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Medial Patellofemoral Ligament (MPFL) Reconstruction

Surgical Protocol by Ronald Navarro, M.D.

Features

· Auniqueweaveinwhichasinglestrandofbraided polyethyleneiswoventhroughitselftwiceinopposite directions. · ThisconstructallowsBiometSportsMedicinetoproduce innovativeproductsthatcanvaryinlengthand compression/tensionaddressingtheindividualneeds ofeachpatient. · ProductsutilizingZipLoopTMTechnologyareresistantto slippagewithouttyingknots1.

Benefits

· Maximizessofttissuegraft-to-tunnelinterface · Oneimplantforvaryingtunnellengths-- eliminatestheneedformultiplesizes · Virtuallynoslippageaftercyclicloading1 · Simplesurgicaltechniquerequiresminimal instrumentation · Designedtocapturecorticalbone

Surgical Technique

Indications for Surgery

· Subluxationofthepatella

· Severeinstabilityofthepatella

Contraindications

Ifpatellarinstabilityisonlyduetothesedifferentialdiagnoses · Trochlearhypoplasia · Generalizedligamentouslaxity · Patellaalta · Patellarfacetdysplasia

General Positioning

Thepatientisbroughttotheoperatingtheaterandplacedinthesupine positiononasplitlegtableifpossible.Afteradequateanesthesiaisobtained thepatient'sinvolvedlowerextremityhasathighhightourniquetplacedbut itisnotinflated.Aftersterileprepanddrape,1%lidocaineandepinephrine isinjectedinferomediallyandinferolaterally(ifdiagnosticarthroscopyisto beperformed)aswellasmediallyatthefemoralepicondyle,mediallyatthe insertionoftheMPFLandinandaroundthehamstringsinsertionsofthetibia.

Thisbrochureispresentedtodemonstrate thesurgicaltechniqueandpostoperative protocolutilizedbyRonaldNavarro,M.D.. BiometSportsMedicine,asthemanufacturerofthisdevice,doesnotpractice medicineanddoesnotrecommendthisor anyothersurgicaltechniqueforuseona specificpatient.Thesurgeonwhoperforms anyprocedureisresponsiblefordeterminingandutilizingtheappropriatetechniques procedureforeachindividualpatient.

Diagnostic Arthroscopy/ Possible Trochleoplasty

Ifdeemedappropriateduetothepossibilityof underlyingintra-articularpathologyortheneed fortrochleoplastyorlateralrelease,adiagnostic arthroscopyisperformed.Incisionsaremade inferomediallyandinferolaterallyinthetypicalportal locationsforkneearthroscopy.Thearthroscopeis introduced.Evidenceofchondralchangeisassessed onthepatella.Thiscanthenbedebridedusinga shaver.Moreelaboratecartilagerestorationmethods aredescribedseparatelyintheliterature.Allother intra-articularmeniscalandchondralpathologycan beassessedandtreatedasdictatedbypriorinformed consent. IfonpreoperativeassessmentincludingCTscan,a supra-trochlearbumpisseenthismaydeviatethe patellaoutofthecentraltrackinthetrochlea.There maybeabenefittotakedownthisbumpanddeepen thetrochlea.Anarthroscopicburrorbonecutting shavercanbeusedtoperformthistask.Anyanterior

femoralcorticaloutcroppingcanbetakendownwhile beingcarefulnottocreateastressriserinthisregion.If relativetrochlearhypoplasiaispresentwithflattening ofthenormaltrochlearconcavity,typicalcaptureofthe patellainearlykneeflexioncannotoccur.Thetrochlear centralgrooveisdeepenedinthissettingwiththeuse ofabonecuttingshaverdirectlyonthemostproximal trochleararticularcartilage.Thegoalistodeepenonly themostproximaltrochleaandnotremovetheentire articularsurface. Anarthroscopiclateralreleaseisperformedifnegative patellartiltexists(wherethelateralpatellacannotbe tiltedmediallyinthecoronalplanetoapositionwhere thepatellacouldbeparalleltothefloorifthepatient isinthesupinepositionandthetoesareintheup pointingor12o'clockposition).Thearthroscopyisthen terminatedandthekneedecompressedtobeginthe medialpatellarfemoralligamentreconstruction.

Surgical Technique (continued)

Figure 1

Figure 2

Figure 3

Adoubledgraftof5.5­7.0mmdoubleddiameteris required.Ifanallograftischosenasthegraftchoice, usuallyasofttissuegraftischosen.Ifahamstrings autograftischosen,anincisionismadeattheanterior medialaspectofthetibia.Thesartorialfasciais visualized.Itisthencutinlinewiththeunderlying tendons.Thesemitendinosusisremovedandtagged usingaclosedendtendonstripperafteritstibial insertionandattachmentstothemedialgastrocnemius arereleased.Thesartorialfasciaisclosedwitharunning stitch.Thesemitendinosusorsofttissueallograftis takentothebacktableanddoubledoverapassing stichifusingtheComposiTCPTMInterferenceScrew (wheretheloopedendisplaced)ortheloopedendof aToggleLocTMFixationDevicewithZipLoopTMTechnology (Figure1).Theresultantdoubledgraftisrunthrougha tendonsizertoobtainitslargestdiameter.Thediameter isnotedforlaterdrilling.

Graft Preparation

Thefreeendsofthegraftarethentaggedwith provisionaltensionstitchesandthegraftisplaced onagraftboardintensiononthebacktable.Itis wrappedinamoistlapsponge,awaitingitsuseinthe reconstructiveeffort.

Femoral Preparation

Ifasplitlegtableisused,theuninvolvedextremityis abductedsomedialworkcanensue.A1cmincision ismadeoverthemedialepicondyleprominenceand theincisionistakendowntobonethroughmultiple mediallayers.Themedialepicondyleispalpatedanda positionjustsuperiorandslightlyposteriortothetip oftheepicondylareminenceischosenforplacement ofaguidepin(Figure2).Thepinisdrilledtothelateral surfaceofthefemur,beingcarefulnottodeviatetoo anteriorlyintothearticularsurfaceofthetrochlea (Figure3).

Figure 4

Figure 5

Isometry

Asuturecanbeplacedaroundthepinandpassed betweenLayer2andLayer3ofthemedialanatomyof thekneetoasmallincisiononthesuperomedialpatella forisometrytesting.Itisimportanttoavoidexcessive medialpatellarfacettensioninflexion(femoralpoint tooproximal)andmedialpatellardisplacementin extension(femoralpointtoodistal).

Thepininthefemurisover-drilledwithanacorn reamerbitofdiametercorrespondingtothediameter ofthegraftpreparedandsizedearliertoadistanceof 30­35mm(Figure4).Theremainingtunnellengthis over-drilledwiththe4.5mmdrillbittoaccommodate thepassageoftheToggleLocTMDevice(Figure5)orleft aloneifutilizingaComposiTCPTMScrew.Flouroscopic guidancecanhelpsimplifythisstep.

Femoral Drilling

Surgical Technique (continued)

Figure 7

25mm 30mm 35mm

Figure 6a Figure 6b

Thegraftisdeliveredintotheclosedendfemoraltunnel usingtheBeathpin.TheToggleLocTMDeviceispassed andthenflippedonthelateralfemoralcortex(Figure 6a&b).ThezipstrandoftheToggleLocTMdeviceisthen pulledtointroducetheloopedendofthegraftintothe tunnel.Thegraftcanbemarkedwithamarkingpenat 25,30and35mmawayfromthebuttendtohelptrack theamountofgraftthathasbeenintroducedintothe femoraltunnel(Figure7).Itisrecommendedthatless thanthefulllengthofgraftthatcanbeintroducedon thefemoralsideinitiallybeintroduced(Figure8a).If usingtheComposiTCPTMInterferenceScrew,thegraftis introducedto30mmandtheComposiTCPTMInterference Screwofappropriatesizeandlengthisplacedinline withthegraftwhileplacingtensiononeithersideof thegraft(Figure8b).

Femoral Graft Delivery

Figure 8a

Figure 8b

Figure 9

Figure 11

Patellar Preparation

Anincisionismadejustmedialtothepatella.Asthe typicalpatellarinsertionsiteoftheMPFLis6mm distaltothesuperiorpoleofthepatella,thefocusis superomediallyonthepatella(Figure9).Anatomical Layer2ofthemedialkneeisincisedandLayer3is sparedunlessopenpatellarcartilagerestoration proceduresarecontemplated.Thissamesuperomedial patellapositionischosenforplacementofaguidepin. Thepinisdrilledtothelateralsurfaceofthepatella, beingcarefulnottodeviate tooanteriorlyintothe nonarticularsurfaceofthe patellaorposteriorlyinto thepatellararticulating facets(Figure10).

Figure 10

Thepininthepatellaisoverdrilledwithanacorn reamerofthediametercorrespondingtothediameter ofthegraftpreparedandsizedearliertoadistanceof 15­25mm(Figure11).Theremainingtunnellengthis overdrilledwiththe4.5mm drillbittoaccommodate thepassageofthe ToggleLocTMDevice (Figure12).Flouroscopic guidancecanhelpsimplify thisstep.

Figure 12

Patellar Drilling

Figure 13

Figure 14

Graft Limb Cutting

Thegraftispassedfromthemedialfemoralincision totheanteriormedialpatellarincisionunderneath Layer2(Figure13).Thegraftlimbsareremeasured fromthepointofinsertionintothemedialpatellar tunnelandtrialedwithvaryingamountsof"MPFL" length.Lateralpatellarlaxityischeckedwitheachof thelengthstofindalengthwherethepatellacanglide onequadrantlaterallyinfullextension.Thisisthepoint wherethecheckreineffectoftheMPFLreconstruction wouldblockanyfurtherabnormallateraldisplacement.

Newsuturesareplacedinthetwofreelimbsfora distancethatmatchesthelengthoftheacornreamed patellartunnelandtheremainingexcessgraftand initialtensionstitchesarecutaway(Figure14).

Surgical Technique (continued)

Figure 15

Figure 16b Figure 16a

Thetwostitchesfromthefreelimbsaretiedtoasecond ToggleLocTMDeviceviatheZipLoopTMsutureloopedends (Figure15).TheToggleLocTMDeviceispassedandthen flippedonthelateralpatellarcortex(Figure16a&b). ThesuturepullingstrandsoftheToggleLocTMDeviceare thenpulledupontointroducethefreelimbsofgraft intothetunnel.Thegraftcanbemarkedwithamarking penat15,20and25mmawayfromtheendsofthe grafttohelptracktheamountofgraftthathasbeen introducedintothepatellartunnel(Figure17).

Patellar Graft Delivery

25mm 20mm

15mm

Figure 17

Figure 18

Atthispoint,thefinaltensioningofthepatellacantake place.BecauseoftheZipLoopTMTechnology,tensioning cantakeplaceonboththepatellasideandthefemoral sidetoensurethepatellahasnormallateralglideinfull extension,trochlearengagementofthepatellain30 to45degreesofflexionandtheabilitytoachievefull flexionwithoutgraftstretch(Figure18).

Customizable Final Tensioning of Patella

Closure and Rehabilitation

Theincisionsarethenirrigatedfreelyandclosedin layers.Steriledressingsareapplied.Ahingedknee braceisplaced.Thepatientcanweightbearinfull extensionimmediatelywithcrutchaide.Rangeof motionisinitiatedfrom0to30degreesofrange immediately(non-weightbearing).Progressiveincrease inflexionshouldoccuroverthenext4­6weeksto achievefullflexionandweaningofthecrutchesand brace.Progressivestrengtheningofthequadriceps andhamstringswithincreaseinfunctionalmovements helpsfacilitaterecovery.Patientscantypicallyreturnto sportsactivitiesin4­6months.

Package Insert

Biomet Sports Medicine 56EastBellDrive P.O.Box587 Warsaw,Indiana46581USA

upon the device by full or partial weight bearing or load bearing, particularly in the presence of nonunion, delayed union, or incomplete healing. Therefore, it is important that immobilization (use of external support, walking aids, braces, etc.) of the treatment site be maintained until healing has occurred. Surgical implants are subject to repeated stresses inuse,whichcanresultinfractureordamagetotheimplant. Factors such as the patient's weight, activity level, and adherencetoweightbearingorloadbearinginstructionshave aneffectontheservicelifeoftheimplant.Thesurgeonmust be thoroughly knowledgeable not only in the medical and surgicalaspectsoftheimplant,butalsomustbeawareofthe mechanicalandmetallurgicalaspectsofthesurgicalimplants. Patientselectionfactorstobeconsideredinclude:1)needfor soft tissue to bone fixation, 2) ability and willingness of the patienttofollowpostoperativecareinstructionsuntilhealingis complete,and3)agoodnutritionalstateofthepatient 1.Correctselectionoftheimplantisextremelyimportant. Thepotentialforsuccessinsofttissuetobonefixationis increasedbytheselectionofthepropertypeofimplant. Whileproperselectioncanhelpminimizerisks,neitherthe devicenorgrafts,whenused,aredesignedtowithstand theunsupportedstressoffullweightbearing,loadbearing orexcessiveactivity. 2.Theimplantscanloosenorbedamagedandthegraftcan failwhensubjectedtoincreasedloadingassociatedwith nonunionordelayedunion.Ifhealingisdelayed,ordoes notoccur,theimplantortheproceduremayfail.Loads producedbyweightbearingandactivitylevelsmaydictate thelongevityoftheimplant. 3.Inadequatefixationatthetimeofsurgerycanincrease theriskoflooseningandmigrationofthedeviceortissue supportedbythedevice.Sufficientbonequantityand qualityareimportanttoadequatefixationandsuccessof theprocedure.Bonequalitymustbeassessedatthetime ofsurgery.Adequatefixationindiseasedbonemaybe moredifficult.Patientswithpoorqualitybone,suchas osteoporoticbone,areatgreaterriskofdeviceloosening andprocedurefailure. 4.Implantmaterialsaresubjecttocorrosion.Implanting metalsandalloyssubjectsthemtoconstantchanging environmentsofsalts,acids,andalkalisthatcancausecorrosion.Puttingdissimilarmetalsandalloysincontactwith eachothercanacceleratethecorrosionprocessthatmay enhancefractureofimplants.Everyeffortshouldbemade tousecompatiblemetalsandalloyswhenmarryingthem toacommongoal,i.e.,screwsandplates. 5.Careistobetakentoensureadequatesofttissuefixation atthetimeofsurgery.Failuretoachieveadequatefixation orimproperpositioningorplacementofthedevicecan contributetoasubsequentundesirableresult. 6.Theuseofappropriateimmobilizationandpostoperative managementisindicatedaspartofthetreatmentuntil healinghasoccurred. 7.Correcthandlingofimplantsisextremelyimportant.Do notmodifyimplants.Donotnotchorbendimplants. Notchesorscratchesputintheimplantduringthecourse ofsurgerymaycontributetobreakage. 8.DONOTUSEifthereisalossofsterilityofthedevice. 9. DiscardandDONOTUSEopenedordamageddevices, anduseonlydevicesthatarepackageinunopenedor undamagedcontainers. 10.Adequatelyinstructthepatient.Postoperativecareis important.Thepatient'sabilityandwillingnesstofollow instructionsisoneofthemostimportantaspectsof successfulfracturemanagement.Patientseffectedwith senility,mentalillness,alcoholism,anddrugabusemaybe atahigherriskofdeviceorprocedurefailure.Thesepatientsmayignoreinstructionsandactivityrestrictions.The patientistobeinstructedintheuseofexternalsupports, walkingaids,andbracesthatareintendedtoimmobilize thefracturesiteandlimitweightbearingorloadbearing. Thepatientistobemadefullyawareandwarnedthatthe devicedoesnotreplacenormalhealthybone,andthatthe devicecanbreak,bendorbedamagedasaresultofstress, activity,loadbearing,orweightbearing.Thepatientisto bemadeawareandwarnedofgeneralsurgicalrisks,possibleadverseeffects,andtofollowtheinstructionsofthe treatingphysician.Thepatientistobeadvisedoftheneed forregularpostoperativefollow-upexaminationsaslong asthedeviceremainsimplanted. PRECAUTIONS Do not reuse implants. While an implant may appear undamaged, previous stress may have created imperfections thatwouldreducetheservicelifeoftheimplant.Donottreat with implants that have been, even momentarily, placed in a differentpatient. Instruments are available to aid in the accurate implantation ofinternalfixationdevices.Intraoperativefractureorbreaking of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible tofracture.Surgicalinstrumentsshouldonlybeusedfortheir intended purpose. Biomet Sports Medicine recommends that all instruments be regularly inspected for wear and disfigurement. If device contains MaxBraidTM suture, refer to manufacturer packageinsertforfurtherinformation. POSSIBLE ADVERSE EFFECTS 1.Nonunionordelayedunion,whichmayleadtobreakage oftheimplant. 2.Bendingorfractureoftheimplant. 3.Looseningormigrationoftheimplant. 4.Metalsensitivityorallergicreactiontoaforeignbody. 5.Pain,discomfort,orabnormalsensationduetothepresenceofthedevice. 6.Nervedamageduetosurgicaltrauma. 7.Necrosisofboneortissue. 8.Inadequatehealing. 9.Intraoperativeorpostoperativebonefractureand/or postoperativepain. STERILITY The ToggleLocTM System devices are supplied sterile and are sterilized by exposure to Ethylene Oxide Gas (ETO) if device containsMaxBraidTMPEsuture.Donotresterilize.Donotuse anycomponentfromanopenedordamagedpackage.Donot usepastexpirationdate. Caution: Federal law (USA) restricts this device to sale, distribution,orusebyorontheorderofaphysician. Commentsregardingtheuseofthisdevicecanbedirectedto Attn:RegulatoryAffairs,Biomet,Inc.,P.O.Box587,WarsawIN 46581USA,Fax:574-372-3968. All trademarks herein are the property of Biomet, Inc. or its subsidiariesunlessotherwiseindicated. AuthorizedRepresentative: BiometU.K.,Ltd. WatertonIndustrialEstate Bridgend,SouthWales CF313XA,U.K.

01-50-1186 Date:03/09

Biomet Sports Medicine ToggleLocTM System ATTENTION OPERATING SURGEON DESCRIPTION TheToggleLocTMSystemisanon-resorbablesystemintendedto aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. MATERIALS TitaniumAlloy Ultra-HighMolecularWeightPolyethylene(UHMWPE) Polypropylene Nylon Polyester StainlessSteel INDICATIONS FOR USE TheToggleLocTMSystemdevicesareintendedforsofttissueto bonefixationforthefollowingindications: Shoulder Bankartlesionrepair SLAPlesionrepairs Acromio-clavicularrepair Capsularshift/capsulolabralreconstruction Deltoidrepair Rotatorcufftearrepair BicepsTenodesis Foot and Ankle Medial/lateralrepairandreconstruction Mid-andforefootrepair Halluxvalgusreconstruction Metatarsalligament/tendonrepairorreconstruction Achillestendonrepair Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B andCanklefractures(only for ToggleLocTM with Tophat) Elbow Ulnarorradialcollateralligamentreconstruction Lateralepicondylitisrepair Bicepstendonreattachment Knee ACL/PCLrepair/reconstruction ACL/PCLpatellarbone-tendon-bonegrafts Double-TunnelACLreconstruction Extracapsularrepair:MCL,LCL,andposteriorobliqueligament Illiotibialbandtenodesis Patellartendonrepair VMOadvancement Jointcapsuleclosure Hand and Wrist Collateralligamentrepair Scapholunateligamentreconstruction Tendontransfersinphalanx Volarplatereconstruction Hip Acetabularlabralrepair CONTRAINDICATIONS 1.Infection. 2.Patientconditionsincludingbloodsupplylimitations,and insufficientquantityorqualityofboneorsofttissue. 3.Patientswithmentalorneurologicconditionswhoare unwillingorincapableoffollowingpostoperativecare instructions. 4.Foreignbodysensitivity.Wherematerialsensitivityis suspected,testingistobecompletedpriortoimplantation ofthedevice. WARNINGS The ToggleLocTM System devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures. While these devices are generally successful in attaining these goals, they cannot be expected toreplacenormalhealthyboneorwithstandthestressplaced

Manufacturer DateofManufacture DoNotReuse ConsultAccompanyingDocuments SterilizedusingEthyleneOxide SterilizedusingIrradiation Sterile SterilizedusingAsepticTechnique SterilizedusingSteamorDryHeat ExpiryDate WEEEDevice CatalogueNumber LotNumber Flammable

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.

Ordering Information ToggleLocTM Fixation Device

ToggleLocTM Fixation Device with ZipLoopTM Technology 50" 904755

ToggleLocTM Disposable Kit 909846 Includes: 2.4mmx13"DrillPointK-Wire

2.4mmx16"GraftPassingPin ToggleLocTM4.5mmDrillBit 2.4mmx10"DrillPointK-Wire 3.2mmDrillBit ACLBonePlug MarkingPen 6"Ruler

ZipLoopTM Puller 904776 Super MaxCutterTM Suture Cutter 900342

1.DataonfileatBiometSportsMedicine.Benchtestresultsarenotnecessarilyindicativeofclinicalperformance.

AlltrademarkshereinarethepropertyofBiomet,Inc.oritssubsidiariesunlessotherwiseindicated. ThismaterialisintendedforthesoleuseandbenefitoftheBiometsalesforceandphysicians. Itisnottoberedistributed,duplicatedordisclosedwithouttheexpresswrittenconsentofBiomet. Forproductinformation,includingindications,contraindications,warnings, precautionsandpotentialadverseeffects,seethepackageinsertandBiomet'swebsite.

One Surgeon. One Patient.

SM

P.O.Box587,Warsaw,IN46581-0587·800.348.9500ext.1501 ©2010,2011SportsMedicine·www.biometsportsmedicine.com FormNo.BSM0224.1·REV021511

www.biometsportsmedicine.com

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