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Transcript
For anterolateral and lateral approach
SynCage-LR 45°/90°
Surgical Technique
Image intensifier control
This description alone does not provide sufficient background for direct use
of DePuy Synthes products. Instruction by a surgeon experienced in handling
these products is highly recommended.
Reprocessing, Care and Maintenance
For general guidelines, function control and dismantling of m
­ ulti-part
instruments, please contact your local sales representative or refer to:
http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance
For general information about reprocessing, care and maintenance of Synthes
reusable devices, instrument trays and cases, please consult the Important
Information leaflet (SE_023827) or refer to:
http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance
Contents
Introduction4
AO Spine Principles
5
Indications/Contraindications6
System Overview
7
SynCage-LR 45°/90° Cage and Trial Implant Overview Chart
9
Essential Instruments for SynCage-LR 45°/90°
10
Surgical Technique for Anterolateral and Lateral Approach
12
Additional Instruments
24
A Comprehensive Solution for ALIF Surgery
25
Implants27
Instruments29
Literature34
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 3
Introduction
The SynCage system is the Synthes implant and instrumen­
tation solution for anterior lumbar interbody fusion (ALIF),
designed in accordance with the AO/ASIF Principles of Interbody Fusion:
1.Provide adequate stability
2.Restore disc height
3.Restore lordosis
4.Maintain the integrity of the endplates
5.Provide an optimised fusion bed
6.Atraumatic technique
4 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
AO Spine Principles
The four principles to be considered as the foundation for
proper spine patient management underpin the design and
delivery of the Curriculum: Stability – Alignment – Biology –
Function.1, 2
Stability
Stabilization to achieve
a specific therapeutic outcome
sagittal
axial
coronal
Alignment
Balancing the spine in three
dimensions
Function
Preservations and restoration of function to prevent
disability
Biology
Etiology, pathogenesis,
neural protection,
and tissue healing
Copyright © 2012 by AOSpine
1
2
Aebi et al (1998)
Aebi et al (2007)
SynCage-LR 45°/90°
Surgical Technique
DePuy Synthes
5
Indications/Contraindications
Indications
Lumbar and lumbosacral pathologies that may require
­anterior segmental arthrodesis, including:
–– Degenerative disc disease and instability
–– Revision surgery for failed decompression syndrome or
pseudarthrosis
–– Reduced spondylolisthesis
Contraindications
–– Spinal fractures
–– Spinal tumour
–– Osteoporosis
–– Infection
Note: The SynCage-LR is not designed or intended to be
used as a stand-alone device; the use of supplementary
posterior instrumentation is therefore strongly
recommended.
When used in the treatment of spondylolisthesis, posterior
pedicle screw assisted reduction is usually performed prior to
the insertion of the SynCage-LR.
6 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
System Overview
The SynCage-LR 45°/90° is an evolutionary
development of the proven SynCage concept
The titanium SynCage system’s wedge-shaped, bi-convex
design offers:
Reduced risk of subsidence
The optimal anatomical shape and supportive superior and
inferior surface d
­ esign reduces the risk of subsidence into the
adjacent vertrebrae.
Enhanced fusion
The perforated structure allows for bony ingrowth through
the cage, and the bi-convex design ensures optimal implantto-endplate contact.
Stability
SynCage is designed to fit snugly into the natural concavity
between two adjacent vertebral bodies. The tension of the
longitudinal ligaments and annulus fibrosus provide stability;
the teeth on the superior and inferior surfaces provide additional initial stability.
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 7
System Overview
The PEEK SynCage-LR 45°/90° offers all the benefits of the
titanium version, plus:
Radiolucency
PEEK facilitates radiographic assessment of the fusion.
Superior biocompatibility
SynCage-LR 45°/90° consists of pure medical grade PEEK
(Polyetherether­ketone). It contains no carbon fibre, thereby
reducing the risk of systemic uptake and local connective
­tissue formation.
Bone integration
The injection-moulded PEEK SynCage-LR 45°/90° has a
roughened surface to promote bone integration and
ongrowth.
Optimal fit
An expanded range of implants including 5 heights and
2 footprints ensures an optimal fit in most patients.
Easy access to anatomy
The slots on the superior and inferior surfaces of the implant
offer a guiding channel for easy implant insertion over the
distractor.
8 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
SynCage-LR 45°/90° Cage
and Trial Implant Overview Chart
The implant’s sterile packaging and trial implants are
colour-coded to avoid mismatching.
SynCage-LR Trial Implant 45°/90°
Dimensions: 24 mm (depth) × 30 mm (width)
For smaller and normal vertebral bodies
Anterior height
Cat. no.
Implant
Cat. no.
Trial implant
12 mm
889.861S
357.170
13.5 mm
889.862S
357.171
15 mm
889.864S
357.172
17 mm
889.866S
357.173
19 mm
889.868S
357.174
Colour
code
SynCage-LR Trial Implant 45°/90°, broad
Dimensions: 28 mm (depth) × 38 mm (width)
For larger vertebral bodies
Anterior height
Cat. no.
Implant
Cat. no.
Trial implant
12 mm
889.881S
397.105
13.5 mm
889.882S
397.106
15 mm
889.884S
397.107
17 mm
889.886S
397.108
19 mm
889.888S
397.109
Colour
code
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 9
Essential Instruments
for SynCage-LR 45°/90°
Handle for SynCage Trial Implants, angled (397.035)
The trial implant is screwed onto the trial implant handle
at a position corresponding to 45° or 90° of the vertebral
midline. The choice of position depends on the surgical
­approach.
Distractor for SynCage-LR (397.113) – anterolateral
approach
The distractor permits simultaneous distraction and implant
insertion without compromising the space available within
the intervertebral disc region for placement of the implant.
Implant Holder for SynCage-LR 45º/90º (397.115),
for smaller and ­normal vertebral bodies – anterolateral
approach only
Permits secure control of the SynCage-LR 45°/90° during
­implantation. The ­instrument grasps the implant on the anterior and lateral faces.
For use with small footprint cages (889.861S–889.868S)
only.
11 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
Implant Holder for SynCage-LR 45°/90°, broad
(397.116), for larger vertebral bodies – anterolateral
approach only
An alternative to the version mentioned above, the implant
holder for SynCage-LR 45°/90° for broad implants is specifically designed to ensure an optimal fit in larger anatomies.
For use with large footprint cages (889.881S–889.888S)
only.
Implant Holder for SynCage-LR 45°/90° (397.114) –
lateral approach
Permits secure control of the SynCage-LR 45°/90° during
­implantation. The ­instrument grasps the implant on the lateral face.
Used for both cage sizes.
397.131
Packing Block for SynCage-LR
50 × 55 × 45 mm
397.132
Packing Block for SynCage-LSR, broad
394.585
Cancellous Bone Impactor, 5.5 × 8.5 mm
394.586
Cancellous Bone Impactor, 13.6 × 3.5 mm
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 11
Surgical Technique for Anterolateral
and Lateral Approach
1. Preoperative planning
The surgical approach is dependent on the level to be
treated and the surgeon’s preference.
Determine the optimal implant size by comparing the relevant SynCage-LR radio­graph template with a lateral radiograph of the adjacent intervertebral discs.
Note: The height indicated on the template is approximately
1 mm lower than that of the actual cage to account for
penetration of the teeth into the vertebral bone.
With the segment fully distracted, the SynCage-LR 45°/90°
must fit firmly with a tight press-fit between the endplates.
It is therefore recommended that the maximum size
SynCage-LR 45°/90° is s­ elected to optimise the stability of
the segment through tension in the a­ nnulus fibrosus and/or
­longitudinal ligaments.
Use 0330.330 with SynCage-LR 45°/90° large and 0330.332
with SynCage-LR 45°/90° (small footprint).
11 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
2. Patient positioning
For both lateral and anterolateral approaches, the patient is
either placed in lateral or supine decubitus position.
3. Approach
The anterolateral approach preserves the longitudinal
ligament.
The lateral approach avoids the retraction of the great
vessels.
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 11
Surgical Technique for Anterolateral
and Lateral Approach
4a. Cut the anterolateral window
Cut a rectangular window the width of the SynCage-LR
45°/90° into the longitudinal ligament and the anterolateral
part of the annulus fibrosus.
A trial implant may be used as a template to indicate the
­required width of the annular window.
Care is taken to retain as much of these structures as possible as they are ­important for the stability of the instrumented segment.
Anterolateral approach
4b. Cut the lateral window
Cut a rectangular window of the width of the SynCage-LR
45°/90° into the lateral part of the annulus fibrosus.
A trial implant may be used as a template to indicate the
­required width of the annular window.
Care is taken to retain as much of these structures as possible as they are ­important for the stability of the instrumented segment.
Lateral approach
11 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
5. Prepare the disc space
Through the window prepared in step 4, the disc material is
excised and the superficial layers of the cartilaginous endplates removed such that bleeding bone is attained.
Adequate cleaning of the endplate is important to enable
the provision of a vascular supply to the bone graft; excessive cleaning or use of a rasp may, however, weaken the
endplate and result in subsidence of the cage.
Once the endplates have been prepared and any additional
surgical procedures completed, the SynCage-LR 45°/90° is
introduced into the vertebral space as per the following
steps.
Note: It is essential that all nuclear material and the inner
annulus is removed to prevent interference with bone
ingrowth and displacement of disc material into the canal as
the cage is inserted.
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 11
Surgical Technique for Anterolateral
and Lateral Approach
6. Distract the segment
Distraction of the segment is essential for restoration of disc
height, opening of the neural foramina and stability of the
SynCage-LR 45°/90°.
Distraction is achieved prior to insertion of the SynCage-LR
45°/90° using the appropriate distractor.
Note: 397.113 Distractor for SynCage-LR must be used.
The same instrument is used for both large and small cages.
Ensure that the distractor is positioned correctly. The blades
of the distractor must correspond with the chosen approach
angle and the slots on the implant to ensure symmetrical insertion of the device.
Anterolateral approach
Compressing the distractor handle opens the disc space.
Note: Due to the wedge-shaped configuration of the disc
and the distractor blades, the distractor must be held in
place during distraction and the insertion of the trial or
implant to prevent its displacement and possible injury to
adjacent structures.
Lateral approach
11 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
7. Trial for implant size
Anterolateral
approach
Select the trial implant that corresponds to the SynCage-LR
45°/90° size d
­ etermined during the preoperative planning
and attach it to the handle for trial implants.
Note: There is one handle for trial implants: 397.034 Handle
for Trial Implants, straight.
For the anterolateral approach mount the handle for trial
­implants on the antero­lateral face of the trial implant.
For the lateral approach mount the handle for trial implants
on the lateral face of the trial implant.
Lateral
Anterolateral
The trial implant is then slid between the distractor blades
into the disc space.
If a tight fit is not achieved, repeat the process using incrementally larger sizes of trial implants. Conversely, if the trial
implant cannot be inserted, repeat ­using incrementally
smaller sizes of trial implants.
Lateral
With the segment fully distracted, the SynCage-LR 45°/90°
or trial implant must fit firmly with a tight press-fit between
the endplates such that disc height is not lost once the distractor is removed.
Anterolateral
Once the optimal size of SynCage-LR 45°/90° has been
determined, the ­distraction is temporarily relaxed.
The image intensifier can now be used to check the trial
implant position.
Note: The trial implants are not for implantation and must
be removed before insertion of the SynCage-LR 45°/90°.
Lateral approach
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 11
Surgical Technique for Anterolateral
and Lateral Approach
8. Select the implant
The SynCage-LR 45°/90° corresponding to the trial implant
is then selected and attached to the appropriate implant
holder.
The trial implants are laser-etched with the nominal height
of the cages, and both trial implant and cage packaging are
colour-coded.
SynCage-LR 45°/90°, large
Note: Use caution in handling the SynCage-LR 45°/90°.
Damage to the surface finish and/or teeth can lead to fatigue
failure or displacement of the SynCage-LR 45°/90°.
SynCage-LR 45°/90°
11 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
9. Pack implant with bone graft
It is recommended to fill the cage with autologous graft
material.
To assist packing the graft, the SynCage-LR 45°/90° with the
implant holder attached is inserted into the appropriate
packing block.
The Cancellous Bone Impactors (394.585 and 394.586)
are used to firmly pack the harvested graft material into the
implant.
It is important to fill the cage until the graft protrudes from
the perforations in the cage to ensure optimal contact with
the vertebral endplates.
Notes:
–– The implant holder must be firmly attached to the cage in
order to avoid damage to either the implant holder or the
cage.
–– There are two Packing Blocks:
397.131
Packing Block for for SynCage-LR,
50 × 55 × 45 mm (Standard)
397.132
Packing Block for SynCage-LSR, broad
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 11
Surgical Technique for Anterolateral
and Lateral Approach
10. Insert implant
With the SynCage-LR 45°/90° ready for insertion, the segment is again ­distracted.
The distraction is fixed by tightening the locking nut on the
handle.
The SynCage-LR 45°/90° is then introduced into the disc
space by sliding it ­between the distractor blades.
The SynCage-LR 45°/90° will require light hammering to fully
introduce it into the disc space.
Note: The distractor should be held firmly in place during
this stage of the procedure.
Anterolateral approach
Lateral approach
22 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
11. Remove instruments
Once the SynCage-LR 45°/90° is positioned in the centre of
the vertebral endplate, the locking nut on the distractor handle is loosened and the distraction released.
The distractor is gently removed while the SynCage-LR
45°/90° is held in position by the implant holder.
Additional hammering will ensure a secure fit.
The implant holder is then released from the SynCage-LR
45°/90° by loosening the locking nut, leaving the SynCage-LR 45°/90° in its optimal position.
Anterolateral approach
Lateral approach
Once the distractor has been removed, the Positioner for
SynCage (389.157) may be used to manipulate the cage
within the disc space, if r­ equired.
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 22
Surgical Technique for Anterolateral
and Lateral Approach
12. Verify placement
3–4 mm
The optimal position for the SynCage-LR 45°/90° is centred
within the periphery of the vertebral endplate.
Depending on the size of the vertebrae, the anterior edge of
the SynCage-LR 45°/90° will usually be approximately three
to four millimetres posterior from the anterior edge of the
vertebrae.
The location of the SynCage-LR 45°/90° relative to the vertebral bodies in the AP direction should be verified using an
image intensifier.
Three X-ray markers are incorporated into the implant to allow for an intra-operative assessment of the position of the
cage.
22 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
Supplemental posterior procedure
The SynCage-LR is not designed or intended to be used as
a stand-alone d
­ evice; the use of supplementary posterior instrumentation is therefore strongly recommended.
When used in the treatment of spon dylolisthesis, posterior
pedicle screw assisted reduction is usually performed prior to
the insertion of the ­SynCage-LR.
Postoperative care
Patients can usually be mobilized once they regain muscular
control of their trunk on the same day or one day after surgery.
However, patients should be cautioned against activities that
place unreasonable stress on the lower back until solid bony
union has been achieved.
Excessive physical activity and trauma may result in failure,
with subsidence of the implant and/or the development of a
non-union.
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 22
Additional Instruments
Other instruments that may be useful during the SynCage-LR
procedure include:
–– Cancellous Bone Impactor (397.730) and Handle with
Quick Coupling (397.700)
–– A larger version of the Cancellous Bone Impactor
(394.570)
–– Bone Spreaders (399.100, 399.130); can be used to
distract the vertebral segment
–– Hammers (399.420, 399.430); for final seating of the
implant and for packing bone graft into the implant
–– SynFrame
22 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
A Comprehensive Solution
for ALIF Surgery
More than just an implant system
Synthes provides an entire range of complementary material
to further ­enhance and simplify the SynCage-LR procedure
for the surgical team.
Click‘X Transpedicular Screw System
The Synthes solution for the required supplementary posterior fixation.
SynFrame
Retractor system for the minimally open approach.
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 22
A Comprehensive Solution for ALIF Surgery
chronOSTM
The approved AO/ASIF bone substitute.
b-TCP Granules for supplementing autologous bone graft
material.
Item no.
Granule size
Quantity
710.014S 1.4–2.8 mm
5cc
710.019S 1.4–2.8 mm
10cc
710.021S
1.4–2.8 mm
20cc
22 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
Implants
889.861SSynCage-LR 45º/90º, 12 × 24 × 30 mm,
PEEK, sterile
889.862S
SynCage-LR 45º/90º, 13.5 × 24 × 30 mm,
PEEK, sterile
889.864S
SynCage-LR 45º/90º, 15 × 24 × 30 mm,
PEEK, sterile
889.866S
SynCage-LR 45º/90º, 17 × 24 × 30 mm,
PEEK, sterile
889.868S
SynCage-LR 45º/90º, 19 × 24 × 30 mm,
PEEK, sterile
889.881S
SynCage-LR 45º/90º, wide,
12 × 28 × 38 mm, PEEK, sterile
889.882S
SynCage-LR 45º/90º, wide,
13.5 × 28 × 38 mm, PEEK, sterile
889.884S
SynCage-LR 45º/90º, wide,
15 × 28 × 38 mm, PEEK, sterile
889.886S
SynCage-LR 45º/90º, wide,
17 × 28 × 38 mm, PEEK, sterile
889.888S
SynCage-LR 45º/90º, wide,
19 × 28 × 38 mm, PEEK, sterile
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 22
Implants
Trial Implants
357.170
SynCage-LR Trial Implant 45°/90°,
12.0 mm, Pure Titanium
357.171
SynCage-LR Trial Implant 45°/90°,
13.5 mm, Pure Titanium
357.172
SynCage-LR Trial Implant 45°/90°,
15.0 mm, Pure Titanium
357.173
SynCage-LR Trial Implant 45°/90°,
17.0 mm, Pure Titanium
357.174
SynCage-LR Trial Implant 45°/90°,
19.0 mm, Pure Titanium
397.105
SynCage-LR Trial Implant 45°/90°, broad,
12.0 mm, Pure Titanium
397.106
SynCage-LR Trial Implant 45°/90°, broad,
13.5 mm, Pure Titanium
397.107
SynCage-LR Trial Implant 45°/90°, broad,
15.0 mm, Pure Titanium
397.108
SynCage-LR Trial Implant 45°/90°, broad,
17.0 mm, Pure Titanium
397.109
SynCage-LR Trial Implant 45°/90°, broad,
19.0 mm, Pure Titanium
22 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
Instruments
389.157
Positioner for SynCage
389.304
Laminectomy Punch, 40° angled upwards,
width 2 mm, length 400 mm
389.306
Laminectomy Punch, 40° angled upwards,
width 4 mm, length 400 mm
389.324
Laminectomy Punch with Reservoir,
3.0 × 3.0 × 200 mm
389.325
Laminectomy Punch with Reservoir,
5.0 × 5.0 × 200 mm
389.326
Laminectomy Punch with Reservoir,
7.0 × 7.0 × 200 mm
389.327
Laminectomy Punch with Reservoir,
3.0 × 3.0 × 300 mm
389.328
Laminectomy Punch with Reservoir,
5.0 × 5.0 × 300 mm
389.329
Laminectomy Punch with Reservoir,
7.0 × 7.0 × 300 mm
389.320
Rongeur for Intervertebral Discs,
width 2 mm, length 400 mm
389.321
Rongeur for Intervertebral Discs,
width 4 mm, length 400 mm
389.323
Rongeur for Intervertebral Discs,
width 6 mm, length 400 mm
389.338
Periosteal Elevator for End Plates,
width 10 mm, length 480/250 mm
389.339
Periosteal Elevator for End Plates,
width 15 mm, length 480/250 mm
389.340
Periosteal Elevator for End Plates,
width 20 mm, length 480/250 mm
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 22
Instruments
389.354Bone Lever, straight, width 15 mm,
length 410/250 mm
389.356
Bone Lever, straight, width 25 mm,
length 410/250 mm
389.370
Bone Lever, curved, width 15 mm,
length 375/218 mm
389.372
Bone Lever, curved, width 25 mm,
length 375/218 mm
389.391
Bone Curette, angled, oval edge,
3.5 × 5.25 mm, length 480/250 mm
389.393
Bone Curette, angled, oval edge,
5.5 × 8.25 mm, length 480/250 mm
389.395
Bone Curette, angled, oval edge,
7.5 × 11.25 mm, length 480/250 mm
389.397
Bone Curette, angled, oval edge,
9.5 × 14.25 mm, length 480/250 mm
389.456
Bone Curette, angled, oval edge,
2.5 × 4.0 mm, length 410/250 mm
389.457
Bone Curette, angled, oval edge,
3.0 × 4.0 mm, length 480/250 mm
389.574
Osteotome, straight, width 5 mm,
length 480/250 mm
389.575
Osteotome, straight, width 10 mm,
length 480/250 mm
33 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
389.696Cancellous Bone Impactor, 12 × 12 mm,
length 480/250 mm
394.585
Cancellous Bone Impactor, 5.5 × 8.5 mm
394.586
Cancellous Bone Impactor, 13.6 × 3.5 mm
397.034
Handle for SynCage Trial Implants, straight
397.035
Handle for SynCage Trial Implants, angled
397.113
Distractor, anterior, for SynCage-LR
397.114
Implant Holder, straight, for SynCage-LR
397.115
Implant Holder for SynCage-LR 45º/90º
397.116
Implant Holder for SynCage-LR 45º/90º,
broad
397.126
Distractor, lumbo-sacral, for SynCage-LRS
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 33
Instruments
397.131Packing Block for SynCage-LR,
50 × 55 × 45 mm
397.132
Packing Block for SynCage-LSR, broad
33 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
Additional Instruments
394.570
Cancellous Bone Impactor, straight
397.700
Handle with Quick Coupling
397.730
Cancellous Bone Impactor B 8.0 mm,
round
399.100
Bone Spreader, speed lock, width 8 mm,
length 210 mm
399.130
Bone Spreader, speed lock, width 12 mm,
length 270 mm
399.420
Hammer 500 g
399.430
Hammer 700 g
SynCage-LR 45°/90° Surgical Technique DePuy Synthes 33
Literature
Aebi M., Arlet V., Webb J.K.: AO Spine Manual (2 vols), Stuttgart,
New York: Thieme. 2007.
Aebi M, Thalgott JS, Webb JK (1998). AO ASIF Principles in Spine Surgery. Berlin: Springer.
Heiden, E.A., Montesano, P.X. Translaminar Facet Screw Fixation in
Manual of Internal Fixation of the Spine, eds.
Jacobs, R.R., Montesano, P.X., Jackson, R.P. Enhancement of Lumbar
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33 DePuy Synthes SynCage-LR 45°/90° Surgical Technique
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