hydroset injectable ha bone substitute · 1. hydroset is indicated to fill bone voids or gaps of...
TRANSCRIPT
HydroSet Injectable HABone Substitute
The difference in Bone SubstituteTechnology:
• Fastsetting• Excellentwet-fieldproperties• Osteoconductive• Enhancedscrewfixationin
cancellousboneatandaftersurgery
2
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
25
20
15
10
5
0
-5
Tem
per
atu
re(
°C)
HydroSet Temperature Equilibrium (Liquid Syringe) - From Frozen State
0:00 0:14 0:28 0:34 0:57 1:12
Time(Hour:Min)
45
40
35
30
25
20
Tem
per
atu
re(
°C)
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
25
20
15
10
5
0
Sett
ing
Tim
e(m
inu
tes)
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
2.0
1.5
1.0
0.5
0.0W1 M3 M6
Scre
wP
ull
out
Wor
kD
one
(J) 300
250
200
150
100
50
0
Pu
ll-o
ut
Forc
e(N
)
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
100
80
60
40
20
0
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
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TheinformationpresentedinthisbrochureisintendedtodemonstrateaStrykerproduct.Alwaysrefertothepackageinsert,productlabeland/oruserinstructionsbeforeusinganyStrykerproduct.Surgeonsmustalwaysrelyontheirownclinicaljudgmentwhendecidingwhichproductsandtechniquestousewiththeirpatients.Productsmaynotbeavailableinallmarkets.Productavailabilityissubjecttotheregulatoryormedicalpracticesthatgovernindividualmarkets.PleasecontactyourStrykerrepresentativeifyouhavequestionsabouttheavailabilityofStrykerproductsinyourarea.
StrykerCorporationoritssubsidiaryusesorhasappliedforthetrademarks:Stryker,HydroSet,VariAx,AxSOS,Hoffmann
LiteratureNumber:90-07900LOTB1008
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