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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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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Inner rail
Outer rail
Upper arm
Lower arm
Threaded tube
1Cannulated nail
(190 mm or 210 mm)
Side buttons
Upper buttons
Locking mechanism
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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.
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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
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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.
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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.
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1 Unlock, 2 Lock
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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
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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.
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