PANTERA® Surgical Technique Guide

Transcription

PANTERA®
Surgical Technique Guide
®
Contents
PANTERA® represents the next generation of fixed angle modular fixation
1
Installing the PANTERA® is a 4-Step Process
2
Patient Positioning3
Become familiar with the Plate and Sterilization Tray
4
Step 1: Preliminary Fracture Reduction 5-6
Step 2: Plate Positioning and Pinning
7
Step 3: Diaphysial Fixation8-10
Step 4: Humeral Head Fixation
11-18
Final Fixation of the Humeral Head
19
Suture Clips20
Essential Information21
Implantable Components22
Instruments and Accessories22
®
®
Represents the next generation
of fixed angle modular fixation
Stability
Soft Tissue Clips
Cross-element fixation minimizes loss of reduction and
Innovative suture clips offer endless possibilities for
protrusion through the articular surface of the humeral
soft tissue reconstruction. This is especially useful
head.
when repairing ruptures of the rotator cuff associated
with some humerus fractures or when repairing soft
TOBY F.I.X.E.D.™ Cross Element Technology
Inspired by the high incidence of joint penetration,
particularly in elderly patients with osteopenic bone,
comminuted tuberosities. The suture clips also act as
extremely low-profile extensions of the plate to buttress
the thin comminuted cortical bone of the tuberosities.
TOBY F.I.X.E.D.™ technology now makes it possible
to apply a screw or peg through a locking post, thus
Thoughtful, Anatomic Design
accomplishing an internal scaffold within the trabecular
The low-profile PANTERA® plate is available in both
bone.
right and left configurations. Its true anatomic design
is aimed at minimizing the potential for impingement.
PANTERA®’s proximal posterior profile is designed to
address displacement of the humeral head posteriorly.
1
Installing the
®
is a 4-Step Process:
The following technique is designed to optimize the surgical exercise.
Step 1
Step 2
Preliminary fracture reduction
Plate positioning and pinning to the humeral head
Step 3
Step 4
Diaphyseal fixation
Humeral head fixation: Use of Cross Elements is
discretionary depending on fracture pattern
2
Patient Positioning
The beach chair position is recommended. For optimal
The forearm may be rested on a Mayo stand for ease of
space management in the operating room, the imaging
manipulation.
equipment may be brought into the field from the
opposite side.
Orthogonal views are necessary for fracture reduction
and fixation.
AP view is readily obtained with the axis of the C-arm
perpendicular to the coronal plane of the proximal
humerus.
Axillary view of the proximal humerus is obtained
rotating the C-arm 45 degrees into a more vertical
position and extending the shoulder 45 degrees in
the opposite direction. As such, there is minimal
maneuvering of the equipment or the arm.
3
The shoulder may be abducted to reduce the tension
on the deltoid.
A delto-pectoral approach is suggested.
Become familiar with the Plate and Inventory
Become Familiar with the Plate
Become familiar with the alignment of the three Post
Become Familar with the implants and
Sterilization tray
holes on the plate by installing the Post Drill Guides in
Prior to the operation ensure that you have sufficient
each of the three corresponding positions. Note that the
sterile implants to complete the operation.
middle Post aims slightly more anterior on the humeral
Note: The Cross Element packages contain two
head than the proximal and distal Posts.
screws.
Knowing the proper orientation of the Posts is very
Ensure also the instrument tray is complete as per list
important to avoid forcing the Post into the humeral
on page 23 and 24.
head in a position other than into its corresponding
pre-drilled hole.
Humeral head fixation in PANTERA® was designed with
the regional variations in bone density in mind. The best
bone and most purchase is achieved in the center of
the humeral head in the posterior hemisphere.
®
4
Step 1: Preliminary Fracture Reduction
Step 1: Preliminary Fracture Reduction
The metaphyseal void that becomes obvious after
Expose and debride the fracture. Make every effort
reduction of the fracture fragments may be filled with
to avoid stripping the soft tissue from the fracture
allograft or a suitable bone substitute.
fragments. The hematoma from the fracture site may
be removed using suction. Use traction and direct
manipulation to reduce the fracture. Re-establish the
anatomical relationship between the articular surface
placed where they do not interfere with the application
of the plate
and the humeral shaft by restoring both its angular
Caution: Exercise care to avoid damaging the
alignment and retroversion.
vasculature to the bone fragments.
Assure the tuberosities can be reduced to their proper
locations. Suture may be applied to the comminuted
bone of the tuberosities for the purposes of fracture
reduction and fixation.
5
Preliminary reduction may be maintained with K-wires
With the plate in place, drive K-wires into each of the
Assemble two Post Drill Guides with their respective
two Post Drill Guide Sleeves and confirm preliminary
K-wire Sleeves to the plate, preferably along the two
positioning.
proximal holes. In this manner, one can drill and apply a
compression screw into the oblong portion of the plate
with minimal interference from the Post Drill Guides.
Assemble a Locking Screw Drill Guide to the most distal
position of the plate. Such assembly allows for ease of
manipulation of the plate early in its implantation
The K-wire inserted into the guide for the middle Post
should coincide with the particular center line of the
humeral head.
Anterior-posterior and lateral views should confirm
proper positioning of the plate.
Identify the position of the plate. It should be placed
immediately posterior to the intertubercular groove and
approximately 1.5 to 2.0 cm distal to the insertion of the
supraspinatus to avoid impingement with the acromion.
6
Take full advantage of the Suture Clips to assist in the
Fixation of the plate to the shaft as in Step 3 can help
reduction and fixation of the comminuted bone of the
complete reduction of the humeral head (with the
tuberosities. The comminuted greater tuberosity is
tuberosities) to the shaft. The manner of reduction has
brought under the proximal and posterior buttress of
been termed “buttress reduction” or “buttress plating.”
the plate.
Application of screws into the humeral head is
discouraged until (proximal) reduction of the head and
the tuberosities is achieved. Avoid having a prematurely
placed screw interfere with fracture reduction.
7
Step 3: Diaphysial Fixation
Use the Depth Gauge to aid in the selection of the
Using the 2.5mm Drill Bit, drill a hole in the humeral
proper length Cortical Screw.
neck through the center of the oblong hole in the plate.
Use the 2.5/3.5mm Drill Guide to avoid injury to the
surrounding soft tissue.
®
8
With the Hex Driver, affix the plate to the humeral shaft
At least one Cortical Locking Screw must be placed
fragment using a 3.5mm diameter Cortical Screw
into one of the distal holes on the plate.
through the oblong hole of the plate. Frequently, this will
contribute to fracture reduction (buttress reduction).
If the plate is not properly positioned, remove the
K-wires and loosen the Cortical Screw. Make the
necessary adjustments, re-apply the K-wires and
tighten the Cortical Screw.
Note: If the medial calcar is fractured, use a more distal
screw hole for the purposes of initial diaphyseal fixation
(and to achieve the desired buttress reduction). The
calcar may then be lagged to the construct through the
oblong screw hole (calcar reduction hole).
9
Thread the Locking Screw Drill Guide into the desired
location on the plate.
Using the 2.5mm Drill Bit, drill a hole through the
Install the Cortical Locking Screw into the threaded hole
Locking Screw Drill Guide into the bone.
of the plate using the Hex Driver.
Use the Depth Gauge to determine the proper screw
This procedure may be repeated as needed for the
length.
remaining holes on the distal segment of the plate
Note: Alternatively, non-locking Cortical Screws may
be used for this application. If so, be certain to use the
non-threaded hole of the plate.
10
Using the 4.0mm Drill Bit, drill the hole for the post as
Once the optimal fracture reduction and proper position
shown.
of the plate and distal fixation have been accomplished,
one may proceed with the definitive proximal fracture
fixation.
Starting with the middle Post Drill Guide, remove the
K-wire and the Post Drill Guide Sleeve.
11
Caution: Avoid penetrating into the joint. It is advisable
to drill only up to 5mm to 10mm away from the
subchondral bone of the joint surface to minimize the
risk of joint penetration.
Remove the Post Drill Guide.
Use the Depth Gauge to select a properly sized Post
w/Cross Elements.
Install the Post w/Cross Elements through the plate
into the humeral head using the Cruciform Driver. The
cruciate screwdriver has asymmetric limbs that match
the corresponding features in the head of the post.
Caution: It is advisable to select a Post w/Cross
These features are necessary for proper installation of
Elements that falls 5mm to
Cross Elements, when indicated.
Caution: Place the Posts in the same orientation as the
pre-drilled holes.
®
12
Confirm proper implantation with intra-operative
fluoroscopy.
Repeat to fill all three Post holes for optimal fracture
fixation.
13
Application of Cross Elements
At surgeon discretion, Cross-Elements may be applied
Note: Always check that the corresponding K-wires
at this point. If Cross Elements are not used, please
can travel freely into the Cross Element Guide. With the
proceed to application of the Post Cap Screw(s).
Guide assembled, the surgeon can proceed.
Insert the three Cross Element Guide Sleeves into the
three locations on the Cross Element Guide.
14
Align the Cross Element Guide with one of the Post
Apply three K-wires through the Cross Element Guide
w/Cross Elements and lock it into place by threading
Sleeves, into the bone, through the Post to prevent
the Cross Element Guide Retainer, as shown.
inadvertent rotation of the Post while placing a Cross
Caution: Ensure that the notches on the Cross Element
Element.
Guide are properly aligned with the reciprocal notches
Evaluate placement using fluoroscopy and re-adjust as
in the Post w/Cross Elements. Failure to do so will result
necessary. Use both anterior-posterior and lateral or
in improoper placement of the Cross Elements.
axillary views for this purpose.
Note: The Cross Elements enter the bone through the
lesser tuberosity and their trajectory is extra-capsular
and extra-articular. The mechanical support afforded
by the Cross Elements is optimal to resist collapse of
the humeral head. The plate provides excellent lowprofile buttress to the greater tuberosity proximally and
posteriorly.
15
Drill back and forth three to four times with the K-wire
Insert the Depth Gauge into the hole vacated by the
to ensure the pilot hole intended for the Cross Element
Cross Element Guide Sleeve.
is well-established. The corresponding Cross Element
should slide into the pilot hole. If necessary, make a
small longitudinal incision on the overlying soft tissue to
Advance the Depth Gauge until it touches the humeral
head.
allow for easier passage of the Cross Element into its
Caution: Do not advance the tip of the Depth Gauge
corresponding hole.
into the bone.
Remove one of the K-wires and one of the Cross
The proper Cross Element length may be determined
Element Guide Sleeves.
by viewing the corresponding scale labeled “Cross
Element Scale” on the cylindrical surface of the Depth
Gauge. The Cross Element Scale includes only the four
corresponding sizes of the Cross Elements: 20mm,
25mm, 30mm, and 35mm.
Note: If the scale points in between two such sizes,
always choose the smaller size.
®
16
Install the Cross Elements, as shown. Ensure that the
Evaluate final reduction and placement using
head of the Cross Element is below the surface of the
fluoroscopy and re-adjust as necessary. Use both
humeral head.
anterior-posterior and lateral or axillary views for this
Repeat up to three times per Post w/Cross Elements
to fill the three holes available for articulation with Cross
Elements.
Note: The actual number of Cross Elements used is left
to the discretion of the surgeon.
Note: An important benefit of using the Cross Elements
is the fixation of the lesser tuberosity. A well-fixed lesser
tuberosity provides additional mechanical buttress
and biologic support to the humeral head. In addition,
stabilization of the lesser tuberosity may play a role in
the restoration of functional internal rotation.
17
purpose.
Lock the Post w/Cross Elements into place by installing
a Post Cap Screw with the Square Driver.
This completes the installation of the Post(s) w/Cross
Elements.
18
Final Fixation of the Humeral Head
Assemble the Locking Screw Drill Guide to one of the
Use the Depth Gauge to determine the proper screw
corresponding holes on the proximal end of the plate.
length.
Using the 2.5mm Drill Bit, drill the hole for the Cortical
Caution: Choose a screw length that is 5mm to 10mm
Locking Screw, as shown.
away from the subchondral bone of the joint surface to
Caution: Avoid drilling through the joint.. Drill up to 5mm
to 10mm short of the articular surface.
avoid joint penetration.
Install the Cortical Locking Screw in the threaded hole
of the plate and confirm proper placement with
intra-operative fluoroscopy.
Repeat until both proximal holes are filled.
19
Suture Clips
Suture Clips may be used to manage the comminuted
Repair of an associated rotator cuff tear may be
bone of the tuberosities and to repair associated soft
undertaken at the end of the procedure after fracture
tissue lesions, such as rotator cuff tears.
fixation has been accomplished. Multiple sutures can
The Clips provide necessary additional fixation of
the tuberosities. Stable tuberosity fixation provides
be made to pass through the Clips with great ease,
demonstrating the versatility of the design.
additional mechanical buttress and biologic support to
Close the wound using appropriate surgical technique
the humeral head.
and use drains, as necessary.
®
20
Essential Information
Note: This sheet does not include all essential
• Do not advance the tip of the Depth Gauge into the
information required for selection and use of a surgical
device. The surgeon should rely on his own training
and experience, as well as consulting the product’s
bone when measuring for Cross Element selection.
• Choose a screw length that is 5mm to 10mm away
from the subchondral bone of the joint surface to
full labeling and Instructions for Use for all necessary
avoid joint penetration.
information.
Indications:
• Re-using Implantable Components may result in an increased risk of infection and hardware failure.
PANTERA® is indicated for fractures and fracture
dislocations, osteotomies, and non-unions of the
Adverse Effects:
proximal humerus.
Potential complications / adverse events associated
Contraindications:
with the use of implantable shoulder plates include, but
are not limited to, the following:
Proximal humerus fractures with significant
fragmentation of the head where reconstruction is not
possible.
Proximal humerus fractures for which there is a
likelihood of development of clinically relevant avascular
• Screw Perforation Into Glenohumeral Joint
• Postoperative Discomfort
necrosis of the fracture fragments.
• Numbness
Cautions:
• Inflammation
• Exercise care to avoid damaging the vasculature to
• Humeral Head Collapse / Fracture Due To Aseptic
the bone fragments.
• Avoid penetrating into the joint while drilling or
installing a Screw, Post w/Cross Elements, or Cross
Element.
• It is advisable to elect a Post w/Cross Elements
that is 5mm to 10mm away from the subchondral
bone of the joint surface to minimize the risk of joint
penetration.
• Ensure that the notches on the Cross Element Guide
are properly aligned with the reciprocal notches in the
Post w/Cross Elements. Failure to do so will result in
improper placement of the Cross Elements.
21
• Postoperative Pain (Shoulder)
Necrosis
• General Infection
• Avascular Necrosis
Sterile Single Use Components
STERILE
Catalogue No
Description
STERILE
Catalogue No
Description
TOS-35-CLS-20
3.5mm Cortical Locking Screw, 20mm
TOS-PHP-L73
PANTERA® Plate, Left, 73mm
TOS-35-CLS-22
TOS-PHP-R73
PANTERA® Plate, Right, 73mm
TOS-35-CLS-24
TOS-PHP-L83
PANTERA® Plate, Left, 83mm
TOS-35-CLS-26
TOS-PHP-R83
PANTERA® Plate, Right, 83mm
TOS-35-CLS-28
TOS-DB25-110
2.5mm Drill Bit X 110mm
TOS-35-CLS-30
TOS-DB25-160
TOS-35-CLS-35
TOS-DB40-110
TOS-35-CLS-40
TOS-DB40-160
TOS-35-CLS-45
TOS-KW-16-130
1.6mm K-Wire X 130mm
TOS-35-CS-20
3.5mm Cortical Screw, 20mm
TOS-6KW-16-130
1.6mm K-Wire X 130mm, Quantity 6
TOS-35-CS-22
TOS-KW-16-230
1.6mm K-Wire X 230mm
TOS-35-CS-24
TOS-6KW-16-230
1.6mm K-Wire X 230mm, Quantity 6
TOS-35-CS-26
TOS-35-CS-28
TOS-35-CS-30
TOS-35-CS-32
TOS-35-CS-34
TOS-20-2CE-20
2.0mm Cross Element, 20mm, Quantity 2
TOS-20-2CE-25
TOS-20-2CE-30
TOS-20-2CE-35
TOS-52-PPCS-30
5.2mm Post and Post Cap Screw, 30mm
TOS-52-PPCS-35
TOS-52-PPCS-40
TOS-52-PPCS-45
TOS-52-PPCS-50
22
Sterilization Tray Instruments
No.
23
Catalogue No
Description
1
TO-FIX-CEG
Cross Element Guide
2
TO-FIX-CEGS
Cross Element Guide Sleeve
3
TO-FIX-CEGR
Cross Element Guide Retainer
4
TO-PH-PDG-28
Post Drill Guide, 28mm
5
TO-PH-PDGS-28
Post Drill Guide Sleeve, 28mm
6
TO-PH-LSDG-28
Locking Screw Drill Guide, 28mm
7
TO-DG-2535
2.5mm/3.5mm Drill Guide
8
TO-DRI-CR
Cruciform Driver
9
TO-PH-DG-50
Depth Gauge, 50mm
10
TO-DRI-25H
2.5mm Hex Driver
11
TO-DRI-PSQ
Precision Square Driver
12
TO-DRI-25PH
2.5mm Hex Driver w/Quick Connect
3
4
2
2
5
3
4
6
10
12
SEE DETAIL
8
7
11
9
1
A
2.6
[64,75 ]
LASER ETCH SERIAL NUMBER
AS SHOWN
2 PLACES
4
HOLE PATTERN REMOVED FOR
GRAPHICAL REASONS ONLY
2
3
®
24
Go to www.jri-ltd.co.uk or
simply scan the QR code with
your smartphone
Manufactured by
Toby Orthopaedics LLC
JRI Orthopaedics is wholly owned by
Orthopaedic Research UK
Distributed By:
Toby Orthopaedics, LLC, 1805 Ponce de Leon Blvd.
Suite 501, Coral Gables, FL 33134 USA

0086
18 Churchill Way, 35A Business Park, Chapeltown, Sheffield S35 2PY
T: 0114 345 0000 F: 0114 345 0004 W: www.jri-ltd.co.uk
??/??/3/2012

PANTERA® Surgical Technique Guide

Transcription

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