for PHILOS is
recommended.

Warnings:
• Do not injure the axillary nerve. The axillary
nerve can be palpated at the lower margin of the
­incision.
• To avoid damaging the axillary nerve, do not split
the deltoid more than 4 cm distal to its origin.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    7


Implantation

1. Reduce fracture and fix temporarily

Proper reduction of the fracture is crucial for good bone


healing and function. In some cases closed reduction
before prepping the patient is beneficial.

Reduce the head fragments and check the reduction


under image intensifier control.

Note: The locking screws are not suitable for reduc­


tion since they cannot exert compression. The head
fragments must be reduced before insertion of lock­
ing screws.

Kirschner wires can be used for reduction as joysticks in


the fragments as well as for temporary fixation. Ensure
that Kirschner wires do not interfere with correct plate
placement.

Suturing
Provisionally reduce the tubercles using sutures through
the insertions of the musculi subscapularis, infra- and
supra-spinatus. The sutures will help to maintain the
stability of the reconstruction when fixing them to the
plate later.

8    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


2. Attach aiming device to plate

Instruments

03.122.057 PHILOS Aiming Device, without Nose


or
03.122.067 PHILOS Aiming Device Stardrive,
without Nose
or
03.122.056 PHILOS Aiming Device, with Nose
or
03.122.066 PHILOS Aiming Device Stardrive,
with Nose

311.431 Handle with Quick Coupling

314.030 Screwdriver Shaft, hexagonal,


small, B 2.5 mm
or
314.116 Screwdriver Shaft Stardrive 3.5, T15,
self-holding, for AO/ASIF Quick
Coupling

Insert the stabilization pin of the aiming device in the


specially provided hole on the PHILOS plate. Use the
screwdriver to tighten the securing screw of the aiming
device.

Precaution: Intraoperative bending of the proximal


portion of the plate is not recommended for main­
taining proper alignment between the aiming device
and the plate.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    9


Implantation

3. Position plate
Position the plate 2–4 mm posterior to the bicipital
groove and 5–7 mm distal to the top of the greater
­tubercule. Align the plate properly to the humeral shaft.

Precaution: Placing the plate too high increases the


risk of ­subacromial impingement. Placing the plate
too low can ­prevent the optimal distribution of
screws in the humeral head.

Warnings:
• Do not injure the axillary nerve. The axillary
nerve can be palpated at the lower margin of the
­incision.
• To avoid damaging the axillary nerve, do not split
the deltoid more than 4 cm distal to its origin.

11    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


Alternative techniques

Instruments

03.122.056 PHILOS Aiming Device, with Nose

03.122.066 PHILOS Aiming Device Stardrive,


with Nose

Option A: Determine the position of the plate using the


PHILOS aiming device with nose. Insert a Kirschner wire
into the proximal guide hole below the rotator cuff so
that the Kirschner wire aims at the proximal joint sur-
face.

Option B: Insert two positioning Kirschner wires


2–4 mm lateral to the bicipital groove and 5–7 mm
­below the tip of the greater tubercule. Position the
plate between the Kirschner wires.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    11


Implantation

4. Fix plate temporarily

Instruments

310.250 Drill Bit B 2.5 mm, length 110/85 mm,


2-flute, for Quick Coupling

323.360 Universal Drill Guide 3.5

319.010 Depth Gauge for Screws


B 2.7 to 4.0 mm,
measuring range up to 60 mm

314.070 Screwdriver, hexagonal, small,


2.5 mm, with Groove

314.116 Screwdriver Shaft Stardrive 3.5, T15,


self-holding, for AO/ASIF Quick
Coupling

311.431 Handle with Quick Coupling

Optional instrument

311.320 Tap for Cortex Screws B 3.5 mm,


length 110/50 mm

Fix the plate temporarily with a cortex screw in the


e­ longated combi-hole in the plate shaft.

Use the B 2.5 mm drill bit with the 3.5 universal drill
guide to drill the bone through both cortices.

Determine the required length of the cortex screw using


the depth gauge.

Insert the appropriate B 3.5 mm cortex screw using


the screwdriver.

11    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


Option: Temporary fixation with Kirschner wires

Instruments

03.122.053 Outer Sleeve 6.0/5.0 for


PHILOS Aiming Device

03.122.054 Drill Sleeve 5.0/2.9, for No. 03.122.053

03.122.055 Centering Sleeve for Kirschner Wire


B 1.6 mm, for No. 03.122.054

If required, use Kirschner wires through the triple sleeve


­system for temporary fixation of the humeral head.

Warning: Do not penetrate the joint surface with the


Kirschner wires.

Option: Temporarily reduce with pull reduction device

Instruments

03.122.059 Pull Reduction Device for use with


No. 03.122.060 for Drill Sleeves

03.122.060 Wing Nut for Pull Reduction for use


with No. 03.122.059 for Drill Sleeves

In good bone stock, the pull reduction device can op-


tionally be used for temporary reduction. Using a power
tool, insert the pull reduction device through the drill
sleeve to the ­desired depth. Slide the wing nut over the
wire and tighten. In this way, bone fragments are pulled
towards the plate.

Warning: Do not penetrate the joint surface with the


pull reduction device.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    11


Implantation

5. O
 ption: Define screw configuration
Augmentation

for augmentation of screw tips with


TRAUMACEM V+ Injectable Bone
A
Cement
Choose 4–6 perforated screws for augmentation with B
TRAUMACEM V+ Injectable Bone Cement. Carefully
­determine the configuration of screws to be augmented
based on the fracture pattern, the anatomy of the C
­humeral head and the following recommendations.
D
Note: Perforated screws are only available with
Stardrive recess.
E

11    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


Favorable configuration: If possible, always augment

Augmentation
screws from levels A and E to enable a wide distribution
of the cement clouds in the humeral head.

Warning: Level E screws can not be implanted in


some small humeri. Their tips can also lie close to
fracture lines. In this case, choose an alternative
configuration.

Alternative configuration/additional screws: If the


level E screw can not be augmented or additional screws
shall be augmented, choose screws from level B and/or D.

It is not recommended to augment level C screws as the


tips often lie at the same height as the level A screw tips.
Furthermore, due to the divergence of the screw, tips
­often end close to fracture lines.

Warning: Do not augment screws with tips ending


close to fracture lines.

Option: The perforated screws may also be used with-


out TRAUMACEM V+ augmentation in the ­humeral
head. If so, at least 6 perforated screws must be inserted
proximally.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    11


Implantation

6. D
 rill the lateral cortex and
determine proximal screw length
6a. Technique for osteoporotic bone:
The following technique describes screw depth measur-
ing optimized for osteoporotic bone. In good bone
stock, change to options A or B for drilling the screw
hole and depth measuring.

Instruments

03.122.053 Outer Sleeve 6.0/5.0


for PHILOS Aiming Device

03.122.051 Drill Bit B 2.8 mm, with Stop,


for Quick Coupling

03.122.052 Length Probe for Nos. 03.122.053


and 03.122.058

Insert the outer sleeve in the desired hole of the aiming


­device. Drill the lateral cortex using the drill bit with stop
through the outer sleeve.

Warning: In porotic bone, only drill the lateral


cortex.

Alternative instrument

03.122.058 Drill Sleeve 6.0/2.9 with thread

Use the drill sleeve with thread independently from the


aiming device.

Warnings:
• Do not drill through the joint surface.
• Do not insert overly long screws in order to
prevent primary or secondary screw penetration.

11    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


Use the length probe through the outer sleeve and push
it carefully into the humeral head. Stop pushing when
­increased bone density is felt. Read off the required
screw length from the length probe.

Warning: Do not push the length probe through the


joint surface.

Note: The tip of the length probe should be ­located


approximately 5–8 mm below the joint surface
for locking screws. Augmented perforated locking
screws can be 4 mm shorter.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    11


Implantation

6b. Alternative techniques for good bone stock

If the bone stock is good, choose one of the following


options:

Option A: Use a B 2.8 mm drill bit through the drill


sleeve and drill 5–8 mm below the joint surface. Read
the required screw length from the drill bit.

Note: The drill bit tip should come as close as possi­


ble to the subchondral bone, approximately 5–8 mm
from the joint surface. Since it may not always be
possible to feel the resistance from the subchondral
bone, and the drill bit represents the final position
of the locking screw, the use of image intensification
is recommended.

Warning: Do not push the drill bit through the joint


surface.

Option B: Check the subsequent position of the screws


using Kirschner wires. Attach the triple sleeve system,
consisting of a outer sleeve, a drill sleeve, and a center-
ing sleeve for the Kirschner wire onto the aiming device
and insert a Kirschner wire B 1.6 mm, 150 mm long.

Check the position of the Kirschner wire. The tip of the


Kirschner wire should be located in the subchondral
bone (5–8 mm below the joint surface).

Slide the PHILOS direct measuring device for Kirschner


wire 1.6 mm over the Kirschner wire and determine the
length of the required screw.

11    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


7. Insert proximal screws

Instruments

511.770 Torque limiter, 1.5 Nm


or
511.773

314.030 Screwdriver Shaft, hexagonal,


small, B 2.5 mm
or
314.116 Screwdriver Shaft Stardrive 3.5,
T15, self-holding, for AO/ASIF
Quick Coupling

311.431 Handle with Quick Coupling


or
397.705 Handle for Torque Limiter

Remove drill sleeve and insert the screw with the appro-
priate screwdriver shaft (hexagonal or Stardrive recess)
and 1.5 Nm torque limiting attachment through the
outer sleeve. The sleeve ­ensures that the locking screw is
correctly locked in the plate. The angular stability is re-
duced if a locking screw is inserted obliquely.

Insert the screw manually or with power until a click is


heard. If using power, reduce speed when tightening the
head of the locking screw into the plate.

Repeat the above steps for all required proximal screw


holes.

Warning: Do not insert overly long screws in order


to prevent primary or secondary screw penetration.

Precaution: The plate should be secured with at


least 4 proximal screws of B 3.5 mm. In poor bone
stock, multiple fixation points using all screws is
re­commended.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    11


Implantation

8. Insert shaft screws


After inserting the proximal screws, determine where
locking or cortex screws will be used in the shaft.

Note: If a combination of cortex and locking screws


is used, cortex screws must be inserted first to pull
the plate to the bone.

22    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


8a. Fixation with B 3.5 mm cortex
screws

Instruments

310.250 Drill Bit B 2.5 mm, length 110/85 mm,


2-flute, for Quick Coupling

323.360 Universal Drill Guide 3.5

319.010 Depth Gauge for Screws


B 2.7 to 4.0 mm,
measuring range up to 60 mm

314.070 Screwdriver, hexagonal, small,


2.5 mm, with Groove

314.116 Screwdriver Shaft Stardrive 3.5, T15,


self-holding, for AO/ASIF Quick
Coupling

311.431 Handle with Quick Coupling

Optional instrument

311.320 Tap for Cortex Screws B 3.5 mm,


length 110/50 mm

Use the B 2.5 mm drill bit with the 3.5 universal drill
guide to drill the bone through both cortices.

To set screws in a neutral position, press the drill guide


down in the non-threaded hole. To obtain compression,
place the drill guide at the end of the non-threaded hole
away from the fracture, avoiding downward pressure
on the spring-loaded tip.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    22


Implantation

Determine the required length of the cortex screw using


the depth gauge.

Insert the appropriate B 3.5 mm cortex screw using the


hexagonal or the Stardrive T15 screwdriver.

Plate holes in the plate shaft (distal to Level E) are LCP


combi-holes (see page 14). An LCP combi-hole can be
fixed with a cortex screw to generate interfragmentary
compression. In this case, the screws are inserted ac-
cording to the technique for fixing LC-DCP standard
plates, but using the universal drill guide instead of the
LC-DCP drill sleeve.

22    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


8b. F
 ixation with B 3.5 mm locking
screws

Instruments

323.027 LCP Drill Sleeve 3.5, for Drill Bits


B 2.8 mm

310.284 LCP Drill Bit B 2.8 mm with Stop,


length 165 mm, 2-flute,
for Quick Coupling

319.010 Depth Gauge for Screws


B 2.7 to 4.0 mm,
measuring range up to 60 mm

314.030 Screwdriver Shaft, hexagonal,


small, B 2.5 mm
or
314.116 Screwdriver Shaft Stardrive 3.5, T15,
Fig. 1
self-holding, for AO/ASIF Quick
Coupling

511.773 Torque Limiter, 1.5 Nm,


for AO/ASIF Quick Coupling

311.431 Handle with Quick Coupling

Insert the LCP Drill Sleeve 3.5 into the locking hole until
fully seated. Drill through both cortices with the 
B 2.8 mm drill bit and use the scale on the Drill Bit
(Fig. 1) to read-off the screw length.

Alternative technique: Remove the drill sleeve. Use the


depth gauge to determine the screw length.

Insert the locking screw with the appropriate screwdriver


shaft (hexagonal or Stardrive recess) mounted on the
1.5 Nm torque limiter. Insert the screw manually or with
the use of a power tool until a click is heard. If a power
tool is used, reduce the speed when tightening the head
of the locking screw into the plate.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    22


Implantation

Repeat the above steps for all required shaft holes.

22    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


9. Attach sutures
Remove the aiming device from the plate.

Knot the sutures through the designated holes in the


plate if this has not already been done. This construct
functions as a tension band and transmits the forces of
the rotator cuff over the plate and into the shaft, while
preventing fragment displacement during the early
rehabilitation period.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    22


Implantation

10. Check position of screw tips


Check the screw lengths under image intensifier control
in the full range of gleno-humeral-motion and ensure
that they do not penetrate the articular surface.

Precaution: It is important to check the screw


lengths in all planes as their angulation and
direction may be difficult to visualize.

Warning: Do not augment screws that perforate the


joint or have tips close to fracture lines.

Check the stability of the suture fixation. The sutures


must not rupture during motion.

22    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


Augmentation of Screw Tips
with TRAUMACEM™ V+ Injectable Bone Cement

Note: Refer to page 14 to determine screw

Augmentation
­configuration for augmentation.

1. Check for possible leakage

Instrument

03.702.140S TRAUMACEM V+ Syringe Kit,


4 × 1 mL, Adapter 2.3 mm, sterile

To avoid potential leakage into the joint or the fracture


line, use a radiographic contrast agent and an appropri-
ate syringe with luer lock (6–10 ml).

Prefill the syringe with contrast agent and attach it to


an adaptor from the TRAUMACEM V+ Syringe Kit.
­Connect the ­assembly to the first perforated screw to
be checked. ­Inject 0.5–1 ml of contrast agent.

Precautions: Use only radiographic contrast agents


that are indicated for this application.
Consult the manufacturer’s directions on indica­
tions, contraindications, use, precautions, warnings
and side effects of the radiographic contrast agent.
• If the contrast agent cannot be injected, the screw
cannu­lation might be jammed with bone chips.
In this event, ­remove the screw, clean the cannu­
lation by pushing a 1.6 mm B Kirschner wire
through it and reinsert the screw.
• Injection may be hindered in dense bone.
• Do not reuse the same syringe or adapter for the
application of TRAUMACEM V+ Injectable Bone
Cement.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    22


Augmentation of Screw Tips
with TRAUMACEM V+ Injectable Bone Cement

Monitor the flow of the contrast agent under image


Augmentation

intensifier control.

Repeat the steps for all other screws intended to be


augmented.


No leakage

Warning: Do not augment if X-ray contrast media


leaks into the joint.

If less than 4 screws can be augmented, ensure that the


humeral head is secured with a total of at least 6 screws
(augmented and non-augmented).

Note: If the contrast agent hinders proper visualiza­


tion during these steps, inject saline solution to
wash the contrast agent out of the humeral head.

If there is no leakage, proceed with step 2.


Leakage into joint


Leakage into fracture line

22    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


2. Prepare TRAUMACEM V+

Augmentation
Injectable Bone Cement

Instrument

07.702.040S TRAUMACEM V+ Bone Cement,


injectable, sterile

Hold the TRAUMACEM V+ Injectable Bone Cement


mixer upright and gently tap the top of the mixing de-
vice to ensure no cement powder sticks to the cartridge
and sterilization lid.

Pull the handle until it is fully retracted.

Note: During preparation, mixing and injection


always handle the mixing device by gripping the
blue part located directly below the transparent
cartridge. If the transparent part is gripped, the
body heat from the user’s hand might result in a
shorter working time than intended.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    22


Augmentation of Screw Tips
with TRAUMACEM V+ Injectable Bone Cement

Open the glass ampoule by breaking the bottle neck


Augmentation

with the plastic cap (1). Remove and dispose the mixing
device sterilization lid. Pour all monomer from the glass
ampoule into the cement powder (2) and close the mix-
ing device tightly using the enclosed transferring lid (3). 3

Precaution: Always use the full amounts of mono­ 2


mer liquid and polymer powder provided in the kit,
respectively, when mixing TRAUMACEM V+ Inject­
able Bone ­Cement. Otherwise the behavior of the 1
TRAUMACEM V+ Injectable Bone Cement can no
longer be guaranteed. Using only one ­of the compo­
nents is not permitted.

Mix the TRAUMACEM V+ Injectable Bone Cement by


moving the blue handle back and forth from stop to
stop approximately 20 times (1). Perform the first mixing
strokes slowly with oscillating-rotating movements (2).
After mixing fully retract the handle (3).

Precaution: Ensure that the powder and liquid com­


ponent are thoroughly mixed before starting cement
transfer.

33    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


3. Fill injection syringes

Augmentation
Instruments
1
03.702.140S TRAUMACEM V+ Syringe Kit,
4 × 1 mL, Adapter 2.3 mm, sterile

Once the cement has been mixed using the


TRAUMACEM V+ Injectable Bone Cement, remove the
small, transparent plug of the mixer lid (1). Connect the
stop-cock (the side without the funnel) to the mixer (2).
Ensure a tight fit between the stop-cock and the mixing
device.

Precaution: Ensure a good fit between the syringe Open


and the stop-cock/used access solution, but make
sure to be on axis and avoid using excessive force
2
when coupling them. They are both made of plastic
and could ­otherwise break.
Closed
First remove the air from the system. With the valve
open, gently turn the handle of the cement mixer clock-
wise. The mixer piston will advance in the translucent 3
cartridge and a steady flow of cement will move into the
stop-cock. As soon as the cement is visible in the stop-
cock, close the valve (3).

Attach a 1 ml syringe (blue) to the funnel side of the


stop-cock.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    33


Augmentation of Screw Tips
with TRAUMACEM V+ Injectable Bone Cement

Open the valve. Use controlled clockwise turning move-


Augmentation

ments on the mixer handle to fill the syringe. As soon as


the syringe is full, close the valve.

Note: Do not push to transfer cement.

Disconnect the filled syringe and attach the next syringe


to be filled. Avoid excessive spillage of cement into
the funnel during the transfer process. Continue to fill
the syringes in the same manner. Always prefill all 1 ml
syringes (blue) at once.

33    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


4. C
 onnect syringe to perforated

Augmentation
screw
Attach the syringe to the adapter.

Insert the tip of the adapter into the recess of the


perforated screw to be augmented.

Ensure that the tip of the adapter is fully inserted into


the screw recess by pushing on the transparent syringe
handle.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    33


Augmentation of Screw Tips
with TRAUMACEM V+ Injectable Bone Cement

5. Augmentation with
Augmentation

TRAUMACEM V+ Injectable Bone


Cement
max
Inject the cement slowly and stepwise in increments
of approximately 0.1 ml. 0.05–0.15 ml of cement
prefill
is required to fill the screw cannulation.

Monitor the flow of the cement under image intensi-


fier ­control.

Precautions:
• If the cement cannot be injected, the screw cannu­
lation might be jammed with bone chips. In this
event, remove the screw, clean the cannulation by
pushing a 1.6 mm B Kirschner wire through it and
reinsert the screw.
• Injection may be hindered in dense bone.

Warning: If there is a danger of cement leakage into


the joint, fracture gap or venous system, stop injec­
tion immediately.

Do not inject more than 0.5 ml of cement per screw


(equates to half the contents of one syringe).

Repeat steps 4 and 5 for all screws to be augmented.


One 1 ml syringe can be used to augment 2 screws.

Do not inject more than 3 ml of cement in total (equates


to the content of three 1 ml syringes (blue)).

If less than 4 screws can be augmented, ensure that the


humeral head is secured with a total of at least 6 screws
(augmented and non-augmented).

Precaution: The working time for TRAUMACEM V+


Injectable Bone Cement at room temperature (20 °C)
is approximately 27 minutes. At body temperature
(37 °C) the setting time is 15 minutes. After last ce­
ment injection, the patient should remain immobile
for 15 minutes to facilitate proper cement ­curing.

33    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


6. Final check

Augmentation
Before closing the wound, check the screw lengths
and the position of the cement under image intensifier
control in the full range of glenohumeral motions.
Ensure that they do not penetrate the articular surface.

Remove any spilled cement from the screw recesses


(with the sharp hook), the plate and the soft tissues.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    33


Implant Removal

Instruments

314.030 Screwdriver Shaft, hexagonal,


small, B 2.5 mm
or
314.116 Screwdriver Shaft Stardrive 3.5, T15,
self-holding, for AO/ASIF Quick
Coupling

311.431 Handle with Quick Coupling

311.440 T-Handle with Quick Coupling

309.520 Extraction Screw, conical,


for Screws B 2.7, 3.5 and 4.0 mm

309.521 Extraction Screw for Screws B 3.5 mm

319.390 Sharp Hook, length 155 mm

Unlock all screws from the plate, then remove the


screws completely from the bone. This prevents simulta-
neous rotation of the plate when unlocking the last
lockscrew. If a screw cannot be removed with the screw-
Augmentation

driver (e.g. if the hexagonal or Stardrive recess of the


locking screw is damaged or if the screw is stuck in the
plate), use the T-Handle with Quick Coupling (311.440)
to insert the Extraction Screw (309.520 or 309.521) into
the screw head, and unscrew the screw in a counter-
clock direction.

Implant removal after augmentation of screw tips


with TRAUMACEM V+ Injectable Bone Cement

Notes:
• The cement will remain in the humeral head.
• If the recess of the screws is blocked with cement,
clean it first with the sharp hook.
• When performing a re-fixation, be aware that
the cement is not intended to be drilled and new
implants might need to be placed in different
positions.

33    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


Implants

PHILOS – Proximal Humeral Plate 3.5


Stainless steel Titanium Shaft holes Length (mm)
241.901 441.901 3  90
241.903 441.903 5 114

PHILOS Long – Proximal Diaphyseal Humeral


Plate 3.5
Stainless steel Titanium Shaft holes Length (mm)
241.916 441.916  3 106
241.917 441.917  4 124
241.918 441.918  5 142
241.919 441.919  6 160
241.920 441.920  7 178
241.921 441.921  8 196
241.922 441.922  9 214
241.923 441.923 10 232
241.924 441.924 11 250
241.925 441.925 12 268
241.926 441.926 13 286

All plates are available nonsterile or sterile packed.


Add suffix “S” to article number to order sterile product.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    33


Implants

Screws used with PHILOS


X12.102 – Locking Screw Stardrive B 3.5 mm,
X12.124 length 12–60 mm, self-tapping

X13.012 – Locking Screw B 3.5 mm,


X13.060 length 12–60 mm, self-tapping

*X04.812 – Cortex Screw B 3.5 mm,


X04.860 length 12–60 mm, self-tapping
Augmentation

0X.200.012 – Cortex Screw Stardrive B 3.5 mm,


0X.200.060 self-tapping, length 12–60 mm

0X.125.124S – Locking Screw Stardrive B 3.5 mm,


0X.125.154S perforated, length 24–54 mm, sterile

TRAUMACEM V+ Injectable Bone Cement


07.702.040S TRAUMACEM V+ Bone Cement,
injectable, sterile

Stardrive

Hexagonal

X = 2: Stainless steel
X = 4: TAN
*X = 4: TiCP

All screws are available nonsterile or sterile packed.


Add suffix “S” to article number to order sterile product.

33    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


Instruments

PHILOS instruments

PHILOS sizing templates


Shaft holes
03.122.003 3
03.122.004 5
03.122.005 long

03.122.051 Drill Bit B 2.8 mm, with Stop,


for Quick Coupling

03.122.052 Length Probe for Nos. 03.122.053 and


03.122.058

03.702.140S TRAUMACEM V+ Syringe Kit,

Augmentation
4 × 1 mL, Adapter 2.3 mm, sterile

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    33


Instruments

319.390 Sharp Hook, length 155 mm

03.122.053 Outer Sleeve 6.0/5.0 for PHILOS


Aiming Device

03.122.054 Drill Sleeve 5.0/2.9,


for No. 03.122.053

03.122.055 Centering Sleeve for Kirschner Wire


B 1.6 mm, for No. 03.122.054

03.122.056 PHILOS Aiming Device, with Nose

03.122.057 PHILOS Aiming Device, without Nose

03.122.066 PHILOS Aiming Device Stardrive,


with Nose

03.122.067 PHILOS Aiming Device Stardrive,


without Nose

44    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


Optional instruments

03.122.058 Drill Sleeve 6.0/2.9 with thread

03.122.060 Wing Nut for Pull Reduction for use


with No. 03.122.059 for Drill Sleeves

03.122.059 Pull Reduction Device for use


with No. 03.122.060 for Drill Sleeves

Standard instruments

309.521 Extraction Screw for Screws B 3.5 mm

309.510 Extraction Screw, conical,


for Screws B 1.5 and 2.0 mm

310.250 Drill Bit B 2.5 mm, length 110/85 mm,


2-flute, for Quick Coupling

311.431 Handle with Quick Coupling

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    44


Instruments

310.284 LCP Drill Bit B 2.8 mm with Stop,


length 165 mm, 2-flute,
for Quick Coupling

319.010 Depth Gauge for Screws


B 2.7 to 4.0 mm, measuring range up
to 60 mm

314.030 Screwdriver Shaft, hexagonal,


small, B 2.5 mm

314.116 Screwdriver Shaft Stardrive 3.5, T15,


self-holding, for AO/ASIF Quick
Coupling

323.027 LCP Drill Sleeve 3.5,


for Drill Bits B 2.8 mm

323.360 Universal Drill Guide 3.5

314.070 Screwdriver, hexagonal, small,


2.5 mm, with Groove

511.773 Torque Limiter, 1.5 Nm,


for AO/ASIF Quick Coupling

44    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


Sets

01.122.031 Proximal Humerus Instruments,


in Modular Tray, Vario Case System
01.122.013 Small Fragment Basic Instruments,
in Modular Tray, Vario Case System
01.122.015 Screw Insertion 3.5/4.0,
in Modular Tray, Vario Case System
01.122.014 Small Fragment Reduction Instruments,
in Modular Tray, Vario Case System

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    44


Bibliography

1 Brunner F, Sommer C, Bahrs C, Heuwinkel R, Hafner C,


­ illmann P, Kohut G, Ekelund A, Muller M, Audigé L,
R
Babst R. Open Reduction and Internal Fixation of
­Proximal Humerus Fractures Using a Proximal Humeral
Locked Plate: A Prospective Multicenter Analysis.
J Orthop Trauma. 2009 Mar; 23(3):163–72.

2 Hirschmann MT, Fallegger B, Amsler F, Regazzoni P,


Gross T. Clinical longer-term results after internal fixation
of proximal humerus fractures with a locking compres-
sion plate (PHILOS). J Orthop Trauma. 2011
May;25(5):286–93.

3 Krappinger D, Bizzotto N, Riedmann S, Kammerlander


C, Hengg C, Kralinger FS. Predicting failure after surgical
fixation of proximal humerus fractures. Injury. 2011
Nov;42(11):1283–8.

4 Unger S, Erhart S, Kralinger F, Blauth M, Schmoelz W.


The ­effect of in situ augmentation on implant anchorage
in proximal humeral head fractures. Injury. 2012
Oct;43(10):1759–63.

5 Kathrein S, Kralinger F, Blauth M, Schmoelz W. Bio­


mechanical comparison of an angular stable plate with
­augmented and non-augmented screws in a newly
­developed shoulder test bench. Clin. Biomech. 2013,
http://dx.doi.org/10.1016/j.clinbiomech.2012.12.013

44    DePuy Synthes  PHILOS with Augmentation  Surgical Technique


MRI Information

Torque, Displacement and Image Artifacts


according to ASTM F 2213-06, ASTM F 2052-14­and
ASTM F 2119-07
Non-clinical testing of worst case scenario in a 3 T MRI
­system did not reveal any relevant torque or displace-
ment
of the construct for an experimentally measured local
spatial gradient of the magnetic field of 3.69 T/m. The
largest image artifact extended approximately 169 mm
from the construct when scanned using the Gradient
Echo (GE). Testing was conducted on a 3 T MRI system.

Radio-Frequency-(RF-)induced heating according


to ASTM F 2182-11a
Non-clinical electromagnetic and thermal testing of
worst case scenario lead to peak temperature rise of
9.5 °C
with an average temperature rise of 6.6 °C (1.5 T) and a
peak temperature rise of 5.9 °C (3 T) under MRI Condi-
tions using RF Coils (whole body averaged specific ab-
sorption rate [SAR] of 2 W/kg for 6 minutes [1.5 T] and
for 15 minutes
[3 T]).

Precautions: The above mentioned test relies on


non-clinical testing. The actual temperature rise
in the patient will ­depend on a variety of factors
beyond the SAR and time of RF application. Thus,
it is recommended to pay particular ­attention to
the following points:
• It is recommended to thoroughly monitor patients
undergoing MR scanning for perceived tempera­
ture and/or pain sensations.
• Patients with impaired thermoregulation or
temperature sensation should be excluded from
MR scanning procedures.
• Generally, it is recommended to use a MR system
with low field strength in the presence of conduc­
tive implants. The employed specific absorption
rate (SAR) should be ­reduced as far as possible.
• Using the ventilation system may further contrib­
ute to ­reduce temperature increase in the body.

PHILOS with Augmentation  Surgical Technique  DePuy Synthes    44


© DePuy Synthes Trauma, a division of Synthes GmbH. 2017.  All rights reserved.  036.001.576 DSEM/TRM/0614/0087(6) 05/17

Synthes GmbH
Eimattstrasse 3 Not all products are currently available in all markets.
4436 Oberdorf
Switzerland This publication is not intended for distribution in the USA.
Tel: +41 61 965 61 11
Fax: +41 61 965 66 00 All surgical techniques are available as PDF files at
www.depuysynthes.com www.depuysynthes.com/ifu 0123

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