technique guide - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/llnwmb8/int mobile/synthes...397.034...

SynCage-LR / SynCage PROmotive.Implant and instrument system for anterior lumbar interbody fusion.

Technique Guide

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Image intensifier control

WarningThis description alone does not provide sufficient background for direct use ofthe instrument set. Instruction by a surgeon experienced in handling theseinstruments is highly recommended.

Reprocessing, Care and Maintenance of Synthes InstrumentsFor general guidelines, function control and dismantling of multi-part instrumentsplease refer to: www.synthes.com/reprocessing

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Introduction

Surgical Technique

Product Information

Bibliography

Overview 2

AO Principles 4

Indications and Contraindications 5

Preoperative Planning 6

Access and Exposure 7

Preparation and Trial Implantation 8

Selection and Packing of Implant 12

Implant Insertion 14

Bone Marrow Extraction for SynCage PROmotive 18

Implants 25

Trial Implants 26

Instruments 27

Additional Instruments 29

Cases 30

Filling Material 31

Additional Recommended Sets 33

36

Table of Contents

Synthes 1

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Overview

2 Synthes SynCage-LR / SynCage PROmotive Technique Guide

The SynCage-LR implant and instru-ment system is designed for anterior lumbar interbody fusion (ALIF). It offers two different implant types:

Made of clinically proven PEEK Optima

Radiolucent– PEEK facilitates radiographic assess-

ment of fusion

Promoting bone ongrowth– Injection molded, roughened PEEK

surface is superior to machined PEEK surface: promotes bone on-growth

SynCage-LR (PEEK cage)

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SynCage PROmotive (PEEK cage prefilled with chronOS)

Synthes 3

SynCage PROmotive is prefilled withsynthetic cancellous bone substitute.

The use of �-tricalcium phosphate inthe spinal column is a valuable alter -native to allografts and autografts,even when larger amounts are re-quired.1

Resorbable– Converted to vital bone within

6 – 18 months

Safe– 100% synthetic – no risk of cross

infection

OsteoconductiveInterconnecting macropores of a de-fined size (100–500 μm) facilitate boneingrowth. Interconnected mi cropores(10–40 μm) allow an optimum supplyof nutrients. The patient’s blood, bloodplatelet concentrate or bone marrowaspirate enhance the properties ofchronOS required for fusion.2

OsteopromotiveThe SynCage PROmotive can be simplyand quickly saturated with the patient’sown blood or bone marrow during surgery using the perfusion system. Thissupports bone integration and rapidongrowth.

1 Muschik et al. 2001; Knop et al. 20062 Allman et al 2002; Stoll et al. 2004; Becker et al. 2006

chronOS Perfusion ConceptThe vacuum method uses the patient’sown bone marrow or blood, forcing or suctioning it through the pores of thecage filled with chronOS, thus expellingany air in the cage. The cage is therebysaturated three times better than usinga conventional dip method. It has alsobeen shown that the vacuum methoddoes not destroy the blood cells.

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AO Principles

In 1958, the AO formulated four basic principles, which havebecome the guidelines for internal fixation.1

They are– Anatomical reduction– Stable fixation– Preservation of blood supply– Early, active mobilization

The fundamental aims of fracture treatment in the limbs andfusion of the spine are the same. A specific goal in the spine is returning as much function as possible to the injuredneural elements.2

AO Principles as applied to the spine3

Anatomical reductionIn the spine, this means reestablishing and maintaining thenatural curvature and the protective function of the spine. By regaining this natural anatomy, the biomechanics of the spine can be improved, and a reduction of pain can beexperienced.

Stable fixationAdd an additional anterior or posterior fixation plate to stabilize the segment to promote bony fusion.

Preservation of blood supplyCreation of an optimal environment for fusion.

Early, active mobilizationMinimized damage to the spinal vasculature, dura, and neural elements, which may contribute to pain reduction and improved function for the patient.


1 Müller et al. 19952 Ibid.3 Aebi et al. 2007

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IndicationsLumbar and lumbosacral pathologies which may require anterior segmental arthrodesis, including:– Degenerative disc disease and instability– Revision surgery for failed decompression

syndrome or pseudoarthrosis– Reduced spondylolisthesis

Contraindications– Spinal fractures– Spinal tumor– Osteoporosis– Infection

Indications and Contraindications

Synthes 5

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Preoperative Planning

1Preoperative planning

Instruments

X000074 X-ray Template for SynCage-LR / SynCage PROmotive 24�30 mm, 12°



Determine the approximate implant size by comparing theSynCage-LR / SynCage PROmotive x-ray template with a lateral radiograph of the patient’s adjacent intervertebraldiscs.

Notes– The height indicated on the template is approximately

1 mm lower than that of the actual spacer to account for penetration of the teeth into the vertebral endplate.

– It is recommended to select the maximum implant size, to optimize the stability of the segment through tension in the longitudinal ligaments.


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Access and Exposure

Synthes 7

1Patient positioning

For an anterior approach to the lower lumbar levels, positionthe patient in a slight Trendelenburg position.

3Exposure

For anterior insertion, expose the intervertebral disc such thatthere is sufficient space on either side of the vertebral midline,equal to half the width of the implant. If the vessels and /ortissues cannot be retracted sufficiently, insertion from an an-terolateral direction may be indicated.

2Anterior access and approach

Recommended set

01.609.102 SynFrame RL, lumbar

187.310 SynFrame Basic System in Vario Case

The surgical approach depends on the level to be treated.Locate the correct operative disc level and incision locationby taking a lateral flouroscopic view while holding a straightmetal instrument at the side of the patient. This ensures thatthe incision and exposure will allow direct visualization intothe disc space on either side of the vertebral midline equal tohalf the width of the SynCage-LR / SynCage PROmotive.

Expose the operative disc level through a standard retroperi-toneal approach.

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Preparation and Trial Implantation

1Cut anterior window

Cut a rectangular window the width of the SynCage-LR /SynCage PROmotive into the anterior longitudinal ligamentand annulus fibrosus.

A trial implant (see page 26) may be used as a template toindicate the width of the window.

Retain as much of the anterolateral, lateral and posterior annulus as possible in order to provide the necessary stabilityof the instrumented segment.

2Prepare disc space

Recommended set

01.600.100 Proprep

Excise the disc material and remove the cartilaginous end-plates to expose the underlying bony vertebral endplates.

Adequate clearance of the endplates is important to enablethe provision of a vascular supply to the bone graft. Excessiveclearance or use of a rasp however, may weaken the endplateand result in subsidence of the cage.

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Synthes 9

3Distract segment

Instruments

397.113 Distractor, anterior

397.126 Distractor, lumbo-sacral

For a safe placement, verify spreader position with the helpof an intraoperative lateral x-ray.

Distraction of the segment is essential for restoration of discheight, opening of the neural foramina and initial stability ofthe SynCage-LR / SynCage PROmotive.

Once the endplates have been prepared, complete eventualadditional surgical procedures (i.e. removal of a disc frag-ment from the spinal canal).

Note: It is essential that the nucleus and the inner annulusare removed to prevent displacement of disc material intothe spinal canal during spacer insertion and interference withbone in-growth.

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4Determine trial implant size

Instruments

357.160– SynCage-LR Trial Implant, 12.0–19.0 mm357.164

397.121 SynCage-LR Trial Implant, broad, 12.0 mm

397.101– SynCage-LR Trial Implant, broad, 397.104 13.5–19.0 mm

357.150– SynCage-LSR Trial Implant, 357.154 12.0–19.0 mm

397.034 Handle for SynCage Trial Implants, straight

397.035 Handle for SynCage Trial Implants, angled

Select the trial implant that corresponds with the SynCage-LR / SynCage PROmotive size determined during the pre -operative planning. Attach it to the handle for trial implants.The handle must be tightened firmly to prevent loosening of the trial implant.

The distractor is used to assist with guiding the trial implantinto the disc space. To ensure that the implant is insertedsymmetrically into the disc space, the central line on the dis-tractor blades should be aligned with the anterior midline ofthe vertebral bodies.

Slide the trial implant between the distractor blades into thedisc space. Controlled and light hammering on the handlefor trial implants may be required to bring the trial implantbetween the vertebral bodys. If a tight fit is not achieved, repeat the process using incrementally larger trial implants. If the trial implant cannot be inserted, repeat using incre-mentally smaller trial implants.

Preparation and Trial Implantation

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Synthes 11

With the segment fully distracted, the trial implant (and finalimplant) must fit firmly with a tight press-fit between theendplates so that the disc height is not lost once the distrac-tor is removed.

The image intensifier may be used to check the position ofthe trial implant, restoration of disc and foraminal height,and overall alignment before selecting the final SynCage-LR /SynCage PROmotive implant size.

Note: The distractor must be firmly held in place to preventits ejection from the disc space and possible injury to adjacentstructures.

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2ASynCage PROmotive

Perfuse the implant with autologous bone marrow aspirate.For detailed instructions, see page 18.

Selection and Packing of Implant

1Select implant

Select the final SynCage-LR or SynCage PROmotive implantcorresponding to the trial implant size.

The package of the SynCage-LR as well as the SynCage PROmotive and the trial implants are color-coded.

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Synthes 13

2BSynCage-LR

Instruments

397.114 Implant Holder, straight

397.117 Implant Holder, angled

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

After attaching the SynCage-LR to the implant holder, insertit into the appropriate packing block.

It is important to fill the spacer until the filling material pro-trudes from its perforations in order to ensure optimal con-tact with the vertebral endplates.

Use a cancellous bone impactor to firmly pack the filling material into the implant cavities.

Note: The implant holder must be firmly attached to thecage in order to avoid damage to either the implant holderor the cage.

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1Insert implant

Instruments

397.113 Distractor, anterior

397.126 Distractor, lumbo-sacral

Insert the implant into the disc space.

The distractor is used to assist with guiding the implant intothe disc space. To ensure that the implant is inserted sym-metrically into the disc space, the central line on the distrac-tor blades should be aligned with the anterior midline of the vertebral bodies.

Slide the implant between the distractor blades and into thedisc space. Controlled and light hammering on the implantholder may be required to bring the implant between the ver-tebral bodies. The implant must fit firmly with a tight press-fitbetween the endplates.

The image intensifier may be used to check the implant posi-tion, restoration of disc and foraminal height, and overallalignment.

Note: The distractor must be firmly held in place to preventits ejection from the disc space and possible injury to adja-cent structures.

Implant Insertion

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Synthes 15

2Remove instruments

When the implant is correctly positioned, loosen the lockingnut on the distractor handle in order to release the distraction.

Gently remove the distractor while the implant holder holdsthe implant in position. Additional hammer blows ensure asecure fit.

Remove the implant holder. The implant should now be in itsoptimal position.

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3Verify placement

The optimal position for the cage is centered within the periphery of the vertebral endplate.

Depending on the size of the vertebrae, the anterior edge ofthe SynCage-LR / SynCage PROmotive will usually be approx-imately three to four millimeters posterior from the anterioredge of the adjacent vertebrae.

Verify the location of the cage relative to the vertebral bodiesin the AP and lateral directions using an image intensifier.Three x-ray markers are incorporated into the implant to al-low accurate intraoperative radiographic assessment of theposition of the implant. The posterior x-ray marker is locatedapproximately 3 mm from the posterior wall of the cage.

Implant Insertion

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Synthes 17

4Additional stabilization

Sets

01.160.204 Instrument Set for ATB Plate System in Vario Case

01.620.015 Pangea Polyaxial Basic Instruments in Vario Case

01.620.018 Pangea Polyaxial Implants in Vario Case

Anterior or posterior stabilizationAdditional anterior fixation (e.g. ATB) or posterior fixation(e.g. Pangea) is required.

Postoperative carePatients can usually be mobilized once they regain muscularcontrol of their trunk on the same day or one day after sur-gery. However, patients should be cautioned against activitiesthat place unreasonable stress on the lower back until solidbony 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.

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1Locate site and prepare the incision

Instrument

710.151S Bone Marrow Aspiration System (Biopsy Needle: 11 ga � 15.0 cm, with Side Holes), sterile

Palpate the anterior superior part of the iliac crest. The entrypoint should be at least 2 cm lateral of the anterior superioriliac tubercle to avoid lateral femoral cutaneous nerve damage.

Anesthetize the area and make a small stab incision to beused for needle insertion.

2Prepare and grasp needle

After removing the plastic guard from the aspiration needle,loosen and remove the stylet to ensure that it functions prop-erly. Reinsert the stylet and lock it in place.

Grasp the bone marrow aspiration needle with the proximalend firmly seated in the palm.

Bone Marrow Extraction for SynCage PROmotive

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Synthes 19

3Introduce the needle

Introduce the needle through the prepared incision site withthe initial trajectory of the needle in line with the dorsal planeand medially in line with the ilium wing, as gauged by pal -pation of the inner and outer cortex.

4Advance the needle

Advance the needle using gentle but firm pressure. Rotatethe needle using alternating clockwise- and counterclockwisemotions or gently tap the needle handle with a mallet. Decreased resistance is encountered upon penetration of thecortex and entrance into the marrow cavity. Advance theneedle 2 cm into the cavity.

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5Remove stylet

Remove the stylet by rotating the upper section of the handle counterclockwise and slowly pulling straight out.


6Screw syringe into hub

Screw the distal end of the included syringe into the proximalhub of the bone marrow aspiration needle. Ensure a firm fit,but do not over-tighten.

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7Withdraw syringe plunger

Withdraw the syringe plunger to draw 2 – 4 ml of bone mar-row into the syringe chamber. Only 2 – 4 ml of marrowshould be aspirated per site, to minimize diluting the marrowwith peripheral blood. If marrow does not aspirate easily,reposition the needle slightly. If marrow still does not aspi-rate, remove the syringe from the needle, remove the needlefrom the incision, reinsert the stylet, and repeat steps 2 to 6with a slight change in needle trajectory.

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1 cm

1

2


8Aspirate additional marrow

If more than 2 –4 ml of marrow is required, remove the syringe from the needle, reinsert the stylet, and either pene-trate deeper within the same site or use the fan technique to pull marrow from a new site using the same incision.

– If pulling additional marrow from deeper within the samesite (1), advance the needle 1 cm along the same trajectory(the markings on the needle are 1 cm apart and may beused as a guide). The needle may also be rotated 90° toexpose side holes to bone from which marrow has not yetbeen drawn.

– If using the fan technique (2), slightly withdraw the needleand reinsert it as described in step 7 at a new trajectoryalong the same plane as the original insertion.

9Remove stylet

Remove the stylet as described in step 8, reattach the collec-tion syringe as described in step 9, and withdraw the syringeplunger to draw an additional 2 – 4 ml of marrow into the syringe chamber.

Repeat steps 11 and 12 until the required quantity of mar-row has been obtained.


10Disengage syringe

Disengage the syringe containing the aspirated bone marrowand dispose of the needle in accordance with applicable lawsand regulations.

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Synthes 23

11Transfer bone marrow into perfusion device

The bone marrow can be transferred directly from the 20 mlsyringe of the Bone Marrow Aspiration System into the per-fusion device containing the SynCage PROmotive. Proceedquickly in order to avoid clotting of the bone marrow.

Take the perfusion container, remove the small dark blue capon top of the device and attach the blue 30 ml syringe at thebottom of the container firmly.

Attach the green 20 ml syringe containing the bone marrowdirectly to the Luer lock connection on top of the perfusioncontainer. Transfer the bone marrow by gently pushing thegreen plunger.

The quantity of bone marrow required is 15 – 20 ml.

12Perfusion of SynCage PROmotive implant

Remove the green syringe from the Bone Marrow AspirationSystem and close the device airtight by firmly screwing thedark blue cap on top of the container. Make sure that the lidis screwed tightly onto the perfusion container. Perfuse theSynCage PROmotive implant uniformly by gently pumpingthe plunger 10 to 15 times.

10 –1

5 tim

es

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13Remove SynCage PROmotive from perfusion box

Instruments

397.114 Implant Holder, straight

397.117 Implant Holder, angled

Take the small dark blue cap off and remove excess bonemarrow from the device. Unscrew the perfusion box and remove the SynCage PROmotive implant using an appropri-ate instrument (e.g. tweezers) and attach it to the implantholder.

Note: The implant may stick to the inside of the lid.

For implant insertion, see page 14, step 1.


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Synthes 25

Dimension, 24�30 mm, 12°For smaller and normal vertebral bodies

Height SynCage-LR SynCage Trial Implant PROmotive (prefilled)*

12 mm 889.851S 08.802.851S 357.160

13.5 mm 889.852S 08.802.852S 357.161

15 mm 889.854S 08.802.854S 357.162

17mm 889.856S 08.802.856S 357.163

19 mm 889.858S 08.802.858S 357.164

Color code trial implant and cage packaging: blue

Dimension, 28�38 mm, 10°For larger vertebral bodies


12 mm 889.871S 08.802.871S 397.121

13.5 mm 889.872S 08.802.872S 397.101

15 mm 889.874S 08.802.874S 397.102

17 mm 889.876S 08.802.876S 397.103

19 mm 889.878S 08.802.878S 397.104

Color code trial implant and cage packaging: gold

Dimension, 28�38 mm, 12°For application in L5–S1


12 mm 870.909S 08.802.899S 357.150

13.5 mm 870.910S 08.802.900S 357.151

15 mm 870.911S 08.802.901S 357.152

17mm 870.912S 08.802.902S 357.153

19 mm 870.913S 08.802.903S 357.154

Color code trial implant and cage packaging: silver

* Perfusion device: Container

Implants

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Trial Implants

Dimension, 24�30 mm, 12°

12 mm 357.160

13.5 mm 357.161

15 mm 357.162

17 mm 357.163

19 mm 357.164

Color code trial implant: blue


12 mm 397.121

13.5 mm 397.101

15 mm 397.102

17 mm 397.103

19 mm 397.104

Color code trial implant: gold


12 mm 357.150

13.5 mm 357.151

15 mm 357.152

17 mm 357.153

19 mm 357.154

Color code trial implant: silver

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Synthes 27

Instruments

397.113 Distractor, anterior, for SynCage-LR397.126 Distractor, lumbo-sacral, for SynCage-LRS

397.114 Implant Holder, straight, for SynCage-LR397.117 Implant Holder, angled, for SynCage-LRS

397.034 Handle for SynCage Trial Implant, straight 397.035 Handle for SynCage Trial Implant, angled

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397.131 Packing Block for SynCage-LR, 50�55�45 mm397.132 Packing Block for SynCage-LRS, broad

394.585 Cancellous Bone Impactor, 5.5�8.5 mm394.586 Cancellous Bone Impactor, 13.6�3.5 mm

Instruments

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Synthes 29

SynCage PROmotive

Bone Marrow Aspiration System (BMAS)

Art. No. Diameter Length Side holes Syringe

710.111S 11 ga 11 cm yes 20 ml

710.151S 11 ga 15 cm yes 20 ml

710.150S 11 ga 15 cm no 20 ml

Additional Instruments

SynCage-LR 45°/90°

397.115 Implant Holder for SynCage-LR 45º/90º

397.116 Implant Holder for SynCage-LR 45°/90°, broad

Trial Implants 45°/90°

Dimension, 24�30 mm

12 mm 357.170

13.5 mm 357.171

15 mm 357.172

17mm 357.173

19 mm 357.174

Color code trail implant: green

Dimension, 28�38 mm

12 mm 397.105

13.5 mm 397.106

15 mm 397.107

17mm 397.108

19 mm 397.109

Color code trail implant: violet

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68.801.001 Vario Case for SynCage PROmotive, with Lid, without Contents

677.796–799 Syncase, for SynCage-LR

Cases

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Synthes 31

Synthetic cancellous bone graft substitute: chronOSchronOS is a fully synthetic and resorbable bone graft substi-tute consisting of pure �-tricalcium phosphate. Its compressivestrength is similar to that of cancellous bone. Based on litera-ture, the use of �-tricalcium phosphate in the spinal columnis a valuable alternative to allografts and autografts, evenwhen larger amounts are required.1

SynCage-LR, 24�30 mm, 12°

Article No. Height Filling Volume (mm3) (cm3)

889.851S 12 mm 2720 2.72

889.852S 13.5 mm 3100 3.10

889.854S 15 mm 3520 3.52

889.856S 17 mm 4060 4.06

889.858S 19 mm 4600 4.60



889.871S 12 mm 3960 3.96

889.872S 13.5 mm 4600 4.60

889.874S 15 mm 5240 5.24

889.876S 17 mm 6100 6.10

889.878S 19 mm 6980 6.98



870.909S 12 mm 3940 3.94

870.910S 13.5 mm 4520 4.52

870.911S 15 mm 5160 5.16

870.912S 17 mm 6020 6.02

870.913S 19 mm 6900 6.90

1 Muschik et al. 2001; Knop et al. 2006; Arlet et al. 2006

Filling Material

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ResorbableIt is remodeled to vital bone within 6 –18 months

OsteoconductiveInterconnecting macropores of defined size (100 –500 μm)facilitate bone ingrowth. Interconnected micropores (10– 40 μm) allow an optimal supply of nutrients. The patient’s blood, blood platelet concentrate or bone marrowaspirate enhances the properties of chronOS required for fusion.2

Safe100% synthetic – consistent quality, sufficient quantity

chronOS granules

710.000S � 0.5– 0.7 mm, 0.5 cc

710.001S � 0.7– 1.4 mm, 0.5 cc

710.002S � 0.7– 1.4 mm, 1 cc

710.003S � 0.7– 1.4 mm, 2.5 cc

710.011S � 1.4– 2.8 mm, 2.5 cc

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

710.024S � 2.8– 5.6 mm, 2.5 cc

710.025S � 2.8– 5.6 mm, 5 cc

710.026S � 2.8– 5.6 mm, 10 cc

710.027S � 2.8– 5.6 mm, 20 cc

Filling Material

2 Allman et al. 2002; Stoll et al. 2004; Becker et al. 2006

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Synthes 33

Anterior stabilization

01.160.204 Instrument Set for ATB Plate System in Vario Case

The Anterior Tension Band Plate (ATB) is a fixation plate forstabilization of the lumbosacral spine (L1–S1).

Additional Recommended Sets

Posterior stabilization

01.620.015 Pangea Polyaxial Basic Instruments in Vario Case

01.620.018 Pangea Polyaxial Implants in Vario Case

The Pangea Degenerative Spine System is a posterior pediclescrew fixation system (T1–S2) intended to provide precise and segmental stabilization of the spine in skeletally maturepatients.

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Additional Recommended Sets

Anterior Lumbar Retraction System

01.609.102 SynFrame RL, lumbar

187.310 SynFrame Basic System in Vario Case

SynFrame Basic System is a surgical approach and retractionsystem. It consists of a basic system (basic construction) and modules that are specially designed for the respective requirements and needs of various indications and/or ap-proach techniques. The SynFrame basic system is always con-structed in the same sequence following the same principles.The SynFrame RL is a supplementary module for the accessand retraction system SynFrame. It contains radiolucent softtissue and muscle retractors and semi transparent bonelevers for minimally invasive surgery.

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Disc Removal System

01.600.100 Proprep Set

A clearly arranged set for intervertebral disc preparation andvertebral body resection for lumber surgery with an anteriorapproach:– Compact but comprehensive: contains all instruments

required for intervertebral disc preparation and vertebralbody resection.

– Simplifies the entire anterior discectomy and corpectomythanks to angled instruments with which even the postero-lateral regions of the intervertebral discs can be reached.

– Ideal for use in extensively collapsed segments as the instruments have a low profile.

– The instrument length is specially designed for anterior surgery and for patients with a high BMI.

– Maximum instrument control thanks to silicon handles thatcan be gripped with two hands.

Synthes 35

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Aebi M, Arlet V, Webb JK (2007): AOSpine Manual (2 vols), Stuttgart, New York: Thieme

Allmann M, Florias E, Stoll T, Hoerger F, Bart F (2002):Haematological evaluation of blood samples after vacuumlike impregnation of a Beta-TCP ceramic bone substitute before implantation (internal communication)

Arlet V, Jiang L, Steffen T, Ouellet, J, Reindl R, Max Aebi(2006): Harvesting local cylinder autograft from adjacent vertebral body for anterior lumbar interbody fusion: surgicaltechnique, operative feasibility and preliminary clinical results. Eur Spine J. 15: 1352-9

Becker et al. (2006): Osteopromotion by a �-TCP/Bone Mar-row Hybrid Implant for Use in Spine Surgery. Spine, Volume31(1): 11–17

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