3679 slim-loc st wtsynthes.vo.llnwd.net/o16/llnwmb8/int mobile/synthes... · cervical spine surgery...

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DePuy Spine™ is a joint venture with Biedermann Motech GmbH. This publication is not intended for distribution in the USA. DePuy Spine™, Slim-loc™ and Cam-loc™ are all trademarks of DePuy Spine, Inc. and Healos ® is a registered trademark of DePuy Spine, Inc. Conduit™ is a trademark of DePuy Orthopaedics, Inc. © 2006 DePuy International Limited. All rights reserved. Cat No: 9082-93-000 Issued: 03/06 Surgical Technique 0086 DePuy International Ltd St Anthony’s Road Leeds LS11 8DT England Tel: +44 (113) 270 0461 Fax: +44 (113) 202 5992

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Page 1: 3679 Slim-Loc ST WTsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes... · cervical spine surgery • Instability associated with major reconstructive surgery for primary tumours

DePuy Spine™ is a joint venture with Biedermann Motech GmbH.

This publication is not intended for distribution in the USA.

DePuy Spine™, Slim-loc™ and Cam-loc™ are all trademarks of DePuy Spine, Inc. and

Healos® is a registered trademark of DePuy Spine, Inc.

Conduit™ is a trademark of DePuy Orthopaedics, Inc.

© 2006 DePuy International Limited. All rights reserved.

Cat No: 9082-93-000

Issued: 03/06

Surgical Technique

0086

DePuy International LtdSt Anthony’s RoadLeeds LS11 8DTEnglandTel: +44 (113) 270 0461Fax: +44 (113) 202 5992

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The Slim-loc™ anterior cervical

plate is a semi-rigid plate system

for anterior intervertebral body

fixation. It is indicated for

stabilisation of the cervical

spine from C2 to C7 employing

the option of either uni-cortical

or bi-cortical screw fixation

at the anterior face of the

vertebral bodies.

Contents

Introduction

Step 1: Choosing Plate Size

Step 2: Adjusting Plate Curvature

Step 3: Placing Temporary Fixation Pins

Step 4: Preparing Screw Hole

Step 5: Drilling Holes

Step 6: Selecting and Using Drill Bits

Step 7: Using The Tap

Step 8: Inserting Screw

Step 9: Locking the Cams

Bone Graft Solutions

Ordening Information

2

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The Slim-loc™ Plate is a semi-rigid plate system intended for anterior cervical intervertebral

body fixation. The design principles of the Slim-loc™ Plate are built upon the clinical heritage

of the comprehensive Codman ACP plate system, but have been modified in order to offer a

lower and slimmer plate profile, as well as offer additional implant options.

The Slim-loc™ System offers maximum implant versatility and integrated instrumentation.

The Slim-loc™ Anterior Cervical Plate System is indicated for stabilisation of the cervical spine

from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies.

Specific clinical indications for anterior cervical plating include:

• Instability caused by trauma

• Instability associated with correction of cervical lordosis and kyphotic deformity

• Instability associated with pseudoarthosis as a result of previously failed

cervical spine surgery

• Instability associated with major reconstructive surgery for primary tumours

or metastatic malignant tumours of the cervical spine

• Instability associated with single or multiple level corpectomy in advanced

degenerative disc disease, spinal canal stenosis and cervical myelopathy

Note: The described technique presents only one of many approaches to the stabilisation of the anterior cervical spine.

The surgeon is encouraged to utilise the Slim-loc™ Anterior Cervical Plating System with those techniques most familiar

to the operating surgeon.

Introduction

Slim-loc™ Anterior Cervical Plates are

available in 1-5 level configuration with a

length ranging from 22 -111 mm. When

handling plates, use caution to avoid

scratching or notching the plate surface

as this can weaken and compromise the

mechanical integrity of the device.

Following anterior bone graft placement,

use the forceps to select the appropriate

plate size and place it on the vertebral

column. Confirm that the length is

appropriate. The plate should span the

entire fusion segment, preferably using the

shortest plate possible, therefore avoiding

the adjacent disc space. Fluoroscopy may

be utilised to optimise plate selection and

screw placement.

Step 1: Choosing Plate Size

Slim-Loc™ Anterior Cervical Plate System

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SurgicalTechnique

Step 2: Adjusting Plate Curvature

Bend Zone

Bend Zone

The Slim-loc™ Plate has a precontoured lordotic curvature, anatom-

ically appropriate in the majority of procedures. If desired, the Plate

Bender may be utilised to optimally contour the sagittal plane to

ensure maximum bone / plate interface.

It is critical to bend the plate in the specified Bend Zone(s), which

has a smooth under-surface and reduced cross-sectional thickness.

If required to achieve additional plate lordosis, the plate is placed

between the lobes (Cam-loc™ facing up) of the Plate Bender. The

Bend Zone must be centrally located on the lower lobe of the Plate

Bender. Plate bending should be evenly distributed at the Bend

Zones along the length of the plate. Contouring titanium plates can

weaken and compromise the mechanical integrity of the device.

The fatigue life of the contoured implant in vivo cannot be precisely

predicted. Do not bend the plates repeatedly, excessively, or any

more than absolutely necessary.

Note: Once the sagittal

contour has been altered

by the Plate Bender, do

not bend in the reverse

direction. During bending

ensure the Cam-loc™ is

facing upwards.

After selecting the appropriate plate, use

the Temporary Fixation Pins (TFPs) to hold

the plate in place while drilling and placing

the screws. Using one of the plate holders

described in step 5, hold and lay the plate

evenly on the anterior cervical spine. Place

the TFP through the pinhole on the plate

using the TFP Holder. The TFP Holder has

a tamping platform at the proximal end for

when it is necessary to strike the TFP to

drive it into place. After placing the two

TFPs, fluoroscopy can be used to confirm

optimal screw placement and trajectory.

Any necessary adjustments may be

done at this time and reconfirmed with

fluoroscopy. Removing soft tissue and

large osteophytes may improve bone-plate

interface.

Note: Pre-drilling is not

required for Temporary

Fixation Pin insertion.

Note: Temporary Fixation

Pins are designed for single

use. Please ensure that all

Temporary Fixation Pins have

been removed and are not

placed back in the set for

re-sterilisation and re-used.

Step 3: Placing Temporary Fixation Pins

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6 7

SurgicalTechnique

Step 5: Drilling Holes

Before drilling it may be necessary to

prepare the screw hole with an awl. To

use the Slim-loc™ Awl, place the tip of the

awl shaft against the screw hole on the

plate and press it in the direction of the

screw angle desired.

The awl will protrude into the desired hole

(the awl also has a striking plate on the handle).

Step 4: Preparing Screw Hole

The screw angle may be selected and

the plate stabilised during the drilling

procedure. The Slim-loc™ System has two

styles of plate holder / drill guides. They

both achieve the same results.

A. Plate Holder / Drill Guide

The Plate Holder / Drill Guide may be

attached to the plate by placing the

expandable end into a lateral screw hole

and turning the knurled knob clockwise.

Note: Before using the Drill Guides, inspect the prongs

for any cracks or abnormality. Do not activate the plate

holding feature of the Drill Guide when the expandable

end is not fully seated in a screw hole.

B. Pistol Grip Plate Holder / Drill Guide

The Pistol Grip Plate Holder / Drill Guide

may be attached to the plate by placing the

expandable end into a lateral screw hole

and compressing the pistol grip handle.

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98

SurgicalTechnique

The Slim-loc™ Anterior Cervical Plate

System offers the ability to select various

angles of screw placement to conform to

individual patient anatomy. (Certain angles

may direct the screws at vulnerable

vascular and neural tissues). Use

fluoroscopy to confirm drill bit penetration

depth and angular orientation to ensure

that those structures are not at risk.

Step 6: Selecting and Using Drill Bits

Note: Avoid severe angulation of the superior screw

(greater than 16 degrees) which may prevent optimal

locking of the screw with the cam.

The drill length should correspond to the

depth of the bone purchase required,

taking into consideration the size of the

vertebra, the quality of the bone, diagnosis,

etc. The Slim-loc™ System is available with

12 mm (blue), 14 mm (gold) and 16 mm

(magenta) fixed length drill bits. The

colours correspond to their respective

screw size colours.

The Variable Depth Drill can be adjusted in

1 mm increments from 12 mm to 26 mm as

desired. The precise length of the Variable

Depth Drill Bit is determined by adjusting

the release on the cylinder gauge at the

end of the Variable Depth Drill.

Ensure that the release button is locked in

place at the desired length before using the

Variable Depth Drill.

Utilising one of the Drill Guides described

in step 5, select the angle of screw

trajectory. Attach the desired drill bit into

the Quick Couple Handle or a power drill.

Insert the drill bit into the Drill Guide and

drill the initial lateral hole into the vertebral

body.

Depth of screw insertion and angular

orientation of the screw must also be

confirmed by fluoroscopy. Typical screw

placement is 5-10 degrees medial angulation

with the screw directed 7.5 degrees rostral

& caudal to correspond with the superior

and inferior disc space respectively.

Superior

7.5º

7.5º

7.5º

Inferior

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SurgicalTechnique

The length of the Tap that will extend beyond

the soft tissue protection sleeve is set by

turning the cylinder gauge mounted near the

handle of the Tap in either direction. Please

ensure that the release button is locked in

place at the desired length before using the

Variable Depth Tap.

Step 7: Using The Tap

Note: The setting for both the

Variable Depth Drill and the

Tap can be approximated by

pre-operative radiographic

measurements (CT or MRI)

or by intra-operative

measurement of the exposed

vertebral endplates following

decompression. The use of

intra-operative fluoroscopy

while drilling and tapping, will

further improve the accuracy

of screw length selection.

Note: Ensure that the

Variable Depth Tap sleeve is

assembled on the Tap and

adjusted to the appropriate

length prior to use.

The Slim-loc™ screws are available as

self-drilling (4.5 mm major diameter) in

lengths ranging from 12-18 mm or

selftapping (4.5 mm major diameter) in

lengths ranging from 12-26 mm. Large

diameter screws (4.8mm major diameter)

are available in 12, 14 and 16 mm lengths.

For identification purposes the 12-17 mm

screws are colour coded for length and

screw type. The most common lengths are

colour-coded to correspond with the fixed

drill shafts.

• For self-tapping screws, the entire screw

is uniformly coloured.

• For self-drilling screws, only the heads

are coloured.

• For large-diameter screws, only the

threads are coloured. Length is denoted

by the following colours and should

always be confirmed with a screw gauge:

Step 8: Inserting Screws

12 mm = Blue

13 mm = Purple

14 mm = Gold

15 mm = Light Blue

16 mm = Magenta

17 mm = Copper

18 mm - 26 mm = Silver

Select the appropriate screw length

corresponding to the hole drilled. Using

the Hex Driver, pick up the screw from the

tray and insert it through the plate.

Drill the first hole, tap if desired, and place

screw without tightening completely. After

confirming proper plate positioning, drill,

tap if desired and place screws in all

remaining screw holes. Begin with the

lateral hole that is opposite and diagonal

to the first prepared hole.

Remove Temporary Fixation Pins and

perform final tightening of all screws in

the same sequence as mentioned above.

The Slim-loc™ System is provided with

self-tapping screws. Hence, tapping is not

always necessary. However, if tapping is

required to prepare the passage of the

screw, the Variable Depth Tap can be

adjusted in 1 mm increments to correspond

to the drill depth setting.

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12

SurgicalTechniqueSurgical

Technique

Locking all screws within the plate is the

last step in the plating procedure. All

screws should be secured to the vertebral

bodies as previously described before

beginning the cam locking procedure.

To lock the screw, engage the Cam-loc™

mechanism by fully seating the

Cam Tightener straight into the slot of the

cam. It is important to maintain a relatively

perpendicular orientation of the

Cam Tightener to the cam slot during the

entire locking procedure so as not to

inadvertently tear or strip the cam slot.

Additional exposure may be temporarily

required to properly align the Cam

Tightener with the cam. Rotate the Cam

Tightener clockwise, resistance will be felt

as the cam contacts the head of the screw.

Ensure you do not rotate the cam beyond

270 degrees (vertical slot).

Step 9: Locking the Cams

Note: Failure to maintain proper alignment of the Cam

Tightener may result in a stripped cam.

The Cam Tightener incorporates a torque

limiting feature (0.76 Nm or 6.7 in-lbs) that

will release when appropriate torque levels

are exceeded and the screw is locked into

place. If this occurs, an audible click will be

heard. For screw trajectories less than 16

degrees, a lock is obtained when the Cam

Tightener torque limiter releases (indicated

by the audible “click”) or when the cam is

positioned in the locking zone. For rostral

Open0°

LockAdvancing

90°

TypicalLocking Zone

180° 270°

Note: Exact position of a locked cam is dependent on a

number of factors and may vary within the typical locking

zone. Do not turn the cam past 270.˚

and caudal screw trajectories more than 16

degrees, the cam may not interfere with the

screw head and therefore the torque limiter

will not release. In this case, the cam

should be positioned within the locking

zone to provide screw backout resistance.

Bone GraftSolutions

“Shape memory” is retained in hydrated Healos® Bone Graft Replacement, resulting

in excellent porosity within the site.

Healos® Bone Graft Replacement, just prior tohydration with bone marrow aspirate.

Hydrated, compacted Healos®

Bone Graft Replacement.

• 3-Dimensional, osteoconductive matrix

constructed of cross-linked type 1

collagen fibres, coated with non-crystal

hydroxyapatite.

• Strong affinity for osteoprogenitor cell

attachment and an ideal environment for

the cellular proliferation needed in the

bone formation process.

• Structural integrity and 95% porosity:

3-D cross-linked structure provides

excellent strength and a “shape-

memory” effect, retaining its structural

integrity and porosity, even when

hydrated.

• Excellent graft handling characteristics:

Flexible, sponge-like strip moulds into

place for complete graft site coverage,

even in irregular or uneven surfaces.

• Conduit™ TCP Granules are made entirely of ß-TriCalcium Phosphate, the porous,

osteoconductive ceramic similar to the mineral constituents of natural bone (i.e. 70%).

• The partially connected pore structure of Conduit™ TCP Granules is well-suited for

cell-to-cell interaction, nutrition and vascularisation. Its high degree of surface area

provides a generous field for cellular attachment.

• 6-9 months resorption rate.

13

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Ordening Information

Notes

Catalogue No. Description Components

2761-01-005 ConduitTM TCP Granules 05 ml

2761-01-010 ConduitTM TCP Granules 10 ml

2761-01-015 ConduitTM TCP Granules 15 ml

2761-01-030 ConduitTM TCP Granules 30 ml

2761-60-002 Healos® Bone Graft Replacement 2.5 ml Strip

2761-60-005 Healos® Bone Graft Replacement 5 ml Strip

2761-60-010 Healos® Bone Graft Replacement 2 x 10 ml Strips

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Notes