ACL Reconstruction Single Tibial Tunnel Double Bundle

Surgical Protocol by Eric McCarty, M.D.

with

Features• Auniqueweaveinwhichasinglestrandofbraidedpolyethyleneiswoventhroughitselftwiceinoppositedirections.

• ThisconstructallowsBiometSportsMedicinetoproduceinnovativeproductsthatcanvaryinlengthandcompression/tensionaddressingtheindividualneedsofeachpatient.

• ProductsutilizingZipLoop™Technologyareresistanttoslippagewithouttyingknots1.

Benefits• Maximizessofttissuegraft-to-tunnelinterface

• Oneimplantforvaryingtunnellengths—eliminatestheneedformultiplesizes

• ForuseinbothtranstibialandanteromedialportalACLreconstruction

• Tensionmaybeappliedfromfemoralsideaftertibialfixationhasbeenachieved

• Virtuallynoslippageaftercyclicloading1

• Simplesurgicaltechniquerequiresminimalinstrumentation

• Femoralfixationdevicedesignedtocapturethecorticalboneofthefemur

ThisbrochureispresentedtodemonstratethesurgicaltechniqueutilizedbyEricMcCarty,M.D..BiometSportsMedicine,asthemanufacturerofthisdevice,doesnotpracticemedicineanddoesnotrecom-mendthisoranyothersurgicaltechniqueforuseonaspecificpatient.Thesurgeonwhoperformsanyprocedureisresponsiblefordeterminingandutilizingtheappropri-atetechniquesforsuchprocedureforeachindividualpatient.

Surgical Technique

Figure 1

Portal Position and Sizing of GraftsCreatemedialandlateralarthroscopicportalsimmediatelyadjacenttotheedgeofthepatellatendonjustdistaltotheinferiorpoleofthepatella.TheuseofanaccessorymedialportalisrecommendedforpreparationofboththeAMandPLfemoraltunnels(Figure1).Next,sizethegrafts.Thetwofemoralgraftsshouldbesizedindividually.Typically,theAMbundleis7–8mmindiameter,whilethePLbundleis6–7mm.TheAMandPLgraftsshouldthenbesizedtogethertodeterminethetibialtunneldiameter.

Figure 2 Figure 3

AM Femoral Tunnel PreparationCleantheposteriorlateralfemoralcondylebyremovingthestumpusingashaverorelectrocautery.Debrideanyremainingsofttissuefromtheover-the-toppositionusingacuppedcurette.

Positionthekneeat90degreesofflexion.PlacethearthroscopeinthemedialportalandidentifythecenteroftheAMbundleinsertionpointonthelateralwallofthefemur.Createapilotholeforthefemoralguidepinwithamicrofracturepickorsimilarinstrumentviatheaccessorymedialportal.

Thekneeisthenhyperflexedandusingeitherfreehandtechniqueoradrillguide,drillacalibratedguidewirethroughthelateralcortex.Checkthattheguidewireisplacedinthe10:00positionforaleftkneeanda2:00positionforarightknee(Figure2).

Drilloverthepreviouslyplacedguidewirewiththe4.5mmToggleLoc™drillbitthroughthelateralcortexofthefemur(Figure3).

Surgical Technique (continued)

Figure 5Figure 4

AM Femoral Tunnel Preparation (continued)Passthe4.5mmdrillinandoutofthecortextwotothreetimestofacilitatepassageoftheimplant.RemovetheguidepinandmeasuretheoveralllengthoftheAMTunnelusingadepthprobe(Figure4).InserttheguidepinbackintotheAMtunnelthroughtheaccessorymedialportal.Drillovertheguidewirewithanendoscopicreamercorrespondingtothediameterofthegraftandreamtothedepththatwillallowthedesiredsoft-tissuegraft-to-tunnelinterface(Figure5).Makesuretheendosopicreamerdoesnotbreakthelateralcortex.

Note: When the knee is hyperflexed, outflow will dramatically increase causing poor visualization. To address this problem, put an open mouthed shaver in the lateral portal and use as suction.

Figure 7

Note: This step is necessary only if utilizing the medial portal

PL Femoral Tunnel PreparationFlexthekneeto90degrees.PositionaPLTunnelFemoralAimerintotheappropriatepositiononthelateralwallofthefemur,utilizingtheaccessoryanteromedialportal(Figure6).Thepositionisidentifiedunderdirectvisualization,ensuringthata2–4mmbonebridgeisvisiblebetweentheAMandPLtunnels(Figure7).TheareaofthePLtunnelshouldbejustabovetheapexofthecurveofthelateralcondylewiththekneeflexedat90degrees.

2mm

Figure 6

Figure 8

Surgical Technique (continued)

PL Femoral Tunnel Preparation (continued)Withthekneehyperflexed,drillacalibratedguidewirethroughtheFemoralAimerandthelateralcortexofthefemur(Figure8).Drilloverthepreviouslyplacedguidewirewiththe4.5mmToggleLoc™drillbitthroughthelateralcortexofthefemur.Passthe4.5mmdrillinandoutofthecortextwotothreetimestofacilitatepassageoftheimplant.RemovetheguidepinandmeasuretheoveralllengthofthePLtunnelusingadepthprobe.ThePLtunnelistypicallyshorterthantheAMtunnel,approximately20–30mminlength.

InserttheguidepinbackintothePLtunnel.Drillovertheguidewirewithanendoscopicreamercorrespondingtothediameterofthegraftandreamtothedepththatwillallowthedesiredsoft-tissuegraft-to-tunnelinterface(Figure9).Makesuretheendosopicreamerdoesnotbreakthelateralcortex.

Figure 9

Tibial Tunnel PreparationUtilizingatibialguidethatallowsforoptimaltunnelplacement,positionthetibialguideappropriatelyanddrilltheguidewire.DeterminetheappropriatetunneldiameterbasedonthediameteroftheAMandPLgrafts.Atibialtunnelwithadiameterofatleast9mmistypical.Oncetheappropriatediameterhasbeenestablished,reamovertheguidewirewiththecorrespondingreamer(Figure10).IfusingaWasherLoc™

devicefortibialfixation,preparethecounterboreatthistime.

Figure 10

Figure 11

Figure 12

Figure 13

Length of Femoral Tunnel

Prepare ToggleLoc™ DevicePassthesofttissuegraftfortheAMtunnelthroughbothloopsoftheToggleLoc™FemoralFixationDevicewithZipLoop™Technology(Figure11).Theimplantshouldbeleftinthewhitecardboardpackaging.Thiswillfacilitatepassingthesofttissuegraftthroughthecorrectloops.Placethegraftthroughtheholeinthepackage.Balancethesofttissuegraftsintheloopsoftheimplanttoallowequalamountsofthesofttissueoneithersideoftheloop.

UsethemeasurementpreviouslyobtainedwiththeToggleLoc™depthgaugetomarkthezipstrandsoftheimplanttoensuredeploymentonthelateralcortex.MeasurefromthedistalendoftheToggleLoc™devicetowardthegraftandmarkthelengthwithasurgical

marker(Figure12).Makeasecondmarkonthegraftbymeasuringthedepthofthe“grafttunnel.”The mark must be 5mm less than the length of the graft tunnel for the AM soft tissue graft. Forexample,ifthegrafttunnelis25mm,thegraftshouldbemarked20mmfromthetopofthegraftloop.Thismarkwillaidinoptimalgraftpositioninglaterintheprocedure.Repeat this process with the PL soft tissue graft, however mark the PL soft tissue graft the same length as the graft tunnel. Forexample,ifthegrafttunnelis25mm,thegraftshouldbemarkedat25mmfromthetopofthegraftloop.

Surgical Technique (continued)

Length of Femoral Reaming

Passing the ToggleLoc™ Device Threadastrandofrelaysuturethroughtheeyeletofthegraftpassingpinsothatthesutureformsacontinuousloop(Figure13).HyperflexthekneeandpasstheguidepinthroughthePLfemoraltunnelandpullproximallyontheguidewiretopulltherelaysuturethroughtheskin(Figure14).Useasuturegrasperorcrochethooktoretrievetherelaysuturethroughthetibialtunnel(Figure15).

Looptheimplantpassingsuture(white#2suturepre-loadedintothetitaniumbutton)oftheToggleLoc™FemoralFixationDevicewithZipLoop™TechnologythroughtherelayloopcorrespondingtothePLsofttissuegraft,whichshouldbeexitingthetibialtunnel.Pullproximallyontherelaysuturetopullthepassingsuturethroughthetibialtunnel,jointspaceandfemoraltunnel,exitingthroughtheskin(Figure16).

Figure 15Figure 14

Figure 16

Surgical Technique (continued)

Figure 18Figure 17

Passing the ToggleLoc™ Device (continued)PassthePLsofttissuegraft.Priortopassing,ensurethattheToggleLoc™FemoralFixationDevicewithZipLoop™Technologyisorientedlaterally,asitwilldeployonthefemur’slateralcortex.The“zipsuture”shouldbeontheanteriorsideofthesoft-tissuegraftpriortograftplacementwithinthefemoraltunnel.PullthepassingsutureproximallyuntilthemarkontheloopsoftheToggleLoc™devicereachtheentranceofthefemoraltunnel.

Positiontheimplantjustbeyondthelateralcortexofthefemur(Figure17).Pullonthedistalendofthesofttissuegraftstofeeltheimplantengageonthelateralfemoralcortex,achievingfemoralfixation(Figure18).

Retrievethezipsuturefromthejointthroughthemedialportalusingasuturegraspingdevice(Figure19).PlacetheknotofthezipstrandintotheZipLoop™pullerandpulldistallytodrawthegraftthroughthePLtibialtunnelandintothePLfemoraltunnel.ThiswillshortentheloopoftheToggleLoc™FemoralFixationDevicewithZipLoop™Technologyandaccuratelypositionthesoft-tissuegraftinthefemoraltunnel(Figure20).

Figure 20Figure 19

Correctplacementisindicatedwhenthemarkonthegraftentersthefemoraltunnel.SeverthezipsuturewiththeMaxCutter™SutureCutter.RepeatthisprocessfortheAMsofttissuegraft.TensionshouldbeappliedtothePLbundlewhenzippingtheAMtunneltoensurethePLbundledoesnotbunchinthetibialtunnel.MakesuretheAMsofttissuegraftiszippedonlytothepointwherethemarkonthegraftentersthefemoraltunnel,sothataftertibialfixationitcanbezippedfurther.

Figure 23

Figure 21

Complete ACL Double Bundle Graft FixationTensionboththeAMandPLsofttissuegraftsinfullextensionandfixatewiththeselectedtibialfixationdevice.Flexthekneeto45degreesandpullthelimbsofthezipstrandfortheAMbundleuntilthedesiredtensionoftheAMbundleismet(Figure21).

PassthelimbsofthezipstrandfortheAMbundlethroughthekeyshapedholeintheSuperMaxCutter™instrument(Figure22).AdvancetheSuperMaxCutter™throughthemedialportalandcutthesutureattheentranceofthefemoraltunnelinthejointspace.RepeatthisprocessforthePLbundle.Reconstructionofthegraftsisnowcomplete(Figure23).

Figure 22

Surgical Technique (continued)

5mm

Package Insert

The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet Sports Medicine at the contact information provided herein.

Biomet Sports Medicine56EastBellDrive

P.O.Box587Warsaw,Indiana46581USA

01-50-1186 Date:03/09

Biomet Sports Medicine ToggleLoc™ System

ATTENTION OPERATING SURGEON

DESCRIPTIONTheToggleLoc™Systemisanon-resorbablesystemintendedtoaid inarthroscopicandorthopedic reconstructiveproceduresrequiring soft tissue fixation, due to injury or degenerativedisease.MATERIALSTitaniumAlloyUltra-HighMolecularWeightPolyethylene(UHMWPE)PolypropyleneNylonPolyesterStainlessSteelINDICATIONS FOR USETheToggleLoc™Systemdevicesareintendedforsofttissuetobonefixationforthefollowingindications:ShoulderBankartlesionrepairSLAPlesionrepairsAcromio-clavicularrepairCapsularshift/capsulolabralreconstructionDeltoidrepairRotatorcufftearrepairBicepsTenodesisFoot and AnkleMedial/lateralrepairandreconstructionMid-andforefootrepairHalluxvalgusreconstructionMetatarsalligament/tendonrepairorreconstructionAchillestendonrepairAnkle Syndesmosis fixation (Syndesmosis disruptions) and asan adjunct in connectionwith trauma hardware forWeber BandCanklefractures(only for ToggleLoc™ with Tophat).ElbowUlnarorradialcollateralligamentreconstructionLateralepicondylitisrepairBicepstendonreattachmentKnee ACL/PCLrepair/reconstructionACL/PCLpatellarbone-tendon-bonegraftsDouble-TunnelACLreconstructionExtracapsularrepair:MCL,LCL,andposteriorobliqueligamentIlliotibialbandtenodesisPatellartendonrepairVMOadvancementJointcapsuleclosureHand and WristCollateralligamentrepairScapholunateligamentreconstructionTendontransfersinphalanxVolarplatereconstructionHipAcetabularlabralrepairCONTRAINDICATIONS 1. Infection. 2.Patientconditionsincludingbloodsupplylimitations,and

insufficientquantityorqualityofboneorsofttissue. 3.Patientswithmentalorneurologicconditionswhoare

unwillingorincapableoffollowingpostoperativecareinstructions.

4.Foreignbodysensitivity.Wherematerialsensitivityissuspected,testingistobecompletedpriortoimplantationofthedevice.

WARNINGSThe ToggleLoc™ System devices provide the surgeon witha means to aid in the management of soft tissue to bonereattachment procedures. While these devices are generallysuccessful in attaining these goals, they cannot be expectedtoreplacenormalhealthyboneorwithstandthestressplaced

upon the device by full or partial weight bearing or loadbearing, particularly in the presence of nonunion, delayedunion, or incomplete healing. Therefore, it is important thatimmobilization (useofexternal support,walkingaids,braces,etc.) of the treatment site be maintained until healing hasoccurred. Surgical implants are subject to repeated stressesinuse,whichcanresult infractureordamagetothe implant.Factors such as the patient’s weight, activity level, andadherencetoweightbearingorloadbearinginstructionshaveaneffectontheservice lifeofthe implant.Thesurgeonmustbe thoroughly knowledgeable not only in the medical andsurgicalaspectsoftheimplant,butalsomustbeawareofthemechanicalandmetallurgicalaspectsofthesurgicalimplants.Patientselectionfactorstobeconsideredinclude:1)needforsoft tissue to bone fixation, 2) ability and willingness of thepatienttofollowpostoperativecareinstructionsuntilhealingiscomplete,and3)agoodnutritionalstateofthepatient.

1.Correctselectionoftheimplantisextremelyimportant.Thepotentialforsuccessinsofttissuetobonefixationisincreasedbytheselectionofthepropertypeofimplant.Whileproperselectioncanhelpminimizerisks,neitherthedevicenorgrafts,whenused,aredesignedtowithstandtheunsupportedstressoffullweightbearing,loadbearingorexcessiveactivity.

2.Theimplantscanloosenorbedamagedandthegraftcanfailwhensubjectedtoincreasedloadingassociatedwithnonunionordelayedunion.Ifhealingisdelayed,ordoesnotoccur,theimplantortheproceduremayfail.Loadsproducedbyweightbearingandactivitylevelsmaydictatethelongevityoftheimplant.

3. Inadequatefixationatthetimeofsurgerycanincreasetheriskoflooseningandmigrationofthedeviceortissuesupportedbythedevice.Sufficientbonequantityandqualityareimportanttoadequatefixationandsuccessoftheprocedure.Bonequalitymustbeassessedatthetimeofsurgery.Adequatefixationindiseasedbonemaybemoredifficult.Patientswithpoorqualitybone,suchasosteoporoticbone,areatgreaterriskofdevicelooseningandprocedurefailure.

4. Implantmaterialsaresubjecttocorrosion.Implantingmetalsandalloyssubjectsthemtoconstantchangingenvironmentsofsalts,acids,andalkalisthatcancausecor-rosion.Puttingdissimilarmetalsandalloysincontactwitheachothercanacceleratethecorrosionprocessthatmayenhancefractureofimplants.Everyeffortshouldbemadetousecompatiblemetalsandalloyswhenmarryingthemtoacommongoal,i.e.,screwsandplates.

5.Careistobetakentoensureadequatesofttissuefixationatthetimeofsurgery.Failuretoachieveadequatefixationorimproperpositioningorplacementofthedevicecancontributetoasubsequentundesirableresult.

6.Theuseofappropriateimmobilizationandpostoperativemanagementisindicatedaspartofthetreatmentuntilhealinghasoccurred.

7.Correcthandlingofimplantsisextremelyimportant.Donotmodifyimplants.Donotnotchorbendimplants.Notchesorscratchesputintheimplantduringthecourseofsurgerymaycontributetobreakage.

8.DONOTUSEifthereisalossofsterilityofthedevice.9. DiscardandDONOTUSEopenedordamageddevices,

anduseonlydevicesthatarepackageinunopenedorundamagedcontainers.

10.Adequatelyinstructthepatient.Postoperativecareisimportant.Thepatient’sabilityandwillingnesstofollowinstructionsisoneofthemostimportantaspectsofsuccessfulfracturemanagement.Patientseffectedwithsenility,mentalillness,alcoholism,anddrugabusemaybeatahigherriskofdeviceorprocedurefailure.Thesepa-tientsmayignoreinstructionsandactivityrestrictions.Thepatientistobeinstructedintheuseofexternalsupports,walkingaids,andbracesthatareintendedtoimmobilizethefracturesiteandlimitweightbearingorloadbearing.Thepatientistobemadefullyawareandwarnedthatthedevicedoesnotreplacenormalhealthybone,andthatthedevicecanbreak,bendorbedamagedasaresultofstress,activity,loadbearing,orweightbearing.Thepatientistobemadeawareandwarnedofgeneralsurgicalrisks,pos-sibleadverseeffects,andtofollowtheinstructionsofthetreatingphysician.Thepatientistobeadvisedoftheneedforregularpostoperativefollow-upexaminationsaslongasthedeviceremainsimplanted.

PRECAUTIONSDo not reuse implants. While an implant may appearundamaged, previous stressmay have created imperfectionsthatwouldreducetheservicelifeoftheimplant.Donottreatwith implants thathavebeen, evenmomentarily,placed inadifferentpatient.Instruments are available to aid in the accurate implantationofinternalfixationdevices.Intraoperativefractureorbreakingof instruments has been reported. Surgical instruments aresubject towearwithnormalusage. Instruments,whichhaveexperienced extensive use or excessive force, are susceptibletofracture.Surgicalinstrumentsshouldonlybeusedfortheirintended purpose. Biomet Sports Medicine recommendsthat all instruments be regularly inspected for wear anddisfigurement.If device contains MaxBraid™ suture, refer to manufacturerpackageinsertforfurtherinformation.POSSIBLE ADVERSE EFFECTS

1.Nonunionordelayedunion,whichmayleadtobreakageoftheimplant.

2.Bendingorfractureoftheimplant. 3.Looseningormigrationoftheimplant. 4.Metalsensitivityorallergicreactiontoaforeignbody. 5.Pain,discomfort,orabnormalsensationduetothepres-

enceofthedevice. 6.Nervedamageduetosurgicaltrauma. 7.Necrosisofboneortissue. 8. Inadequatehealing. 9. Intraoperativeorpostoperativebonefractureand/or

postoperativepain.STERILITYThe ToggleLoc™ System devices are supplied sterile and aresterilized by exposure to Ethylene Oxide Gas (ETO) if devicecontainsMaxBraid™PEsuture. Donotresterilize. Donotuseanycomponentfromanopenedordamagedpackage.Donotusepastexpirationdate.Caution: Federal law (USA) restricts this device to sale,distribution,orusebyorontheorderofaphysician.CommentsregardingtheuseofthisdevicecanbedirectedtoAttn: RegulatoryAffairs,Biomet, Inc.,P.O.Box587,WarsawIN46581USA,Fax:574-372-3968.All trademarks herein are the property of Biomet, Inc. or itssubsidiariesunlessotherwiseindicated.AuthorizedRepresentative: BiometU.K.,Ltd. WatertonIndustrialEstate Bridgend,SouthWales CF313XA,U.K.

Manufacturer

DateofManufacture

DoNotReuse

ConsultAccompanyingDocuments

SterilizedusingEthyleneOxide

SterilizedusingIrradiation

Sterile

SterilizedusingAsepticTechnique

SterilizedusingSteamorDryHeat

ExpiryDate

WEEEDevice

CatalogueNumber

LotNumber

Flammable

1.DataonfileatBiometSportsMedicine.Benchtestresultsarenotnecessarilyindicativeofclinicalperformance.

P.O.Box587,Warsaw,IN46581-0587•800.348.9500ext.1501©2010SportsMedicine•www.biometsportsmedicine.com

FormNo.BSM0227.0•REV022810

www.biometsportsmedicine.com

AlltrademarkshereinarethepropertyofBiomet,Inc.oritssubsidiariesunlessotherwiseindicated.

ThismaterialisintendedforthesoleuseandbenefitoftheBiometsalesforceandphysicians.Itisnottoberedistributed,duplicatedordisclosedwithouttheexpresswrittenconsentofBiomet.

Forproductinformation,includingindications,contraindications,warnings,precautionsandpotentialadverseeffects,seethepackageinsertandBiomet’swebsite.

One Surgeon. One Patient.SM

Ordering Information

Double Bundle Femoral Aimer909753 5mm909754 6mm909747 7mm909748 8mm909749 9mm

Medial Portal Femoral Aimer909590 6mm909591 7mm909592 8mm909593 9mm909594 10mm

4.5mm Drill Bit904760 Disposable904765 Reusable

ToggleLoc™ Fixation Devicewith ZipLoop™ Technology 50"

904754

ToggleLoc™ Depth Gauge904766

ToggleLoc™ Disposable Kit909846 Includes: 2.4mmx13"DrillPointK-Wire 2.4mmx16"GraftPassingPin ToggleLoc™4.5mmDrillBit 2.4mmx10"DrillPointK-Wire 3.2mmDrillBit ACLBonePlug MarkingPen 6"Ruler

ZipLoop™ Puller904776

Super MaxCutter™ Suture Cutter900342

Illustrationsinthissurgicaltechniqueareintendedtohighlightstepsoftheprocedureandmaynotbetoscale.