sr sacral rods

SR
SACRAL RODS
emergency team for broken bones®
Features
Features
Material:
Implant:
• Material: TiAL6V4 ELI
• Easier removal of implant after fracture has healed
• Improved fatigue strength of implant
• Reduced risk of cold bonding
• Reduced risk of inflammation and allergy
• Threaded rods with washers and
locknuts for ilio-iliac compression
osteosynthesis
• Stepped thread to increase fatigue
strength
• Washer: wedge-shaped, ribbed,
anatomically contoured
• Stable guiding instrument for simple
and safe positioning of threaded rods
• Socket spanner system with AO
standard adapter for fast and simple
fastening of nuts
SACRAL RODS
emergency team for broken bones®
Advantages
• Simple and safe operative technique
• Low possibility of iatrogenic injury to
neural structures
• Low intraoperative X-ray exposure
02 i.t.s.
Sacral Rods
X-ray
Simple and safe operative
technique
Low possibility of iatrogenic
injury to neural structures
stepped thread
low possibility of iatrogenic
injury
SACRAL RODS
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Indications
• Dorsal stabilisation on the posterior pelvic ring for unstable pelvic ring
injures type C/AO,
especially in the case of:
• Unstable sacral fractures in all three zones
• Osteo-ligament instabilities of the sacro-iliac joint
SACRAL RODS
emergency team for broken bones®
Sacral Rods
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Sacral Rods
The operative management of pelvic ring disruptions has always represented a challenge to the treating
surgeon. The sufficient stabilisation of such an injury requires both a profound knowledge of the anatomy and
biomechanics of the pelvis and an understanding of the mechanism of fracture.
The chosen technique of a posterior stabilisation depends on the one hand on the kind of fracture, and on the
other hand on the personal experience of the individual operator.
Threaded rods as fixators of posterior pelvic ring instability have been well known and well proven for a long
time, especially for sacral fractures in all three zones and for detachments of the SI joint (the technique was first
described in 1913 by A. Lambotte, but frequent use of sacral rods only started in the 1980s.)
The stability of Sacral Rods has been proved in numerous studies, and in many investigations the rods have
been used as a „gold standard“ and reference value.
In the case of type C injuries, surgical intervention has first to be ventrally undertaken as a rule by means of plate
osteosynthesis.
The rear stabilisation is carried out either in the same session or in a quickly following second surgical
intervention. The Sacral Rods are attached by means of the dorsal parts of the crista iliaca dorsal to the sacrum
and dorsal to the sacro-iliac joint. The rods are secured on both sides by a nut and locknut.
With the present technically perfected armamentarium, the technique has been standardised and considerably
simplified.
The use of titanium plates imposes no restrictions on postoperative imaging diagnostics.
Contraindications
• Fractures of the ala of the ilium in
the posterior area
• Fractures of the os sacrum in
the transforaminal area with
CT-verified fractured parts and
fragments requiring an open
revision and decompression
• For the case that the relevant
anatomy appears to preclude
a safe positioning of the rods
behind the sacral canal (rare)
SACRAL RODS
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Description of Surgery
Ventral stabilisation
As a rule, a ventral stabilisation is carried out
as the first intervention since a secondary
reposition of the anterior pelvic ring in the case
of an already reduced dorsal fracture could lead
to an uncontrolled compression of the plexus
sacralis.
SACRAL RODS
emergency team for broken bones®
Dorsal stabilisation
Dorsal stabilisation is carried out in the prone position of the patient, usually under full anaesthesia and in the
same session.
A curved skin incision is made on both sides lateral to the sacro-iliac joint, from the spina iliaca posterior
superior extending cranially with a length of about 5 cm.
Linea glutea posterior
M. Glutaeus maximus
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Skin incision
Preparation
Spina iliaca post.
superior
Preparation of the subcutaneous fat tissue and carried
down to the fascia of the glutaeus maximus muscle.
Loosen the musculature from the outer surface of the
dorsal os ileum.
Linea glutea posterior
m. Glutaeus maximus
Reposition
A possibly necessary reposition of half of the pelvis is
carried out by means of a Schanz screw attached to
the crista iliaca.
Deployment of the guiding instrument and checking by
means of image converter.
Guiding instrument:
It is strongly advised not to use
the enclosed guiding device for
reducing bone fragments since it
could be damaged in this way and
prevent a trouble-free attachment
of the Sacral Rods.
Right
SACRAL RODS
Wrong
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Description of Surgery
Spina iliaca post. superior
The linea glutea posterior acts as the reference point.
The guiding instrument is positioned on a considered line
between the origin of the linea glutaea posterior on the
iliac crest and the spina iliaca inferior; the drill hole will
then lie some 0.5 cm higher.
The caudal screw is attached first, and the point of entry
is to be chosen such that the rod is at a tangent to the
crista centralis of the os sacrum or even perforates it,
but at least comes to rest behind the lamina dorsalis of
the sacrum.
connecting line
Linea glutea posterior
– spina iliaca post. inferior
SACRAL RODS
emergency team for broken bones®
The guiding instrument can be swivelled in the caudal
direction during radioscopy (otherwise the guiding
instrument can become loose due to divergence with the
ala of the ileum).
The threaded rod is equipped with a drill bit, and young
bones should be predrilled. After that, the threaded rod
is introduced over the guiding instrument.
Pre drilling:
For predrilling we recommend the use of the enclosed
drill to achieve a satisfying results.
After the threaded rod has penetrated the second
corticalis of the opposite os ileum, the guiding instrument
is dismantled on this side.
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Schanz screw
secure area
The asymmetric washer, nut and locknut are
attached (this is done the most simply by
continuing to turn the rod with the drill).
Both nuts must be definitively tightened.
The drill chuck is released, the guiding
instrument removed, and the washer is attached
as are, successively, both nuts on the second
side using the special socket spanner and the
soft-part protector.
Wedge shaped spacers:
Please note the exact anatomical
position shown here to arrive at the
best result.
Right
SACRAL RODS
Wrong
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SACRAL RODS
emergency team for broken bones®
X-ray
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Description of Surgery
socket spanner with soft-part protection
The first nut is tightened until the desired
compression of the fracture area is reached (care
must be taken not to use excessive compression with
transforaminal fractures of the sacrum.) Both nuts
must be tightened. Remove the excess end using the
bolt cutters.
The same procedure is undertaken with the second
screw, which is to be positioned some 2 cm cranially
to the first screw.
adapter for socket spanner
Check
Final check using image converter or X-ray, redon
drainage, subsequent closure of the wound.
SACRAL RODS
Postoperative Treatment
Dependent on type of fracture:
In the case of instabilities of the SI joint and transalar fractures, we recommend a partial stress of the injured
side for six weeks, then moving on to full stress.
In the case of transforaminal and central fractures, we recommend the injured side not be subject to stress
for six weeks, then six weeks partial stress, moving on to full stress after CT check after the 12th week at the
earliest.
The materials should be removed since two joints are bridged over.
Removal of the implants is carried out as a rule after one year at the earliest.
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Implants & Instruments
SACRAL RODS
emergency team for broken bones®
Instruments
Order No.
5 Guiding Instrument, 5 Parts, Sacral Rod
12 i.t.s.
62403
6 Socket Spanner, WS 7, L=240 mm
56702-240
7 Socket Spanner, WS 10, L=200 mm
561002-200
8 Tissue Protection Sleeve
62160-180
9 Spiral Drill, D=4.0mm, L=225 mm
61403-225
10 Flatwrench, SW 7
70007
11 Flatwrench, SW 10
70010
12 AO Screw Adaptor, Socket Wrench
53400
13 Bolt Cutter, Pelvis Screws, Sacral Rod
65394
14 Sterilization Tray, Sacral Rods
50140
4
13
10
11
3
6
1
7
2
8
5
9
5
5
13
12
14
SACRAL RODS
Implants
Order No.
1 Sacral Rod, Threaded
39401-01
2 Washer, Wedge-Shaped, Ribbed
39401-02
3 Nut, Gauge 10
39401-03
4 Counternut, Gauge 7
39401-04
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®
DOTIZE
Chemical process - anodization in a strong alkaline solution *
Type III anodization
Dotize
Type II anodization
Layer thickness 60-200nm
Layer thickness 2000-10 000nm
+
Different colors
+
Film become an interstitial part of the titanium
-
Implant surface remains sensitive to:
Chipping
Peeling
Discoloration
-
No visible cosmetical effect
Anodization Type II leads to following benefits *
•
•
•
•
•
•
•
•
Oxygen and silicon absorbing conversion layer
Decrease in protein adsorption
Closing of micro pores and micro cracks
Reduced risk of inflammation and allergy
Hardened titanium surface
Reduced tendency of cold welding of titanium implants
Increased fatigue resistance of implants
Improved wear and friction characteristics
* White Paper: Ti6Al4V with Anodization Type II: Biological Behavior and Biomechanical Effects; Axel Baumann, Nils Zander
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Notes:
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Sterilization Guidelines
The following remarks should serve as a guideline in the sterilization of medical
products.
IMPORTANT INDICATIONS FOR DOCTORS AND
OPERATING THEATRE PERSONNEL
This instruction leaflet refers to all supplied nonsterile implants and all reusable instruments
from I.T.S. GmbH. Detailed information for the
identification of the product (such as system
classification, cat. no.) can be found in the product
identification code and/ or on the package label.
Make sure that you are familiar with the possibilities
of application, combinability and correct handling
of the product. Please note that product systems
can undergo modifications which can affect the
combinability of the implant with other implants
or instruments. Detailed user information can be
found in the respective surgical instructions.
Intended Use of the Implant
The implant temporarily stabilises bone segments
until bony consolidation has taken place. After
this, the implant has no more use and can be
removed.
Indications and Contra-Indications of the Implant
Indications and contra-indications are determined
by current medical practice.
Side Effects of the Implant
Up to now, no allergic reactions have been known
with titanium implants. Allergic reactions to steel
implants cannot be excluded.
Warnings and Preventive Measures
• Pay attention to the instructions on the package.
• Implants are only to be used once.
• Always treat implants carefully to avoid surface
damage or geometric alterations.
• Any alterations to the design of implants of I.T.S.
GmbH are prohibited.
• Regular postoperative follow-up examinations
(e.g. X-ray check-ups) are to be carried out.
• For metallurgical, mechanical and design reasons,
never combine implants from different producers.
Materials used are stated in the product catalogue
or on the label.
• The length, angle and right or left version of an
implant of a particular type can differ.
• The precise positioning and fastening of a
properly made connection between implant and
instrument must be repeatedly checked during the
course of an operation.
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• In the case of magnetic resonance imaging
(MRI), it is generally recommended to check back
with the manufacturer of the MR scanner. The use
of MRI with steel implants is prohibited by I.T.S.
GmbH, and in such cases the user must contact
the manufacturer of the MRI scanner.
• Staff who come into contact with contaminated
or potentially contaminated medical products
should follow the generally recognised preventive
measures. Due care is to be taken when handling
medical products with sharp points or edges.
• Appropriate protective measures must be
taken to ensure safe handling when dealing with
contaminated or potentially contaminated medical
products (e.g. gloves, etc.)
• In countries with stricter safety requirements
regarding recycling medical products, these safety
requirements apply and are to be adhered to.
• Supplied non-sterile medical products must be
thoroughly prepared according to these instructions
before use.
• No metal brushes or abrasive cleaning materials
are to be used for manual cleaning purposes.
The use of these materials can lead to damage of
surfaces and coatings. Instead, soft brushes made
of nylon should be used.
• Steam (damp heat) is the recommended
sterilization method of medical products of I.T.S.
GmbH.
• All the following described steps for cleaning and
sterilization are made easier when contaminants
(e.g. blood) are not allowed to dry beforehand.
Restrictions
• Unless otherwise stated, repeated preparation of
re-usable instruments of I.T.S. GmbH has minimal
effects on them when following the procedures
mentioned below.
• The end of the product service life is usually
determined by wear and damage caused by use.
• Instruments containing aluminium or anodised
aluminium are damaged by alkaline (pH > 7)
cleaning agents and solutions.
INSTRUCTIONS FOR RECONDITIONING
Preparation at the Location of Use
• Remove surface dirt using a disposable cloth or
paper towel.
Storage and Transport
• No special requirements.
• It is recommended to recondition medical products
as soon as possible after their previous use.
Cleaning/ Disinfection/ Drying
Cleaning automatic
Recommended equipment: commercially available
disinfector authorized for use with medical
products, with tested efficiency; commercially
available cleaning agent authorized for use with
medical products (alkaline – with pH value < 11).
Step 1 Each instrument that can be dismantled
should be taken apart for cleaning. Jointed
instruments are to be opened so that water can
flow out of cannulae and blind holes.
Step 2 Set the cycle. Adhere to the guidelines
of the manufacturer of the disinfector.
Step 3 After removing the instruments from
the disinfector, check cannulae, blind holes, etc,
for visible dirt. If required, repeat cycle or clean by
hand.
Cleaning manual
Recommended equipment: commercially available
cleaning agent authorized for medical products
(alkaline – with a pH value < 11); soft brushes
made of nylon; running water
Step 1 Each instrument that can be dismantled
should be taken apart for cleaning. Rinse off
surface dirt from instrument.
Step 2 Apply cleaning agent solution to all surfaces
using a brush. Make sure that jointed instruments
are cleaned in both open and closed positions.
N.B.: A suitable brush must be used for cleaning
cannulae and blind holes so that every part can be
reached. The concentration and residence time as
stated by the cleaning agent manufacturer must be
adhered to unconditionally.
Step 3 Rinse the medical product for a minimum
of 1 minute with clean water. Openings and other
areas which are not easily accessible should be
thoroughly rinsed.
Sterilization Guidelines
Disinfection
Equipment: Commercially available disinfectants
authorized for use with medical products e.g..
MEDICLEAN FORTE) can be used (but only
according to the instructions of the disinfectant
producer).
In the case of automatic cleaning, a final rinse
cycle at 90 °C for 5 minutes can be finally carried
out to provide thermal disinfection.
Drying
Drying as part of the cleaning/ disinfection cycle
should not exceed 110 °C.
Checking, Maintenance and Inspection
• Each instrument or implant is to be inspected
carefully to make sure that all visible dirt has
been removed. If any ingrained dirt is found, the
cleaning/ disinfection cycled should be repeated.
• Any instruments with an attached movable
mechanism should be treated with a commercially
available lubricant authorized for sterilisable
surgical instruments.
• The mobility of movable parts should be checked
to ensure that the planned sequence of motion can
be completely carried out.
• In the case of instruments which can be
reassembled into larger units, check whether the
single parts can be put together easily.
Package
The delivery package is purely for transport use
and not suitable for sterilization.
Sterilization
• The hospital is responsible for in-house
procedures regarding assembly, inspection and
packaging of instruments. Furthermore, the
hospital should recommend protective measures
covering sharp or potentially dangerous parts of
the instruments.
• All instruments and implants should be laid out
in such a way that the steam should reach all the
surfaces.
• Each instrument that can be dismantled should
be taken apart for sterilization.
• Sterilization by means of heat/ steam is the
preferred method for instruments and implants of
I.T.S. GmbH.
• Manufacturer’s recommendations regarding
sterilization appliances should always be followed.
When several instruments are sterilised in one
sterilization cycle, care must be taken not to exceed
the maximum amount of items to be sterilised in
the appliance as stated in the manufacturer’s
instructions.
Cycle
Duration of
sterilization
Temperature
Pressure
Duration of
drying
Prevacuum
5 minutes
134°C
273°F
3,04 bar
27 psi
30 minutes
Prevacuum²
18 minutes
134°C
273 °F
3 bar
28,5 psi
30 minutes
² From the World Health Organization’s (WHO)
recommended disinfection/ steam sterilization
parameters for the reconditioning of instruments
when there is a risk of TSE/CJD contamination
Important Note
• The above-mentioned instructions have been
validated by the manufacturer of medical products
for the preparation of a medical product whose reuse is deemed SUITABLE. It is the responsibility
of the reconditioner to ensure that reconditioning
actually carried out using the equipment, materials
and staff in the preparation facility achieves the
desired results. For this, validation and routine
inspections of the preparation process are
usually necessary. Likewise, any deviation from
the provided instructions by the preparer should
be evaluated for its efficiency and possible
disadvantageous consequences.
• In the case of questions or problems, please
contact us at the address above.
Symbols
Single use
Expiry date (year/month)
Disposal
The valid guidelines of the hospital operator apply
for disposal.
Charge number
Sterilization by steam
Sterilization by radiation
Sterilization by ethylene oxid
Patient Information
Order number
Implantation has consequences for the discomfort,
mobility and general life circumstances of the
patient. For this reason, the patient should be
given instructions for appropriate behaviour after
implantation, and it should be explained to him or
her the necessity of reporting negative changes in
the area of the implant as well as any falls and
accidents which may appear not to have damaged
the implant nor the site of the operation.
Package content (no. of items)
Material used
Size
Pay attention to instructions
RL 93/42/EWG
ÖNORM EN ISO 13485
ISO 17664
Responsibility of the Hospital for Instruments lent
by I.T.S. GmbH
• Surgical instruments generally have a long
service life. But their life expectancy can be quickly
reduced due to misuse or insufficient protection.
Instruments which no longer work correctly,
whether due to wear, misuse or improper care,
have to be disposed of.
• Medical products which are returned to I.T.S.
GmbH must undergo cleaning, disinfection,
inspection and a final sterilization. Products
returned to I.T.S. GmbH must be accompanied by
a confirmation of the decontamination they were
subjected to.
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Notes:
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19
I.T.S. GmbH
part of the MED-HOLD GROUP
Autal 28, 8301 Lassnitzhöhe
Austria
Order No. SR-OP-0111-E
Edition: January/2011
Tel.:+43 | 316 | 211 21 0
Fax:+43 | 316 | 211 21 20
[email protected]
www.its-implant.com
© I.T.S. GmbH Graz/Austria
2011. Subject to technical
alterations, errors and
misprints excepted.