uol ulna osteotomy locking plate

UOL
ULNA OSTEOTOMY
LOCKING PLATE
emergency team for broken bones®
CONTENTS
Preface
Surgical Technique
Information
Preface
3
Screws
4
Properties
5
Indications & Contraindications
5
Assembling of the instruments
6
Positioning of the patient
7
Exposure
7
Plate insertion
8
Placement of the tensile bolts
9
Shortening
12
Reduction
16
Placement of the screws
19
Removal of the instruments
22
Postoperative treatment
24
Summary
25
Order information
26
Locking
28
Dotize®
28
Sterilization guidelines
30
Preface
Preface:
The Ulna Osteotomy Locking Plate provides a plate system (hybrid system) to be studded with locking
screws and compression screws, which is specially adapted to the anatomic and biomechanic
requirements after shortening osteotomy of the distal ulna. In a single device, the Ulna Osteotomy
Locking Plate allows for unique coplanar orientation of the incisions with rotation-stable shortening
and the option for compression.
The standardization of a plurality of surgical procedures into a single device system obtained thereby
increases and secures the quality of the surgical procedure.
03
Ulna Osteotomy Locking Plate
37301-XX
Cortical Screw, Locking, D=3.0mm
61243-100
Spiral Drill, D=2.4mm, L=100mm, AO Connector
56095-70
Screwdriver, Torque, T9x70
56095-70-2
Self-holding sleeve, Screwdriver, Torque 9
32271-XX
Cortical Screw, D=2.7mm
61203-100
Spiral Drill, D=2.0mm, L=100mm, AO Connector
56095-70
Screwdriver, Torque, T9x70
56095-70-2
Self-holding sleeve, Screwdriver, Torque 9
37302-XX
Cancellous Screw, Locking, D=3.0mm
61203-100
Spiral Drill, D=2.0mm, L=100mm, AO Connector
56095-70
Screwdriver, Torque, T9x70
56095-70-2
Self-holding sleeve, Screwdriver, Torque 9
All I.T.S. locking plates are anatomically pre-contoured. In the unlikely event that the plate has to be formed to the bone please notice
that slight contouring is possible.
04
ATTENTION: Significant bending at the locking holes will reduce locking effectiveness and if bend more than once in both directions it
might weaken the titanium plate strongly.
Properties
Properties of the implant:
•
•
•
•
•
•
Multidirectional locking
Anatomically shaped
Plate length: 5-hole
No dislocation of the parts of the bone due to fixation using long-bore hole
Positioning of the plate prior to the osteotomy
Compression instrument for simple joining of the osteotomy surfaces (compression strength freely selectable)
• No loss of correction due to locking
• A screw can be placed through both osteotomy surfaces as a tension or fixating screw, optionally locking
Properties of the material:
•
•
•
•
•
•
Plate material: Titanium Grade 2
Material of screws: 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
Indications, Contraindications
Indications:
Impaction syndrome of the ulnar wrist
• Symptomatic, post-traumatic ulnar malposition in the distal radio-ulnar joint
(DRUJ)
• Degenerative ulnar wrist
• Correction of the ulnar position relative to the unaffected other side up to a
maximum of 6mm in one step or 13mm in two steps (see figures page 18)
Extended indications:
• Primary ulnar shortening in forearm fractures with insufficient reconstruction of
the length of the radius
• Deformities
• Degenerative ulnar variant in conically shaped DRUJ according to Förstner
05
Assembling of the instruments
1
2
1
680858
680857
680853
2
680850
680856
1
680854
3
680855
680852-1
2
680851-1
680854
06
Positioning of the patient
Place the patient on his back, cover the arm to be freely movable and place it on an X-ray
transparent table at a shoulder abduction of 90°. Perform the operation under regional or general
anaesthesia with or without using an arrest of blood supply on the upper arm. The shape of the
implant allows for palmar, ulnar or dorsal positioning of the plate. The plate should be completely
fitted to the bone without protruding. As the the distal palmar section of the ulna is usually curved,
more proximal positioning of the plate or pre-bending of the implant are recommended.
Attention: When bending the plate, make sure you bend the plate at the 2 distal bore holes only.
If you bend the plate to much, it may happen that the “Locking” System doesn’t work due to
deformation.
Exposure
The upper extremity is rotated outwards, the elbow is bent and the wrist is supported with a roll. Begin the incision of the skin approximately 2–3cm proximal of the palpable processus styloideus ulnae.
It shall run 5mm palmar, parallel to the palpable margo interosseus approximately 8–9cm proximal. It is mandatory to pay attention to the ramus dorsalis n. ulnaris.
07
Plate insertion
After opening the forearm fascia, mobilize bluntly the belly of the FCU (M. flexor carpi ulnaris) at its
insertion point at the ulna and retract it medial using Hohmann retractors. Define the optimal position of
the plate and incise the dorsal forearm fascia in the designated osteotomy area.
08
Placement of the tension bolts
Place the assembled osteotomy system upon the ulna osteotomy plate, which is attached to the ulna
using the plate holes alternatingly from the outside centrad; distally with D=3.0mm locking cancellous
screws (37302-XX) or D=3.0mm locking cortical screws (37301-XX) (spiral drill, D=2.0mm, L=100mm,
AO Connector (61203-100) for locking cancellous screw / spiral drill, D=2.4mm, L=100mm, AO
Connector (61243-100) for locking cortical screw), proximally with 2 tension bolts (680859) after
inserting the drill guide, D=2.0mm (62208) for the tension bolt and a D=2.0mm bore (optionally
D=2.4mm for hard bone).
09
The bore diameter depends on the choice of the screw. (spiral drill, D=2.0mm, L=100mm, AO Connector
(61203-100) for locking cancellous screw / spiral drill, D=2.4mm, L=100mm, AO Connector (61243-100)
for locking cortical screw).
10
D=2.0 mm
D=2.0 mm
11
Shortening
Incise the periosteum at the osteotomy site and retract it minimally before performing, using the incision
gage and producing as little heat as possible, two atraumatic, parallel cuts according to the measured
shortening.
The maximum recommended osteotomy length is 6mm.
Caution: In osteoporotic bones, traction bolts may tilt due to high traction forces (malformation of drilled
holes in osteoporotic bone).
The thickness of the saw blade may amount to 0.7mm maximally. We recommend a thickness of the
saw blade amounting to 0.5–0.7mm in order to achieve precision.
12
13
14
15
Reduction
After removal of the dissecate, the osteotomy surfaces must be cleaned meticulously of bone
or soft tissue remnants before, after loosening the tension bolts (1/2 to 3/4 turn), shortening is
performed using the setscrew. If there are excessive tensions and shortening difficulties, this is usually
the consequence of an interponate. After contact of the osteotomy surfaces, prior to a desired
compression the reduction may be additionally secured using holding tongs. After that, tighten the
tension bolts firmly.
1/2 to 3/4 turn (loosening)
16
1/2 to 3/4 turn (loosening)
17
If shortening of more than 6mm is desired, two subsequent osteotomies may be performed. For recommended OT-widths please refer to table stated below.
Shortening in mm
First Osteotomy
Second Osteotomy
0-6
required length
-
7
4
3
8
5
3
9
6
3
10
6
4
11
6
5
12
6
6
13
7
6
Any desired shortening of 7-13mm
may be performed following the
initial OT by manual support and
protected against rotation using
a clamp, without using the adjusting screw on compression (for
OT-widths, please see table above). As a result, the drill holes will
stay undeformed to the greatest
extent even in osteoporotic bone,
while the shortening is still protected against rotation.
After successful shortening, the
instrument is attached to the ulna
in a stable manner, and the second OT is performed according
to existing standards. Due to the
stepwise approach, no extended
implant is required, even with
enhanced shortenings, and the
length of the surgical incision will
be unchanged.
Caution: At OT-widths of 11 to
13mm, we recommend not to use
hole G (see figure beside), since
the bridge between the drilled
hole for the proximal traction bolt
and the drilled hole in G will be too
narrow thus, a safe fixation cannot
be guaranteed, particularly not in
osteoporotic bone.
Shortening in
mm
A
B
C
D
E
F
G
H
A
B
C
D
E
F
G
H
A
B
C
D
E
F
G
H
A
B
C
D
E
F
G
H
A
B
C
D
E
F
G
H
A
B
C
D
E
F
G
H
A
B
C
D
E
F
G
H
0
8
9
10
11
12
13
18
Displacement of the bores
Placement of the screws
After making a bore with the spiral drill, D=2.0mm, L=100mm, AO Connector (61203-100), place a
D=2.7mm cortical screw (32271-XX) as a fixation screw into the oblique bore.
The cortical screw may optionally be used as a tension screw (bore into the corticalis near the plate
using a spiral drill, D=2.7mm, L=100mm, AO Connector (61243-100)).
D=2.0 mm
19
Loosen the pre-tension and replace first the tension bolt in the slide hole close to the osteotomy site,
second the one at the end of the plate with a D=2.7mm cortical screw (32271-XX). Subtract 4 mm
from the length measured.
20
21
Removal of the instruments
Remove the osteotomy system from the ulna osteotomy plate, and insert D=3.0mm locking cancellous
screws (37302-XX) or D=3.0mm locking cortical screws (37301-XX) into the remaining plate holes. The bore diameter depends on the choice of the screws. (spiral drill, D=2.0mm, L=100mm, AO
Connector (61203-100) for locking cancellous screw / spiral drill, D=2.4mm, L=100mm, AO Connector
(61243-100) for locking cortical screw)
22
To avoid collision of the fixation/tension screw with screw A (see figure), it must be installed with
an angle of up to 15° proximal. The direction of the bore is to be selected so that the opposite
corticalis is not weakened. Monocortical installation with an angle-stable screw is likewise possible.
A
A
23
The repositioned periosteum should cover the osteotomy area. After verifying the rotation and
radiologically controlling the osteotomy gap, plate position and screw length, suture the fascia and
the skin. Drainage as required.
Postoperative treatment
Forearm splint for 3 weeks. Concomitant physiotherapy aiming at freely closing the fist and bending/
stretching of the elbow joint. During this period, rotation of the forearm should be restricted to R: 30/0/30. From the 5th postoperative week on, this is to be focused upon in accordance with the
clinical and radiological follow-up examination results.
24
Summary
The Ulna Osteotomy Locking Plate provides a plate system (hybrid system) to be studded with locking
screws and compression screws, which is specially adapted to the anatomic and biomechanic
requirements after shortening osteotomy of the distal ulna. In a single device, the Ulna Osteotomy
Locking Plate allows for unique coplanar orientation of the incisions with rotation-stable shortening and
the option for compression.
The standardization of a plurality of surgical procedures into a single device system obtained thereby
increases and secures the quality of the surgical procedure.
25
Order information
Ulna Osteotomy Plate, 5-Hole
21231-5
Cancellous Screw, Locking, D=3.0mm, L=10mm
Cancellous Screw, Locking, D=3.0mm, L=12mm
Cancellous Screw, Locking, D=3.0mm, L=14mm
Cancellous Screw, Locking, D=3.0mm, L=16mm
Cancellous Screw, Locking, D=3.0mm, L=18mm
Cancellous Screw, Locking, D=3.0mm, L=20mm
Cancellous Screw, Locking, D=3.0mm, L=22mm
Cancellous Screw, Locking, D=3.0mm, L=24mm
37302-10
37302-12
37302-14
37302-16
37302-18
37302-20
37302-22
37302-24
Cortical Screw, D=2.7mm, L=10mm
Cortical Screw, D=2.7mm, L=12mm
Cortical Screw, D=2.7mm, L=14mm
Cortical Screw, D=2.7mm, L=16mm
Cortical Screw, D=2.7mm, L=18mm
Cortical Screw, D=2.7mm, L=20mm
Cortical Screw, D=2.7mm, L=22mm
Cortical Screw, D=2.7mm, L=24mm
Cortical Screw, D=2.7mm, L=26mm
32271-10
32271-12
32271-14
32271-16
32271-18
32271-20
32271-22
32271-24
32271-26
Cortical Screw, Locking, D=3.0mm, L=8mm
Cortical Screw, Locking, D=3.0mm, L=10mm
Cortical Screw, Locking, D=3.0mm, L=12mm
Cortical Screw, Locking, D=3.0mm, L=14mm
Cortical Screw, Locking, D=3.0mm, L=16mm
Cortical Screw, Locking, D=3.0mm, L=18mm
Cortical Screw, Locking, D=3.0mm, L=20mm
Cortical Screw, Locking, D=3.0mm, L=22mm
Cortical Screw, Locking, D=3.0mm, L=24mm
37301-8
37301-10
37301-12
37301-14
37301-16
37301-18
37301-20
37301-22
37301-24
Screwdriver, WS 2.5
Screwdriver, Torque, T9x70
Self-holding sleeve, Screwdriver, Torque 9
56252
56095-70
56095-70-2
Depth Gauge, PROlock
59023
Drill Guide, D=2.7/2.0mm
Drill Guide, D=2.0mm
62202
62208
Spiral Drill, D=2.0mm, L=100mm, AO Connector
Spiral Drill, D=2.4mm, L=100mm, AO Connector
61203-100
61243-100
Instruments, Ulna Osteotomy Plate
Transection Gauge, Right, Ulna
Transection, Left, Ulna
26
680851-1
680851-2
Support for Transection Gauge Right
Support for Transection Gauge Left
680852-1
680852-2
Carrier Unit
680850
Set-screw guide
680853
Fixing Screw
680854
Fixing Screw for Transection Gauge
680855
Setscrew
680856
Crossbolt
680857
Slide
680858
Tension Bolt
680859
Sterilization Tray, Ulna Osteotomy Plate
50199
27
Locking
Locking works because of:
• Screw material (TiAlV) is slightly harder than plate
material (Titanium Grade 2)
• Screw head forms thread into the plate (no cutting)
Benefits:
•
•
•
•
•
± 15° and Locking
No pre threading
No cold welding
No debris
Re-setting of screw (up to 3 times)
30°
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
Dotize®
Type - II
Type - III
Ti-Oxid
Anodization Type II leads to following benefits*
•
•
•
•
•
•
•
•
28
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
Notes
29
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.
30
• 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.
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.
31
I.T.S. GmbH
part of the MED-HOLD GROUP
Autal 28, 8301 Lassnitzhöhe, Austria
Tel.:+43 | 316 | 211 21 0
Fax:+43 | 316 | 211 21 20
[email protected]
www.its-implant.com
Order No. UOL-OP-0112-E
Edition: January/2012
© I.T.S. GmbH Graz/Austria 2012.
Subject to technical alterations,
errors and misprints excepted.