Global Cup™ System - Global Orthopaedic Technology

Global Cup™ System
Surgical Technique
Contents
Introduction
2
Pre-operative Planning
3
3
Suggested Templating Method
Surgical Technique
4
Surgical Exposure
4
Acetabular Reaming
4
Acetabular Cup Trialling
5
Acetabular Cup Insertion
6
Acetabular Cup Screw Placement & Fixation
6
Acetabular Cup Trial Liner Evaluation
8
Acetabular Cup Dome Hole Cover Insertion
9
Acetabular Cup Liner Insertion
9
Poly Liner Insertion:
9
Ceramic Liner Insertion:
11
Final Assessment
12
Acetabular Cup Liner Removal
12
Ceramic Liner Removal:
12
Poly Liner Removal:
12
Implant Catalogue
13
Instrument Catalogue
15
XLPE Liner Specifications
17
A/Prof Michael J. Neil MBBS, FRCSEd(Orth), FRACS, FAOrthA
Dr Craig Waller MBBS, FRACS, FRCS(Ed)
Dr Simon Coffey MBBS (Hons), FRACS (Orth), FAOA
A/Prof Rami Sorial MBBS (Hons), FAOrthA, FRACS
Surgical Technique 1
Introduction
The Global Cup System is a cementless, press-fit, primary acetabular cup that is to be used in conjunction with a compatible
Surgical Technique
femoral head and femoral stem component. There are two primary cup options; a 3-hole and a multi-hole cup. The 3-hole acetabular
Globalthreaded
Cup System
cup includes
sector screw holes and a threaded dome hole for accurate insertion and placement of the implant into the
acetabulum. The multi-hole cup has an array of 6-12 non-threaded screw holes and a threaded dome hole.
Introduction
The Global Cup System utilises a hemispherical outer profile to the equator and a taper profile between the equator and the top
The Global Cup System is a cementless, press-fit, primary acetabular cup that is to be used in conjunction with a
face. On the inside of the cup a female taper is designed to engage multiple liner options, while a circumferential locking groove and
compatible
head and
femoral
stemfor
component.
There are
cupSystem
options;ranges
a 3-hole
andfrom
a multianti-rotation
featurefemoral
adds additional
locking
support
the polyethylene
liner.two
Theprimary
Global Cup
in size
44mm to
holeincreasing
cup. The incrementally
3-hole acetabular
cup manufactured
includes threaded
screw
and a threaded
domea hole
for accurate
68mm OD
by 2mm,
from sector
Titanium
alloy.holes
The surface
finish includes
Titanium
coating and a
composite
coating
of plasma
sprayed
Hydroxyapatite
the Titanium coating
to increase
the acetabulum
insertion
and
placement
of the
implant into over
the acetabulum.
The multi-hole
cuposseointegration
has an array of between
6-12 non-threaded
and the implant cup.
screw holes and a threaded dome hole.
The Global Cup System utilises a hemispherical outer profile to the equator and a taper profile between the
equator and the top face. On the inside of the cup a female taper is designed to engage multiple liner options,
while a circumferential locking groove and anti-rotation feature adds additional locking support for the
®
XLPE
XLPE
BIOLOX
delta
polyethylene
The Global
Cup Size
System ranges
in sizeInsert
from 44mm to
68mmInsert
OD increasing
incrementally
by
Group liner.Global
Cup
Neutral
Lipped
Insertand a
2mm, manufactured from Titanium alloy. The surface
finish includes a high
porosity Titanium coating
composite coating of plasma sprayed Hydroxyapatite over the high porosity Titanium coating to increase
osseointegration
between44-46
the acetabulum and28
the implant cup.
Grey
28
28
Table 1: Global Cup System Compatibility Table
Table 1: Global Cup System Compatibility Table
Orange
Blue
Purple
48-50
Group
Grey
Global Cup Size
52-54
48-50
28
52-54
28
32
36
Purple
56-58
28
32
36
40
Green
60-68
28
32
36
40
Blue
2 Global Cup
2™ System
60-68
Global Cup
Multi-Hole
Global Cup
Multi-Hole
32
32
36 40
32
28
28
36 40
28
Global Cup XLPE
Neutral
32
36
32
32
36
28
36 40
28
32
36 40
32
36
28
32
36
28
32
36
28
32
36
40
28
32
36
28
32
36
40
Global Cup XLPE
Neutral
Figure 1: Global Cup Primary System
Figure 1: Global Cup Primary System
Global Cup System
32
XLPE Insert
BIOLOX® delta Insert
Lipped
32 36
36
28
Global Cup 3-Hole
Global Cup
3-Hole
32
XLPE Insert
32 Neutral
36
44-46
56-58
Orange
Green
32
Global Cup XLPE
Lipped 15°
Global Cup XLPE
Lipped 15°
Global Cup
BIOLOX® delta
Global Cup
BIOLOX® delta
Global Cup System
Pre-operative Planning
Suggested Templating Method
Surgical Technique
A pre-operative assessment of Global
the acetabulum
is recommended to determine the appropriate size and position of the implant. Cup System
The templates are provided at 120% and 100% magnification for compatibility with standard radiographs.
Pre-Operative Planning
The Global Cup templates are positioned at 45 degrees and allow measurement for any hip that is suitable for the Global Cup System primary range from 44-68mm. The outline of the cup templates represents the porous coated diameter of the Global Cup. A peripheral dot and horizontal cut-out are located at the edges of the equator for marking, along with the head centres of the largest available head sizes.
Suggested Templating Method
A pre-operative assessment of the acetabulum is recommended to determine the appropriate size and
wi
radiographs.
To start, position the overlay over the A/P radiograph at approximately 45 degrees of abduction against the radiographic teardrop.
the implant.
templates are provided at 120% and 100% magnification for compatibility
It is recommended to use a radiographic
markerThe
or scale.
Determine the hip’s centre of rotation. Size the acetabular component using the appropriate templates. If medialising the acetabular
cup the native centre of rotation may be slightly different from the centre of rotation for the templated interface porous cup, place a
The Global Cup templates are positioned at 45 degrees and allow measurement for any
small mark on the radiograph at the centre of rotation of the selected porous cup.
hip that is suit
Global Cup System primary range from 44-68mm. The outline of the cup templates represents the po
diameter
the
GlobaltheCup.
dot andThe
horizontal
cut-out that
are appears
located at the edges of the
The objective is to determine the
templateof
that
provides
bestA
fitperipheral
and bony coverage.
largest component
suitable is to be chosen.
marking, along with the head centres of the largest available head sizes.
Note: The final component size is to be determined intra-operatively. Templating is for planning purposes only.
To start, position the overlay ove
radiograph at approximately 45 d
abduction against the radiographic tea
recommended to use a radiographic
scale.
Determine the hip’s centre of rotatio
acetabular component using the a
templates. If medialising the acetabu
native centre of rotation may be slight
from the centre of rotation for the
interface porous cup, place a small m
radiograph at the centre of rotati
selected porous cup.
The objective is to determine the te
provides the best fit and bony co
largest component that appears suita
chosen.
Note: The final component size
determined intra-operatively. Templ
planning purposes only.
Figure 2: Global Cup acetabular templating system.
Figure 2: Global Cup acetabular templating System
Surgical Technique 3
Surgical Technique
Global Cup System
Surgical Technique
Surgical
Technique
Surgical
Exposure
Surgical Exposure
The approach to the hip is the surgeon’s choice; it varies and is influenced to a degree by the pathology present.
The approach to the hip is the surgeon’s choice; it varies and is influenced to a degree by the pathology present. The Global Cup can
The
Global
Cup
canease
be using
inserted
with equal
ease using
a posterior,
posterolateral,
anterolateral,
straight lateral or
be
inserted
with
equal
a posterior,
posterolateral,
anterolateral,
straight
lateral or transtrochanteric
approach.
transtrochanteric approach.
Acetabular Reaming
Acetabular Reaming
Figure
Attach
reamer
to acetabular
reamer
connect
Figure 3:3:Attach
reamer
to acetabular
reamer
quickquick
connect
handle.handle
Figure
Acetabular
reaming
Figure 4:4:Acetabular
reaming.
Note:
The acetabular
reamerreamer
and Global
are “True
For aSizing”.
52mm Cup
to 51mm
a 1mm
press-fit.
Note:
The acetabular
andCup
Global
CupSizing”.
are “True
For ream
a 52mm
Cupfor
ream
to 51mm
for a 1mm press-fit.
The acetabular reamers and definitive cup implants are marked with the true size and measure 180 degrees. For a 52mm cup ream
toThe
51mm
for a 1mm reamers
press-fit. The
are available
40mm
to 68mm
in 1mm
acetabular
andacetabular
definitivereamers
cup implants
are from
marked
with
the true
size increments.
and measure 180 degrees. For
a
52mm
reamsize
to 51mm
for progress
a 1mm press-fit.
acetabular
reamersbleeding
are available
frombone,
40mm
to 68mm
in 1mm
Start
withcup
a smaller
reamer and
to the nextThe
largest
size until exposing
cancellous
reaming
a continuous
surface.
Take care to centre the reamer and apply a constant pressure in the recommended final implant orientation of 45 degrees increments.
of abduction and 20 degrees of anteversion.
Start with a smaller size reamer and progress to the next largest size until exposing bleeding cancellous bone,
reaming a continuous surface. Take care to centre the reamer and apply a constant pressure in the recommended
final implant orientation of 45 degrees of abduction and 20 degrees of anteversion.
4
4 Global Cup™ System
Global Cup System
Global Cup System
Surgical Technique
Global Cup System
Acetabular
CupTrialling
Trialling
Acetabular Cup
Figure
Cuptrialling.
trialling
Figure 5:5:Cup
TrialCup
Cup Sizes
Trial
Sizes
Group
Group
Shell Size
Size
Shell
Grey
Grey
44-46
44-46
Orange
Orange
48-50
48-50
Blue
Blue
52-54
52-54
Purple
Purple
56-58
56-58
Green
Green
60-68
60-68
Trial
areare
available
to assess
the bone
quality
the reamed
acetabulum
to
Trialcups
cups
available
to assess
the
boneofquality
of the
reamedand
acetabulum
determine the appropriate implant size. Trial cups are 1mm undersized from the marked
and(e.g.
to determine
implant size. Trial cups are 1mm undersized
size
a 52mm trialthe
cupappropriate
is 51mm in diameter).
from the marked size (e.g. a 52mm trial cup is 51mm in diameter).
While holding the cup impactor screw the trial cup onto the impactor shaft through
the threaded hole, until the impactor sleeve has bottomed out and the trial is secure.
While holding the cup impactor screw the trial cup onto the impactor shaft
through the
threadedguide
hole,onto
untilthe
the
impactor
has bottomed
out
Assemble
the alignment
cup
impactorsleeve
by inserting
the shaft into
theand the
alignment
tower
on
the
impactor
until
you
hear
a
click
and
the
alignment
guide
does
trial is secure.
not pull out. The alignment tower can be rotated by loosening the knob and then retightened once in position.
Assemble the alignment guide onto the cup impactor by inserting the shaft into
the alignment tower on the impactor until you hear a click and the alignment
guide does not pull out. The alignment tower can be rotated by loosening the
knob and then retightened once in position.
Orientate
the trial
in an cup
anatomic
approximately
Orientate
the cup
trial
in position
an anatomic
position
45 degrees of abduction and 20 degrees of anteversion and impact
approximately
45 degrees
of abduction
and 20 seated
degrees
the
handle with a mallet.
Verify that
the trial has properly
by
throughand
the cut-outs
the trial
and confirm
of sighting
anteversion
impactinthe
handle
with afit.mallet.
Verify that the trial has properly seated by sighting
through the cut-outs in the trial and confirm fit.
Note: The trial cup is not to be used with the trial liners.
Note: The trial cup is not to be used with the trial liners.
Figure
6: 6:
Adjusting
tower
Figure
Adjustingalignment
alignment tower.
Global Cup System
5
Surgical Technique 5
SurgicalTechnique
Technique
Surgical
GlobalCup
CupSystem
System
Global
Acetabular
CupInsertion
Insertion
AcetabularCup
Cup
Acetabular
Insertion
Both
3-Hole
and and
Multi-Hole
primaryprimary
cups
Boththe
the
3-Hole
Multi-Hole
Both
3-Hole
andthe
Multi-Hole
primary
can bethe
implanted
using
same surgical
cups can
can be
be implanted
implanted using
using the
the same
same
technique.
cups
surgicaltechnique.
technique.
surgical
Secure the cup implant onto the cup impactor
by threading the shaft of the impactor into Secure the cup
cup implant onto
onto the cup
cup
Secure
the apicalthe
hole of theimplant
cup. Ensure thatthe
the impactorsleeve
by threading
threading
the
shaft ofof
the
impaction
is flush with
theshaft
internal
radius
impactor
by
the
the
of
the
cup.
Take
care
when
threading
the
cup
impactorinto
intothe
theapical
apicalhole
holeofofthe
thecup.
cup.
impactor
onto the impactor as excessive force may cause
Ensure to
that
the
impactionsleeve
sleeveisisflush
flush
Ensure
the
impaction
damagethat
the
thread.
Figure7:
Threadcup
cuponto
onto
impactor.
Figure
Thread
cup
onto
impactor
Figure
7:7:Thread
impactor.
Figure8:8:
8:Orientate
Orientate
the
cup
into
the
Figure
the
cup
into
the
Figure
Orientate
the
cup
into
anatomical
position.
theanatomical
anatomical
position
position.
..
: :. .
..
withthe
theinternal
internalradius
radiusofofthe
thecup.
cup.Take
Take
with
Orientate the cup in the acetabulum using the
care when
when threading
threading the cup
cup onto
onto the
the
care
alignment
guide and bonythe
landmarks.
Confirm
impactor
force
may
the
placement
ofexcessive
the cup and
impact
thecause
cause
impactor
asas excessive
force
may
implant
into
position.
damage
to
the
thread.
damage to the thread.
Additional impaction may be required, confirm
Orientate the
the
cup ininthrough
the acetabulum
acetabulum
Orientate
the
proper seating
by cup
sighting
the apical
using
the
alignment
guide
and
bony
hole.
The
required
impaction
force
is
dictated
using the alignment guide and
bony
by
the quality Confirm
of the bone.
landmarks.
the
placement
of
the
landmarks. Confirm the placement of the
cupand
andimpact
impact
theimplant
implant
into
position.
Take
care
when
repositioning
the
cup,position.
do not
cup
the
into
lever on the impactor or cup as this may cause
damage
to theimpaction
internal diameter
of
cup and
Additional
may be
bethe
required,
Additional
impaction
may
required,
threads.
confirm proper
proper seating
seating by
by sighting
sighting
confirm
through
the
apical
hole.
The
required
through the apical hole. The required
impactionforce
forceisisdictated
dictatedby
bythe
thequality
quality
impaction
thebone.
bone.
ofofthe
Figure9:9:Cup
Cupinsertion.
insertion.
Figure
Figure 9: Cup insertion
Takecare
carewhen
whenrepositioning
repositioningthe
the
cup,do
donot
notlever
leveron
onthe
theimpactor
impactorororcup
cupasasthis
thismay
maycause
causedamage
damagetotothe
the
: :. . cup,
Take
internaldiameter
diameterofofthe
thecup
cupand
andthreads.
threads.
internal
..
Acetabular
Cup
Screw
Placement
& Fixation
AcetabularCup
Cup
Screw
Placement
Fixation
Acetabular
Screw
Placement
&&Fixation
TheGlobal
Global
Cup
3-Hole
packaged
withpre-installed
pre-installed
screw-hole
covers
whichcan
can
beadditional
removed
when
additional
The
Cup
3-Hole
is packaged
with pre-installed
screw-holescrew-hole
covers whichcovers
can bewhich
removed
when
screw
fixation
is
The
Global
Cup
3-Hole
isispackaged
with
be
removed
when
additional
required.
The Global
Cup Multi-Hole
does
notCup
utilize
screw-holedoes
covers.
screw
fixation
is
required.
The
Global
Multi-Hole
not
utilize
screw-hole
covers.
screw fixation is required. The Global Cup Multi-Hole does not utilize screw-hole covers.
Figure10:
10:Removal
Removalofofscrew-hole
screw-holecovers
coversfrom
fromthe
theGlobal
GlobalCup.
Cup.
Figure
Figure 10: Removal of screw-hole covers from the Global Cup
Toremove
removethe
thescrew-hole
screw-holecovers
coversfrom
fromthe
theacetabular
acetabularcup,
cup,attach
attachthe
the3.5mm
3.5mmhex
hexscrewdriver
screwdrivershaft
shafttotothe
theratchet
ratchet
To
To
remove
the
screw-hole
covers
from
the
acetabular
cup,
attach
the
3.5mm
hex
screwdriver
shaft
to
the
ratchet
handle.
handle.Unscrew
Unscrewthe
theappropriate
appropriatescrew-hole
screw-holecover
coverasasneeded.
needed.
handle.
Unscrew the appropriate screw-hole cover as needed.
6
6 Cup™ System
6 Global
GlobalCup
CupSystem
System
Global
GlobalCup
CupSystem
System
Global
Surgical
Technique
Surgical
Surgical
Technique
Technique
Cup
GlobalGlobal
Global
Cup System
CupSystem
System
Safe
Safe Quadrant
SafeQuadrant
Quadrant
Figure
11:
Recommended
placement
ofofthe
bone
screw.
Figure
12:
screw-hole
preparation.
11:
placement
of
the
bone
screw Figure 12:
Figure
12:Acetabular
Acetabular
screw-hole
preparation
Figure Figure
11:
Figure
Recommended
11:Recommended
Recommended
placement
placement
of the bone
the
screw.
bone
screw.
Figure
Acetabular
12:
Acetabular
screw-hole
screw-hole
preparation.
preparation.
To
the
bone
screw
for
drill
aahole
pilot
hole
using
the
drill
3.2mm
drill
and
drill
shaft.
Toprepare
prepare
the
bone
screw
for
insertion,
drill aapilot
using
the drill
guide,
3.2mm
drill
and
flexible
drill
shaft.
The
3.2mm
diameter
To prepare
To
prepare
the bone
the
screw
bone
for
screw
insertion,
forinsertion,
insertion,
drill
pilot
drillhole
pilot
using
hole
the
using
drill
the
guide,
drillguide,
3.2mm
guide,
3.2mm
drill and
drill
flexible
andflexible
flexible
drill
shaft.
drill
shaft.
drill is available in a length of 50mm and 70mm. Ensure that the drill guide is fully inserted into the screw-hole. Approximately 15
The
3.2mm
diameter
drill
is
available
in
a
length
of
50mm
and
70mm.
Ensure
that
the
drill
guide
is
fully
inserted
The 3.2mm
The
3.2mm
diameter
diameter
drill
is available
drill
is available
in awith
length
in
length
of guide
50mm
ofand
50mm
and
70mm.
and 70mm.
Ensure
that
the
that
drill
the
guide
drill
isguide
fully
isinserted
fully
degrees
of range
of motion
is available
theadrill
bone
screws
(FigureEnsure
14). Ensure
that
the
screw
lies within
theinserted
safe
into
the
screw-hole.
Approximately
15
degrees
of
range
of
motion
is
available
with
the
drill
guide
and
bone
quadrant,
refer to
FigureApproximately
11 (Wasielewski
et
1990).
into theinto
screw-hole.
the screw-hole.
Approximately
15 degrees
15al.,degrees
of range
ofof
range
motion
of motion
is available
is available
with the
with
drillthe
guide
drilland
guide
bone
andscrews
bonescrews
screws
(Figure
14).
Ensure
that
the
screw
lies
within
the
safe
quadrant,
refer
to
Figure
11
(Wasielewski
et
al.,
1990).
(Figure(Figure
14). Ensure
14). Ensure
that thethat
screw
thelies
screw
within
lies the
within
safethe
quadrant,
safe quadrant,
refer torefer
Figure
to 11
Figure
(Wasielewski
11 (Wasielewski
et al., 1990).
et al., 1990).
Figure
13:
Verify screw-hole
depth
Figure
13:
Verify
Figure 13:
Figure
Verify
13:
screw-hole
Verifyscrew-hole
screw-hole
depth. depth.
depth.
Figure
14:
Global
Cup6.5mm
6.5mm
cancellous
bone screw
Figure
14:
Global
Cup
bone
Figure 14:
Figure
Global
14:Cup
Global
6.5mm
Cupcancellous
6.5mmcancellous
cancellous
bone screw.
bonescrew.
screw.
Verify
the
of the
screw-hole
using
depth
gauge.
Select
the appropriate
length
Global
Cup 6.5mm
cancellous
bone6.5mm
screw
the
depth
ofof
the
using
the
depth
gauge.
Select
the
appropriate
length
Global
Cup
Verify Verify
Verify
the
depth
thedepth
depth
of the
screw-hole
the screw-hole
screw-hole
usingthe
the
using
depth
the
depth
gauge.
gauge.
Select
Select
the appropriate
the
appropriate
length
length
Global
Global
Cup 6.5mm
Cup
6.5mm
and while holding the bone screw with the screw forceps use the 3.5mm hex universal joint screwdriver shaft with ratchet handle to
cancellous
bone
screw
and
while
the
bone
with
the
use
the
hex
cancellous
cancellous
bone
screw
bone
and
screw
while
and
whileholding
holding
the bone
thescrew
bonescrew
with
screw
the
with
screw
thescrew
forceps
screwforceps
forceps
use the
use
3.5mm
the3.5mm
3.5mm
hex universal
hexuniversal
universal
joint joint
joint
insert
the bone
screw
into
the holding
acetabulum.
screwdriver
shaft
with
ratchet
handle
to
insert
the
bone
screw
into
the
acetabulum.
screwdriver
screwdriver
shaft with
shaft
ratchet
with ratchet
handle handle
to insert
tothe
insert
bone
thescrew
boneinto
screw
theinto
acetabulum.
the acetabulum.
Cup
GlobalGlobal
Global
Cup System
CupSystem
System
7
77
Surgical Technique 7
mm
mm
mm
mm
Surgical Technique
Global Cup System
Surgical Technique
During insertion
evaluate
the quality of the bone when tightening. After tightening verify that the screw head is
Global Cup
System
below
theinsertion
inner evaluate
diameter
the of
cup,
cantightening
prevent verify
the liner
from
seating
the
During
theof
quality
the incorrect
bone whenplacement
tightening. After
that the
screw
head isproperly
below the in
inner
During
insertion
evaluate
thecan
quality
ofthe
the
bone
when
tightening.
After
tightening
verify that the screw head is
diameter
of
the
cup,
incorrect
placement
prevent
liner
from
seating
properly
in
the
acetabular
cup.
acetabular cup.
below the inner diameter of the cup, incorrect placement can prevent the liner from seating properly in the
acetabular cup.
Figure
15: 15:
Bone
screw
verifyproper
properseating
seating
after
insertion
(right)
Figure
Bone
screwinsertion
insertion(left),
(left), verify
after
insertion
(right).
Figure 15: Bone screw insertion (left), verify proper seating after insertion (right).
Acetabular Cup Trial Liner Evaluation
Acetabular
Cup
Trial
Liner Evaluation
Provisional
acetabular
liners
are available
to trial in the definitive cup implant. The trial liners are not to be used in
Acetabular Cup Trial Liner Evaluation
conjunction
with
the trial
cups as final to
seating
of the cup implant
mayThe
vary.
The
trial
liners
areused
available
in neutral
Provisional
acetabularacetabular
liners are available
in the definitive
implant.
trial
liners
are not The
to betrial
in conjunction
Provisional
liners aretrial
available
to trialcup
in the
definitive
cup
implant.
liners
are not with
to be used in
andthe
lipped
in the
listed of
in the
Table
trial cups
as sizes
final seating
cup2.
implant may vary. The trial liners are available in neutral and lipped in the sizes listed in
Table 2. conjunction with the trial cups as final seating of the cup implant may vary. The trial liners are available in neutral
Table 2: Trialand
Linerlipped
Size Availability
in the sizes listed in Table 2.
Table 2: Trial Liner Size Availability
Table 2: Trial Liner Size Availability
Global Cup Trial Liner Neutral
Global Cup Trial Liner Lipped Group
Head
Size
Group
Head
Size
Global
Lipped
GlobalCup
CupTrial
TrialLiner
Liner
Neutral
Global Cup Trial Liner
Lipped
Global
Cup
Trial
Liner
Neutral
Global
Cup
Trial
Liner
Group
Group
Head
Group
Head
Size
Grey
28mmSize
Grey
28mmLipped
Group 28mm
Head Size
Group
Head Size
Orange
32mm
Orange
32mm
Grey
Grey
28mm
Grey
28mm
Grey
28mm
Grey
Blue
32mm
36mm
Blue
36mm
Orange
Orange
28mm32mm
32mm
Orange
32mm 28mm
Orange
28mm
32mm
Orange
32mm
Purple
36mm
40mm
Purple
36mm
Blue
Blue
32mm36mm
36mm
Blue
36mm
Blue
32mm
36mm
Blue
36mm
Green
36mm
40mm
Green
36mm
Purple
Purple
36mm36mm
40mm
Purple
36mm
Purple
36mm
40mm
Purple
36mm
Green
Green
36mm36mm40mm
Green
36mm
Green
36mm
40mm
Green
36mm
Remove
any debris from inside of the cup before inserting
theRemove
trial liner.
Insertfrom
theinside
trial of
into
implant
bythe
hand.
any debris
thethe
cupcup
before
inserting
trial liner.
Remove
anycup
debris
from
insideThread
of the
cup
before
inserting
Insert
the
trial
into
the
implant
by
hand.
the
trial
liner
into the
Thread the trial liner into the dome hole of the cup implant
dome hole
the cup
implant
using
3.5mm
hexthe
driver
shaft
and ratchet
theoftrial
liner.
Insert
thea trial
into
cup
implant
by hand.
using
a 3.5mm
shaft and
ratchet
handle
the
handle
until thehex
trialdriver
liner bottoms
out on
the internal
cupuntil
radius.
The liner
Thread the trial liner into the dome hole of the cup implant
should
flush without
theon
topthe
surface
of the cup
cup implant.
trial
linerbebottoms
internal
radius. The liner
using a 3.5mm hex driver shaft and ratchet handle until the
should be flush with the top surface of the cup implant.
Assess the
cupliner
implant
stability,out
position
andinternal
range of cup
motion
with the
trial
bottoms
on the
radius.
The liner
femoral components. Once the appropriate liner selection has been made,
should
be
flush with
the top
surface and
of therange
cup implant.
Assess
the
cup
implant
stability,
position
of
remove
the
trial liner.
motion with the femoral components. Once the appropriate
thethecup
stability,
position and range of
Note: DoAssess
not impact
trial implant
liner as damage
may occur.
liner selection has been made, remove the trial liner.
motion with the femoral components. Once the appropriate
linerimpact
selection
remove
theoccur.
trial liner.
Figure 16: Trial liner insertion.
Note: Do not
thehas
trialbeen
linermade,
as damage
may
8
Global Cup
System
Note: Do not impact the trial liner as damage
may
occur.
8
8 Global Cup™ System
Global Cup System
Figure
16:16:
Trial
insertion
Global
Cup System
Figure
TrialLiner
liner
insertion.
Global Cup System
Surgical Technique
Global Cup System
Acetabular
Cup
Dome
Hole
Cover
Insertion
Acetabular Cup
Dome
Hole
Cover
Insertion
Uponcompletion
completion of
trialtrial
evaluation,
insert the
dome-hole
cover into the
Upon
ofthe
the
evaluation,
insert
the dome-hole
cover
threaded
dome
hole
of
the
cup
implant
using
the
3.5mm
hex
screwdriver
into the threaded dome hole of the cup implant using the 3.5mmshaft
hex
and ratchet handle. Use care to ensure that the dome-hole cover is not over
screwdriver
shaft
and
ratchet
handle.
Use
care
to
ensure
that
the
tightened and that the dome hole is below the internal radius of the cup.
dome-hole cover is not over tightened and that the dome hole is below
the internal radius of the cup.
Acetabular Cup Liner Insertion
Acetabular
Cup
Insertion
Prior to inserting
the Liner
acetabular
liner into the cup implant, ensure that the Figure
17: Dome-hole
Dome-holecover
cover
insertion
Figure 17:
insertion.
internal surfaces of the cup implant are free from any debris and are cleaned Prior
to inserting the acetabular liner into the cup implant, ensure that
and dried. Inspect the internal taper of the cup implant and check that all thescrew-hole
internal covers,
surfaces
of the cover
cup implant
are
freeare
from
any debrisinto
and
dome-hole
and screw
heads
not protruding
the
internal
radius.
It
is
important
to
ensure
that
the
locking
groove
and
the
are cleaned and dried. Inspect the internal taper of the cup implant
entire internal surface of the cup implant is free from debris.
and check that all screw-hole covers, dome-hole cover and screw
heads are not protruding into the internal radius. It is important to
ensure that the locking groove and the entire internal surface of the
cup implant is free from debris.
Poly Liner
Poly
LinerInsertion:
Insertion
Figure
18: Depress
suctioncup
cupinto
into the
the poly
Figure
18: Depress
thethe
suction
poly liner
liner.
Note:
Note: Do
Donot
notimpact
impactthe
theliner
liner
inserter
instrument.
inserter instrument.
Figure
Figure20:
20:Poly
Poly liner
liner insertion
insertion.
Figure 19: Place poly liner into the acetabulum.
Figure 19: Place poly liner into the acetabulum
Place
polyethylene
liner liner
into the
acetabular
cup either
by either
hand orby
with
the liner
inserter
If using
the liner inserter,
Placethe
the
polyethylene
into
the acetabular
cup
hand
or with
theinstrument.
liner inserter
instrument.
If using
engage the liner by depressing the suction cup into the liner. Water or saline may be used to lubricate the suction cup for assistance
the
liner
inserter,
engage
the
liner
by
depressing
the
suction
cup
into
the
liner.
Water
or
saline
may
be
used
to
with assembly and dis-assembly. Remove the liner inserter suction cup by placing one hand on the liner rim and cup face and pulling
lubricate
the
suction
cup
for
assistance
with
assembly
and
dis-assembly.
Remove
the
liner
inserter
suction
cup
by
up on the suction cup.
placing one hand on the liner rim and cup face and pulling up on the suction cup.
Select the appropriate liner impactor adapter that corresponds with the implant liner head size. There are four available liner impactor adapters: 28mm, 32mm, 36mm and 40mm.
Select the appropriate liner impactor adapter that corresponds with the implant liner head size. There are four
available liner impactor adapters: 28mm, 32mm, 36mm and 40mm.
Global Cup System
9
Surgical Technique 9
Surgical Technique
Global Cup System
Figure 21: Assembly
Assembly ofofthe
polyethylene
linerliner
and and
cup implants.
Figure
the
polyethylene
cup implants
Before
liner
impaction,
the polyethylene
liner will extend
the top face
of the
cup
implant.
selected
liner impactor
Before
liner
impaction,
the polyethylene
liner above
will extend
above
the
top
face Thread
of thethe
cup
implant.
Thread the
adapter onto the liner impactor instrument. Place the impactor adapter into the liner and impact until the liner is fully seated.
selected liner impactor adapter onto the liner impactor instrument. Place the impactor adapter into the liner and
Take care to align the impacter and impact the liner directly into the cup.
impact until the liner is fully seated. Take care to align the impacter and impact the liner directly into the cup.
Figure 22: Poly liner impaction.
Figure 22: Poly liner impaction
Verify
that
thethe
linerliner
is fully
and thatand
the that
rim isthe
flushrim
with
topwith
face of
cupface
by running
finger
theatop
surface.
Verify
that
isseated
fully seated
isthe
flush
thethetop
of the acup
by around
running
finger
around
Additional impactions may be required if the liner has not fully seated.
the top surface. Additional impactions may be required if the liner has not fully seated.
10
10 Global Cup™ System
Global Cup System
Global Cup System
Surgical Technique
Global Cup System
Ceramic
LinerInsertion:
Insertion
Ceramic Liner
Placethethe
ceramic
into
the acetabular
either
by hand
orinserter
with the
liner inserter
instrument.
If engage
using the
Place
ceramic
liner liner
into the
acetabular
cup eithercup
by hand
or with
the liner
instrument.
If using the
liner inserter,
liner
engage
the liner
theor suction
cup
into tothe
liner. the
Water
orcup
saline
may be with
used to
the
linerinserter,
by depressing
the suction
cup by
intodepressing
the liner. Water
saline may
be used
lubricate
suction
for assistance
dis-assembly.
Remove
the liner inserter
suction cupand
by placing
one handRemove
on the liner
rimliner
and cup
face and
pulling
up by
assembly
lubricateand
the
suction cup
for assistance
with assembly
dis-assembly.
the
inserter
suction
cup
on
the
suction
cup.
placing one hand on the liner rim and cup face and pulling up on the suction cup.
Note:
impact the
theliner
liner
Note: Do
Do not
not impact
inserter instrument.
inserter
instrument.
Figure 23:
23: Ceramic
Ceramic liner
Figure
linerinsertion.
insertion
Select
appropriate
liner impactor
adapter that
corresponds
with the implant
liner
head
size. There
four available
liner are four
Selectthethe
appropriate
liner impactor
adapter
that corresponds
with
the
implant
linerarehead
size. There
impactor
adapters:
28mm, 32mm,
36mm28mm,
and 40mm.
Before
liner impaction,
verify
that the
ceramic
liner is uniformily
seated
available
liner impactor
adapters:
32mm,
36mm
and 40mm.
Before
liner
impaction,
verify that
the relative
ceramic
to the top face of the cup implant. Eccentric placement may cause improper seating and subsequent ceramic fracture.
liner is uniformily seated relative to the top face of the cup implant. Eccentric placement may cause improper
seating and subsequent ceramic fracture.
Figure
linerimpaction.
impaction
Figure24:
24: Ceramic
Ceramic liner
Thread
the
selected
linerliner
impactor
adapter
onto theonto
liner impactor
Place the impactor
into the liner
and firmly
Thread
the
selected
impactor
adapter
the linerinstrument.
impactor instrument.
Placeadapter
the impactor
adapter
into the
strike with a mallet once to fully seat the liner. Verify that the liner is properly seated and flush with the top face of the cup.
liner and firmly strike with a mallet once to fully seat the liner. Verify that the liner is properly seated and flush with
the top face of the cup.
Global Cup System
11
Surgical Technique 11
Surgical Technique
Global Cup System
Final
FinalAssessment
Assessment
A final assessment should be completed to verify correct placement of the implant components. Assess range of
A final assessment should be completed to verify correct placement of the implant components. Assess range of motion, hip motion,
hip leg
stability
stability and
length.and leg length.
Acetabular
Cup
Liner
Removal
Acetabular
Cup
Liner
Removal
Should it become necessary to remove a liner from the acetabular cup, care should be taken not to damage the
Should it become necessary to remove a liner from the acetabular cup, care should be taken not to damage the cup.
cup.
Ceramic
Liner
Removal:
Ceramic
Liner
Removal
To remove the ceramic liner from the cup implant,
To remove the ceramic liner from the cup implant, position
position
ofremover
the liner
remover
in a dimple
the tip ofthe
thetip
liner
in a
dimple located
on the top
face of on
the the
cup.top
Apply
a few
shortcup.
mallet
blows,
until short
the located
face
of the
Apply
a few
liner is loosened from the taper.
mallet blows, until the liner is loosened from the
taper.
Note: Once a hard bearing insert has been used with the
cup implant, the cup should not be used with another hard
bearing
insert.
Note:
Once
a hard bearing insert has been used with
the cup implant, the cup should not be used with
another hard bearing insert.
FigureFigure
25: Position
the liner
tipliner
of
the
liner remover in a dimple located on the top face of the cup
Figure
25:
Ceramic
removal.
25:
Ceramic
removal.
Poly
Removal:
PolyLiner
Liner
Removal
To remove the polyethylene liner from the cup implant, drill a hole slightly off centre from the liner apex using the
To remove the polyethylene liner from the cup implant, drill a hole slightly off centre from the liner apex using the drill guide and
drill
guide
3.2mm
drill.forceps
Usingand
theascrew
and a 3.5mm
hexratchet
screwdriver
shaftawith
ratchet
handle,
insert
3.2mm
drill.and
Using
the screw
3.5mmforceps
hex screwdriver
shaft with
handle, insert
cancellous
screw
into the
pilot
hole
and
advance
the
screw
until
the
liner
disengages
from
the
cup.
a cancellous screw into the pilot hole and advance the screw until the liner disengages from the cup.
Figure 26:
Drill26:
a hole
centre
fromfrom
the liner
apex
(left)
and
advance
screwinto
intopoly
poly
liner
insert
(right)
Figure
Drill aoff
hole
off centre
the liner
apex
(left)
and
advancebone
bone screw
liner
insert
(right).
12
12 Global Cup™ System
Global Cup System
Global Cup System
Surgical Technique
Global Cup System
Surgical Technique
Global Cup System
Implant Catalogue
Implant
Catalogue
Implant Catalogue
Images included in the catalogue below are representative only, please contact your representative for the most current information
Global Cup 3-Hole Porous Coated + HA
Global Cup 3-Hole Porous Coated + HA
Global Cup Multi-Hole Porous Coated + HA
Global Cup Multi-Hole Porous Coated + HA
Global Cup XLPE Liner Neutral
Global Cup XLPE Liner Neutral
Global Cup System
Global Cup System
Catalogue Number
GM09002-211-44
Catalogue
Number
GM09002-211-46
GM09002-211-44
GM09002-211-48
GM09002-211-46
GM09002-211-50
GM09002-211-48
GM09002-211-52
GM09002-211-50
GM09002-211-54
GM09002-211-52
GM09002-211-56
GM09002-211-54
GM09002-211-58
GM09002-211-56
GM09002-211-60
GM09002-211-58
GM09002-211-62
GM09002-211-60
GM09002-211-64
GM09002-211-62
GM09002-211-66
GM09002-211-64
GM09002-211-68
GM09002-211-66
Catalogue
Number
GM09002-211-68
GM09002-212-44
Catalogue
Number
GM09002-212-46
GM09002-212-44
GM09002-212-48
GM09002-212-46
GM09002-212-50
GM09002-212-48
GM09002-212-52
GM09002-212-50
GM09002-212-54
GM09002-212-52
GM09002-212-56
GM09002-212-54
GM09002-212-58
GM09002-212-56
GM09002-212-60
GM09002-212-58
GM09002-212-62
GM09002-212-60
GM09002-212-64
GM09002-212-62
GM09002-212-66
GM09002-212-64
GM09002-212-68
GM09002-212-66
Catalogue
Number
GM09002-212-68
GM09002-207-01
Catalogue
Number
GM09002-207-02
GM09002-207-01
GM09002-207-03
GM09002-207-02
GM09002-207-03
GM09002-207-04
GM09002-207-03
GM09002-207-05
GM09002-207-05
GM09002-207-04
GM09002-207-06
GM09002-207-06
GM09002-207-05
GM09002-207-08
GM09002-207-07
GM09002-207-06
GM09002-207-09
GM09002-207-08
GM09002-207-07
GM09002-207-10
GM09002-207-09
GM09002-207-08
GM09002-207-12
GM09002-207-10
GM09002-207-09
GM09002-207-13
GM09002-207-11
GM09002-207-10
GM09002-207-14
GM09002-207-12
GM09002-207-11
GM09002-207-13
GM09002-207-12
GM09002-207-14
GM09002-207-13
GM09002-207-14
Size (mm)
44
Size46
(mm)
44
48
46
50
48
52
50
54
52
56
54
58
56
60
58
62
60
64
62
66
64
68
Size66
(mm)
68
44
Size46
(mm)
44
48
46
50
48
52
50
54
52
56
54
58
56
60
58
62
60
64
62
66
64
68
Head Size 66 Shell Size
68
(mm)
(mm)
Head
Shell
Size
28Size
44-46
(mm)
(mm)
28
48-50
28
44-46
32
28
32
48-50
28
48-50
32
32
52-54
52-54
28
36
36
32
52-54
28
36
56-58
32
56-58
28
40
36
32
40
56-58
36
60-68
28
40
32
60-68
28
36
32
40
60-68
36
40
13
13
Surgical Technique 13
Global Cup XLPE Liner Lipped
Catalogue Number
GM09002-208-01
GM09002-208-03
GM09002-208-05
GM09002-208-06
GM09002-208-08
GM09002-208-09
GM09002-208-11
GM09002-208-12
Global Cup Ceramic Liner
Catalogue Number
GM09002-204-01
GM09002-204-03
GM09002-204-06
GM09002-204-09
GM09002-204-10
GM09002-204-13
GM09002-204-14
Global Cup Bone Screw
Global Cup Dome Hole Cover
Global Cup Screw Hole Cover
14 Global Cup™ System
Head Size
(mm)
28
32
32
36
32
36
32
36
Head Size
(mm)
28
32
36
36
40
36
40
Shell Size
(mm)
44-46
48-50
52-54
56-58
60-68
Shell Size
(mm)
44-46
48-50
52-54
56-58
60-68
Catalogue Number
Size (mm)
GM09002-203-15
GM09002-203-20
GM09002-203-25
GM09002-203-30
GM09002-203-35
GM09002-203-40
GM09002-203-45
GM09002-203-50
15
20
25
30
35
40
45
50
Catalogue Number
Size (mm)
GM09002-201-00
N/A
Catalogue Number
Size (mm)
GM09002-202-00
N/A
Surgical Technique
Global Cup System
Instrument Catalogue
Surgical Technique
Global Cup System
Global Cup Instrument Box 1
Catalogue Number
Size (mm)
Instrument
Catalogue
Instrument Catalogue
Images included in the catalogue below are representative only, please contact your representative for the most current information
Global Cup Instrument Box 1
Catalogue
Number
GM09002-320-00
SizeN/A
(mm)
Global Cup Trial Cup
GM09002-320-00
Catalogue
Number
GM09002-305-44
GM09002-305-46
GM09002-305-48
GM09002-305-50
Catalogue Number
GM09002-305-52
GM09002-305-44
GM09002-305-54
GM09002-305-46
GM09002-305-56
GM09002-305-48
GM09002-305-58
GM09002-305-50
GM09002-305-60
GM09002-305-52
GM09002-305-62
GM09002-305-54
GM09002-305-64
GM09002-305-56
GM09002-305-66
GM09002-305-58
GM09002-305-68
GM09002-305-60
Catalogue Number
GM09002-305-62
GM09002-305-64
GM09002-303-00
GM09002-305-66
GM09002-305-68
Catalogue
Catalogue Number
Number
SizeN/A
(mm)
44
46
48
50
Size (mm)
52
44
54
46
56
48
58
50
60
52
62
54
64
56
66
58
68
60
Size (mm)
62
64
N/A
66
68
Size
Size (mm)
(mm)
GM09002-323-00
GM09002-303-00
N/A
Catalogue Number
Size (mm)
GM09002-323-00
GM09002-304-00
N/A
N/A
Catalogue Number
Catalogue Number
Size (mm)
Size (mm)
GM09002-317-00
GM09002-304-00
N/A
Catalogue Number
Catalogue
Number
GM09002-318-00
GM09002-318-01
GM09002-317-00
GM09002-318-02
GM09002-318-03
Catalogue
Number
Size (mm)
Size28
(mm)
32
N/A
36
Size40
(mm)
GM09002-318-00
GM09002-318-01
GM09002-318-02
GM09002-318-03
28
32
36
40
Global Cup Trial Cup
Global Cup Straight Cup Impactor
Global Cup
Cup Straight
Curved Cup
Global
Cup Impactor
Impactor
Global
Cup
Curved
Cup Impactor
Global
Cup
Alignment
Guide
Global Cup Alignment Guide
Global Cup Liner Impactor
Global Cup Liner Impactor Adapter
Global Cup Liner Impactor
Global Cup Liner Impactor Adapter
Global Cup System
Global Cup System
15
15
Surgical Technique 15
Surgical Technique
Global Cup System
Global Cup Liner Inserter
Global Cup Instrument Box 2
Global Cup Liner Remover
Catalogue Number
Size (mm)
GM09002-316-00
N/A
Catalogue Number
Size (mm)
GM09002-321-00
GM09002-320-00
N/A
Catalogue Number
Size (mm)
GM09002-319-00
N/A
Global Cup Trial Liner Lipped
Catalogue Number
Global Cup Ratchet Handle
GM09002-307-00
GM09002-307-01
GM09002-307-02
GM09002-307-02
GM09002-307-04
GM09002-307-04
GM09002-307-05
GM09002-307-05
GM09002-307-07
GM09002-307-07
GM09002-307-08
GM09002-307-08
GM09002-307-10
GM09002-306-10
GM09002-307-10
GM09002-307-11
GM09002-306-11
Catalogue Number
Head Size
Shell Size
(mm)
(mm)
28
44-46
28
32
48-50
48-50
32
32
52-54
32
36
52-54
36
36
36
56-58
56-58
40
40
36
36
60-68
40
Head Size
Shell Size
(mm)
(mm)
28
44-46
28
32
48-50
48-50
32
32
52-54
32
36
52-54
36
32
32
56-58
56-58
36
36
32
32
60-68
36
Size (mm)
GM09002-315-00
N/A
Catalogue Number
Size (mm)
GM09002-314-00
N/A
Global Cup Trial Liner Neutral
Catalogue Number
GM09002-306-00
GM09002-306-01
GM09002-306-02
GM09002-306-02
GM09002-306-04
GM09002-306-04
GM09002-306-04
GM09002-306-05
GM09002-306-05
GM09002-306-08
GM09002-306-08
GM09002-306-09
GM09002-306-09
GM09002-306-12
GM09002-306-12
GM09002-306-13
Global Cup 3.5mm Hex UJ Driver Shaft
16
16 Global Cup™ System
Global Cup System
Global Cup System
Surgical Technique
Global Cup System
Global Cup 3.5mm Hex Driver Shaft
Global Cup Flexible Drill Shaft
Global Cup Screw Forceps
Catalogue Number
Size (mm)
GM09002-313-00
N/A
Catalogue Number
GM09002-308-00
GM09002-308-00
or SGM09002-308-00
Catalogue Number
Size (mm)
GM09002-312-00
N/A
Catalogue Number
GM09002-309-02
Size (mm)
GM09002-309-04
Catalogue Number
70
Size (mm)
GM09002-310-00
3.2
Catalogue Number
Size (mm)
GM09002-311-00
N/A
Global Cup Bayonet Drill 3.2mm
Global Cup Drill Guide 3.2mm
Global Cup Depth Gauge
N/A
Size (mm)
50
XLPE Liner
Specifications
XLPE
Liner
Specifications
XLPE
XLPE
XLPE Liner XLPE XLPE Liner
XLPE XLPE Global XLPE XLPE Liner
Global Liner
Liner
Liner thickness
Global
Cup
Size
Liner Liner Cup Liner thickness
Head Size
Cup (DIM A) thickness (DIM B)
thickness
thickness Size thickness Head Size
Head Size (DIM
28mmSize 44-46
5.4 (DIM B) 5.8
(DIM A) (DIM B) A)
28mm
44-46
5.60
6.02
48-50
7.0
28mm 28mm44-­‐46 5.5 5.9 6.3
28mm
48-50
6.51
7.16
52-54
9.2
28mm 28mm48-­‐50 6.4 7.1 8.6
Surgical Technique
28mm
52-54
8.75
9.42
28mm 28mm52-­‐54 8.7 9.4 56-58
10.6
11.0
28mm 10.7 56-58 11.2 10.75
11.24
Global Cup System
28mm 28mm56-­‐58 60-68
12.5
13.0
28mm
60-68
12.72
13.15
28mm 60-­‐68 12.6 13.1 Head Size: 28mm-40mm
32mm
5.6
Head Size: 28mm-­‐40mm 32mm 48-50
48-50
5.515.3
5.85
32mm 48-­‐50 5.4 5.8 32mm 32mm 52-54
7.2
52-54
6.756.5
7.42
32mm 52-­‐54 6.7 7.4 32mm 56-58
56-58
8.758.5
9.22
32mm
9.0
32mm 56-­‐58 8.7 9.2 32mm
60-68
10.72
11.15
60-68
10.9
32mm 32mm60-­‐68 10.6 11.1 10.5
36mm
52-54
5.75
6.11
52-54
5.9
36mm 36mm52-­‐54 5.7 6.0 5.5
36mm
56-58
7.75
7.91
36mm 36mm56-­‐58 7.7 7.8 7.5
56-58
7.7
36mm
60-68
9.72
9.84
36mm 36mm60-­‐68 9.6 9.8 60-68
9.5
9.6
40mm
56-58
7.75
7.38
7.7 7.3 Head Size: 28mm-36mm40mm 40mm56-­‐58 56-58
7.5
7.0
Head Size: 28mm-­‐36mm 40mm
60-68
9.72
9.31
40mm 60-­‐68 9.6 9.2 40mm
60-68
9.5
8.9
References:
1. Wasielewski R, Cooperstein L, Rubash H. Acetabular anatomy
and the transacetabular fixation of screws in total hip arthroplasty.
J Bone Joint Surg Am. 1990; 72: 501-508.
Global Cup System
17
Surgical Technique 17
Global Orthopaedic Technology
Unit 10, 7 Meridian Place
Norwest Business Park
Baulkham Hills NSW 2153 Australia
PO Box 7745
Baulkham Hills BC NSW 2153 Australia
Toll Free: 1800 456 225
Phone: 02 8887 0100
Fax: 02 8887 0199
[email protected]
globalortho.com.au
Manufactured by
Global Manufacturing Technology Europe Ltd
15 Rudchesters, Bancroft, Milton Keynes
MK13 OPH, United Kingdom
GM09002-501 Global Cup Surgical Technique REV 6