Medial Patellofemoral Ligament (MPFL) Reconstruction

Surgical Protocol by Ronald Navarro, M.D.

with

Features• Auniqueweaveinwhichasinglestrandofbraidedpolyethyleneiswoventhroughitselftwiceinoppositedirections.

• ThisconstructallowsBiometSportsMedicinetoproduceinnovativeproductsthatcanvaryinlengthandcompression/tensionaddressingtheindividualneedsofeachpatient.

• ProductsutilizingZipLoop™Technologyareresistanttoslippagewithouttyingknots1.

Benefits• Maximizessofttissuegraft-to-tunnelinterface

• Oneimplantforvaryingtunnellengths—eliminatestheneedformultiplesizes

• Virtuallynoslippageaftercyclicloading1

• Simplesurgicaltechniquerequiresminimalinstrumentation

• Designedtocapturecorticalbone

ThisbrochureispresentedtodemonstratethesurgicaltechniqueandpostoperativeprotocolutilizedbyRonaldNavarro,M.D..BiometSportsMedicine,asthemanu-facturerofthisdevice,doesnotpracticemedicineanddoesnotrecommendthisoranyothersurgicaltechniqueforuseonaspecificpatient.Thesurgeonwhoperformsanyprocedureisresponsiblefordetermin-ingandutilizingtheappropriatetechniquesprocedureforeachindividualpatient.

Surgical Technique

Indications for Surgery• Severeinstabilityofthepatella

• Subluxationofthepatella

ContraindicationsIfpatellarinstabilityisonlyduetothesedifferentialdiagnoses• Trochlearhypoplasia• Generalizedligamentouslaxity• Patellaalta• Patellarfacetdysplasia

General PositioningThepatientisbroughttotheoperatingtheaterandplacedinthesupinepositiononasplitlegtableifpossible.Afteradequateanesthesiaisobtainedthepatient'sinvolvedlowerextremityhasathighhightourniquetplacedbutitisnotinflated.Aftersterileprepanddrape,1%lidocaineandepinephrineisinjectedinferomediallyandinferolaterally(ifdiagnosticarthroscopyistobeperformed)aswellasmediallyatthefemoralepicondyle,mediallyattheinsertionoftheMPFLandinandaroundthehamstringsinsertionsofthetibia.

Diagnostic Arthroscopy/ Possible TrochleoplastyIfdeemedappropriateduetothepossibilityofunderlyingintra-articularpathologyortheneedfortrochleoplastyorlateralrelease,adiagnosticarthroscopyisperformed.Incisionsaremadeinferomediallyandinferolaterallyinthetypicalportallocationsforkneearthroscopy.Thearthroscopeisintroduced.Evidenceofchondralchangeisassessedonthepatella.Thiscanthenbedebridedusingashaver.Moreelaboratecartilagerestorationmethodsaredescribedseparatelyintheliterature.Allotherintra-articularmeniscalandchondralpathologycanbeassessedandtreatedasdictatedbypriorinformedconsent.

IfonpreoperativeassessmentincludingCTscan,asupra-trochlearbumpisseenthismaydeviatethepatellaoutofthecentraltrackinthetrochlea.Theremaybeabenefittotakedownthisbumpanddeepenthetrochlea.Anarthroscopicburrorbonecuttingshavercanbeusedtoperformthistask.Anyanterior

femoralcorticaloutcroppingcanbetakendownwhilebeingcarefulnottocreateastressriserinthisregion.Ifrelativetrochlearhypoplasiaispresentwithflatteningofthenormaltrochlearconcavity,typicalcaptureofthepatellainearlykneeflexioncannotoccur.Thetrochlearcentralgrooveisdeepenedinthissettingwiththeuseofabonecuttingshaverdirectlyonthemostproximaltrochleararticularcartilage.Thegoalistodeepenonlythemostproximaltrochleaandnotremovetheentirearticularsurface.

Anarthroscopiclateralreleaseisperformedifnegativepatellartiltexists(wherethelateralpatellacannotbetiltedmediallyinthecoronalplanetoapositionwherethepatellacouldbeparalleltothefloorifthepatientisinthesupinepositionandthetoesareintheuppointingor12o’clockposition).Thearthroscopyisthenterminatedandthekneedecompressedtobeginthemedialpatellarfemoralligamentreconstruction.

Figure 1

Figure 2

Graft Preparation Adoubledgraftof5.5–7.0mmdoubleddiameterisrequired.Ifanallograftischosenasthegraftchoice,usuallyasofttissuegraftischosen.Ifahamstringsautograftischosen,anincisionismadeattheanteriormedialaspectofthetibia.Thesartorialfasciaisvisualized.Itisthencutinlinewiththeunderlyingtendons.Thesemitendinosusisremovedandtaggedusingaclosedendtendonstripperafteritstibialinsertionandattachmentstothemedialgastrocnemiusarereleased.Thesartorialfasciaisclosedwitharunningstitch.ThesemitendinosusorsofttissueallograftistakentothebacktableanddoubledoverapassingstichifusingtheComposiTCP™InterferenceScrew(wheretheloopedendisplaced)ortheloopedendofaToggleLoc™FixationDevicewithZipLoop™Technology(Figure1).Theresultantdoubledgraftisrunthroughatendonsizertoobtainitslargestdiameter.Thediameterisnotedforlaterdrilling.

Thefreeendsofthegraftarethentaggedwithprovisionaltensionstitchesandthegraftisplacedonagraftboardintensiononthebacktable.Itiswrappedinamoistlapsponge,awaitingitsuseinthereconstructiveeffort.

Femoral PreparationIfasplitlegtableisused,theuninvolvedextremityisabductedsomedialworkcanensue.A1cmincisionismadeoverthemedialepicondyleprominenceandtheincisionistakendowntobonethroughmultiplemediallayers.Themedialepicondyleispalpatedandapositionjustsuperiorandslightlyposteriortothetipoftheepicondylareminenceischosenforplacementofaguidepin(Figure2).Thepinisdrilledtothelateralsurfaceofthefemur,beingcarefulnottodeviatetooanteriorlyintothearticularsurfaceofthetrochlea(Figure3).

Figure 3

Surgical Technique (continued)

Figure 5Figure 4

IsometryAsuturecanbeplacedaroundthepinandpassedbetweenLayer2andLayer3ofthemedialanatomyofthekneetoasmallincisiononthesuperomedialpatellaforisometrytesting.Itisimportanttoavoidexcessivemedialpatellarfacettensioninflexion(femoralpointtooproximal)andmedialpatellardisplacementinextension(femoralpointtoodistal).

Femoral DrillingThepininthefemurisover-drilledwithanacornreamerbitofdiametercorrespondingtothediameterofthegraftpreparedandsizedearliertoadistanceof30–35mm(Figure4).Theremainingtunnellengthisover-drilledwiththe4.5mmdrillbittoaccommodatethepassageoftheToggleLoc™Device(Figure5)orleftaloneifutilizingaComposiTCP™Screw.Flouroscopicguidancecanhelpsimplifythisstep.

Femoral Graft DeliveryThegraftisdeliveredintotheclosedendfemoraltunnelusingtheBeathpin.TheToggleLoc™Deviceispassedandthenflippedonthelateralfemoralcortex(Figure6a&b).ThezipstrandoftheToggleLoc™deviceisthenpulledtointroducetheloopedendofthegraftintothetunnel.Thegraftcanbemarkedwithamarkingpenat25,30and35mmawayfromthebuttendtohelptracktheamountofgraftthathasbeenintroducedintothefemoraltunnel(Figure7).Itisrecommendedthatlessthanthefulllengthofgraftthatcanbeintroducedonthefemoralsideinitiallybeintroduced(Figure8a).IfusingtheComposiTCP™InterferenceScrew,thegraftisintroducedto30mmandtheComposiTCP™InterferenceScrewofappropriatesizeandlengthisplacedinlinewiththegraftwhileplacingtensiononeithersideofthegraft(Figure8b).

Figure 6a

Figure 6b

Figure 7

Figure 8a

Figure 8b

25mm

30mm

35mm

Surgical Technique (continued)

Patellar PreparationAnincisionismadejustmedialtothepatella.AsthetypicalpatellarinsertionsiteoftheMPFLis6mmdistaltothesuperiorpoleofthepatella,thefocusissuperomediallyonthepatella(Figure9).AnatomicalLayer2ofthemedialkneeisincisedandLayer3issparedunlessopenpatellarcartilagerestorationproceduresarecontemplated.Thissamesuperomedialpatellapositionischosenforplacementofaguidepin.Thepinisdrilledtothelateralsurfaceofthepatella,beingcarefulnottodeviatetooanteriorlyintothenonarticularsurfaceofthepatellaorposteriorlyintothepatellararticulatingfacets(Figure10).

Patellar DrillingThepininthepatellaisoverdrilledwithanacornreamerofthediametercorrespondingtothediameterofthegraftpreparedandsizedearliertoadistanceof15–25mm(Figure11).Theremainingtunnellengthisoverdrilledwiththe4.5mmdrillbittoaccommodatethepassageoftheToggleLoc™Device(Figure12).Flouroscopicguidancecanhelpsimplifythisstep.

Figure 9 Figure 11

Figure 10

Figure 12

Graft Limb CuttingThegraftispassedfromthemedialfemoralincisiontotheanteriormedialpatellarincisionunderneathLayer2(Figure13).Thegraftlimbsareremeasuredfromthepointofinsertionintothemedialpatellartunnelandtrialedwithvaryingamountsof“MPFL”length.Lateralpatellarlaxityischeckedwitheachofthelengthstofindalengthwherethepatellacanglideonequadrantlaterallyinfullextension.ThisisthepointwherethecheckreineffectoftheMPFLreconstructionwouldblockanyfurtherabnormallateraldisplacement.

Newsuturesareplacedinthetwofreelimbsforadistancethatmatchesthelengthoftheacornreamedpatellartunnelandtheremainingexcessgraftandinitialtensionstitchesarecutaway(Figure14).

Figure 13

Figure 14

Figure 15

Figure 16a

Patellar Graft DeliveryThetwostitchesfromthefreelimbsaretiedtoasecondToggleLoc™DeviceviatheZipLoop™sutureloopedends(Figure15).TheToggleLoc™Deviceispassedandthenflippedonthelateralpatellarcortex(Figure16a&b).ThesuturepullingstrandsoftheToggleLoc™Devicearethenpulledupontointroducethefreelimbsofgraftintothetunnel.Thegraftcanbemarkedwithamarkingpenat15,20and25mmawayfromtheendsofthegrafttohelptracktheamountofgraftthathasbeenintroducedintothepatellartunnel(Figure17).

Surgical Technique (continued)

Figure 16b

Figure 17

25mm

20mm

15mm

Customizable Final Tensioning of PatellaAtthispoint,thefinaltensioningofthepatellacantakeplace.BecauseoftheZipLoop™Technology,tensioningcantakeplaceonboththepatellasideandthefemoralsidetoensurethepatellahasnormallateralglideinfullextension,trochlearengagementofthepatellain30to45degreesofflexionandtheabilitytoachievefullflexionwithoutgraftstretch(Figure18).

Figure 18

Closure and RehabilitationTheincisionsarethenirrigatedfreelyandclosedinlayers.Steriledressingsareapplied.Ahingedkneebraceisplaced.Thepatientcanweightbearinfullextensionimmediatelywithcrutchaide.Rangeofmotionisinitiatedfrom0to30degreesofrangeimmediately(non-weightbearing).Progressiveincreaseinflexionshouldoccuroverthenext4–6weekstoachievefullflexionandweaningofthecrutchesandbrace.Progressivestrengtheningofthequadricepsandhamstringswithincreaseinfunctionalmovementshelpsfacilitaterecovery.Patientscantypicallyreturntosportsactivitiesin4–6months.

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

Ordering Information

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

ToggleLoc™ Fixation Device with ZipLoop™ Technology 50"

904755

ToggleLoc™ Fixation DeviceZipLoop™ Puller904776

Super MaxCutter™ Suture Cutter900342

P.O.Box587,Warsaw,IN46581-0587•800.348.9500ext.1501©2010,2011SportsMedicine•www.biometsportsmedicine.com

FormNo.BSM0224.1•REV021511

www.biometsportsmedicine.com

AlltrademarkshereinarethepropertyofBiomet,Inc.oritssubsidiariesunlessotherwiseindicated.

ThismaterialisintendedforthesoleuseandbenefitoftheBiometsalesforceandphysicians.Itisnottoberedistributed,duplicatedordisclosedwithouttheexpresswrittenconsentofBiomet.

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

One Surgeon. One Patient.SM

1.DataonfileatBiometSportsMedicine.Benchtestresultsarenotnecessarilyindicativeofclinicalperformance.