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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.

Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

SynCage-LR 45°/90° Surgical Technique DePuy Synthes 3

Contents

Introduction 4

AO Spine Principles 5

Indications/Contraindications 6

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

One of the Comprehensive Solutions for ALIF Surgery 25

Implants 27

Instruments 29

Bibliography 34

4 DePuy Synthes SynCage-LR 45°/90° Surgical Technique

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 stability2. Restore disc height3. Restore lordosis4. Maintain the integrity of the endplates5. Provide an optimised fusion bed6. Atraumatic technique

coronalaxial

sagittal


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

StabilityStabilization to achieve a specifi c therapeutic out-come

BiologyEtiology, pathogenesis, neural protection, and tissue healing

AlignmentBalancing the spine in three dimensions

FunctionPreservations and resto-ration of function to pre-vent disability

AO Spine Principles

Copyright © 2012 by AOSpine

1 Aebi et al (1998)2 Aebi et al (2007)


Indications/Contraindications

IndicationsLumbar 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 supple-mentary posterior instrumentation is therefore strongly recommended.

When used in the treatment of spondylolisthesis, poste-rior pedicle screw assisted reduction is usually performed prior to the insertion of the SynCage-LR.


System Overview

The SynCage-LR 45°/90° is an evolutionary development of the SynCage concept

The titanium SynCage system’s wedge-shaped, bi-convex design offers:

Reduced risk of subsidenceThe anatomical shape and supportive superior and infe-rior surface design reduces the risk of subsidence into the adjacent vertrebrae.

Enhanced fusionThe perforated structure allows for bony ingrowth through the cage, and the bi-convex design provides enhanced implant-to-endplate contact.

StabilitySynCage 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.


The PEEK SynCage-LR 45°/90° offers all the benefits of the titanium version, plus:

RadiolucencyPEEK facilitates radiographic assessment of the fusion.

BiocompatibilitySynCage-LR 45°/90° consists of pure medical grade PEEK (Polyetherether ketone). It contains no carbon fibre, thereby reducing the risk of systemic uptake and local connective tissue formation.

Bone integrationThe injection-moulded PEEK SynCage-LR 45°/90° has a roughened surface designed to promote bone integra-tion and ongrowth.

FitAn expanded range of implants including 5 heights and 2 footprints is designed to ensure enhanced fit in most patients.

Ease of access to anatomyThe slots on the superior and inferior surfaces of the implant offer a guiding channel for ease of implant insertion over the distractor.

System Overview


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 Cat. no. Cat. no. Colour height Implant Trial implant code

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

SynCage-LR Trial Implant 45°/90°, wideDimensions: 28 mm (depth) × 38 mm (width)

For larger vertebral bodies

Anterior Cat. no. Cat. no. Colour height Implant Trial implant code

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


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 verte-bral midline. The choice of position depends on the sur-gical approach.

Distractor for SynCage-LR (397.113) – anterolateral approachThe distractor is designed to permit simultaneous dis-traction 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 onlyDesigned to permit 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.


Implant Holder for SynCage-LR 45°/90°, broad (397.116), for larger vertebral bodies – anterolateral approach onlyAn alternative to the version mentioned above, the implant holder for SynCage-LR 45°/90° for broad implants is specifically designed to ensure a desired 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 approachDesigned to permit 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



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 desired implant size by comparing the relevant SynCage-LR radio graph template with a lateral radiograph of the adjacent intervertebral discs.

Note: The height indicated on the template is ap-proximately 1 mm lower than that of the actual cage to account for penetration of the teeth into the verte-bral 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 maxi-mum size SynCage-LR 45°/90° is selected to provide the stability of the segment through tension in the annulus fibrosus and/or longitudinal ligaments.

Use 0330.330 with SynCage-LR 45°/90° large and 0330.332 with SynCage-LR 45°/90° (small footprint).


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.


4a. Cut the anterolateral window

Cut a rectangular window the width of the SynCage-LR 45°/90° into the longitudinal ligament and the anterolat-eral 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.

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.

Anterolateral approach

Lateral approach



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 addi-tional 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 mate-rial into the canal as the cage is inserted.


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.

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 reduce its displacement and possible injury to adjacent structures.


Lateral approach



7. Trial for implant size

Select the trial implant that corresponds to the SynCage-LR 45°/90° size determined 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 antero lateral face of the trial implant.

For the lateral approach mount the handle for trial implants on the lateral face of the trial implant.

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.

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.

Once the desired 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

Anterolateral

Lateral

Anterolateral

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.

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°

SynCage-LR 45°/90°, large



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 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 SynCage-LR, 50 × 55 × 45 mm (Standard)



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



11. Remove instruments

Once the SynCage-LR 45°/90° is positioned in the centre of the vertebral endplate, the locking nut on the distrac-tor 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 desired position.

Once the distractor has been removed, the Positioner for SynCage (389.157) may be used to manipulate the cage within the disc space, if required.


Lateral approach

3–4 mm


12. Verify placement

The desired 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 appro x-imately 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.



Supplemental posterior procedureThe SynCage-LR is not designed or intended to be used as a stand-alone device; the use of supplementary poste-rior instrumentation is therefore strongly recommended.

When used in the treatment of spon dylolisthesis, poste-rior pedicle screw assisted reduction is usually performed prior to the insertion of the SynCage-LR.

Postoperative carePatients 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.


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


One of the Comprehensive Solutions for ALIF Surgery

More than just an implant systemSynthes provides an entire range of complementary material designed to further enhance the SynCage-LR procedure for the surgical team.

Click‘X Transpedicular Screw SystemThe Synthes solution for the required supplementary posterior fixation.

SynFrameRetractor system for the minimally open approach.


One of the Comprehensive Solutions 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 5 cc

710.019S 1.4–2.8 mm 10 cc

710.021S 1.4–2.8 mm 20 cc


Implants

889.861S SynCage-LR 45º/90º, 12 × 24 × 30 mm, PEEK, sterile

889.862S SynCage-LR 45º/90º, 13.5 × 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





Trial Implants

357.170 SynCage-LR Trial Implant 45°/90°, 12.0 mm, Pure Titanium





397.105 SynCage-LR Trial Implant 45°/90°, broad, 12.0 mm, Pure Titanium





Implants


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






389.320 Rongeur for Intervertebral Discs, width 2 mm, length 400 mm



389.338 Periosteal Elevator for End Plates, width 10 mm, length 480/250 mm



Instruments


389.354 Bone 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






389.574 Osteotome, straight, width 5 mm, length 480/250 mm

389.575 Osteotome, straight, width 10 mm, length 480/250 mm

Instruments


389.696 Cancellous Bone Impactor, 12 × 12 mm, length 480/250 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-LSR


397.131 Packing Block for SynCage-LR, 50 × 55 × 45 mm


Instruments


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


Bibliography

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.

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Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com

Not all products are currently available in all markets.

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©

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