Xia Low Profile Spinal System Ilios Application of the Xia Family

Xia Low Profile Spinal System
Ilios Application
of the Xia Family
Surgical Technique
Xia Ilios Application
Introduction
Introduction
The evolution of the XIA Ilios
Application is further evidence of
Stryker Spine’s commitment to
continue to listen to the global surgeon
community and to provide implants
and instruments that strive to offer
optimal surgical solutions.
Stryker Spine’s new Ilios Application
was developed and built upon the
success of the XIA Application. The
Ilios system provides a comprehensive
offering of XIA Long Screws,
Offset Connectors and Rod-to-Rod
Connectors to provide solutions for
Sacral-Iliac fixation.
Stryker Spine would like to extend
their thanks to:
Frank F. Rand, M.D., Boston, MA
for his participation in the continued
development of the Ilios Application
and Surgical Technique.
2
Patient
Positioning
Table of Contents
Operative Technique
4
B. Surgical Access
5
C. Pelvic Screw Path Preparation
6
D. Pelvic Screw Placement
7
E. Axial Connection
8
F. Parallel Connection
9
G. Offset Iliac Connectors
11
H. Rod-to-Rod Connectors
12
I. Indications
13
J. Contraindication
14
Implant Overview
16
Instrument Overview
20
Implants &
Instruments
Contraindication
Indication
Rod to Rod
Connection
Offset Iliac
Connection
Parallel
Connection
Axial
Connection
Pelvic Screw
Placement
Surgical
Access
A. Patient Positioning
3
Patient
Positioning
Xia Ilios Application
Patient Positioning
Patient Positioning
Diagnosis of deformity is based upon
patient history, physical findings and
preoperative radiographic assessment.
The patient is usually positioned
prone on an appropriate spinal
table. Care is taken to pad all bony
prominences. The abdomen should not
be compressed to help lower venous
pressure.
Surgical levels may be verified
clinically or radiographically. To
ensure adequate exposure, the incision
is made to extend just beyond the
length of the intended fusion.
Presurgical planning defines the most
appropriate implants, as well the
optimal location of insertion.
4
The lumbar spine is exposed first. To
begin the pelvic anchorage procedure,
a separate fascial incision over the
posterior iliac crest is made to allow
placement of intra iliac screws. The
lumbar spine exposure, surgical
procedure (decompression, etc) and
instrumentation are completed prior
to placement of iliac/pelvic screws.
Following the initial incision, a
subperiosteal dissection of the outer
table of the pelvis provides access
to the pelvic anchorage site. The
inner table is exposed to a depth of
approximately 1.5cm to facilitate
notching the crest and tunneling
of the connector. This tunneling
approach is straight forward and
leaves the muscle attached, providing
better coverage and a simpler closure.
ASIS
Crest
Iliac Tubercle
PSIS
5
Surgical
Access
Surgical Access
Xia Ilios Application
Operative Technique
Pelvic Screw Path Preparation
Pelvic Screw
Placement
With the posterior crest and outer
table exposed the surgeon is ready to
place the pelvic screw. Approximately
1.0 to 2.0 centimeters up from the
tip of the spine is an ideal starting
point. At this point, the crest widens
and provides a wide channel for the
implant. Use a rongeur to make a
notch in the crest of sufficient depth
and width to accept the head of the
implant. The top of the implant (after
insertion) should not be proud beyond
the contour of the crest. Prominent
implants can be a problem in this area.
Use a curette to start the path between
the tables of the pelvis. This curette is
used for the first 1.0 to 2.0 centimeters.
After the curette, use a straight
probe to sound the path between the
tables over the notch. Stop every few
centimeters to check with a ball tip
feeler to verify integrity of the canal.
When the trajectory and depth are
proven, measure the depth of the canal
using the Xia Depth Gauge (884025).
6
Pelvic Screw Placement
Generally speaking, a 6.5 − 8.5mm
diameter screw by 80mm long is used
in most patients.
Both the Xia Polyaxial Screwdriver
(48041310) and Xia Monoaxial
Screwdriver (48041320) provide a
rigid connection between the screw
and screwdriver.
7
Pelvic Screw
Placement
With the pelvic pathway prepared
and proper screw length and diameter
determined, the screw is prepared for
insertion.
Xia Ilios Application
Operative Technique
Axial Connection
Axial
Connection
The connection of the pelvic screw to
the axial construct can either be direct
(Main construct rod captured by
the iliac screw) or with a connecting
implant.
Frequently on the convex side of the
fractional lumbosacral curve, the
axial rod can be easily contoured to
continue from the S1 screw to the
pelvic screw without the need of an
additional connector.
The surgeon may choose to connect to
the axial rod either above or below the
S1 screw with one of the Xia Offset
Connectors (03820130, 03820131,
03820132, 03820133, 48220130,
48220131, 48220132, 48220133).
Note:
When using Xia Titanium
implants, the surgeon may select
a Xia Vitallium Rod (03822601).
Vitallium Rod is recommended to be
cut by the Xia Table Top Rod Cutter
(03808400) only.
8
Axial Connection
The Xia Inserter (48047009) can help
align the Xia Universal Tightener,
5mm (03807008) and the Blocker
(03756230) with the implant.
The final tightening of the Blocker is
done by utilizing the Xia Anti-Torque
Key (03807026) and the Torque
Wrench (03807028). The Torque
Wrench indicates the optium force
which has to be applied to the implant
for final tightening. Line up the two
arrows to achieve this optimum torque
of 12Nm.
9
Parallel
Connection
Use a Shindt Clamp in order to tunnel
to the lumbar wound. After tunneling
through the wound, pass the axial rod
or connector through.
Xia Ilios Application
Operative Technique
Parallel Connection
The Xia Spinal System also offers a
parallel connection from the main
construct to the ilium. The Xia Rodto-Rod Connectors enable a surgeon
to connect from the lumbar region to
the ilium using one of four options:
Axial
Connection
1)Small R-R Connector (Neutral)
2)Small R-R Connector (30 degrees)
3)Large R-R Connector (Neutral)
4)Large R-R Connector (10 degrees)
These connectors can be used for
iliac fixation in a revision surgery,
on a stand alone basis or can be
used in conjunction with an offset
rod connection to place two screws
in the ilium for supplemental iliac
fixation. This provides surgeons
with added strength and flexibility in
treating complicated spinal disorders
in the lumbar and sacral regions.
10
Offset Connectors
Four Offset Connector designs are
offered in the Ilios Application. All
designs are available in stainless steel
and titanium. All of these connectors
use a Xia Blocker for final rod fixation.
1)Long Neutral Offset Connector:
This connector is 80mm long and will be perpendicular to the rod when attached. This connector can be cut and bent for additional inter-
operative flexibility.
2)Neutral Offset Connector:
This connector is 35mm long and will be perpendicular to the rod when attached.
This connector is 35mm long and has a 75 degree angle allowing better anatomical placement of the connector in the iliac region.
4)Offset Connector 105 degree bend: This connector is 35mm long and has a 105 degree angle allowing better anatomical placement of the connector in the iliac region.
11
Offset Iliac
Connection
3)Offset Connector 75 degree bend: Xia Ilios Application
Operative Technique
Rod-to-Rod Connectors
Four Rod-to-Rod Connectors are
offered with this set. All designs
are available in stainless steel and
titanium. All of these connectors use
the Xia Blocker for final rod fixation.
1)Small Rod-to-Rod Connector (Neutral):
This open Rod-to-Rod
Connector accommodates parallel rods that are 12mm apart.
2)Small Rod-to-Rod Connector (30 degrees):
This open Rod-to-Rod Connector accommodates rods that are 12mm apart at angles of 30 degrees.
3)Large Rod-to-Rod Connector (Neutral):
Rod to Rod
Connection
This open Rod-to-Rod Connector
accommodates parallel rods that
are 16mm apart.
4)Large Rod-to-Rod Connector
(10 degrees):
12
This open Rod-to-Rod Connector accommodates rods that are 16mm apart at angles of 10 degrees.
Xia Ilios Application
Indications
Indications
Indication
STRYKER Spinal Fixation Systems are
indicated for temporary or permanent
correction or stabilization of the
vertebral column from the thoracic
to the sacrum and with the aim of
helping consolidation or bone fusion.
XIA, OPUS and DIAPASON-RPS
SYSTEMS are designed for posterior
fixation procedure. XIA is also
designed for anterior fixation
procedure.
They are indicated for degenerative
disc disease of the thoracic and lumbar
spine, which is defined as back pain of
discogenic origin with degeneration
of the disc confirmed by history and
radiographic studies, spondylolisthesis,
fracture, spinal stenosis, spinal
deformities such as scoliosis, kyphosis,
lordosis, tumor, pseudarthrosis or
revision of failed fusion attempts.
13
Contraindications
Contraindications
Contraindication
Contraindications may be relative or
absolute. The choice of a particular
device must be carefully weighed
against the patient’s overall evaluation.
Circumstances listed below may
reduce the chances of a successful
outcome:
14
•Any abnormality present which
affects the normal process of bone
remodeling including, but not
limited to, severe osteoporosis
involving the spine, bone absorption,
osteopenia, primary or metastatic
tumors involving the spine, active
infection at the site or certain
metabolic disorders affecting
osteogenesis.
•Insufficient quality or quantity
of bone which would inhibit rigid
device fixation.
•Previous history of infection.
•Excessive local inflammation.
•Open wounds.
•Any neuromuscular deficit which
places an unusually heavy load on
the device during the healing period.
•Obesity. An overweight or obese
patient can produce loads on the
spinal system which can lead to
failure of the fixation of the device or
to failure of the device itself.
•Patients having inadequate tissue
coverage of the operative site.
•Pregnancy.
•A condition of senility, mental
illness, or substance abuse. These
conditions, among others, may
cause the patient to ignore certain
necessary limitations and precautions
in the use of the implant, leading to
failure or other complications.
•Foreign body sensitivity. Where
material sensitivity is suspected,
appropriate tests should be made
prior to material selection or
implantation.
•Other medical or surgical condition
which would preclude the potential
benefit of spinal implant surgery,
such as the presence of tumors,
congenital abnormalities, elevation
of sedimentation rate unexplained
by other diseases, elevation of white
blood cell count (WBC), or marked
left shift in the WBC differential
count.
These contraindications can be relative
or absolute and must be taken into
account by the physician when making
his decision. The above list is not
exhaustive.
Caution and Warning
Caution
Warning
The implantation of pedicle screw
spinal systems should be performed
only by experienced spinal surgeons
with specific training in the use
of this pedicle screw spinal system
because this is a technically
demanding procedure presenting a
risk of serious injury to the patient.
Based on the fatigue testing results,
the physician/ surgeon should
consider the levels of implantation,
patient weight, patient activity level,
other patient conditions, etc which
may impact on the performance of
the system.
The safety and effectiveness of
pedicle screw spinal systems
have been established only for
spinal conditions with significant
mechanical instability or
deformity requiring fusion with
instrumentation. These conditions
are significant mechanical instability
or deformity of the thoracic, lumbar,
and sacral spine secondary to
spondylolisthesis (grades 3 and 4)
of the L5-S1 vertebrae, degenerative
spondylolisthesis with objective
evidence of neurological impairment,
fracture, dislocation, scoliosis,
kyphosis, spinal tumor, and failed
previous fusion (pseudoarthrosis).
The safety and effectiveness of these
devices for any other conditions are
unknown.
15
Implants &
Instruments
Xia Ilios Application
Implants
16
REF
Titanium
REF
Stainless Steel
03756230
48220000
Description
Blocker
03820425 − 0445
48220425 − 0445
Monoaxial Screw
Ø 4.5mm 25mm − 45mm
03820525 − 0555
48220525 − 0555
Monoaxial Screw Ø 5.5mm
25mm − 55mm
03820630 − 0600
48220630 − 0600
Monoaxial Screw Ø 6.5mm
30mm − 100mm
03820730 − 0700 48220730 − 0700
Monoaxial Screw Ø 7.5mm
30mm − 100mm
03820830 − 0800
48220830 − 0800
Monoaxial Screw Ø 8.5mm
30mm − 100mm
03820960 − 0900
48220960 − 0900
Monoaxial Screw Ø 9.5mm
60mm − 100mm
03821425 − 1445
48221425 − 1445
Polyaxial Screw Ø 4.5mm 25mm − 45mm
03821525 − 1555
48221525 − 1555
Polyaxial Screw Ø 5.5mm 25mm − 55mm
03821630 − 1600
48221630 − 1600
Polyaxial Screw Ø 6.5mm 30mm − 100mm
03821730 − 1700
48221730 − 1700
Polyaxial Screw Ø 7.5mm 30mm − 100mm
03801830 − 1800
N / A
Polyaxial Screw Ø 8.5mm 30mm − 100mm
03801960 − 1900
N / A
Polyaxial Screw Ø 9.5mm 60mm − 100mm
REF
Titanium
REF
Stainless Steel
Description
671040 − 671300
N / A
Titanium Alloy Rods
Ø 6.0mm
40mm − 300mm
03802070 − 2480
N/A
CP Titanium Rods
Ø 6.0mm
70mm − 480mm
Standard Rod
Ø 5.5mm
480mm
Ø 5.5mm
480mm
Ø 6.0mm 600mm
N/A
48222000
N/A
48222001
03822601
N/A
48218030 − 8090
N/A
RAD Rod
Ø 6.0mm 30mm − 90mm
48219050 − 9080
N/A
MAX RAD Rod
Ø 6.0mm 50mm − 80mm
Stiff Rod
Vitallium Rod
Implants &
Instruments
17
Xia Ilios Application
Implants
REF
Titanium
REF
Stainless Steel
03805002
48220102
Rod to Rod Clamp Axial
03805001
48220103
Rod to Rod Clamp Parallel
03820101
48220101
Offset Connector
03820100
48220100
Washer
03820104
48220104
Staple
03805000
N/A
Implants &
Instruments
03805025 − 5035
N/A
18
Description
Sacral Block
Sacral Block Bone Screw
Ø 6.5mm
25mm−35mm
REF
Stainless Steel
Description
03820134
48220134
Small Rod-to-Rod Connector, 0°
03820135
48220135 Small Rod-to-Rod Connector, 30°
03820136
48220136
Large Rod-to-Rod Connector, 0°
03820137
48220137 Large Rod-to-Rod Connector, 10°
03820131
48220131 Offset Connector Neutral
03820130
48220130
Offset Connector 75° bend
03820132
48220132 Offset Connector 105° bend
03820133
48220133 Long Offset Connector Neutral
Implants &
Instruments
REF
Titanium
19
Xia Ilios Application
Instruments
REF
Description
Implants &
Instruments
Standard Instruments
20
03807019
Xia Rod Pusher
03710620
Xia Rod Template
03807003
Xia Probe-Feeler (set of 4)
03807024
Xia Blunt Probe
48047011L/R
Xia Bending Irons
03807010
Xia French Bender
03807004
Xia Tap, 4.5 / 5.5mm
03807005
Xia Tap, 6.5 / 7.5mm
REF
Description
03807002 Xia Probe-Finder
03807001
Xia Awl
03807008
Xia Universal Tightener, 5mm
48047009
Xia Inserter
48047018
Xia Rod Fork
48047016
Xia Persuader
03807028
Xia Torque Wrench
03807026
Xia Anti-Torque Key
48047800
Xia Cutting Pliers
Implants &
Instruments
Standard Instruments
21
Xia Ilios Application
Instruments
REF
Description
Implants &
Instruments
Standard Instruments
22
48026100
Compressor
48026000
Distractor
48041310
New Xia Screwdriver, Polyaxial
48041311
New Xia Polyaxial, Shaft
48041320
New Xia Screwdriver, Monoxial
48041321
New Xia Monoaxial, Shaft
03807030
Xia Screwdriver Handle
48040100
Rod Rotation Forceps
REF
Description
Standard Instruments
48040140
Rod Insertion Forceps
03807031
*Polydriver
03807006
*Polyaxial Screwdriver
48040005
Common Instrument Tray
48040001
Xia (SS) Screw Tray
48040007
Xia (SS) Hook Tray
48040006
Xia (Ti) Hook Tray
48040015
Xia (SS) Ilios Tray
48040016
Xia (Ti) Ilios Tray
Implants &
Instruments
* Needed for use with 8.5mm and 9.5mm polyaxial screws
23
Simple Way to Strong Support
Spinal Systems of the Xia Family:
Modern Solutions for All Your Applications
Stryker SA
Cité Centre
Grand-Rue 90
1820 Montreux
Switzerland
t: +41 21 966 12 01
f: +41 21 966 12 00
This document is intended solely for the use of healthcare professionals.
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular
product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be
trained in the use of any particular product before using it in surgery.
The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always
refer to the package insert, product label and/or instructions for use before using any Stryker product.
Products may not be available in all markets because product availability is subject to the regulatory and/or medical
practices in individual markets. Please contact your Stryker representative if you have questions about the availability of
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trademarks or service marks: DIAPASON, OPUS, Stryker, XIA. All other trademarks are trademarks of their respective
owners or holders.
The products listed above are CE marked according to the Medical Device Directive 93/42/EEC.
Literature Number: MTXTLILSST06051
MTX6779/GS 06/10
Copyright © 2010 Stryker
www.stryker.eu