Synthes Pelvic C-Clamp II User manual

Emergency Stabilization Instrument for Unstable
Injuries and Fractures of the Pelvic Ring
Pelvic C-Clamp II
Surgical Technique

Introduction
Surgical Technique
Product Information
Table of Contents
Pelvic C-Clamp II 2
Indications 4
Preoperative Preparation 5
Preparation of the Pelvic C-Clamp 6
Identify Insertion Point 8
Place Kirschner Wire 9
Apply Pelvic C-Clamp 10
Postoperative Management and Removal 12
Disassembly of the Pelvic C-Clamp 13
Care and Maintenance 15
Implants 16
Instruments 17
Set List 18
Pelvic C-Clamp II Surgical Technique DePuy Synthes 1
MR Information
The Pelvic C-Clamp II System has not been evaluated for safety and compatibility
in the MR environment. It has not been tested for heating, migration or image
artifact in the MR environment. The safety of the Pelvic C-Clamp II System in the
MR environment is unknown. Scanning a patient who has this device may result
in patient injury.
Image intensifier control

Pelvic C-Clamp II
The Pelvic C-Clamp is an emergency stabilization
instrument for unstable injuries and fractures of the
pelvic ring. Unstable pelvic ring fractures can be
associated with massive blood loss that can cause
terminal shock. The pelvic C-clamp allows rapid
reduction and stabilization of these unstable pelvic
ring fractures. It is a valuable tool for gaining control
of the shock reaction, without delaying subsequent
diagnosis and therapy.
The pelvic C-clamp does not control arterial bleeding.
However, by mechanical stabilization alone, or
enhanced by pelvic packing, concomitant venous
bleeding can be managed, to gain time for denitive
hemorrhage or arterial embolization control.
The pelvic C-clamp is composed of rails and arms with
a locking mechanism, allowing linear movement of
the arms. The pelvic C-clamp should always be used
in combination with the system’s cannulated nails.
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2 DePuy Synthes Pelvic C-Clamp II Surgical Technique

Features and benets
– Permits quick and efcient compression
and stabilization of fractures or luxations, and
control of hemorrhaging in the unstable posterior
pelvic ring
– Gains time for subsequent diagnostic or
therapeutic procedures
– Allows passing the patient through a CT-gantry
without removing the device
– Provides unrestricted access to the abdomen,
pelvis or proximal femur
– Can be applied quickly outside the operating room,
e.g. in the emergency room or on the x-ray table
In cases of sacral fractures or disruptions of the
sacroiliac joint, there is often concomitant blood
loss from the fracture surface and from the veins of
the presacral plexus. The use of the pelvic C-clamp
in those settings can save lives.
Direct transverse compression of the sacroiliac
joint controls bleeding from the fracture surfaces
and from the presacral plexus. With the pelvic
C-clamp applied, there is still adequate access
for a laporotomy or tamponade.
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2
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Inner rail
Outer rail
Upper arm
Lower arm
Threaded tube
1Cannulated nail
(190 mm or 210 mm)
Side buttons
Upper buttons
Locking mechanism
2
3
4
5
6
7
8
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Pelvic C-Clamp II Surgical Technique DePuy Synthes 3

Indications
The Pelvic C-Clamp II is intended for emergency stabilization
of sacrum fractures or disruptions of the sacroiliac joint with
associated circulatory instability.
Precautions: Avoid use where:
– Fractures of the ilium are present, as there is risk of pin
perforation through the fracture line
– There are comminuted sacral fractures with the risk
of compression of the sacral nerve plexus
Note: In life-threatening situations, hemorrhage control takes
priority over the potential risk of nerve root compression.
4 DePuy Synthes Pelvic C-Clamp II Surgical Technique

1
Preoperative preparation
Required set
01.306.000 Pelvic C-Clamp II Set
The complete sterile pelvic C-clamp set should be kept
ready for use in the resuscitation room. Depending on the
type of injury, the orientation points in the pelvic region
of the injured person may be unclear.
Use an image intensier during application of the pelvic
C-clamp to verify anatomic references.
– Anteroposterior (AP) plain pelvic radiograph if necessary,
oblique views (inlet and outlet) or CT
– Patient positioning must allow for intraoperative
uoroscopic controls in AP, inlet and outlet projections
– Have an image intensier available
Positioning
– Place the patient in a supine position
– To facilitate reduction, ensure free draping of the leg on
the injured side and good coverage of the genital region
– To prepare the patient, disinfect the proximal femur and
the buttocks and cover with sterile sheets
Preoperative Preparation
Pelvic C-Clamp II Surgical Technique DePuy Synthes 5

Preparation of the Pelvic C-Clamp
2
Preparation of the pelvic C-clamp
Instrument
03.306.010 Pelvic C-Clamp II
Open the lower side arms by depressing the buttons on the
arms to prepare the pelvic C-clamp for use.
Note: Hold upper and lower arms with both hands and
ensure that the lower arm is locked when fully extended.
Extend the upper bars by depressing the buttons on the
upper rails while pulling on the side arms.
Note: Maximum extension of the pelvic C-clamp facilitates
safe positioning.
6 DePuy Synthes Pelvic C-Clamp II Surgical Technique

With a light twist, place the cannulated nails of preferred
length into the threaded tubes.
The buttons on the top of the pelvic C-clamp can be locked.
Ensure the buttons are not locked when applying the pelvic
C-clamp to the patient, or the side arms cannot be adjusted
to apply compression.
12
1 Unlock, 2 Lock
Pelvic C-Clamp II Surgical Technique DePuy Synthes 7

3
Identify insertion point
Instrument
03.306.009 2.5 mm K-Wire Insertion Handle
Make an incision at the intersection between the extension
of the line of the femoral axis over the tip of the greater
trochanter, and a vertical line from the anterior superior iliac
spine in the dorsal direction.
If orientation is difcult, use an image intensier.
The surface reference point of the outer side of the ilium
changes at the level of the sacroiliac joints. In emergency
situations, the resulting “fossa” can be used as a relatively
secure point of reference aid. For secure anchoring, the
pelvic C-clamp must be placed at the level of the sacroiliac
joints. Palpation with a blunt instrument, such as the K-wire
insertion handle, allows easy identication of this site, even
with severe soft-tissue swelling.
Warnings:
– If the nails are placed too ventrally to the correct insertion
point, there is a risk of perforation of the ilium, which can
result in organ injury.
– Placement of the pins in an excessively dorsal position may
result in injury to gluteal nerves and vessels.
– Inserting the nail too distally endangers the sciatic nerve
and the gluteal vessels in the sciatic notch. Malpositioning
of the nail in osteoporotic bone, combined with excessive
compression, can result in unwanted nail penetration.
Identify Insertion Point
8 DePuy Synthes Pelvic C-Clamp II Surgical Technique

4
Place Kirschner wire
Instruments
03.306.009 2.5 mm K-Wire Insertion Handle
292.26 2.5 mm K-Wire with Trocar Point, 285 mm
398.32 Socket Wrench with Hammer
Optional instrument
359.204* Locking Pliers
After identifying the insertion point, a Kirschner wire can
be placed through the K-wire insertion handle (only on the
uninjured side). Gently hammer the Kirschner wire into the
bone with the socket wrench with hammer. This Kirschner
wire will ensure exact placement of the cannulated nail and
prevent the nail from slipping.
Note: Malpositioned Kirschner wires can be removed with
the pliers.
Precautions:
– Instruments and screws may have sharp edges or moving
joints that may pinch or tear user’s glove or skin.
– Handle devices with care and dispose of worn bone cutting
instruments in an approved sharps container.
– Select the appropriate Schanz screw for the patient’s
bony anatomy.
Place Kirschner Wire
*Also available.
Pelvic C-Clamp II Surgical Technique DePuy Synthes 9

5
Apply pelvic C-clamp
Instruments
03.306.010 Pelvic C-Clamp II
03.306.011 8 mm Protective Cap
321.20 Ratchet Wrench, 11 mm width across ats
391.93 Wire Cutter, 220 mm
Be sure the fracture is correctly reduced before placement
of the pelvic C-clamp. After inserting the Kirschner wire on
the uninjured side, slide the clamp with cannulated nails
over the wire and ensure that the tip of the nail grips the
bone securely. Then place the second nail on the injured
side (no Kirschner wire is necessary on this side).
Note: In cases of severe dislocations of the pelvis, pulling
on the leg, internal rotation and even lateral compression
may improve reduction and facilitate application of the
pelvic C-clamp.
Apply Pelvic C-Clamp
10 DePuy Synthes Pelvic C-Clamp II Surgical Technique

Alternative technique
Both nails can be placed at the same time by removing one
side arm. After both nails have been seated properly the arm
can be placed over the rail again and compression can be
applied as described below.
When both nails are correctly seated, manually compress
the upper side arms (gure A) and ensure nal xation by
tightening the threaded tubes with the ratchet wrench
(gure B).
The Kirschner wire must be cut off with the wire cutter. Place
protective caps on each end of the two cannulated nails.
After complete application of the pelvic C-clamp, verify
xation with an image intensier or x-ray (pelvic AP view)
and pad the nails.
Note: The locking mechanism locks the upper buttons,
thus preventing unintended loss of compression during
movement of the pelvic C-clamp.
Once mounted, the pelvic C-clamp can be swung caudally
and cranially, e.g. for a laparotomy or an angiography.
Note: It is recommended to place a drape cloth or lap
sponges as a cushion between the pelvic C-clamp and
the patient.
Warning: Do not use the pelvic C-clamp to lift the patient.
Figure A
Figure B
Pelvic C-Clamp II Surgical Technique DePuy Synthes 11

6
Postoperative management
– AP plain radiograph, CT if required, rarely oblique
view lms after application of pelvic C-clamp and
during follow-up
– Do not use the pelvic C-clamp to lift the patient.
– Wound closure; extended incisions may require a
coapting skin suture
– Continuing injury management according to
polytrauma protocols
– The nail insertion sites must be meticulously
disinfected and dressed
– Should the patient need to be moved, he/she should
on no account be placed on his/her side as this could cause
one of the nails to penetrate the bone excessively
7
Removal
The pelvic C-clamp is removed before denitive treatment
of the posterior pelvic ring injury. Be sure to remove the
protective caps from the cannulated nails and Kirschner
wire from the uninjured side.
Postoperative Management and Removal
12 DePuy Synthes Pelvic C-Clamp II Surgical Technique

8
Disassembly of the pelvic C-clamp
The lower arms can be raised by
pressing the side buttons as depicted
by the red arrows (1).
Disassembly of the Pelvic C-Clamp
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1
2
2
2
To remove the lower arms completely,
keep the buttons depressed (1) and
slide the arms out (2).
The threaded tubes can be unscrewed
from the lower arms.
Pelvic C-Clamp II Surgical Technique DePuy Synthes 13

1
3
3
1
Before removing the upper arms
from the rails, make sure the locking
mechanism is unlocked. The upper
arms can be removed from the rails
by pressing the top buttons (2) while
pulling on the arms. Be sure to hold
the rails during this procedure to
prevent the rails from falling.
Disassembly of the Pelvic C-Clamp
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2
The outer rails can be separated from
the inner rail by pressing the buttons
on the outer rails (3) and pulling the
two rails apart.
2
14 DePuy Synthes Pelvic C-Clamp II Surgical Technique

Care and Maintenance
9
Care and maintenance
Instrument
519.97* Special Autoclavable Oil
After disassembly, clean the rails, arms and threaded tubes
manually, e.g. by using a brush. The springs in the upper arm
at button (1) should be cleaned also. Broken or damaged
parts should be replaced.
The cannulated nails are intended for single use only.
After cleaning, oil the thread of the threaded tube and the
two holes located next to the side buttons and reassemble
the device.
The pelvic C-clamp should be checked after every use/
cleaning/sterilization to conrm that all parts move freely
as intended.
The complete, sterile pelvic C-clamp should be kept ready
for use in the resuscitation room.
Because the pelvic C-clamp consists of stainless steel,
aluminum and a few pieces of polymer, it should always
be cleaned at temperatures below 284ºF (140°C), using
a detergent with a pH between 7 and 9.5.
*Also available.
Special autoclavable oil
Pelvic C-Clamp II Surgical Technique DePuy Synthes 15

Implants
02.306.006 Short Cannulated Nail for Pelvic C-Clamp II
02.306.007 Long Cannulated Nail for Pelvic C-Clamp II
292.26 2.5 mm Kirschner Wire, 285 mm, trocar point
16 DePuy Synthes Pelvic C-Clamp II Surgical Technique

Instruments
03.306.009 2.5 mm K-Wire Insertion Handle
321.20 Ratchet Wrench, 11 mm width across ats
391.93 Wire Cutter, 220 mm
398.32 Socket Wrench with Hammer
03.306.010 Pelvic C-Clamp II (shown with cannulated nails)
03.306.011 8 mm Protective Cap
Pelvic C-Clamp II Surgical Technique DePuy Synthes 17

Pelvic C-Clamp II Set (01.306.000)
Graphic Case
68.306.000 Vario Case for Pelvic C-Clamp II
689.886 Bin for Vario Case, 64 mm x 29 mm x 53 mm
Contents
02.306.006 Short Cannulated Nail for Pelvic C-Clamp II,
2 ea.
02.306.007 Long Cannulated Nail for Pelvic C-Clamp II,
2 ea.
292.26 2.5 mm Kirschner Wire, 285 mm, trocar point,
1 pkg. of 10
03.306.009 2.5 mm K-Wire Insertion Handle
03.306.010 Pelvic C-Clamp II
03.306.011 8 mm Protective Cap, 4 pkgs. of 2
321.20 Ratchet Wrench, 11 mm width across ats,
2 ea.
391.93 Wire Cutter, 220 mm
398.32 Socket Wrench with Hammer
Also Available
359.204 Locking Pliers
519.97 Autoclavable Oil
Note: The Pelvic C-Clamp II (03.306.010) consists of:
03.306.000 Inner Rail for Pelvic C-Clamp II
03.306.001 Outer Rail for Pelvic C-Clamp II, 2 ea.
03.306.002 Upper Side Arm for Pelvic C-Clamp II, 2 ea.
03.306.003 Lower Side Arm for Pelvic C-Clamp II, 2 ea.
03.306.008 Threaded Tube for Pelvic C-Clamp II, 2 ea.
18 DePuy Synthes Pelvic C-Clamp II Surgical Technique
For detailed cleaning and sterilization
instructions, please refer to
www.synthes.com/cleaning-sterilization or
sterilization instructions, if provided.

© DePuy Synthes 2008–2017. All rights reserved.
DSUS/TRM/0117/1316 4/17 DV
Synthes USA, LLC
1101 Synthes Avenue
Monument, CO 80132
Manufactured or distributed by:
Synthes USA Products, LLC
1302 Wrights Lane East
West Chester, PA 19380
To order (USA): 800-523-0322
To order (Canada): 855-946-8999
Note: For recognized manufacturer, refer to the product label.
www.depuysynthes.com
Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship
and materials. Any other express or implied warranties, including warranties of merchantability or tness, are hereby disclaimed.
Please also refer to the package insert(s) or other labeling associated with the devices identied in this surgical technique for additional information.
CAUTION: Federal Law restricts these devices to sale by or on the order of a physician.
Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada.
Please contact your sales consultant for items approved for sale in Canada.
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