hydroset injectable ha bone substitute · 1. hydroset is indicated to fill bone voids or gaps of...

HydroSet Injectable HABone Substitute

The difference in Bone SubstituteTechnology:

• Fastsetting• Excellentwet-fieldproperties• Osteoconductive• Enhancedscrewfixationin

cancellousboneatandaftersurgery

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Special acknowledgement is made to:

• Dr.PeterCatalano,M.D.,Otolaryngology,LaheyClinic,Burlington,MA,USA,forhisvaluablecontributioninthedevelopmentoftheproductandpremarkettesting

Introduction

PackagingandSterility 3SterileNeedles 3StorageInformation 3HandlingCharacteristics 3

Indications 4Contraindications 4

Advantages 5ApplicationProperties 5HistologicalProperties 5

BoneAugmentationRationale 6

StepstoImplantation 8

DistalRadiusVoidFilling 10TibialPlateauVoidFilling 12TibialPilonVoidFilling 13BoneAugmentation 14OrderingInformation 15

Table of Contents

• Prof.SuneLarsson,M.D.,DepartmentofOrthopaedicandTraumaSurgeryatUppsalaUniversityHospitalinSwedenforhisvaluablecontributioninthedevelopmentoftheproductandpremarkettesting

• Dr.WaltVirkus,M.D.,AssistantProfessoroftheDepartmentofOrthopaedicSurgeryatRushUniversityMedicalCenterinChicago,Illinois,forsharinghistechnicalknow-howandsurgicalexpertiseandprovidingassistanceinthepreparationofthisOperativeTechnique.

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Product Overview

Packaging and Sterility HydroSetispackagedsterileinexact,pre-measuredingredients.

Sizes offered:3cc,5cc,10cc,15cc

Therearetwoseparatesterilepacks.(Syringeandcannulaareforsingleuseonly.Donotresterilize).

1. Foil Pouch: Thepowderispackagedinaplasticbowl.ThebowlisplacedinaTyvek®container.Underneaththebowlcontainingthepowderisadesiccanttocontrolmoisture.Thisshouldneverbeimplantedormixedwiththepowder.

TheTyvek®containerisplacedinafoilpouchanditissterilizedviagammairradiation.

Caution:Theproductshouldbeusedwithin60minutesofopeningtheouterpowderpackaging.

2. Liquid Blister Kit: Thepackagingwhichcontainsthesterile,liquidfilledsyringealsoincludesthecementdeliverysyringewithapreattachedfunnel,plungerrod,8gacannulaandmixingspatulawhicharesterilizedviaEthyleneoxide.

TheHydroSetpackagecontainsan8gacannula.10gaand12gacannulasareavailableassingleuse,sterilepackagedtomeetavarietyofsurgeonsneeds.

-8gacannulaOD=4.2mm-10gacannulaOD=3.4mm-12gacannulaOD=2.8mm

Note:AlwaysrefertotheIFUaswellbeforeusingHydroSet.

Sterile Needles

Roomtemperaturebetween15and25°C(approx.59-77°F).

Storage Information

HydroSetisquick-settingandeasytomixanddeliverviahandapplicationorsyringeinjection.

MixingTime:45secondsTransferTime:1minute45secondsInjectionandSculptingTime:2minutesSettingTime:4minutesat32°Cdefectsitetemperature

Handling Characteristics

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HydroSet Temperature Equilibrium (Liquid Syringe) - From Frozen State

0:00 0:14 0:28 0:34 0:57 1:12

Time(Hour:Min)

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HydroSet Temperature Equilibrium (Liquid Syringe) - From Heated State

0:00 0:14 0:28 0:34 0:57 1:12 1:26 1:40

Time(Hours:Min)

Caution:HydroSetistemperaturesensitive,therefore,handlingtimesareapproximatebasedonproductandORtemperaturesof18to22°C(approx.64−72°F).Ahighertemperaturecanleadtoashortersettingtimeandalowertemperaturetoalongersettingtime.

RoomTemp=22°C

RoomTemp=20°CRoomTemp=22°C

INJECTION or MANUAL IMPLANTATION

Mixing(45seconds)

CementConditioning/SyringeLoadingTime(1minute45seconds)

InjectionorManualImplantation&SculpingTime(2minutes)

SettingTime(4minutes)

Note:Sculpingandmaterialmanipulationmustceaseafter4minutesand30seconds.

0:00 0:45 2:30 4:30 8:308:30

Elapsed Time

Tyvek®isaDuPontregisteredtrademark.

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Rationale, Features & Benefits

HydroSetisaninjectable,sculptableandfast-settingbonesubstitute.

HydroSetisacalciumphosphatecementthatconvertstohydroxyapatite,theprinciplemineralcomponentofbone.ThecrystallinestructureandporosityofHydroSetmakesitaneffectiveosteoconductivematerial,withexcellentbiocompatibilityandmechanicalproperties1.HydroSetisspecificallyformulatedtosetinawetfieldenvironmentandexhibitsoutstandingwet-fieldcharacteristics2.ThechemicalreactionthatoccursasHydroSethardensdoesnotreleaseheatthatcouldbepotentiallydamagingtothesurroundingtissue.Afterimplantation,theHydroSetisremodelledovertimeataratethatisdependentonthesizeofthedefectandtheaverageageandgeneralhealthofthepatient.

Contraindications

•Useindefectsasasoleanchoragematerialforfixationofimplants.

•Useincurrentlyinfectedfieldorsurgicalsitenearaninfection

•Useinpatientswithacutetraumaticinjurieswithopenwoundsnearthedefectthatarelikelytobecomeinfected

•Useforopenfractures

Indications

1.HydroSetisindicatedtofillbonevoidsorgapsoftheskeletalsystem(i.e.,extremities,craniofacial,spineandpelvis).Thesedefectsmaybesurgicallycreatedorosseousdefectscreatedfromtraumaticinjurytothebone.HydroSetisindicatedonlyforbonevoidsorgapsthatarenotintrinsictothestabilityofthebonestructure.

HydroSetcuredinsituprovidesanopenvoid/gapfillerthatcanaugmentprovisionalhardware(e.g.,K-wires,plates,screws)tohelpsupportbonefragmentsduringthesurgicalprocedure.

Thecuredcementactsonlyasatemporarysupportmediaandisnotintendedtoprovidestructuralsupportduringthehealingprocess.

2.Thecuredcementisintendedtoenhancescrewfixationincancellousboneatandafterthetimeofsurgery*.InjectingHydroSetintocancellousbonecreatesacompositeofboneandcement;thisisreferredtoasBoneAugmentation,andresultsinbetterfixationofscrews.HydroSetisnotintendedforuseinareaswherethesurroundingboneisosteoporotic,avascularorotherwisenotcapableofsupportingoranchoringtheimplant.

*ThisindicationisnotclearedforuseintheU.S.

•Useforbonevoidsthatlinkjointspacesand/articulatingsurfaces•Useforloadbearingapplications•Useinareaswheresurrounding

boneisavascularorisincapableofsupportingoranchoringtheimplant

•Useinpatientswhohavenotreachedanageatwhichskeletalsystemgrowthisessentiallycomplete.

•Useinpatientswiththefollowingconditions:abnormalcalciummetabolism,metabolicbonedisease,arecentuntreatedinfection,immunologicabnormalitiesandsystemicdisorderswhichresultinpoorwoundhealingorwillresultintissuedeteriorationovertheimplantsite.

•Useforaugmentingpediclescrews.•UseinVertebroplastyorKyphoplasty

Warning:•HydroSetshouldnotbeusedin

areaswherethesurroundingboneisosteoporotic,avascularorotherwisenotcapableofsupportingoranchoringtheimplant.

•Careshouldbetakentoavoidoverpressurizingthedevicebecausethismayleadtoextrusionofthedevicebeyondthesiteofitsintendedapplicationanddamagetothesurroundingtissues

•Careshouldbetakentoavoidoverpressurizingthedevicebecausethismayleadtofatembolizationorembolizationofthedevicematerialintothebloodstream.

Note:AlwaysrefertotheIFUaswellbeforeusingHydroSet.

Scanning Electron Microscope image of HydroSet material crystalline microstructure at 15000× magnification

References

1.Chow,L,Takagi,L.ANaturalBoneCement–ALaboratoryNoveltyLedtotheDevelopmentofRevolutionaryNewBiomaterials.J.Res.Natl.Stand.Technolo.106,1029-1033(2001).

2.TR-1808.E703.Wetfieldsetpenetration(DataonfileatStryker)

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Advantages

• Injectableormanualimplantation• FastSetting• Isothermic• Excellentwet-fieldCharacteristics• Osteoconductive• Augmentationofprovisional

hardware• Radiopaquetoallowconvenient

visualizationofhealingduringfollow-up

• EnhancedScrewfixationincancellousboneatandaftersurgery*

Rationale, Features & Benefits

Self-curingcalciumphosphatecements(CaP)areusedclinicallytoreplace,repairandaugmentnonloadbearingdefectsincancellousbonevoids1.Nexttounderstandingandadvancingthemechanicalpropertiesofthesematerialsaswellasthebiologicalintegrationwiththesurroundingbonystructure;theclinicaleaseofapplicationandhandlingofCaPmaterialscannotbeoverlooked.ORanddefecttemperature,wetfieldpropertiesanddefectsizeplayakeyrole.

Wet Field Setting1

HydroSetdemonstratedsuperiorcementwashoutresistanceandsettingpropertieswhensubjectedtobloodand/orsalineduringapplicationcomparedtootherevaluatedcommerciallyavailablecements.

Application Properties

InawetfieldenvironmentHydroSetsetssignificantlyfasterthanNorian®,SRS,MIIG®andAlpha-BSM®.

Histological Properties

Biological Rabbit Model1

• HistologyprovedHydroSettobebiocompatible&osteoconductiveasaneffectivebonevoidfiller

• Histologyresultsindicatedgoodcementintegrationintothebonydefectsiteforallthreebonesubstitutesoverthe1yearstudywindow.

• AllthreeCaP’stested(Norian,BoneSourceandHydroSet)wereresorbedbyanosteoclasticmechanism.AllcementswerefoundtobevariablewithnoneoftheCaP’sfullyremodelledintheoneyearstudytimeperiod.

1.TR-1808A701AnimalStudyconductedattheBallina,IrelandAnimalsTestingfacilitiesbyPeterCatalano,M.D.,LaheyClinic,oncaninesinusdefectmodelinawetenvironment(27°C).

• Alpha-BSM®isaregisteredtrademarkofDepuyaJohnson&JohnsonCompany.

• Norian®isaregisteredtrademarkofSynthes®.• MIIG®X3isaregisteredtrademarkofWright.

Canine sinus cavity defect, wet field with blood and saline

ACaPindefectafter6weekssurroundedbynewlyformedvitalbone(mag12.5×).

BDetailoftightcontactbetweennewboneandcementsurfaceafter52weeks(mag25×)

CNon-decalcifiedsectionafter52weeks(mag100×)

A TRAP-positivecellsresorbingcementafter26weeks

BHEstainedsectionshowingnewboneformationonHydroSetafter26weeks

patella

patellaligament

siteofimplantation

medialcollateralligament

plasticplugbonecement

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HydroSet Norlan®SRS MIIG®X3 AlphaBSM®

Adult New Zealand Rabbit

medial view

frontal view

*ThisindicationisnotclearedforuseintheU.S.

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CalciumPhosphatebased(CaP)cementsresorbslowly(overyears)soitcanbeexpectedthatboneaugmentationeffectsobtainedatthetimeofsurgeryshouldbemaintainedforanextendedperiodoftime.Thiseffecthasbeendemonstrated,toalimiteddegree,inastudy 2inwhichscrew(3.5mmdia.)pulloutstrengthwasshowntobeimprovedat1week(W1),3months(M3)and6months(M6)ingoatbonethatwasaugmentedwithCaPcement(Fig.1).

InsummaryCaPcementshavethefollowingcharacteristicswhenusedforboneaugmentation2:

• inlowdensitymaterials(bonemodels/animal&humancadaverbone)thereisincreasedpulloutstrengthwhenscrewsareaugmentedwithcalciumphosphates

• thiseffectisgreatestintheleastdensecancellousbone

• theaugmentationeffectisseenindiametersoforthopaedicscrews1.5mmto8.0mm

Screwfixationfailureincancellousbonerepresentsasurgicalchallenge.Inthesecases,augmentationofscrewpurchasewithinjectablebiomaterialshasbeenproposedtoincreasethestrengthofthefixation.Anin-vitrostudyinvestigatedthebiomechanicalconditionsthatimprovefixationstrengthinanin-vitromodelofcancellousbonewithandwithoutaugmentationwithHydroSetaswellastoexploretheeffectofacorticalshell.Itwassuggestedthatthepresenceofacorticalshellisasignificantfactorinpulloutstrengthofascrew 3.

Forthisin-vitrostudyofscrewfixationinHydroSetaugmentedcancellousbonemodels,anopenporefoammodel(Sawbonesmaterial1521-59)wasutilisedtosimulatecancellousbone.

Cancellousbonescrews(Stryker325460SA5mm×60mm,threadlength20mm,pitch2mm),wereinsertedinthecancellousboneblockstomodel4differentclinicalscenarios:a)screwpurchasethroughcancellous

boneonly;b)screwpurchaseincancellousbone

traversingacorticallayer;c)screwpurchasethroughaugmented

cancellousboneand,finally,d)screwpurchasethroughaugmented

cancellousboneandtraversingcorticallayer(Fig.2).

Bone Augmentation Rationale*

Fig. 1Difference in Pullout Work Done

Fig. 2

Control=screwaloneExpt=screw+BoneSource

Rationale, Features & Benefits

Ineachexperimentthecancellousscrewwasinsertedintothesimulatedboneblockusingtheappropriatesurgicaltooling.Theinsertiondepthforeachscrewwasstandardisedto20mmthroughapredrilled3.5mmpilothole.

ThecorticallayerwassimulatedbyapplicationofaPerspexlayer2mmthicktotheuppermostsideofeachblock.

Themeanpulloutstrengthandstandarddeviationsforeachofthetestconfigurationsareshownin(Fig3).

Theexperimentalresultsshowedthebenefitsofaugmentationwithafour-foldincreaseinpulloutstrengthintheaugmentedfoamwithoutacorticallayerandnearlyfourteen-foldincreasewiththeaugmentationinthepresenceofacorticallayer.Astatisticallysignificantincreaseinpull-outstrengthinopenporefoamwasachievedwiththeaugmentedspecimenscomparedtothenon-augmentedones.

Fig. 3Pull-out force for each test configuration

2.5

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a)purecancellous b)purecancellous+cortex

c)augmentedcancellous

d)augmentedcancellous+cortex

a) purecancellous

b)purecancellous+cortex

d)augmentedcancellous+cortex

*ThisindicationisnotclearedforuseintheU.S.

c)augmentedcancellous

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Rationale, Features & Benefits

Anotherin-vitro4testwasperformedattheUniversityofBath,UKtomeasurethescrewpull-outforcesfor5mm,4mmand2mmcancelleousbonescrewsinanopenporepolyurethanefoam,withandwithoutHydroSet.Statisticalanalysisofthedataclearlyindicatedthattherewasnosignificantdifferencebetweenanyaugmentedtestgroups.Therewasasignificantdifferencebetweenallthetestgroupsandthenon-augmentedscrewswithintheopenporematerial(Fig.4)

Fig. 4Screw Pull-out force

140

120

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80

60

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Lo

ad(

N)

non-aug´d aug´d aug´d aug´d

Screws: Ø5mm Ø4mm Ø2mm

non-aug´d non-aug´d

References

1 HessB,InsleyG,MurphyM.ApplicationpropertiesandhistologicalcharacteristicsofinjectableCaPbonesubstitutes.Injury,Int.J.CareInjured(2006)37S,S3−S9

2 Leung,KS,Tam,KF,Cheung,WH.Applicationofinjectablehydro-xyapatiteonimplantfixationinosteoporoticgoatmodel.ORS2006

If HydroSet is used for bone augmentation, please mind the following information:

Warning:•HydroSetshouldnotbeusedinareaswherethesurroundingboneissteoporotic,

avascularorotherwisenotcapableofsupportingoranchoringtheimplant.•Careshouldbetakentoavoidoverpressurizingthedevicebecausethismaylead

toextrusionofthedevicebeyondthesiteofitsintendedapplicationanddamagetothesurroundingtissues

•Careshouldbetakentoavoidoverpressurizingthedevicebecausethismayleadtofatembolizationorembolizationofthedevicematerialintothebloodstream.

Caution:•Insertionofscrewsinhardenedcementmustbedoneinacontrolledmanner

(slowlydrillingat<1000rpm.).Drillingofcementshouldbegin12minutesafterinitialmixingofthecement.

•Ifusingcementtoaugmentscrewsforenhancedfixationstrength,placescrewintocement2.5to4.5minutesfromthestartofmixing.

Contraindication:·HydroSetiscontraindicatedforuseinaugmentingpediclescrews.

3 ProcterP,HessB,MurphyM,In-vitrostudyofscrewfixationinaugmentedcancellousbonemodels.AbstractpresentedatORS2008

4 Screwpull-outreport,CentreforOrthopaedicBiomechanics,UniversityofBath,UK,Dec.2006(T.R.1862.E503)

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Technical Details

Steps to Implantation

Mixing

Eachkitcontainsoneliquid-filledglasssyringeandonebowlofpowder.PeeloffthelidontheLiquidBlisterKitandplacetheinnerTyvectrayonthesterilefield.Placethecementdeliverysyringebarrelatanangledpositionusingthefixtureaidintheblistertraytoholdthesyringesecurely.

Note:Approachthefixtureaidholdingthesyringeata45degreeangleandthenpushthesyringeontothefixtureaidtoachieveastablefooting.Peelbackthelidonthebowlandemptytheliquidcontentsofthesyringeintothebowlwithpowder(Fig.1).Takecautionwheninjectingtheliquidintothepowder.Lossofliquidmaycauseadrymixturethatisdifficulttoinject.

Caution:Idealoperatingroomtemperaturesshouldbebetween18°and22°C(64.4°−71.6°F).

Mixtheliquidandpowderthoroughlyinacircularmotionfor45seconds,ensuringthatallthesolutionhasbeendistributedthroughoutthepowder(Fig.2).Compressthematerialagainstthesidesofthebowluntilahomogeneous,consistentpasteisachieved.

Caution:Thecementpastemaylookuniformlymixedafter10−15secondsofmixing;however,continuetomixfor45secondstoensurethepowderisthoroughlymixedintosolution.Ifmanualimplantationisdesired,itisrecommendedtowaituntil2minutesand30secondshaveelapsed(fromthestartofmixing)priortoimplantation.

Transferthepastefromthemixingbowltothedeliverysyringeusingthesuppliedspatula(Fig.3).

Fig. 4

Fig. 1

Fig. 2

Fig. 3

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Technical Details

Thiswillallowthepastetorunslowlydownthesyringebarrelkeepinganopenairpathwaythroughthesyringeassemblyatalltimes.Thefunnelcomespre-attachedtothesyringebarrel.Oncecementtransferiscomplete,removethefunnel(counterclockwisedirection)(Fig. 4)andattachthesuppliedcannula(clockwisedirection)(Fig.5).

Caution:Iftheplacementofprovisionalhardwareisrequired,waituntiltwelveminutesfromthestartofmixinguntilimplantationofK-wires,platesorscrews(ensuringhardwarefixationistobone).

Attachtheplungerrodintothepistonatthesyringebarrelentrancebythreadingintoplacewhilekeepingthesyringesystemverticalwiththecannulapointingup(Fig.6).Fullyloadtheplungerrodintothesyringebarreltoremovetrappedairinthesyringeassemblyandtoaccumulatethepastetothebaseofthesyringe(Fig.7).Removingtrappedairisnecessary.Trappedairwillcompromiseinjectability.

Theloadingprocessshouldbecompleteby2minutesand30secondsfromthestartofmixing.

Implantation & Sculpting

Oncethesyringeisfullyloadedandreadytoinject,therewillbe2minutesofinjectiontimebeforethematerialbeginstohardenanditmaybecometoodifficulttoinject.

Caution:Contactandheattransferbetweenthepalmofhandsandsyringebarrelmaydecreasethisinjectabilitytimewindow.Deliverthematerialtothedefectsite.Usethespatulatocontourasdesired.

Sculptingandmaterialmanipulationmustceaseafter4minutes30secondsfromthestartofmixing.

Fig. 6

Set time

Allowthematerialtosetcompletelybeforeclosing.Settimeis4minutes30secondsto8minutes30secondsfromthestartofmixing(potentiallylongerifthedefecteffectivetemperatureislessthan32°C).Leavethematerialundisturbeduntilitiscompletelyset.

Fig. 5

Fig.7

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Plate Technique

1.Performavolarapproachtothedistalradius.Additionaldorsalapproachmaybenecessaryifdirectvisualizationofthearticularsurfaceisrequired.

2.Obtainpreliminaryreductionofthearticularsurface.TemporaryfixationwithK-wiresishelpfulinstabilizingtheelevatedarticularfragmentsuntiltheHydroSetBoneSubstituteordefinitivehardwareareplaced.

Inpreparationforuse,thoroughlymixtheliquidandHydroSetpowderfor45seconds.

Note:PerformeitherStep3orStep4.

3.InjecttheHydroSetBoneSubstituteusingtheprovidedsyringeandcannuladirectlyintotheresidualdefect.Afterthecementhasset,followwithplacementofdefinitivehardware.Additionalfragmentspecificplatesmaybeplacedasnecessary.

OR

4.PlacethevolarplateandinjecttheHydroSetBoneSubstituteusingtheprovidedsyringeandCannulaunderfluoroscopicguidance.Thecannulamaybeinsertedthroughanexposedfractureline.TheHydroSetistheninjectedunderfluoroscopiccontroltominimizeextrusionoutsideofthedefect.

Caution:ForVariAxDistalRadiusplates*,a12gaugecannula(OD2.8mm)orsmallertopassthroughtheholeintheplatemayberequiredasthestandard8gaugecannula(OD4.2mm)providedmightbetoowideforthisindication.

Technical Details

Distal Radius Void Filling

Note:Screwfixationmustbeprovidedbybone.

Note:BoneaugmentationwithHydroSetcanbeappliedbeforeinsertionofthefixation/lockingscrewsincancellousbone.Pleaserefertopage14fortheinstructionfor use of the HydroSet for bone augmentation.

1 2

3 4

*FormoreinformationabouttheVariaxDistalRadiusLockingPlateSystem,

pleaserefertotheLiteratureNumber:90-07800or90-70801

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Technical Details

External Fixator Technique

1.Placeanexternalfixator*inaccordancewiththemanufacturer’stechnique.

2.Applydistractionacrossthewristwiththeexternalfixator.

3.PlaceK-wiresintoanyunreducedfragmentsandmanipulatetoadjustthereductionandmaintainpreliminaryfixation.Additionalwiresareplacedasneededtoachieveadequatefracturestability.

Inpreparationforuse,thoroughlymixtheliquidandHydroSetpowderfor45seconds.

4.PlacetheHydroSetcannulaintothefracturedefectthroughanexposedfracturelineorthroughacorticaldrillhole.TheHydroSetBoneSubstitutecanbeinjectedunderfluoroscopiccontroltominimizeextrusionintothesofttissues.

Distal Radius Void Filling

1 2

3 4

Note:Hardwarefixationmustbeprovidedbybone.

*FormoreinformationaboutStrykerExternalFixationSystemspleaserefertofollowingLiteratureNumbers:5075-1-500HoffmannIICompactBrochure

5075-1-600HoffmannIICompactMRIBrochure

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Technical Details

Plate Technique

1.Obtainanterolateralexposure.Submeniscalarthrotomymaybeusefulfordirectjointvisualizationofthearticularsurface(optional).

2.Reducethearticularsurfaceby:Option1-Directelevationofdepressedarticularfragments.Option2-Indirectelevationofdepressedarticularfragmentsthroughcorticalwindow(medialorlateral).TemporaryfixationwithK-wiresmaybehelpfulinstabilizingtheelevatedarticularfragmentsuntilHydroSetBoneSubstituteordefinitivehardwareisplaced.

Inpreparationforuse,thoroughlymixtheliquidandHydroSetpowderfor45seconds.

Note:PerformeitherStep3orStep4.

3.InjecttheHydroSetBoneSubstituteusingtheprovidedsyringeandcannuladirectlyintotheresidualdefect.Afterthecementhasset,placethedefinitivehardware.

Note:BoneaugmentationwithHydroSetcanbeappliedbeforeinsertionofthefixation/lockingscrewsincancellousbone.Pleaserefertopage14fortheinstructionforuseoftheHydroSetforboneaugmentation.

OR

4.PlacethedefinitivehardwareandinjecttheHydroSetBoneSubstituteusingtheprovidedsyringeandcannulaunderfluoroscopicguidance.The8gacannulamaybeinsertedthroughanexposedfracturelineora4.2mmdrillhole.TheHydroSetistheninjectedunderfluoroscopiccontroltominimizeextrusionoutsideofthedefect.

Tibial Plateau Void Filling

1 2

3 4

Caution:ForAxSOSProximalTibia*plates,a10gaugecannula(OD3.4mm)orsmallertopassthroughtheholeintheplatemayberequiredasthestandard8gaugecannula(OD4.2mm)providedmightbetoowideforthisindication.

Note:Screwfixationmustbeprovidedbybone.

*FormoreinformationabouttheAxSOSProximalTibiaLockingPlateSystem

pleaserefertotheLiteratureNumber:982278

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Plate Technique

1.Obtainexposureofdistaltibia.Anterolateraloranteromedialexposuresarestandard.

2.Obtainpreliminaryreductionofthearticularsurface.K-wiresareusefultotemporarilymaintainarticularreduction.Reductioncanbeobtainedbydirectmanipulationofthedepressedfragmentsorindirectlybytheuseoftampsandelevatorsplacedthroughcorticalwindows.

Inpreparationforuse,thoroughlymixtheliquidandHydroSetpowderfor45seconds.

Note:PerformeitherStep3orStep4.

3.InjecttheHydroSetBoneSubstituteusingtheprovidedsyringeandcannuladirectlyintotheresidualdefect.AftertheHydroSethasset,followwithplacementofdefinitivehardware.

Note:BoneaugmentationwithHydroSetcanbeappliedbeforeinsertionofthefixation/lockingscrewsincancellousbone.Pleaserefertopage14fortheinstructionforuseoftheHydroSetforboneaugmentation.

OR

4.PlacethedefinitivehardwareandinjecttheHydroSetBoneSubstituteusingtheprovidedsyringeandcannulaunderfluoroscopicguidance.The8gacannulamaybeinsertedthroughanexposedfracturelineora4.2mmdrillhole.HydroSetcanbeinjectedunderfluoroscopiccontroltominimizeextrusionoutsideofthedefect.

Tibial Pilon Void Filling

Caution:ForAxSOSDistalTibia*plates,a10gaugecannula(OD3.4mm)orsmallertopassthroughtheholeintheplatemayberequiredasthestandard8gaugecannula(OD4.2mm)providedmightbetoowideforthisindication.

Note:Screwfixationmustbeprovidedbybone.

Technical Details

1 2

3 4

*FormoreinformationabouttheAxSOSDistalTibiaLockingPlateSystemplease

refertotheLiteratureNumber:982279

Bone Augmentation*

Plate Technique

With“lockingscrew-platesystems”resultshaveimprovedcomparedwithconventionalplatesandscrewswhendealingwithweakbone.However,boneaugmentationwithcalciumphosphatecementcanpotentiallyfurtherimprovethescrewfixationofthe“anglestableconstruction”inanosteoporoticbone.Thecementmaypotentiallyprovideamorestablesurroundingaroundthemetalthatcanresultinamorestableconstructionthanwithoutaugmentation.WhenusingHydroSetforboneaugmentationwithaplateandscrewfixationsystem,thefollowingsurgicalstepsarerecommended:

1.Obtainpreliminaryreductionofthearticularsurface.K-wiresareusefultotemporarilymaintainarticularreduction.

Reductioncanbeobtainedbydirectmanipulationofthedepressedfragmentsorindirectlybytheuseoftampsandelevatorsplacedthroughcorticalwindows.

2.Locatetheplateonbonetostabilizethefracture(useK-wireforinitialstability)

3.Drilltheholesforscrewsaccordingtotherespectiveimplanttechnicalrequirements.

Warning:UseofHydroSetindefectsasasoleanchoragesiteforfixationimplantsisacontraindication.ScrewshouldrelyonthesurroundingcancellousbonefordefinativefixationandHydroSetisusedtoaugmentthecancellousbonetoenhancethescrewfixationstrength.InspectandremoveextraHydroSetcementdebrisfromthedefectafterinjectionand/ordrillingandtappingforscrewplacementtoeliminatepotentialfordefectsoreness,redness,orskinirritation.

4.Insertoneortwoscrewstokeeptheplatestable.

5.PrepareHydroSetandinjectthecementintothedrilledholesunderfluoroscopicguidance.

• Usetheback-filltechnique(fillingthescrewholeinretrogradefashion)iftheODofthecannulaissmallerthanthedrillused(Fig.1aand1b)

or

• Usea“pressurized”technique(fillingthescrewholeinantegradefashion,withthetipofthecannulaatthescrewholeentrance)iftheODofthecannulaislargerthanthedrillused(Fig.2aand2b).

6.Insertthescrewsintotheholewhilethecementisstillsoft(approx.2minafterinjection).

Caution:DonotuseHydroSetforboneaugmentationoflagscrews.Whenusinglockingplates,alwayslagbeforeyoulock.

Note:ForVariAxDistalRadiusplates,a12gaugecannula(OD2.8mm)orsmallertopassthroughtheholeintheplatemayberequiredasthestandard8gaugecannula(OD4.2mm)providedmightbetoowideforthisindication.ForAxSOSProximalHumerus,ProximalandDistalTibiaplates,a10gaugecannula(OD3.4mm)orsmallertopassthroughtheholeoftheplatemayberequiredasthestandard8gaugecannula(OD4.2mm)providedmightbetoowideforthisindication.

TheamountofHydroSetneededisestimatedtobe3−5ccofcementforaugmenting6−10screws.(dependingonscrewdiameterandlength)

Fig. 1a Fig. 1b

Fig. 2a Fig. 2b

Fig. 1c

Fig. 2c

14

Technical Details

*ThisindicationisnotclearedforuseintheU.S.

REF Description

397003 3ccHydroSetBoneSubstitute

397005 5ccHydroSetBoneSubstitute

397010 10ccHydroSetBoneSubstitute

397015 15ccHydroSetBoneSubstitute

707010 8gax10cmcannula(1cartonboxwith10units)

397022 10gax10cmcannula(1cartonboxwith10units)

397024 12gax7.5cmcannula(1cartonboxwith10units)

15

Ordering Information

Biologics

Surgical Products

Neuro & ENT

Trauma, Extremities & Deformities

Biologics

Surgical Products

Neuro & ENT

Trauma, Extremities & Deformities

StrykerLeibingerGmbH&Co.KGBötzingerStraße41D-79111FreiburgGermany

www.osteosynthesis.stryker.com

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TheinformationpresentedinthisbrochureisintendedtodemonstrateaStrykerproduct.Alwaysrefertothepackageinsert,productlabeland/oruserinstructionsbeforeusinganyStrykerproduct.Surgeonsmustalwaysrelyontheirownclinicaljudgmentwhendecidingwhichproductsandtechniquestousewiththeirpatients.Productsmaynotbeavailableinallmarkets.Productavailabilityissubjecttotheregulatoryormedicalpracticesthatgovernindividualmarkets.PleasecontactyourStrykerrepresentativeifyouhavequestionsabouttheavailabilityofStrykerproductsinyourarea.

StrykerCorporationoritssubsidiaryusesorhasappliedforthetrademarks:Stryker,HydroSet,VariAx,AxSOS,Hoffmann

LiteratureNumber:90-07900LOTB1008

Copyright©2008Stryker