TraXis® Surgical technique.pdf · determined to meet the demands of spine surgeons by offering a complete MIS solution, one that combines the capabilities of an open technique with

Solutions by the people of Zimmer Spine.zimmerspine.com

TraXis®

TLIF Interbody System

Surgical Technique

A TLIF that’s ahead of the curve. From the people of Zimmer Spine.

Minimally Invasive Surgery (MIS) represents one of the most exciting and dynamic segments of spine surgery. At Zimmer Spine, we are committed to developing minimally invasive techniques that are simple and intuitive. We are determined to meet the demands of spine surgeons by offering a complete MIS solution, one that combines the capabilities of an open technique with the benefits of a minimalist approach.

Ideal for use with the PathFinder® MIS Pedicle Screw System, the TraXis implant’s crescent shape and articulating instruments facilitate precise placement, even through the smallest working space.

A preferred TLIF for the surgeon who demands the benefits of a transforaminal approach, brought to you by the people of Zimmer Spine.

Indications/Contraindications 1

TraXis Implants 3

Harmony™ PosteriorInstruments 4

TraXis Instruments 5

SurgicalTechnique 8

KitContents 19

WarningsandPrecautions 25

Table of Contents

1

Indications

TheintendedpurposeoftheTraXissystemisthatitbeusedforinterbodyfusionand/or

resectionorexcisionofthevertebralbodiesofthethoracolumbarspine.TraXisisindicatedfor

thetreatmentofdegenerativediscdisease,discherniation,foraminalstenosis,tumor,trauma,

deformity(includingscoliosis,spondylolisthesisandretrolisthesis)andfailedpreviousfusion.

TraXiswasdesignedtobeplacedthroughaposteriorincision.

Indications/Contraindications

2

Contraindications

1.Diseaseconditionswhichhavebeenshowntobesafelyandpredictablymanagedwithoutthe

useofinternalfixationdevicesarerelativecontraindicationstotheuseofthesedevices.

2.Activesystemicinfectionorinfectionlocalizedtothesiteoftheproposedimplantationare

contraindicationstoimplantation.

3.Severeosteoporosisisarelativecontraindicationbecauseitmaypreventadequatefixationof

spinalanchorsandthusprecludetheuseofthisoranyotherposteriorspinalinstrumentation

system.Severeosteoporosismayincreasetheriskofpostoperativelossofdischeight.

4.Anyentityorconditionthattotallyprecludesthepossibilityoffusion,i.e.cancer,kidney

dialysisorosteopenia,isarelativecontraindication.Otherrelativecontraindicationsinclude

obesity,pregnancy,certaindegenerativedisease,andforeignbodysensitivity.

Inaddition,thepatient’soccupationoractivitylevelormentalcapacitymayberelative

contraindicationstothissurgery.Specifically,somepatientsmay,becauseoftheiroccupation

orlifestyle,orbecauseofconditionssuchasmentalillness,alcoholismordrugabuse,place

unduestressesontheimplant.

5.Whenusedwithoutposteriorfixation,thedeviceshouldonlybeusedforGrade1orless

spondylolisthesisorretrolisthesis.

3

Vue

TraXis Implants

Withacrescentshapethat’sidealforatransforaminalapproach,thisinnovativedevicefacilitates

preciseimplantplacementeventhroughminimalistaccess.

Ti

9mm Width Implant

21mm

25mm

X

X

7mm*Height

Leng

th

X

X

11mmX

X

9mm

11mm Width Implant

21mm

25mm

X

X

15mmHeight

Leng

th

X

X

11mmX

X

13mm

*Available in Vue (PEEK-OPTIMA) only.

4

Harmony Posterior Instruments

Curettes

Prepare vertebral body endplates and remove disc material. Feature bayoneted shaft and reduced glare finish. Curettes available: Straight, Right, Left, Up-biting, Down-biting, Ring and O’Brien.

Smooth Distractors (6 - 15mm)

Incrementally distract the disc space.

Cutting Distractors (6 - 15mm)

Incrementally distract the disc space and shave vertebral endplates.

Pituitary Rongeurs (2 - 4mm)

Cut boney structures and remove disc material. Feature bayoneted shaft and reduced glare finish.

Kerrison Rongeurs (2 - 4mm)

Cut boney structures and remove disc material. Feature bayoneted shaft and reduced glare finish.

5

Fixed Trial (7 – 15mm)

Identifiesappropriateimplantsizeviafixedinstrumentationinvariedheights.

Fixed Rasp (7 – 15mm)

Createsapathwayforimplantplacementviafixedinstrumentationinvariedheights.

TraXis Instruments

Fixed Tamp

Advancestheimplantintoitsfinalposition.

Fixed Instrumentation

6

Trial Rod

Attaches to Modular Trials, Rasps and Tamp Tip for flexible angled instrumentation.

Modular Trial (9 – 15mm)

Identifies appropriate implant size via modular instrumentation in a full variety of sizes that match the implant.

Modular Tamp Tip

Provides flexibility to determine the correct Tamp angle to advance the implant into final position.

Modular Rasp (9 – 15mm))

Creates a pathway for implant placement via modular instrumentation.

Modular Instrumentation

7

Inserter/Extractor

Mateswithimplantchannels,providingmaximumcontrolwithminimalprofileforimplantplacementand/orremoval.

Slaphammer

Providesadditionalforceforremovalofinstrumentation,ifneeded.

Bone Funnel

Bone Tamp

Usedtopackautograftmaterialintodiscspaceorimplant.

Additional Instrumentation

8

Patient Positioning Positionthepatientonaradiolucenttablewith

adequateclearanceforafluoroscopicC-arm(forA/P,

lateralandobliqueimagesofpedicleandvertebral

body).

Allotherhardwareutilizedforpatientpositioning

shouldbecheckedforradiolucency.

Pedicle TargetingObtainA/Pandlateralimagesoftheaffectedlevel.

BeginHarmonyPortplacement,accessingthefacet

withtheTargetingNeedleandK-wire.

Step 1

Step 2

Surgical Technique

Preparation and Access

9

Sequential DilationSequentiallyslideDilators#1–6overtheK-wire;

slidethematchingDepthGaugeoverthelargest

Dilator,flangepositioneddistally.

Note: Depth Gauges may be used as pushers to advance

Dilators through the musculature.

Step 3

Port MeasurementResttheflangeagainsttheskin,locatingtheproximal

endofDilator#6intheDepthGaugewindow.Identify

thenecessaryportlength,referencingmeasurements

onsideoftheDepthGaugeandroundingup.The#4

Dilatordiametercorrelatestoa19mmport,the#5

Dilatorcorrelatestoa22mmportandthe#6Dilator

correlatestoa26mmport.

Port Placement Removetheportfromthesterilepackage,slide

itovertheDilatoranddockonthefacet.Adjust

theanglebywandingtheDilators.Attachtheport

totheSnakeArm.

Step 4

Step 5

10

Boney DecompressionUsingosteotomesandKerrisonRongeurs,removethe

facetandportionsofthelamina.

Step 6

Disc Preparation

Ligamentum Flavum Mobilization Cuttheligamentumflavumfromtheinferiorportion

ofthelamina.MobilizeitwithWoodsonorFine

Curettes.Controlepiduralbleedingwithbipolar

cautery,avoidingcontactwiththeportorother

instruments.

Nerve Root, Dura MobilizationFreethenerverootanddurafromthesofttissue;probe

theboneystructureswiththeBallProbe.Retractthe

nerverootanddura.

Step 7

Step 8

11

Annular WindowRemovebloodandsmalltissuefragmentswitha

suctioncatheter;createanannularwindowwithan

annulusknife.

Step 9

Remove Disc TissueInserttheCuttingDistractorsintothedisc,rotatingto

freethedisctissue.Removethediscfragmentswith

PituitaryRongeurs.

Endplate PreparationWithosteotomes,removetheosteophytesand

posteriorlipoftheadjacentvertebralbodies.Remove

theremainingendplatecartilagewithcurettes.

Step 10

Step 11

12

Distraction and SizingWithprogressivelysizedDistractors,openthespace

tothedesiredheight.ConnecttheDistractortothe

ComfortT-Handle.Insertitintothespace;thehandle

shouldbeparalleltothevertebralendplate.Rotate

itsaxis,openingthespacetoaheightequaltothe

Distractor.

Step 12

Distraction

13

Fixed Rasp Option InserttheRaspintothediscspaceinanarcing

trajectoryuntilit’sacrossthemidline.

TheT-HandlemaybeattachedtotheFixedRaspstem

forimprovedcontrol.

Modular Rasp OptionConnecttheModularRasptotheTrialRod.Withthe

Rasplockedinastraightposition,advanceitintothe

discspace.Countersink,loosenthelockingknob,angle

therodmediallyandrelocktheRaspatthedesired

angle.

Drawtherodlaterallyandimpactitinanarcing

trajectory,advancingtheRaspmediallyuntilithas

traversedthemidline.Fullyloosenthelockingknob,

allowingtheRasptofreelyrotateduringextraction.

Channel Preparation

Step 13 Option 1

Step 13 Option 2

14

Modular Trial OptionConnectthedesiredTrialtotheTrialRod.Position

acrossthemidline,adjustingthetipwiththeTrialRod

asdescribedinStep 13, Option 1.

Confirmfinalpositionradiographically.

Fixed Trial OptionPositiontheTrialacrossthemidline.TheT-Handle

maybeattachedtotheFixedTrialstemforadditional

control.

Confirmfinalpositionradiographically.

Final Implant Sizing

Step 14 Option 1

Step 14 Option 2

15

Implant InsertionIntroducetheimplantintothediscspace,carefully

advancingintothepreviouslycreatedchannel.

Countersink1–2mmfromtheposterioredgeofthe

vertebralbody.

Confirmpositionradiographicallyanddetachthe

implantfromtheInserter.

Final Implant Preparation SelecttheimplantsizebasedontheTrial’sfit.With

theBoneFunnel/BoneTamp,filltheimplantwithgraft

material.ConnecttotheInserter,matingthegripsto

theimplant’sproximalchannels.

Step 16

Step 15

Implant Placement

16

Modular Tamp OptionConnecttheModularTampTiptotheTrialRod.With

theModularTampTipinastraightposition,mateit

totheimplantandtapwiththeMallettoadvance

anteriorly,followingthechannelcreatedbytheRasp.

Torepositionthetip,removefromdiscspaceand

turn,lockingtheknobtoreposition.Maintainthe

finalpositionwhileextractingtherod.

Fixed Tamp OptionMatetheFixedTamptotheimplantandtapwiththe

Mallettoadvanceanteriorly,followingthechannel

createdbyaRasp.

Final Positioning

Step 17 Option 1

Step 17 Option 2

17

Radiographic ConfirmationConfirmtheimplantplacementradiographically.

IfusingTraXis Vue implants,refertothetantalum

markerbeadstoconfirmorientation.Beadsshould

appearonlateral(Fig.18a)andA/P(Fig.18b).

Additionalbonegraftmaybepackedintothespace

aroundtheimplant.

Step 18a

Step 18b

Position Confirmation

18

Compression Option

Implant CompressionInsertrodsintothepediclescrewconstruct,

completingtheassembly.UsingtheCompressorfrom

thepediclescrewsystem,applyaloadtotheTraXis

implantandlocktheconstruct.

Step 19

25

Warnings and Precautions

Warnings

Followingarespecificwarnings,precautions,andadverseeffects,whichshouldbeunderstoodby

thesurgeonandexplainedtothepatients.Thesewarningsdonotincludealladverseeffects,which

canoccurwithsurgeryingeneral,butareimportantconsiderationsparticulartometallicinternal

fixationdevices.Generalsurgicalrisksshouldbeexplainedtothepatientpriortosurgery.

1.THESAFETYANDEFFECTIVENESSOFINTERBODYFUSIONHASBEENESTABLISHEDONLY

FORSPINALCONDITIONSWITHSIGNIFICANTMECHANICALINSTABILITYORDEFORMITY

REQUIRINGFUSIONWITHINSTRUMENTATION.Theseconditionsaresignificantmechanical

instabilitysecondarytodegenerativespondylolisthesiswithobjectiveevidenceofneurologic

impairment,fracture,dislocation,scoliosis,kyphosis,spinaltumorandfailedpreviousfusion

(pseudarthrosis).Thesafetyandeffectivenessofthesedevicesforanyotherconditionsis

unknown.(APPLICABLEONLYTOINDICATIONSOUTSIDETHEUNITEDSTATES)

2.Potentialrisksidentifiedwiththeuseofthisdevicesystem,whichmayrequireadditional

surgery,include:

a)Devicecomponentfracture

b)Lossoffixation

c)Non-union

d)Fractureofthevertebra

e)Neurologicalinjury

f)Vascularorvisceralinjury

3.CORRECTSELECTIONOFTHEIMPLANTISEXTREMELYIMPORTANT.Thepotentialforsatisfactory

fixationisincreasedbytheselectionofthepropersize,shapeanddesignoftheimplant.While

properselectioncanhelpminimizerisks,thesizeandshapeofhumanbonespresentlimitations

onthesize,shape,andstrengthofimplants.Implantsheightshouldbedeterminedsuchthat

adequatedecompressionandstabilityareimpartedtotheinstrumentedsegment.

26

4.THENEEDFORSUPPLEMENTALFIXATIONMUSTBEDETERMINEDBYTHESURGEONBASEDUPON

THEAMOUNTOFINSTABILITYIMPARTEDBYTHESURGERY,ASWELLASTHEPATHOLOGYITSELF.

(APPLICABLEONLYTOINDICATIONSOUTSIDETHEUNITEDSTATES)

5.IMPLANTSCANBREAKWHENSUBJECTEDTOTHEINCREASEDLOADINGASSOCIATEDWITH

DELAYEDUNIONORNON-UNION.Internalfixationappliancesareloadsharingdeviceswhich

areusedtoobtainanalignmentuntilnormalhealingoccurs.Ifhealingisdelayedordoes

notoccur,theimplantmayeventuallybreakduetofatigue.Thedegreeorsuccessofunion,

loadsproducedbyweightbearing,andactivitylevelswill,amongotherconditions,dictate

thelongevityoftheimplant.Notches,scratchesorbendingoftheimplantduringthecourse

ofsurgerymayalsocontributetoearlyfailure.Patientsshouldbefullyinformedoftherisksof

implantfailure.

6.MIXINGMETALSCANCAUSECORROSION.Therearemanyformsofcorrosiondamageand

severaloftheseoccuronmetalssurgicallyimplantedinhumans.Generaloruniformcorrosion

ispresentonallimplantedmetalsandalloys.Therateofcorrosiveattackonmetalimplant

devicesisusuallyverylowduetothepresenceofpassivesurfacefilms.Dissimilarmetalsin

contact,suchastitaniumandstainlesssteel,acceleratethecorrosionprocessofstainless

steelandmorerapidattackoccurs.Thepresenceofcorrosioncompoundsreleasedintothe

bodysystemwillalsoincrease.Internalfixationdevices,suchasrods,hooks,wires,etc.which

comeintocontactwithothermetalobjects,mustbemadefromlikeorcompatiblemetals.

27

7.PATIENTSELECTION.Inselectingpatientsforinternalfixationdevices,thefollowingfactorscan

beofextremeimportancetotheeventualsuccessoftheprocedure:

a)Thepatient’sweight.Anoverweightorobesepatientcanproduceloadsonthedevicethat

canleadtoalossofinterbodyheightorfailureofthedeviceand/ortheoperation.

b)Thepatient’soccupationoractivity.Ifthepatientisinvolvedinanoccupationoractivitythat

includessubstantialwalking,running,liftingormusclestrain,theresultantforcescancause

lossofdischeightand/orfailureofthedevice.

c)Aconditionofsenility,mentalillness,alcoholism,ordrugabuse.Theseconditions,among

others,maycausethepatienttoignorecertainnecessarylimitationsandprecautionsinthe

useoftheappliance,leadingtoimplantfailureorothercomplications.

d)Certaindegenerativediseases.Insomecases,theprogressionofdegenerativediseasemay

besoadvancedatthetimeofimplantationthatitmaysubstantiallydecreasetheexpected

usefullifeoftheappliance.Forsuchcases,orthopaedicdevicescanonlybeconsidereda

delayingtechniqueortemporaryrelief.

e)Foreignbodysensitivity.Wherematerialsensitivityissuspected,appropriatetestsshouldbe

madepriortomaterialselectionorimplantation.

f)Smoking.Patientswhosmokehavebeenobservedtoexperiencehigherratesof

pseudarthrosisfollowingsurgicalprocedureswherebonegraftisused.

8.Thesewarningsdonotincludealladverseeffectsthatcanoccurwithsurgeryingeneral.

Generalsurgicalrisksshouldbeexplainedtothepatientspriortosurgery.

28

Precautions

1.THEIMPLANTATIONOFSPINALSYSTEMSSHOULDBEPERFORMEDONLYBYEXPERIENCED

SURGEONSWITHSPECIFICTRAININGINTHEUSEOFSUCHSYSTEM.THISISATECHNICALLY

DEMANDINGPROCEDUREPRESENTINGARISKOFSERIOUSINJURYTOTHEPATIENT.

2.SURGICALIMPLANTSMUSTNEVERBEREUSED.Anexplantedimplantshouldneverbere-

implanted.Eventhoughthedeviceappearsundamaged,itmayhavesmalldefectsandinternal

stresspatternsthatmayleadtoearlybreakage.

3.CORRECTHANDLINGOFTHEIMPLANTISEXTREMELYIMPORTANT.Contouringofthemetal

implantsshouldonlybeperformedwithproperequipment.Theoperatingsurgeonshould

avoidanynotching,scratchingorreversebendingofthedevice.Alterationswillproduce

defectsinsurfacefinishandinternalstresseswhichmaybecomethefocalpointforeventual

breakageoftheimplant.

4.ADEQUATELYINSTRUCTTHEPATIENT.Postoperativecareandthepatient’sabilityand

willingnesstofollowinstructionsareoneofthemostimportantaspectsofsuccessfulbone

healing.Thepatientmustbemadeawareofthelimitationsoftheimplantandthatphysical

activityandfullweightbearinghavebeenimplicatedinbendingorfracture.Thepatientshould

understandthatametallicimplantisnotasstrongasnormal,healthyboneandwillfracture

ifexcessivedemandsareplacedonitintheabsenceofcompletebonehealing.Anactive,

debilitated,ordementedpatientwhocannotproperlyuseweight-supportingdevicesmaybe

particularlyatriskduringpostoperativerehabilitation.

Solutions by the people of Zimmer Spine.

You are devoted to helping your patients reduce their pain and improve their lives.

And the people of Zimmer Spine are devoted to you. We are dedicated to supporting

you with best-in-class tools, instruments and implants. We are driven by the opportunity

to share our unrivaled education and training. We are committed partners who will

do everything in our power to assist you in your quest to provide the absolute best in

spinal care. And we can be counted on always to act with integrity as ethical partners

who are worthy of your trust. We are the people of Zimmer Spine.

PEEK-OPTIMA® Polymer is a trademark of Victrex PLC Corporation, United Kingdom.

Distributed by:Zimmer SpineCité Mondiale23, parvis des Chartrons33080 Bordeaux - France

Tel +33(0)5 56 00 18 20Fax +33 (0)5 56 00 18 21

www.zimmerspine.eu

Lit. N° 06.02022.012026E5AS000AN - Dec 2009 - V0

Manufactured by:Zimmer Spine, Inc.5301 Riata Park CourtBuilding FAustin, Texas 78727USA

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