Surgical Technique Guide

TM
Surgical
Technique
Guide
Unabridged Version
Table of Contents
Clavicle Anatomy and Implant Position.............................................p.2
Patient Positioning..................................................................................p.3
Views Needed and C-arm Positions....................................................p.4
How to set up a C-arm for rainbow positioning.................................p.5
How to set up a C-arm entering from the contralateral
side of the patient..................................................................................p.6
Lateral Segment Visualization – Obtaining images without
moving the C-arm.................................................................................p.7
STEP 1 Pre-Operative Evaluation..........................................................p.8
STEP 2 Patient Positioning......................................................................p.8
STEP 3 Medial Segment Preparation....................................................p.9
STEP 4 Lateral Segment Preparation....................................................p.10-11
STEP 5 Fracture Reduction and Full Clavicle Reaming......................p.12
STEP 6 CRx® Implant Selection..............................................................p.13-14
STEP 7 CRx® Implant Insertion................................................................p.15-17
STEP 8 Lateral Screw Placement..........................................................p.18-19
STEP 9 Confirm Reduction and Fixation...............................................p.20
STEP 10 Post-Operative Care................................................................p.21
Appendix A: Additional techniques for medial canal preparation.....p.22-23
Appendix B: P. Acnes Information.......................................................p.24-25
Implant Specifications and Part Numbers..........................................Back Cover
1
®
CLAVICLE ANATOMY AND IMPLANT
POSITION
The optimal lateral exit point of the CRx® is posterior to the centerline of the bone,
and lateral and posterior to the conoid tubercle. Additionally, the CRx® must be
positioned 50mm past the fracture on the medial side, and 20mm past the fracture
on the lateral side.
Acromioclavicular Joint
Sternoclavicular Joint
Superior (Overhead) View
Acromioclavicular Joint
Sternoclavicular Joint
AP (Front) View
20mm
Minimum
50mm
Minimum
Implant Position in Relation to the Fracture
2
®
PATIENT POSITIONING
1
2
Position the patient in a modified beach chair position.
NOTE: Many “beach chair”
Use an Allen table to gain access to the posterior shoulder
positioning tables feature back
- Figure 1.
support bars. If the patient is
The patient should be prepared and draped for standard
posterior-lateral shoulder access. Expose and prepare the
entire aspect of the clavicle from medial to lateral, including
the acromioclavicular (AC) joint and posterior shoulder.
positioned in front of the bars, it may
obstruct x-ray views. Ensure
the patient is not seated in front of
these bars to avoid imaging
interference - Figure 2.
NOTE: It is recommended to
take preparatory x-ray images
before draping to ensure the
appropriate views will be
available intraoperatively.
3
NOTE: Many surgeons prepare the patient’s skin with
Chlorhexidine to avoid Propionibacterium acnes (P. acnes)
bacteria transmission. P. acnes is one of the most common
causes of infection after shoulder surgery*- Figure 3.
For more information see Appendix B, Page 24.
3
Clavicle
Claviclelooks
looksstraight
straight
Vie
“S”-shape
curve is evident
The
Thetwo
twomost
mostcommonly
commonlyused
usedC-arm
C-armpositions
positionsare:
are:rainbow
rainbow(over
(over
the
shoulder)
and
entering
from
the
contralateral
side
(this
is
the shoulder) and entering from the contralateral side (this is
especially
especiallyhelpful
helpfulininaasmaller
smallersurgical
surgicalsuite)
suite)––Figure
Figure77and
and8.8.
Turbercle
Note:
totoachieve
with
Note:Superior
Superiorviews
viewsmay
maybebedifficult
difficultConoid
achieve
with
some
Acromio-clavicular
Joint
someoperative
operativetables.
tables.
Exit Point of CRx®
45°Cephalic Tilt View
There
visua
45-de
VIEWS NEEDED AND
C-ARM POSITIONS
55
AP
APView
View
4
No
to d
vie
wil
Views
Needed and C-arm Positions
Clavicle looks straight
“S”-shape
curve
isisevident
“S”-shape
curve
evident
“S”-shape
curve
is evident
There are three views of the shoulder consistently utilized for
visualization of anatomy and instrument and implant position:
45-degree cephalic tilt, A/P and overhead – Figures 4, 5 and 6.
The t
the sh
espec
Conoid Turbercle
Acromio-clavicular Joint
Exit Point of CRx®
Superior
Superior(overhead)
(overhead)View
View
45° CephalicTilt
Tilt View
View
45°Cephalic
Note: Prior to starting the procedure, it is recommended
to determine the C-arm angles needed to obtain effective
5
views.
These angle numbers must be noted because they5
AP
AP View
View
will be used repeatedly throughout the case.
4
66
4
Clavicle looks straight
No
som
curve is evident
The“S”-shape
two most commonly
used C-arm positions are: rainbow (over
the shoulder) and entering from the contralateral side (this is
especially helpful in a smaller surgical suite) – Figure 7 and 8.
Note: Superior views may be difficult to achieve with
some operative tables.
6
AP View
22
7
6
Contralateral Side C-arm Position
Rainbow C-arm Position
Rainbow
C-arm
Position
Rainbow
C-armcurve
Position
“S”-shape
is evident
Superior (overhead) View
5
77
Contralateral
ContralateralSide
SideC-arm
C-armPosition
Position
88
There are two views of the shoulder consistently utilized for visualization of anatomy and instrument and
implant position: 45-degree cephalic tilt and AP - Figures 4 and 5.
NOTE: Prior to starting the procedure, it is recommended to determine the C-arm angles needed to obtain
effective views. These angle numbers must be noted because they will be used repeatedly throughout the case.
Superior (overhead) View
6
The two most commonly used C-arm positions are: rainbow (over the shoulder) and entering from the
contralateral side (this is especially helpful in a smaller surgical
suite)
- Figures
6 and 7.
Rainbow
C-arm
Position
7
2
4
Rainbow C-arm Position
2
7
Contralateral Side C-arm Position
8
Contralateral S
ee views of the shoulder consistently utilized for
of anatomy and instrument and implant position:
phalic tilt, A/P and overhead – Figures 4, 5 and 6.
Align the patient’
Place the flouros
r to starting the procedure, it is recommended
ne the C-arm angles needed to obtain effective
ese angle numbers must be noted because they
ed repeatedly throughout the case.
It may be necess
fracture side to a
shoulder with the
HOW TO SET UP A C-ARM FOR
t commonly used C-arm positions are: rainbow (over
45°Cephalic Tilt View
and entering RAINBOW
from the contralateral side (this is POSITIONING
9
pful in a smaller surgical suite) – Figure 7 and 8.
Before prepping t
(if possible) view
elicit visualization
Figures 9, 10 a
erior views may be difficult to achieve with
ative tables.
8
45° Cephalic Tilt View
9
AP View
AP View
10
Align the patient’s torso roughly 45-degrees relative to the floor.
Place the flouroscopy unit over the patient’s shoulder.
It may be necessary to situate the patient off-center towards the fracture side to allow the
surgeon enough room to access the shoulder with the C-arm in place.
Before prepping the patient, take cephalic tilt and AP views to ensure the patient is in the correct
position to elicit visualization of the fracture throughout the procedure - Figures 8 and 9.
rm Position
Superior (overhead) View
11
8
5
How to set up
the contralat
Introduce the C-arm acr
Before prepping the pa
(if possible) views to en
to elicit visualization of
Figures 12 and 13.
HOW TO SET UP A C-ARM ENTERING
FROM THE CONTRALATERAL SIDE OF
45°Cephalic Tilt View
12
THE PATIENT
How to set up a C-arm entering from
the contralateral side of the patient
Introduce the C-arm across the patient from the non-operative side.
Before prepping the patient take cephalic tilt, AP and superior
(if possible) views to ensure the patient is in the correct position
to elicit visualization of the fracture throughout the procedure –
Figures 12 and 13.
10
11
45° Cephalic Tilt View
AP View
45°Cephalic Tilt View
12
AP View
13
Introduce the C-arm across the patient from the non-operative side.
Before prepping the patient, take cephalic tilt and AP views to ensure the patient is in the correct
position to elicit visualization of the fracture throughout the procedure - Figures 10 and 11.
AP View
13
4
6
Position the patient in an Allen beach ch
fracture on the medial fragment) can be achieved
Before prepping the patient take cephalic tilt, AP and superior
can achieve
Using anterior to posterior (AP) 45-degrees,
and 45° cephalic
and set the C-arm parallel to
(if possible) views to ensure the patient is in the correct position
the clavicle.
tilt fluoroscopic views, determine if a minimum
to elicit visualization of the fracture throughout the procedure –
depth of 50mm (from the most medial edge of the
• For a cephalic tilt view, Position
move the
Arm moved superiorly –
Figures 12 and 13.
the
fracture on the medial fragment) can be achieved
cephalic tilt equivalent
• For an A/P view, move45-degrees,
the arm i
Surgical
Technique
LATERAL SEGMENT
14
Lateral Segment
VISUALIZATION
OBTAINING IMAGES
Visualization – Obtaining images
14
WITHOUT MOVING
C-ARM
without movingTHE
the C-arm
Arm moved superiorly –
Guide
cephalic tilt equivalent
• For a c
• For an
Surgical
Technique
Guide
erative Evaluation
Lateral Segment
By moving the arm up or down
the arm superiorly
or inferiorly, oneimages
Visualization
– Obtaining
can achieve views nearly equivalent
a cephalic tiltthe
or APC-arm
view of
or to posterior (AP)
and1 45° cephalic
STEP
withoutto moving
the clavicle.
pic views, determine
if a minimum Evaluation
Pre-Operative
By moving the arm up or down the arm superiorly or inferiorly, one
mm (from the most medial edge of the
can achieve
equivalent to a cephalic tilt or AP view of
Using
anterior
to
posterior
(AP)
and
45°
cephalic
Position the patient in an Allen
beachviews
chairnearly
at approximately
he medial fragment) can be achieved
the
clavicle.
tilt fluoroscopic views, determine 45-degrees,
if a minimum
and set the C-arm parallel to floor.
depth of 50mm (from the most medial edge of the
fracture on the medial fragment) can be achieved
riorly –
Position the patient in an Allen beach chair at approximately
For a cephalic
move the
– Figure
12 tilt view,
13
Arm •moved
inferiorly
– 45-degrees,
and arm
set thesuperiorly
C-arm parallel
to floor.14
AP equivalent
• For an A/P view, move the arm inferiorly – Figure 15Arm moved inferiorly Arm moved superiorly -
eriorly –
ivalent
Arm moved superiorly –
cephalic tilt equivalent
cephalic tilt equivalent
• ForArm
a cephalic
view, move
– Figure 14
movedtiltinferiorly
– the arm
AP superiorly
equivalent
• ForAPanequivalent
A/P view, move the arm inferiorly – Figure 15
14
15
14
15
By moving the arm superiorly or inferiorly, one can achieve views nearly equivalent to a
cephalic tilt or AP view of the clavicle.
Position the patient in an Allen beach chair at approximately 45-degrees, and set the C-arm
parallel to floor.
• For a cephalic tilt view, move the arm superiorly - Figure 12
• For an A/P view, move the arm inferiorly - Figure 13
Arm moved inferiorly –
AP equivalent
15
15
5
5
7
STEP 1
PRE-OPERATIVE EVALUATION
Using anterior to posterior (AP) and 45° cephalic tilt
fluoroscopic views, confirm a minimum depth of 50mm can
be achieved in the medial canal from the most medial edge
of the fracture - Figure 14. If 50mm of depth on the medial
1
side isSTEP
not achievable,
evaluate whether to use a
50mm
14
Pre-Operative
medial-to-lateral
approachEvaluation
(technique LB-0668). For the
lateral segment, 20mm of canal must be available.
Using anterior to posterior (AP) and 45° cephalic tilt fluoroscopic
views, confirm a minimum depth of 50mm can be achieved in the
NOTE:
To confirm
medial
or to
ensure
medial
canal from50mm
the mostofmedial
edgesegment,
of the fracture
– Figure
16.
®
the canal
diameter
CRx implant
If 50mm
of depthcan
on theaccommodate
medial side is notthe
achievable,
evaluate
whether
use4.5mm
a medial-to-lateral
(technique
LB-0668).
(4.2mm),
laytothe
bandedapproach
Reamer
along the
top of
For the lateral
20mm of canalwith
mustfluoroscopy.
be available.
the shoulder
and segment,
verify dimensions
16
Note: To confirm 50mm of medial segment, or to ensure the
canal diameter can accommodate the CRx® implant (4.2mm),
lay the 4.5mm banded reamer along the top of the shoulder
and verify dimensions with fluoroscopy.
STEP 2
PATIENT POSITIONING
STEP
2
Position
the patient
in a modified beach chair position. Use
an Allen
table toPositioning
gain access to the posterior shoulder Patient
Figure 15.
Position the patient in a modified beach chair position. Use an Allen
table to gain access to the posterior shoulder – Figure 17.
Position the C-Arm to allow for AP and cephalic tilt views.
Position the C-Arm from behind the patient to allow for AP and
15
Expose
and prep
the entire aspect of the clavicle from
cephalic
tilt views.
medial to lateral, including the AC joint and posterior
Expose and prep the entire aspect of the clavicle from medial to
17shoulder.
lateral, including the AC joint and posterior shoulder.
8
Surgical
Technique
Guide
STEP 3
STEP 3
Medial SegmentPREPARATION
Preparation
MEDIAL SEGMENT
Surgical
Technique
Guide
Important Note: For stable fracture fixation, the medial
STEP 3
segment canal must be prepared
to a minimum depth of 50mm
Medial
Segment Preparation
from the most medial aspect of the fracture.
Important Note: For stable fracture fixation, the medial
Make a 2-3cm oblique incision directly
site toalong
segment over
canal the
mustfracture
be prepared
a minimum depth of 50mm
from
the
most
medial
aspect
of
the
fracture.
Langer’s lines – Figure 18.
18
Make a 2-3cm oblique incision directly over the fracture site along
Note: Initially, surgeons may
be more comfortable with an
Langer’s lines – Figure 18.
16
17
incision parallel to the clavicle. However, once comfortable
18an incision
with the technique,
Note:along
Initially,Langer’s
surgeonslines
may is
be more comfortable with an
IMPORTANT NOTE: For stable
fracture for
fixation,
theincision
medial
segment
canal
must
prepared
to a
recommended
improved
cosmesis
and
a
reduced
to be once
parallel to the clavicle.risk
However,
comfortable
minimum depth of 50mm from
the most
medial aspectwith
of the
thetechnique,
fracture.an incision along Langer’s lines is
sensory
nerves.
recommended for improved cosmesis and a reduced risk to
sensory nerves.
Make a 2-3cm oblique incision directly over the fracture site along Langer’s lines - Figure 16.
Break down the callus to expose the IM canal. Elevate the medial
fracture segment and establish a 20mm-deep
starter
hole inthetheIM canal. Elevate the medial
callus
toparallel
expose
NOTE: Initially, surgeons may be more comfortableBreak
withdown
an the
incision
to the clavicle.
center of the medullary canal using
2mm and
Drillestablish
– Figure
19.
fracturethe
segment
a 20mm-deep
starter hole in the
However, once comfortableCentering
with thethetechnique,
Langer’s
lines
is recommended
drill will helpanto incision
ensure
drills
not
center ofsubsequent
thealong
medullary
canaldousing
the 2mm
Drill – Figure 19. for
improved cosmesis19
and a reduced
to sensory
Centering
theDrill
drill to
willfurther
help toexpand
ensure subsequent
drills do not
breach therisk
cortex.
Next, utilizenerves.
the 3.5mm
the
19
breach
the
cortex.
Next,
utilize
the
3.5mm
Drill
to
further
expand the
portal.
Break down the callus to expose the IM canal. Elevate the medial fracture segment and establish a
portal.
20mm deep starter hole in the center of the medullary canal using the 2mm Drill - Figure 17.
Note: The flutes on the 2mm
DrillTheareflutes
25mm
long.
Note:
on the
2mm Drill are 25mm long.
Note: Using
both AP ensure
and cephalic
Note: Using both AP and cephalic
tilt views,
the tilt views, ensure the
3.5mm
Drill
does
not
violate
the
anterior cortex.
NOTE: The flutes on the 2mm
Drill are
3.5mm
Drill 25mm
does notlong.
violate the anterior cortex.
IMPORTANT NOTE: If an intramedullary canal is not evident and must be created, or if the canal
bone is very hard, follow the surgical steps outlined in Appendix A, pages 22-23.
7
9
7
STEP 3
STEP 4
STEP 4
Lateral Segment Preparation
Lateral Segm
Medial Segment Preparation (Cont.)
Retain the Guide Wire. Confirm with fluoroscopy and utilize a
powered reamer to advance the 4.5mm Flexible Banded Reamer
Conoid
Tubercle
into the canal to a minimum depth of 50mm
– Figure
24. Take care
not to advance the Reamer
past
the
tip
of
the
Wire,
it
may
cause the
Coracoid Circle
Wire to becomeAClodged
Jointin the Reamer tip.
The ideal lateral exit point is at the clavicle equator posterior
to the “coracoid circle”, which is half-way between the conoid
Conoid Tubercle
tubercle and the acromioclavicular (AC) joint – Figure 26.
Coracoid Circle
AC
Joint
3 Suggestions to Obtain Correct Trajectory of the Lateral
Exit Point:
26
45° Cephalic Tilt view of the lateral exit point
The ideal lateral ex
to the “coracoid circ
tubercle and the ac
Figure 25.
• Use the non-drilling hand to pinch the distal clavicle with
a thumb and forefinger, then direct the drill between
these digits.
• Use the non-dril
a thumb and for
these digits.
• Place the 2mm drill bit over the lateral segment and view it
with fluoroscopy, this will help indicate the trajectory needed
• Place the 2mm d
with fluoroscopy
• Palpate the posterior edge of the acromio-clavicular joint
as the target for the drill.
• Palpate the pos
as the target fo
STEP 4
LATERAL
PREPARATION
The Flexible
Reamer
featuresTilt
a band
indicate
the 50mm
26
45°
Cephalic
viewto of
theSEGMENT
lateral
exitdepth
point–
Note: Reaming should be performed in short pulses while
lavaging to prevent heat generation.
Alternatively: Use the 3.0mm Curved Trocar and 4.5
Curved Cutting Awl to prepare the medial canal to a depth
of 50mm. Make sure the curves of the Trocar and Awl
are aligned with the curvature of the clavicle. Ensure the
anterior cortex is not punctured by the Awl.
45° Cephalic Tilt view of the lateral exit point
18
27
25
20
3 Suggestions to
Exit Point:
19
Elevate the lateral segment. This is usually accomplished with an
elevator and/or towel clip. Externally rotating the shoulder and 27
lifting the elbow may facilitate access.
The ideal lateral exit point is posterior along the
Establish a 20mm deep starter hole in the canal using the 2.0mm
centerline of the bone, lateral and posterior to the
Drill – Figure 27. Confirm the trajectory to the correct exit point
conoid
tubercle
- Figure
The– Figure
exit point
with
fluoroscopy
in AP and
cephalic 18.
tilt views
28. can
be described as the point right after the heel of a
Advance
the stick.
3.5mm Drill just to the cortex. Again, use fluoroscopy
hockey
in AP and cephalic tilt views to verify optimal trajectory to the exit
point.
28
Elevate the lateral se
elevator and/or towe
lifting the elbow may
Establish a 20mm de
Drill – Figure 27. Co
with fluoroscopy in A
Advance the 3.5mm
in AP and cephalic ti
point.
28
Notes with
for Greater
Accuracy: and/or towel clip. Externally Notes for Greater
Elevate the lateral segment. This is usually accomplished
an elevator
rotating the shoulder and lifting the elbow may facilitate
Establish
20mm
starter
• Whileaccess.
introducing
the 2mmaand
3.5mmdeep
Drill Bits,
the hole in • While introducin
surgeon’s hand
handstoshould
be kept close
the patient’s
the canal using the 2mm Drill - Figure 19. Confirm thesurgeon’s
trajectory
the correct
exit topoint
with
neck and chest
neck and chest to prevent excess angulation.
fluoroscopy in AP and cephalic tilt views - Figure 20.
• The surgeon ma
• The surgeon may achieve greater drilling accuracy by
moving to the o
moving to the other side of the table and drilling away,
Three suggestions to obtain correct trajectory of the lateral
exit
point:
instead of towa
instead of towards himself.
• Use the non-drilling hand to pinch the distal clavicle with a thumb and forefinger, then direct the drill between these digits.
• Place the 2mm Drill over the lateral segment and view it with fluoroscopy, this will help indicate
11 the trajectory needed.
• Palpate the posterior edge of the acromioclavicular joint as the target for the Drill.
NOTES FOR GREATER ACCURACY:
• While introducing the 2mm Drill, the surgeon’s hands should be kept close to the patient’s neck and chest to prevent excess angulation.
• The surgeon may achieve greater drilling accuracy by moving to the other side of the table and drilling away, instead of towards themself.
10
STEP 4
LATERAL SEGMENT PREPARATION, CONT.
21
23
22
Under fluoroscopic guidance, drive the rear-end
Trocar point of the Guide Wire into the lateral
segment while “hugging the posterior wall” - Figure 21.
Drive the wire through the lateral cortex until it tents the
skin - Figure 22. If the Trocar tip exits too medially, or
too laterally, the path may be redirected with a curved
Hand Awl or Trocar from the CRx® instrument set.
NOTE: Ensure the lateral segment is raised to allow sufficient access to its axis.
Make a small incision over the palpable Guide Wire - Figure 23. Drive the Guide Wire further into the
lateral segment until the bulbous end is within the lateral segment past the fracture. The powered driver
can be used on the outside of the shoulder to pull the Guide Wire into the lateral segment - Figure 24.
24
25
Run the 4.5mm Cannulated Drill over the Guide Wire to enlarge the canal for the forthcoming 4.5mm
Flexible Reamer. The 4.5mm Cannulated Drill can be driven from lateral to medial to the fracture site
(a Skin Protector is available to prevent the Drill from damaging the soft tissues). The Drill may be used
as a “joystick” to direct the lateral segment towards the medial segment.
Reduce the fracture and clamp it with the Bone Clamps. Carefully drive the Guide Wire through the clavicle
until it reaches a minimum of 50mm into the medial segment - Figure 25. While driving the Guide Wire, it
may be necessary to manually apply downward pressure to the medial segment to maintain alignment.
11
STEP 5
FRACTURE REDUCTION AND FULL
CLAVICLE REAMING
26
27
NOTE: It is critical to hold the segments in alignment during Guide Wire introduction and reaming. If
the segments fall out of alignment, it may kink the Guide Wire or Reamer and cause breakage.
Additionally, breakage can be caused through excessive driving force and torque (especially when the
Reamer is not advancing).
Remove the Drill and advance the 4.5mm Flexible Banded Reamer over the Guide Wire - Figure 26.
Carefully drive the Flexible Reamer through the entire clavicle while maintaining the reduction - Figure 27.
NOTE: Reaming should be performed in short pulses while lavaging to prevent heat generation.
Use fluoroscopy to ream to the tip of the Guide Wire and confirm the 50mm indicator band on the
Reamer is beyond the most medial edge of the fracture on the medial segment. Take care not to
advance the Reamer past the tip of the Wire, it may cause the Wire to become lodged in the Reamer tip.
Centralizing Tip of the
Guide Wire
4.5mm Flexible Reamer
NOTE The centralizing tip of the Guide Wire cannot pass through the cannulated Reamers or Drills.
12
STEP 6
CRX® IMPLANT SELECTION
Surgical
Technique
Guide
Tips for Prop
CRx Reamer
STEP 6
®
®
CRx Implant Selection
Advance the Reamer Depth Gauge over the Reamer until it contacts
Note: An implant on
the posterior-lateral cortex. Read the length on the scale from the
should be considere
laser mark on the reamer to determine implant length – Figures
beyond the most me
35 and 36.
29
28
segment. This may r
within the posterior
Measurement
laser laser
line line
35 Measurement
30
4.5mm flexible Banded Reamer
38
Note: Be careful not to read the length on the scale from Alternatively, remove t
a longer implant.
the end of the reamer.
Measurement laser line
Read the depth gauge
Advance the Reamer Depth Gauge over the Reamer until it contacts the posterior-lateral cortex. Read thethe end of the reamer.
length on the scale from the laser mark on the 36
Reamer to determine implant length - Figures 28 and 29.in too short an implan
NOTE: Read the Depth Gauge from the laser line on the Reamer and NOT the end of the Reamer longer implant. Ensure you have adequate depth to accommodate
Figure 30. Reading off the end of the Reamer will result in too short an implant selection. If the implant
the Lateral Screw. If necessary reattach the Reamer to power and When to use
measurement falls between two sizes, choose the longer
ream implant.
an additionalEnsure
5mm. you have adequate depth tothe sizing ga
accommodate the Lateral Screw. If necessary, reattach the Reamer to power and ream an additional 5mm.
If the implant measurement falls between two sizes, choose the
TIPS FOR PROPER USE OF THE CRX® REAMER DEPTH GAUGE
Here are some sugges
Appropriate implant se
Tips for Proper Use of the
CRx Reamer Depth Gauge
39
®
1. Ensure bony apposition at the fracture. Provisionally
hold the reduction with Bone Clamps if necessary.
Confirm visually and fluoroscopically.
other surgeons for wh
referenced from the si
Note: In all cases
be 50mm past th
• If the medial m
2. Use clear fluoroscopic images. The top-down superior
31
Figure 39. The
view is best to ensure the depth gauge is at the cortex
and not below the cortex, or impinging on soft-tissues.
not progressing t
37
1. Ensure bony apposition at the fracture. Confirm
visually and fluoroscopically.
the talons have c
3. Ensure
of the
depth gauge
flush toGauge
the surface
2. Use clear fluoroscopic images. The top-down superior
viewthe
is tip
best
to ensure
theisDepth
is bone
– Figure 37. If the gauge is not flush to
at the cortex and not below the cortex, or impinging of
onthesoft
tissues.
• If the reading
the bone, it may recommend a longer implant than
3. Ensure the tip of the Depth Gauge is flush to the surface of the bone - Figure 31. If the Gauge is not implant length
necessary. This may result in the implant being left
flush to the bone, it may recommend a longer implantproud.
than necessary. This may result in the implant – For example, i
implant could be
being left proud.
15
13
Tips for Proper Use of the
CRx Reamer Depth Gauge (Cont.)
®
Note: An implant one-size shorter than the Gauge reading
WHEN TO USE A SHORTER IMPLANT
THAN THE SIZING
should be considered only if 50mm of the implant will reach
beyond the most medial edge of the fracture on the medial
GAUGE RECOMMENDS
NOTE: An implant one-size shorter than the Gauge reading should be considered only if 50mm of the
segment. This may require the implant to be countersunk
within the posterior lateral cortex.
implant will reach beyond the most medial edge of the fracture on the medial segment. This may require
38
Measurement
laser line
Alternatively,
the implant to be countersunk within the posterior lateral
cortex.remove the Depth Gauge, ream more deeply, and use
a longer implant.
Alternatively, remove the Depth Gauge, ream more deeply,
longer
implant.
Read theand
depthuse
gaugea from
the laser
line on the reamer and NOT
the end of the reamer. Reading off the end of the reamer will result
in too short an implant selection – Figure 38.
When to use a shorter implant than
the sizing gauge recommends
32
Appropriate implant selection is the responsibility of the surgeon.
Here are some suggestions taken from the clinical experience of
39
other surgeons for when to use a shorter implant than what is
Appropriate implant selection is the responsibility of the
surgeon.
Here
some suggestions taken from
referenced
from the
sizingare
gauge.
the clinical experience of other surgeons for when to use a shorter implant than what is referenced from
the sizing Gauge.
®
Note: In all cases, it is still necessary for the CRx to
be 50mm past the fracture on the medial side.
NOTE: In all cases, it is still necessary for the CRx® to be
pastmedullary
the fracture
medial wide
side.–
• If50mm
the medial
canalonis the
excessively
• If the medial medullary canal is excessively wide - Figure
Figure
of theflare
implant
39.32.
The The
talonstalons
of the implant
to 8mm,flare
so to the talons
have cortical
• If the reading on the Depth Gauge is between implant
lengths,
but isfixation.
close to the shorter reading
progressing
too deeply
the medial
may ensure
8mm, so not progressing too deeply into the medial not
side
may ensure
the into
talons
have side
cortical
fixation.
For example, if the Gauge is reading 103mm, a 100mm implant could be warranted.
• If the reading on the depth gauge is between
implant lengths, but is close to the shorter reading
– For example, if the gauge is reading 103mm, a 100mm
implant could be warranted.
16
14
STEP 6
®
lacigruS
euqinhceT
CRx Implant Insertion (Cont.)
(Outrigger Assembly)
ediuG
Surgical
Technique
Assemble the Outrigger and attach the appropriate CRx implant to Guide
the Outrigger assembly. Ensure the cut-out of the Implant Hub mates
with the cut-out of the assembly. Insert the Actuation Driver into the
STEP– 6
hub of the implant
Figure 40.
Surgical
®
CRx Implant Insertion (Cont.)
®
STEP 7).tnoC( noitresnI tnalpmI xRC
.)
)ylbmessA reggirtuO(
®
r Proper Use of the
(Outrigger Assembly)
CRX
IMPLANT
INSERTION
eamer Depth
Gauge
(Cont.)
CRx Implant I
eading
ot tnalpmi xRC etairporppa eht hcatta dna reggirtuO eht elbmessA
Note:
Turn
knob
clockwise
for
assembly
Assemble
the
Outrigger
and
attach
the
appropriate
CRx implant to
will reach (OUTRIGGER
setam buH tnalpmI eht fo tuo-tuc eht erusnEASSEMBLY)
.ylbmessa reggirtuO eht
(Outrigger
Ass
with theassembly.
implant.Ensure the cut-out of the Implant Hub mates
the Outrigger
mplant
medial one-size shorter
eht otnithan
revirDthe
noiGauge
tautcA ereading
ht tresnI .ylbmessa eht fo tuo-tuc eht htiw
6 PETS
®
Technique
STEP 6
Guide
®
®
®
considered
only if 50mm of the implant will reach.04 erugiF – tnalpmi eht fo buh
rsunk
e most medial edge of the fracture on the medial
This may require the implant to be countersunk
,posterior
and use lateral cortex.
ylbmessa rof esiwkcolc bonk nruT :etoN
40
y, remove the Depth Gauge, ream more deeply, and.tnuse
alpmi eht htiw
plant.
nd NOT
will result
pth gauge from the laser line on the reamer and NOT
he reamer. Reading off the end of the reamer will result
41
an implant selection – Figure 38.
the Outrigger assembly. E
with the cut-out of the as
hub of the implant – Fig
Assemble the Outrigger and attach the appropriate CRx implant to
the Outrigger assembly. Ensure the
cut-out
the Implant
Hub mates
Note:
Turnof knob
clockwise
for33Aassembly
with
the
cut-out
of
the
assembly.
Insert
the
Actuation
Driver
into
the
bends
more easily
Important note: The Wavibody
with the
implant.
hubin ofsome
the implant
– Figure
40. When the outrigger is
directions
than others.
Note:
properly attached, the Wavibody has a bendable angle of
with
22-degrees towards the outrigger – Figure 41.
han
40
STEP 6 with the cut-out of the assembly. Insert the Actuation
AssembleDriver
the Outrigger
into the a
®
CRx Implant
hub of the Insertion
implant – Figure(Cont.)
40.
(Outrigger Assembly)
®
®
®
04
®
33 Note: Turn knob clockwise for assembly
with the implant.
ylisae erom sdneb ydobivaW ehT :eton tnatropmI
Important note: The Wavibody
to use a shortersi rimplant
eggirtuo eht than
nehW .srehto naht snoitcerid emos ni
40 bends more easily
in some directions than others. When the outrigger is
urgeon.gauge recommends
fo elgna elbadneb a sah ydobivaW eht ,dehcatta ylreporp
ing
Important
note:
angle
of The
properly attached, the Wavibody has a bendable
nce of
.14 erugiF – reggirtuo eht sdrawot seerged-22
in 41.
some directions th
22-degrees towards the outrigger – Figure
implant
14
hat
is selection is the responsibility of the surgeon.
34 attached, th
41
properly
me suggestions taken from the clinical experience of
40
22-degrees towards
ons for when to use a shorter implant than what is
bends
more
easily
Important
note:
The
Wavibody
41
rom thetosizing gauge.
CRx
in some directions than others. When the outrigger is
.
35
42
properly
attached,Driver
the Wavibody
all cases, it is still necessary for the CRx to
Insert
the Actuation
into the hub has
of thea bendable angle of
22-degrees
towards
the outrigger
– Figure 41.
– fracture on the medial side.
my wide
past the
Outrigger
assembly
– Figure
42.
41
so
medial medullary canal is excessively wide –
ensure
e 39. The talons of the implant flare to 8mm, so
ogressing too deeply into the medial side may ensure
24
en
ons have cortical fixation.
eht fo buh eht otni revirD noitautcA eht tresnI 42
17
reading
Insert the Actuation Driver into the36
hub of the
.24 erugiF – ylbmessa reggirtuO
reading on the depth gauge is between
00mm
Outrigger assembly – Figure 42.
42
Assemble
Outrigger
and attach the appropriate CRx® implant to the Outrigger assembly. Ensure Insert
the the Actuation Drive
ant lengths, but
is closethe
to the
shorter reading
cut-out
of
the
Implant
Hub
mates
with
the
cut-out
of
the
assembly
Figure
33.
example, if the gauge is reading 103mm, a 100mm
Outrigger assembly – Fig
nt could be warranted.
NOTE: Turn knob clockwise for assembly with the implant - Figure 33A.
42
Insert the Actuation Driver into the hub of the
71
®
in some
directions
than
IMPORTANT NOTE: The Wavibody bends more easilyOutrigger
1
assembly
– Figure
42.others. When the Outrigger
®
®
o
22
®
®
®
®
®
®
is properly attached, the Wavibody has a bendable angle of 22-degrees towards the Outrigger - Figure 34.
Insert the Actuation Driver into the hub of the Outrigger assembly - Figure 35. This can also be performed
before attaching the implant to the Outrigger assembly to help guide the implant into position - Figure 36.
15
17
STEP 7
CRX® IMPLANT INSERTION, CONT.
37
Remove the Depth Gauge and Reamer, leaving the Guide Wire in place. Advance the Implant Insertion
Guide over the Guide Wire and into the lateral segment (no more than 25mm). Utilize fluoroscopy to
confirm the Guide is in the bone - Figure 37.
38
Remove the Implant Insertion Guide inner handle and the Guide Wire, retaining the Guide Channel Figure 38.
16
STEP 7
CRX® IMPLANT INSERTION, CONT.
39
Advance the implant along the Guide Channel and into the lateral fragment. Position the Outrigger in a
plane parallel with the top of the shoulder. This should allow the Wavibody® to more easily bend
in the direction of the curve of the medial segment - Figure 39.
Withdraw the Guide Channel before advancing the implant to the final position. Confirm the position with
fluoroscopy. Ensure the fracture is reduced.
40
Expand the ACTIVLOC® Talons by turning the Actuation Driver clockwise until the white lines become
collinear. Remove the Actuation Driver - Figure 40.
Important Note: Once the Talons are engaged, do not rotate the CRx® implant. This may
weaken the implant and lead to eventual separation of the Wavibody® portion of the
implant. In addition, the Talons may be weakened if they are de-activated and the implant is repositioned.
If the CRx® requires repositioning, deactivate the Talons by turning the Actuation Driver counter-clockwise
and utilize a new implant.
17
STEP 8
Rx Implant Insertion
LATERAL SCREW PLACEMENT
TEP 7
®
move the Depth Gage and Reamer, leaving the Guide Wire in
ace.
Surgical
STEP 8
Technique
Guide
Lateral Screw Placement
®
Important Note: Use of the CRx without th
is contraindicated. The lateral screw secur
the lateral clavicle segment, reduces fractu
protects the CRx from metal fatigue.
47
42A
®
STEP 8
vance the Implant Insertion Guide over the Guide Wire and into
e lateral segment (no more than 25mm). Utilize fluoroscopy to
nfirm the Guide is in the bone – Figure 43.
41
Surgical
Lateral Screw Placement
Technique
®
47
move the Implant Insertion Guide inner handle and the Guide
re, retaining the Guide Channel – Figure 44.
Important Note: Use of the CRx without the lateral screw
Guide
is contraindicated. The lateral screw secures the CRx in
the lateral clavicle segment, reduces fracture motion and
protects
STEPthe
8 CRx from metal fatigue.
42
®
Insert the Soft Tissue Trocar into the External She
Make a stab incision and advance the Sheath wi
Trocar until it rests firmly against posterior bone –
®
Lock the position of the Sheath using the plastic
Lateral Screw Placement
48
vance the implant along the guide channel and into the lateral
Insert
the
Soft
Tissue
Trocar
into
the
External
Sheath
–
Figure
47.
®
lateral
screw
is Surgical
contraindicated.
The lateral screw
gment. PositionIMPORTANT
the Outrigger in a planeNOTE:
parallel withUse
the topof
of the CRx without
Make Important
athe
stab incision
andUse
advance
Sheath
with the
Note:
of thetheCRx
without
theinserted
lateral screw Remove the Soft Tissue Trocar and insert the Dril
Technique
47
®
in
the
lateral
clavicle
segment,
reduces
fracture
motion
and
protects
CRx®sheath
fromuntil
metal
secures
the
CRx
e shoulder. This should allow the Wavibody to more easily bend
Guide
Trocarisuntil
it rests firmly against
posterior
bonesecures
– Figurethe48.CRx in the external
contraindicated.
The lateral
screw
the guide rests on the poste
the direction of fatigue.
the curve of the medial segment – Figure 45.
the lateral clavicle segment, reduces fracture motion and
from using
metalthe
fatigue.
protects
STEP
8 the
Lock
positiontheof CRx
the Sheath
plastic Thumb Screw.
thdraw the Guide Channel before advancing the implant to the
Under fluoroscopic guidance, use the 2.0mm Dril
48 Lateral Screw Placement
Insert
the Soft
Trocar into the External Sheath
- Figure
41.
Load
the
Trocar
into
the 47.
Outrigger
al position. Confirm
the position
with Tissue
fluoroscopy.
the CRx and
implantmake
down to athe edge of the anterio
Insert
the
Soft
Tissue
Trocar
into
the
External
Sheath
–
Figure
Important
Use
the CRx Trocar
withoutand
the insert
lateral screw
RemoveNote:
theTrocar
Softof Tissue
the Drillagainst
Guide into the
ide Wire in
47 the inserted
stab incision. Advance the Sheath with
until
it
rests
firmly
posterior
bone
Figure
42.
Figure 49.
Make a stab
andsecures
advance
with the inserted
is contraindicated.
The incision
lateral screw
the the
CRx Sheath
in
external
sheath
until
the
guide
rests
on
the
posterior
cortex.
the lateral
clavicle
and bone – Figure 48.
sure the fracture is reduced.
Trocar
untilsegment,
it restsreduces
firmlyfracture
againstmotion
posterior
protects the CRx from metal fatigue.
The screw should not be placed bicortically. To de
Wire and into
Lock the position of the Sheath using the plastic Thumb Screw - Figure 42A. Remove the Soft
TissuetheTrocar
oroscopy
to
size, measure
screw length on the Drill Guide
pand the ACTIVLOC Talons by turning the actuation driver
InsertUnder
the Soft
Tissue
Trocar
into
the
External
Sheath
–2.0mm
Figure
47.
fluoroscopic
guidance,
use
the
Drill
to
bore
through
Lock
the
position
of
the
Sheath
using
the
plastic
Thumb
Screw.
and
insert
the
Drill
Guide
into
the
External
Sheath
until
the
Guide
rests
on
the
posterior
cortex.
for
countersinking.
a stab
and advance
with the
ckwise until the white lines become collinear. Remove the
48Makethe
CRxincision
implant
downthetoSheath
the edge
of inserted
the anterior cortex – 49
Trocar until it rests firmly against posterior bone – Figure 48.
dtuation
the GuideDriver – Figure 46.
Figure 49.
Insert the screw using the 2.5mm Captive Clip Sc
Remove the SoftSlide
Tissue
Trocar and insert the Drill Guide into the
External Sheath guidance, drive the 2mm Drill through
Under
fluoroscopic
Verify the lateral screw has passed through the C
Lock the position
of
the
Sheath
using
the
plastic
Thumb
Screw.
sheathnotuntil
the
guide
rests on the
posterior cortex.
offbe
of Driver
The external
screw should
placed
bicortically.
To determine
screw
mportant
48
to the lateral Note: Once the Talons are engaged, do not rotate
®
reinserting
CRx screw
implant
path
to the edge of the
theActuation Driver and ensuring it c
Wiggle
Driver2mm
size,thethe
measure
length
onscrew
the Drill
Guide
anddown
subtract
with
top ofimplant. This may weaken the implant and lead
he the
CRx
Remove
Soft Tissuethe
Trocar and insert
the Drill
Guide
into the
the
shaft.
back-and-forth
while
ore easily bend
anterior
- Figure
43. to bore through
for sheath
countersinking.
the guidecortex
rests on the posterior
o eventual separation of the Wavibody portion of the
49 external
Underuntilfluoroscopic
guidance, usecortex.
the 2.0mm Drillpulling
– Figure 45.
Note: If the Driver feels stuck in the scr
mplant. In addition, the Talons may be weakened if they
implant
to the edge
of the
cortex –
InsertthetheCRxscrew
usingdown
the 2.5mm
Captive
Clip anterior
Screwdriver.
mplantde-activated
to the
Under fluoroscopic guidance, use the 2.0mm Drill to bore through
insertion:
are
and the implant
is repositioned.
Slide External
Sheath
Figure
49.
The
screw
bicortically.
To determine
Verify
the down
lateral
screw
through
CRx implant
by
the CRx
implant
to the
edgeshould
ofhas
the passed
anterior not
cortex
–betheplaced
off of Driver
Figure
49.
reinserting
the
Actuation
Driver
and
ensuring
it
cannot
pass
down
screw
size,notmeasure
the screw
length
Driver
1. TurnGuide
the Driver slightly in the reverse
The
screw should
be placed bicortically.
To determine
screwon the Drill
f the CRx requires
43repositioning, deactivate the Talons byWiggle
the shaft.
back-and-forth while The screw
should
not
be
placed
bicortically.
To
determine
screw
direction
and
pull again.
size,
measure
the screw2mm
length on
thecountersinking.
Drill Guide and subtract 2mm
and
subtract
for
Insert
the
screw
using
urning the Actuation Driver counter-clockwise and utilize pulling
a
size, measure the screw length on the Drill Guide and subtract 2mm
on driver
for
countersinking.
Note:
If
the
Driver
feels
stuck
in
the
screw
head
after
new
implant.
for
countersinking.
the 2.5mm Captive Clip Screwdriver. Verify the lateral
move the
49 49
2. If that fails to free the Driver, loosen t
insertion:
Insert the screw
using
2.5mmusing
Captive
Screwdriver.
screw
has
passed
through
CRx® implant by reinserting
Insert
thethe
screw
theClip2.5mm
Captive Clipthe
Screwdriver.
Slide External Sheath
Verify
the
lateral
screw
has
passed
through
the
CRx
implant
by
Slide External
Sheath
off of Driver
, do not rotate
the
lateral
screw
has
through
the
CRx implant
by
the
Actuation
Driver
and
it cannot
pass
down
reinsertingVerify
Actuation
Driver
and
ensuring
it passed
cannot
pass
down ensuring
3. Slide
the External Sheath back over t
off of Driver
1.the
Turn
the
Driver
slightly
in the
reverse
(loosening)
Wiggle Driver
ant and lead
reinserting
the
Actuation
Driver
and
ensuring
it
cannot
pass
down
the
shaft.
back-and-forth
while
Wiggle Driver
wiggle
the Driver back and forth whil
.
direction
and
pull
again
ion of the
50
the
shaft.
pulling
back-and-forth whileNote: Ifthe
theshaft.
Driver feels stuck in the screw head after
ened if they
Figure 50.
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
pulling
ed.
insertion:
If the
Driver
feels stuck in the
1. TurnNOTE:
the Driver slightly
in the reverse
(loosening)
insertion:
direction
and
pull
again
.
3.insertion:
Slide the External Sheath back over the Driver and
screw head after
2.Note:
If thatIffails
to free feels
the Driver,
thumb
screw.
the Driver
stuckloosen
in thethe
screw
head
after
the Talons by
e and utilize a
44
50
1.1.Turn
Driver
slightly
inslightly
thescrew.
reverse
2. If that
toTurn
freethe
the Driver,
the thumb
fails
the loosen
Driver
in(loosening)
the reverse
wiggle the Driver back and forth while pulling –
Figure
50. and pull again.
direction
(loosening)
direction
and
pullandagain.
3. Slide
the External
Sheath back over
the Driver
19
wiggle the Driver back and forth while pulling –
50.
2.If Ifthatthat
Driver,
loosen
2.
failsfails
to freeto
thefree
Driver,the
loosen
the thumb
screw. the
Figure
50
Thumb Screw.
3. Slide the External Sheath back off of the Driver and 3. Slide the External Sheath back over the Driver and
wiggle the Driver back and forth while pulling wiggle the Driver back and forth while pulling –
Figure
Figure
50. 44.
19
50
19
18
TIPS: CAPTIVE SCREWDRIVER
1. TheCaptive
CaptiveScrewdriver
Screwdriver will pick screws from the screw caddy and pass them Tips:
STE
down the Solid External Sheath to the threaded screw hole in the implant hub - 1. The Captive Screwdriver will pick screws from the screw
Figure
45.
caddy and pass them down the Solid External Sheath to the
Co
Evalu
deplo
Figur
threaded screw hole in the implant hub – Figure 51.
2. If the Screwdriver fails to insert into the screw head: Do not force the
2. If the Screwdriver fails to insert into the screw head:
Screwdriver.
Lift theLiftScrewdriver
Do not force the Screwdriver.
the Screwdriver andand attempt insertion with a different
hex
orientation.
Be sure
the screw
is aligned with AP
theView
axis of the Driver.
attempt
insertion with a different
hex orientation.
Be sure
For co
appo
mate
52
the screw is aligned with the axis of the driver.
If the
screw
needs
to be and
removed
anddoesthe Screwdriver does
If the
screw needs
to be removed
the Screwdriver
engage: Rotate
the clipthe
90 degrees
engaging theand try engaging the
not not
engage:
Rotate
clip and
90trydegrees
screw
again.
screw again.
51
45
NOTE:
The
tiptheofcaptive
the captive
clip sharp
is somewhat
sharp and
NOTE: The
tip of
clip is somewhat
and
45° Cephalic Tilt View
damage a surgical
glove. Special
careSpecial
should be care should be
cancandamage
a surgical
glove.
exercised if attempting to place a screw on the Driver
exercised
if attempting to place a screw on the Driver
tip from one’s hand. Replace the Captive Driver if the
tip clip
with
one’s
hand.
Replace
tongs
are visibly
bent or
damaged. the Captive Driver if the
clip tongs are visibly bent or damaged.
Use a
53
54
STE
Pos
Restr
Fit th
Patie
90°
19
Technique
Guide
STEP 9
Confirm Reduction and Fixation
STEP 9
ips: Captive Screwdriver
Confirm Reduction and Fixatio
Evaluate the reduction and fixation of the fracture, including the
deployment of the Talons, in both AP and 45° cephalic tilt views –
Evaluate the reduction and fixation of the fracture, inc
Figure 52 and 53.
deployment of the Talons, in both AP and 45° cephal
Surgical
Figure 52 and 53.
For comminuted or long, oblique fractures, ensure cortical
Technique
™
apposition with cerclage using PDS No. 1 or FiberWire suture
Guide
For comminuted or long, oblique fractures, ensure cort
52
materials and the notched Crego elevator – Figure 54.
apposition with cerclage using PDS™ No. 1 or FiberWi
AP View
52
materials and the notched Crego elevator – Figure 54
Use appropriate soft tissue and wound closure procedures.
STEP 9
CONFIRM REDUCTION AND FIXATION
1. The Captive Screwdriver will pick screws from the screw
caddy and pass them down the Solid External Sheath to the
threaded screw hole in the implant hub – Figure 51.
®
2. If the Screwdriver
AP Viewfails to insert into the screw head:
Do not force the Screwdriver. Lift the Screwdriver and
attempt insertion with a different hex orientation. Be sure
the screw is aligned with the axis of the driver.
STEP 9
Use appropriate soft tissue and wound closure proced
Confirm Reduction and Fixation
If the screw needs to be removed and the Screwdriver does
not engage: Rotate the clip 90 degrees and try engaging the
screw again.
46
45° Cephalic Tilt View
NOTE: The tip of the captive clip is somewhat sharp and
View glove. Special care should be
can damage
aView
surgical
APAP
exercised if attempting to place a screw on the Driver
tip from one’s hand. Replace the Captive Driver if the
clip tongs are visibly bent or damaged.
Evaluate the reduction and fixation of the fracture, including the
deployment of the Talons, in both AP and 45° cephalic tilt views –
Figure 52 and 53.
47comminuted or long, oblique fractures, ensure cortical
For
apposition
with
using PDS™ No. 1 or FiberWire suture
Cephalic
Tiltcerclage
View
45°
Cephalic
Tilt View
53
52 45°
materials and the notched Crego elevator – Figure 54.
53
®
Use appropriate soft tissue and wound closure procedures.
48
45° Cephalic Tilt View
Evaluate the reduction and fixation of the fracture, including the deployment of the Talons, in both AP and
54
45° cephalic tilt views - Figure 46 and 47.
53
54
STEP 10
For comminuted or long, oblique fractures, ensure cortical apposition with cerclage using PDS™ No. 1 or
Post-Operative Care
Restrict lifting until fracture union.
FiberWire® suture materials and the notched Crego elevator - Figure 48.
Post-Operative Care
STEP 10
Fit the patient with a sling or shoulder immobilizer.
Restrict lifting until fracture union.
Patients
should avoid repetitive forward flexion or abduction past
Use appropriate soft tissue and wound closure
procedures.
Fit the patient with a sling or shoulder immobilizer.
90° until there is evidence of healing.
Patients should avoid repetitive forward flexion or abd
90° until there is evidence of healing.
21
54
STEP 10
Post-Operative Care
Restrict lifting until fracture union.
Fit the patient with a sling or shoulder immobilizer.
Patients should avoid repetitive forward flexion or abduction past
90° until there is evidence of healing.
21
20
STEP 10
POST-OPERATIVE CARE
POST-OPERATIVE PRECAUTIONS FOR PATIENTS TREATED WITH THE CRX® NAIL
Provided by: Terry L. Whipple, MD
Medical Director for Sonoma Orthopedic Products
The Sonoma CRx® intramedullary clavicle nail is designed to maintain fracture alignment until biological
fracture union. It is not designed to withstand strenuous activities of daily living or excessive shoulder
motion while the fracture heals. Implant instructions specify the Wavibody® junction with the solid hub of
the nail should extend no less than 50mm medial to the most medial aspect of the fracture. Lesser
implantation into the medial fracture fragment jeopardizes the strength of the CRx® nail.
As described in the Instructions For Use, and as a reminder to healthcare professionals, it is highly
recommended that patients be admonished to protect the extremity from shoulder flexion or abduction
>90o until x-ray evidence of ample callus formation. If it is impossible to implant the CRx® to the
recommended 50mm depth medially, then the medial to lateral surgical approach or Sonoma FastracTM
should be considered. If the surgeon still decides to implant the CRx® with less than 50mm of depth,
patients should be cautioned and protected in a sling 24/7 until callus formation.
No fracture fixation device stimulates bone healing; it is a biological process and takes time. Patient
compliance with post-operative instructions is obligatory for satisfactory surgical results. The CRx® clavicle
nail provides the advantages of earlier fracture comfort, minimally invasive surgical scars and reduced
prominence beneath the skin. These worthwhile advantages may be lost, however, without proper
implantation technique or without patient compliance post-operatively.
21
APPENDIX A
ADDITIONAL TECHNIQUES FOR MEDIAL CANAL PREPARATION
If the medial segment canal cannot be penetrated,
un-reduce the fracture. Utilize the 3.5mm Drill to open the
canal further. If successful, drive the Centralizing Guide
Wire 50mm into the medial segment, followed by the
4.5mm flexible reamer. If this is unsuccessful, using
1
fluoroscopy, advance the tip of the 3mm hand Trocar in
10mm increments down the medial segment - Figure 1.
Two practices are imperative to prevent the curved Trocar
tip from breaching the bone cortex:
2A
·Constant use of fluoroscopy to determine Trocar position
· Minimal rotation (approximately 15-degrees) of the 15o
Trocar as it is progressed into the canal. Too much rotation can easily push the sharp tip through the bone cortex - Figure 2A.
Using flouroscopic guidance, by hand or with power, feed
the Spade-tip Guide Wire into the medial segment until
the
50mm
STEP
3 gold section is completely past the most medial
edge
of theSegment
fracture - Figures
3 & 4. If (Cont.)
using power, it is
Medial
Preparation
recommended to advance the Guide Wire while oscillating
STEP 3
for more controlled penetration. Ensure the tip of the wire
MedialUsing
Segment
fluoroscopicPreparation
guidance, by hand(Cont.)
or with power, feed the
Spade-tip
Guide by
Wire
intoor the
segment
Using fluoroscopic
guidance,
hand
withmedial
power, feed
the until the 50mm gold
is
not
lodged
in
bone
before
initiating
powered
section
is
completely
past
the
most
medial
edge
fracture – reaming; a
Spade-tip Guide Wire into the medial segment until the 50mm
goldof the
Figure 20
and
21.
wire
break.
section islodged
completely
past
themay
most medial
edge of the fracture –
Figure 20 and 21.
20
If using power, it is recommended to advance the guide wire with
3
If the
resistance
in encountered
while
drivingEnsure
the the
Wire
If using power,
it is recommended
tofor
advance
guide
wire
with
reamer
oscillating
more the
controlled
penetration.
tip into the
the
reamer
oscillating
for
more
controlled
penetration.
Ensure
the
tip
20 medial
segment,
utilize
bendable
Suction Tip to
of the wire
is not lodged
in boneabefore
initiatingFrasier
powered reaming;
of the wire is not lodged in bone before initiating powered reaming;
a lodged wire
break.
navigate
themay
curve.
a lodged wire may break.
21
4
21
If resistanceIf isresistance
encountered
while driving the
Wiredriving
into thethe
medial
is encountered
while
Wire into the medial
segment:
segment:
1. Replace the Spade-tipped Wire with the Ball-Tipped
1. Replace
the Spade-tipped
Wire with
Guide Wire
and attempt
to follow the existing
canal.the Ball-Tipped
Guide Wire
andthe
attempt
to follow
If using a powered
reamer,
Ball-tipped
Guide the existing canal.
Wire must Ifbeusing
loadeda into
the reamer
fromthe
theBall-tipped
Wire’s
powered
reamer,
Guide
proximal end.
Wire must be loaded into the reamer from the Wire’s
proximal end.
22
2. Utilize a bendable Frasier Suction Tip to navigate
the curve. (See following page)
2. Utilize a bendable Frasier Suction Tip to navigate
Use of a Frazier Suction Tip
APPENDIX A
As mentioned previously, if the Guide Wire has difficulty
maneuvering around the curve of the medial segment, some
surgeons have employed a standard Frazier Suction Tip to help
direct the wire. The Suction Tip is generally bent manually to
accommodate the curve and then introduced into the canal. The
Guide Wire is then driven through until approximately 10mm is
extending past the distal end of the Frazier Tip. The Frazier is then
pushed more deeply into the clavicle until it meets the end of the
Wire, and the Wire is then driven an additional 10mm into the
clavicle. This process is repeated until the Wire reaches 50mm past
the most medial segment of the fracture – Figures 22 and 23.
ADDITIONAL TECHNIQUES FOR MEDIAL CANAL PREPARATION
p
22
USE OF A FRAZIER SUCTION TIP
STEP 3
Use o
10mm
Medial Segment Preparation (Cont.)
Using fluoroscopic guidance, by hand or with power, feed the
Spade-tip Guide Wire into the medial segment until the 50mm gold
section is completely past the most medial edge of the fracture –
Figure 20 and 21.
20
10mm
5
6
If using power, it is 23
recommended to advance the guide wire with
the reamer oscillating for more controlled penetration. Ensure the tip
of the wire is not lodged in bone before initiating powered reaming;
22
a lodged wire may break.
The Frazier Suction Tip is generally bent manually to accommodate the medial clavicle curve and then
As mentio
maneuveri
surgeons h
direct the
accommod
Guide Wir
extending
pushed m
Wire, and
clavicle. T
the most m
introduced into the canal. The Guide Wire is then driven through until approximately 10mm is extending
past the Frazier Tip - Figure 5. The Frazier is then pushed more deeply into the clavicle until it meets the end
21
of the Wire, and the Wire is driven an additional
10mm into the clavicle. The process is repeated until the m
10m
Wire reaches 50mm past the most medial segment of the fracture - Figure 6.
If resistance is encountered while driving the Wire into the medial
segment:
Retain
STEP the
3 Guide Wire. Confirm with flouroscopy and
1. Replace the Spade-tipped Wire with the Ball-Tipped
utilize
a powered
Reamer
to advance (Cont.)
the 4.5mm Flexible
Medial
Segment
Preparation
Guide Wire and attempt to follow the existing canal.
Banded Reamer into canal to a minimum depth of 50mm
If using a powered reamer, the Ball-tipped Guide
Retain the Guide Wire. Confirm with fluoroscopy and utilize a
- Figure 7. Take care not to advance the Reamer past the
Wire must be loaded into the reamer from the Wire’s
powered reamer to advance the 4.5mm Flexible Banded Reamer
tip
Wire,
it maydepth
cause
the –Wire
become
proximal end.
intoofthethe
canal
to a minimum
of 50mm
Figureto24.
Take care lodged
innotthe
Reamer
to advance
the tip.
Reamer past the tip of the Wire, it may cause the
2. Utilize a bendable Frasier Suction Tip to navigate
Wire
to
become
lodged
in the Reamer tip.
7
the curve. (See following page)
23
9
The Flexible Reamer features a band to indicate the 50mm depth –
Note: Minimum medial penetration must be 50mm 24
Figure 25.
past the fracture to ensure adequate fracture support. A
maximum
of 60mm medial penetration is recommended to
50mm depth band
8 should be performed in short pulses while
Reaming
4.5mm flexible Banded Note:
Reamer
prevent the CRx shaft from being directed off-axis by the
lavaging to prevent heat generation.
curvature of the medial side.
AC Jo
45° Ce
®
Alternatively:
Use depth
the 3.0mm
Curved8.
Trocar and 4.5
The 4.5mm Flexible Reamer features a band to indicate
the 50mm
- Figure
Curved Cutting Awl to prepare the medial canal to a depth
of 50mm. Make sure the curves of the Trocar and Awl
NOTE: Reaming should be performed in short pulses while lavaging to prevent heat generation.
are aligned with the curvature of the clavicle. Ensure the
anterior cortex is not punctured by the Awl.
25
23
APPENDIX B
SHOULDER SURGERY AND PROPIONIBACTERIUM ACNES (P. ACNES) BACTERIA
Terry L. Whipple, M.D., F.A.C.S.
About P. acnes
P. acnes is a rod-shaped, anaerobic (but oxygen tolerant) bacteria that develops in low oxygen
environments such as hair follicles and deep within pores – Figure 1. It is closely linked with the
commonly known “acne” skin condition, and is therefore prevalent on the shoulders, as well as
Terry L. Whipple, M.D., F.A.C.S.
the neck and face.
SHOULDER SURGERY AND PROPIONIBACTERIUM
ACNES (P. ACNES) BACTERIA
ABOUT P. ACNES
Additionally, P. acnes is gram-positive,
it turnsanaerobic
violet during
Gram
staining
method
P. acnesmeaning
is a rod-shaped,
(but the
oxygen
tolerant)
bacteria
that
of bacterial determination – Figure
2.
Fortunately,
its
gram-positive
nature
makes
P.
acnes
develops in low oxygen environments such as hair follicles and deep
more vulnerable to antibiotics. within pores - Figure 1. It is closely linked with the commonly known
“acne” skin condition, and is therefore prevalent on the shoulders, as
P. acnes shoulder infections
well as the neck and face.
P. acnes shoulder infections are generally similar in their manifestation. The slow
1
growth of the bacteria results
in late-stage infections with frequently negative
1
Additionally,
P. acnes
is gram-positive,
it turns
P. acnes bacteria
. To identify P. acnes, studies
normally
recommend
culturemeaning
incubation
for violet during
cultures
the Gram staining method of bacterial determination - Figure 2. For14 to 28-days2.
tunately, its gram-positive nature makes P. acnes more vulnerable to
antibiotics.
Infection appears 37 weeks after
P. ACNES SHOULDER INFECTIONS
surgery
P. acnes shoulder infections are generally similar in their manifestation.
Initial bacterial
cultures are 2
negative
Gram staining of P. acnes bacteria
Infection appears
3-7 weeks after
surgery
Initial bacterial
cultures are
negative
The slow growth of the bacteria results in late-stage infections with
frequently negative cultures1. To identify P. acnes, studies normally
recommend culture incubation for 14 to 28 days2.
Not
necessarily
painful
EXTRAORDINARILY SLOW GROWING
Peer-reviewed studies demonstrate infection
rates between 2% and 7.8% for most shoulder
procedures3-6. In these procedures, P. acnes is
Figure 3. How a P. acnes shoulder infection generally manifests
Not necessarily
Extraordinarily
slow growing
painful
one of the three most commonly found bacteria7.
However, the time taken to positively identify
Peer-reviewed studies demonstrate infection rates
between
2%a and
7.8%
for mostlonger
P. acnes
through
culture
is significantly
3-6
one
of two
the three
most
commonly
shoulder procedures . In these procedures, 3P. acnes
thanisthe
other
bacteria
- Table
1.
7
found bacteria . However, the time taken to positively identify P. acnes through a culture is
How a P. acnes shoulder infection generally manifests
significantly longer than the other two bacteria – Table 1.
Bacteria
Staphylococcus aureus (Staph)
Staphylococcus epidermidis (Staph)
Propionibacterium acnes (P. acnes)
24
Culture Time to Positively Identify
2 hours to 4 days8
10 to 24 hours9
Minimum of 13-days in anaerobic
environment10
Table 1
Sonoma Orthopedics Products, Inc
LB-1231 Rev. A
APPENDIX B
MANAGING P. ACNES
Peer-reviewed literature suggests the following measures for reducing incidence of P. acnes infections:
•Prepare the surgical site several times with ChloraPrep® (or other chlorhexidine solution)11
•Perform routine intraoperative cultures and incubate for 28 days2
•Administer antibiotics for sustained periods upon observing signs of inflammatory reaction12
•Incise and drain any fluctuant process, or skin swab re-culture without fluctuance without necessarily removing the implant, if possible13
REFERENCES
1. Pierre Yves Levy, et al. Propionibacterium acnes Postoperative Shoulder Arthritis: An Emerging Clinical Entity Clin Infect Dis. Jun 2008
2. Sethi, Vadasdi, Greene, et al. Incidence of positive P. acnes in shoulder arthroscopy. AOSSM Poster 2014
3. Leroux T et al. Rate of and risk factors for reoperation after ORIF of midshaft clavicle fractures. JBJS July 2014 (2.6% deep infection)
4. Blonna D. Incidence and risk factors for acute infection after prox hum fx. JSES April 2014 (4% infection)
5. Liu PC et al. Infection after surgical reconstruction of a clavicle fracture using a recon plate. J Med Sci Jan 2008 - Infection after surg recon of clavicle (4.9% infection)
6. Bostman, et al. Complications of plates in midclavicular fractures. J Trauma. Nov 1997 (7.8% deep
infection)
7. Saltzman MD et al. Infection after shoulder surgery. J Am Acad Orthop Surg. Apr 2011
8. Paule M. Detection of Staphylococcus aureus using real-time PCR. JMD Aug 2004
9. Haimi-Cohen Y, et al. Initial concentration of Staph in pediatric blood cultures. J Clin Microbiol.
Mar 2002
10.Butler-Wu S, et al. Anaerobic thioglycolate broth culture for recovery of P. acnes. J Clin Microbiol. Jul 2011
11.Edmiston CE Jr, et al. Reducing risk of surgical site infections: does chlorhexidine provide a benefit? Am J Infect Control. May 2013
12.Portillo M, et al. Propionibacterium acnes: an underestimated pathogen in implant-associated infections. Biomed Res Int. 2013
13.M. Nisbet. P. acnes: an under-appreciated cause of post-neurosurgical infection. J Antimicrobial
Chemother. Sep 2007
25
Implant Specifications
IMPLANT SPECIFICATIONS
ifications
Implant Specifications
SONOMA CRX® IMPLANTS
Implant Specifications
Implant Specifications
CRX-WG2-40100-S 4.2mm x 100mm Sonoma CRx®
Implant Specifications
Implant Specifications
CRX-WG2-40110-S 4.2mm x 110mm Sonoma CRx®
{{
Grippers expand
to 8Grippers
mm. expand
{
{
{
{
CRX-WG2-40120-S 4.2mm x 120mm Sonoma CRx®
to 8 mm.
Grippers expand
to 8 mm.
ImplantGrippers
Part
Numbers
expand
Implant
Part Numbers
CRX-WG2-40130-S 4.2mm x 130mm Sonoma CRx®
to 8 mm.
Bone Screws
Sonoma CRx Implants
Implants
Bone Screws 4.2mm diameter
Sonoma
CRx
Grippers4.2mm
expand
5.2mm diameter
Implant
Part
Numbers
CRX-WG2-40100-S
x
100mm
Sonoma
CRx
WG
SC2714
14mm
Self-Bone
Tapping,
CRX-WG2-40100-S
4.2mm x 100mm Sonoma CRx WG
SC2714
2.7mm2.7mm
x 14mmxSelfTapping,
Screw Bone Screw
to
8
mm.
Grippers
Bone
Screws
Sonoma
CRx Implants
Numbers CRX-WG2-40110-S
4.2mm
x4.2mm
110mm
Sonoma
CRxCRxWGWG
SC2716
16mm
Self-Bone
Tapping,
CRXWG2-40110-S
x 110mm
Sonoma
SC2716
2.7mm2.7mm
x 16mmxSelfTapping,
Screw Bone Screw
Grippers
expand
expand
Implant
Part
Numbers
CRX-WG2-40100-S
4.2mm
x 100mm Sonoma CRx WG
SC2714 2.7mm x 14mm Self-Tapping, Bone Screw
SC2718
2.7mm2.7mm
x 18mmxSelfTapping,
Screw Bone Screw
CRX-Wto
G2-40120-S
x 120mm
Sonoma
8 mm. x4.2mm
SC2718
18mm
Self-Bone
Tapping,
CRX-WG2-40120-S
120mm
Sonoma
CRxCRxWGWG
8to4.2mm
mm.
nts
Bone
Screws
CRX-WG2-40110-S
4.2mm
x 110mm
Sonoma CRx WG
SC2716 Screws
2.7mm x 16mm Self-Tapping, Bone Screw
Bone
Sonoma
CRx Implants
SC2720 2.7mm x 20mm Self-Tapping, Bone Screw
CRXWG2-40130-SPart
4.2mm
x 130mm Sonoma CRx WG
Implant
Numbers
m x 100mm Sonoma
CRx
WG CRXSC2714
2.7mm
x WG
14mm
Screw
SC2720
20mm
SelfTapping,
CRXWG2-40130-S
4.2mm x 4.2mm
130mm
Sonoma
CRx CRx
xx 100mm
Sonoma
WG
2.7mm
xx 14mm
TTapping,
Bone
Screw
SC2718
2.7mm2.7mm
18mmxSelfSelfapping,
Bone
Screw Bone Screw
CRX-W
WG2-40100-S
G2-40120-S
4.2mm
120mm
Sonoma
CRx
WG Self-Tapping, BoneSC2714
5mm
SC2722 2.7mm x 22mm Self-Tapping, Bone Screw
Bone
Screws
CRx Implants
CRX4.2mm
xx 110mm
Sonoma
2.7mm
xx16mm
TTapping,
Bone
Screw
WG
SC2720
2.7mm
20mmxSelfSelfapping,
Bone
Screw Bone Screw
CRX-W
WG2-40110-S
G2-40130-S
4.2mm
130mm2.7mm
Sonoma CRx
CRx
WG Self-Tapping, BoneSC2716
m x 110mm Sonoma CRx WG Sonoma
SC2716
x
16mm
Screw
SC2722
2.7mm
22mm
SelfT
apping,
Implant
Part
Numbers
SC2724 2.7mm
xx 24mm
Self-TTapping,
apping, Bone
Bone Screw
Screw
CRX-W
WG2-40120-S
G2-40100-S 4.2mm
4.2mm xx 120mm
100mm Sonoma
Sonoma CRx
CRx WG
2.7mm
SC2718
2.7mm
xx14mm
18mm
SelfTTapping,
Bone
Screw
WG Self-Tapping, BoneSC2714
SC2722
2.7mm
22mmxSelfSelfapping,
Bone
Screw Bone Screw
SC2718
2.7mm
x 18mm
Screw
m x 120mm Sonoma CRx WG CRXSC2724
2.7mm
24mm
SelfTapping,
Implants
Bone
Screws
Sonoma
CRx
SC2726
2.7mm
x
26mm
CRXW
G2-40110-S
4.2mm
x
110mm
Sonoma
CRx
SC2716
16mm
SelfT
apping,
Bone
Screw
WG
SC2720
CRX-WG2-40130-S 4.2mm x 130mm Sonoma CRx WG
SC2724 2.7mm
2.7mm xx 20mm
24mm SelfSelf-TTapping,
apping, Bone
Bone Screw
Screw
8mm
CRX-W
WG2-40120-S
G2-40100-S 4.2mm
4.2mm
100mm Sonoma
Sonoma
CRx
WG
SC2714
2.7mm
xx 14mm
SelfTTapping,
Bone
Screw
SC2720
2.7mmCRx
x 20mm
Screw
m x 130mm Sonoma CRx WG CRXSC2718
2.7mm
18mm
Selfapping,
Bone
Screw
xx 120mm
WG Self-Tapping, Bone
SC2726
2.7mm
x
26mm
SelfT
apping,
Bone
Screw
SC2722
2.7mm
x
22mm
SelfT
apping,
Bone
Screw
SC2726 2.7mm
2.7mmxx16mm
26mmSelfSelf-TTapping,
apping,Bone
BoneScrew
Screw
CRXxx 110mm
CRx
SC2716
WG
SC2720
CRX-W
WG2-40110-S
G2-40130-S 4.2mm
4.2mm
130mm Sonoma
Sonoma
CRx
WG Self-Tapping, Bone
SC2722
2.7mm
x 22mm
Screw 2.7mm
BONE
SCREWS
SC2724
2.7mm xx 20mm
24mm SelfSelf-TTapping,
apping, Bone
Bone Screw
Screw
SC2718 2.7mm
CRX-WG2-40120-S 4.2mm x 120mm Sonoma CRx WG
2.7mm xx 18mm
22mm SelfSelf-TTapping,
apping, Bone
Bone Screw
Screw
SC2724 2.7mm x 24mm Self-Tapping, BoneSC2722
Screw
SC2726
2.7mm x 26mm Self-Tapping, Bone Screw
A
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®
®®
®
®
®
®
®
®
®
®
®
®
®
®
®
CRX-WG2-40130-S
SC2720
SC2724 2.7mm
2.7mm xx 20mm
24mm SelfSelf-TTapping,
apping, Bone
Bone Screw
Screw
4.2mm x 130mm Sonoma CRx WG
SC2726 2.7mm x 26mm Self-Tapping, BoneSC2722
Screw 2.7mm x 22mm Self-Tapping, Bone Screw
SC2726 2.7mm x 26mm Self-Tapping, Bone Screw
SC2724 2.7mm x 24mm Self-Tapping,1.9mm
Bone 2.7mm
Screw
5mm
SC2726 2.7mm x 26mm Self-Tapping, Bone Screw
2mm
SC2714 2.7mm
SC2716 2.7mm
SC2718 2.7mm
Sonoma Orthopedic
Products,
Inc.
SC2720
2.7mm
2.7mm
3589 WestwindSC2722
Blvd.
Sonoma Orthopedic Products, Inc.
SC2724
Santa Rosa, California
954032.7mm
3589 Westwind Blvd.
SC2726
2.7mm
P:
707-526-1335
Fax:Products,
707-526-2022
Sonoma
Orthopedic
Santa Rosa,
California
95403 Inc.
Sonomawww.sonomaorthopedics.com
Orthopedic
Products,
Inc.
x
x
x
x
x
x
x
14mm Self-Tapping Bone Screw
16mm Self-Tapping Bone Screw
18mm Self-Tapping Bone Screw
Sonoma Orthopedic Products, Inc. has made these technique
20mm
Self-Tapping Bone Screw
guidelines available for informational purposes only and to illustrate
the physician authors’ suggested treatment for an uncomplicated
22mm
Self-Tapping
Bone
Screw
Sonoma
Orthopedic
Products,
Inc. hasand
made
these technique
procedure. Proper surgical
procedures
techniques
are the
guidelines available
for informational
purposes
only
to illustrate
responsibility
of the surgeon,
who must
evaluate
theand
appropriateness
24mm
Self-Tapping
Bone
Screw
the
physician
authors’
suggested
for an
uncomplicated
of
the
procedures
described,
basedtreatment
upon his/her
own
personal medical
procedure.
Proper surgical
and
techniques
are the
training,
experience
and theprocedures
needs of the
individual
patient.
Prior to the
26mm
Self-Tapping
Bone
Screw
Sonoma
Products,
Inc.
has
these
technique
responsibility
of theOrthopedic
surgeon, who
mustmade
evaluate
the
appropriateness
use
of theOrthopedic
Sonoma
Products
system,
the
surgeon
should
Trademarks and ® Registered Marks of Sonoma
Orthopedic Products, Inc.
TM
MediTech Strategic Consultants B.V.
®
Maastrichterlaan
127-129
Trademarks and
Registered Marks
of Sonoma
Orthopedic Products,
Inc.Vaals
6291 En
TM
Netherlands
MediTech Strategic Consultants B.V.
0344 The
Maastrichterlaan 127-129
©2013
Sonoma Orthopedic
Products, Inc.
TM
®
Trademarks and6291
Registered
En Vaals Marks of Sonoma
All Rights Reserved
Orthopedic Products,
Inc.
TheTM
Netherlands
guidelines
available
for informational
purposes
andpersonal
toindications,
illustrate
Trademarks
and ®and
Registered
Sonoma
Orthopedic
Products,
Inc.
has
made
these
technique
USA Patents
7,846,162; 7,909,825;
7,914,533
7,942,875 Marks of Sonoma
0344
of the
based
upon
his/her
own
medical
refer
toprocedures
the
productdescribed,
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