Evidenced Based Use of Biologics with the Shoulder• The benefit of syntheSc versus biological...
Transcript of Evidenced Based Use of Biologics with the Shoulder• The benefit of syntheSc versus biological...
Evidenced Based Use of Biologics
with the Shoulder
ChristopherDoumas,MD
ClinicalAssistantProfessorOrthopaedicSurgery
Rutgers:RWJMedicalSchool
ChiefofHandSurgeryJerseyShoreUniversityMedical
Center
Discolsure – Ihavenorelevantdisclosurestodiscuss.
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Questions???
• Whatdobiologicsoffertoshouldersurgery?
• IsthereanyevidencethatbiologicsmakeshouldersurgerybeIer?
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Why Biologics? • Rotatorcuffre-tearrates=22-94%!
• Timing• LocaSon• Size• Age• Chronicity
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BrianJ.ColeMD,MBA,L.PearceMcCartyMD,RichardW.KangMD,MS,WinslowAlfordMD,PaulB.LewisMD,MSandJenniferK.HaydenMSN,RN.JournalofShoulderandElbowSurgery,2007-09-01,Volume16,Issue5,Pages579-585
Early Failed Repair = Poor Construct
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Late Failed Repair = Poor Biology
Chronic Rotator Cuff tears
• Typicallyretract• Maybelarge• Reliablyprogresswithatrophytothemusclebelly
• Doesitreallyma-eriftheRTCheals?
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Patients prefer a strong shoulder
StructuralIntegrityAaerRotatorCuffRepairDoesNotCorrelatewithPaSentFuncSonandPain:AMeta-Analysis.Russell,RobertDMD;Knight,JusSnRMD;Mulligan,EdwardDPT;Khazzam,MichaelSMD.JournalofBone&JointSurgery-AmericanVolume.96(4):265-271,February2014.
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14studieswith861paSentsMeta-analysis
78.3%Healedand21.7%Re-tearHealedpa(entshadgreaterstrengthandsa(sfac(on
Can we improve the tendon bone interface?
• PatchespromotematerialproperSes
• GrowthfactorspromotestructuralproperSes
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Patches
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SyntheScs
Xenograas
Allograas
Preclinical For Patches Rotatorcuffrepairusinganacellulardermalmatrixgraa:aninvivostudyinacaninemodel.AdamsJE1,ZobitzME,ReachJSJr,AnKN,SteinmannSP.Arthroscopy.2006Jul;22(7):700-9.
RotatorCuffRepairUsinganAcellularDermalMatrixGraa:AnInVivoStudyinaCanineModel.JulieE.Adams,M.D.a,MarkE.Zobitz,M.S.b,JohnS.ReachJr,M.D.a,Kai-NanAn,Ph.D.b,ScoIP.Steinmann,M.D.Arthroscopy.Volume22,Issue7,July2006,Pages700–709
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BiomechanicalanalysisofgapformaSonandfailuremechanicsofaxenograa-reinforcedrotatorcuffrepairinacadavericmodel.KevinP.SheaMD,ElimoObopilweMS,JohnW.SperlingMD,MBAandJosephP.IannonMD,PhD.JournalofShoulderandElbowSurgery,2012-08-01,Volume21,Issue8,Pages1072-1079
ReconstrucSonoflargerotator-cufftearswithacellulardermalmatrixgraasinrats.JunjiIdeMD,KenshiKikukawaMD,JunHiroseMD,Ken-ichiIyamaMD,HidetoshiSakamotoDrEngandHiroshiMizutaMD.JournalofShoulderandElbowSurgery,2009-03-01,Volume18,Issue2,Pages288-295
Patch Augmentation Indications
• Young• Failuresoratriskforfailure• Massivetears• Chronicchanges• Salvagecases
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Relative Contraindications
• Rotatorcuffarthropathy• Pseudoparalysis• Irreparabletears• UnrealisScexpectaSons
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Patch Interposition Outcomes Level of Evidence 4
Long-termsuccessfularthroscopicrepairoflargeandmassiverotatorcufftearswithafunc(onalanddegradablereinforcementdevice.ChristopherS.ProctorMDJournalofShoulderandElbowSurgery,2014-10-01,Volume23,Issue10,Pages1508-1513
• Thepoly-l-lacScacidbioabsorbablepatchdesignedspecificallytoreinforcethesurgicalrepairoftendonssupportedsuccessfulrepairoflargetomassiverotatorcufftearsin83%ofpa(entsat12monthsaOersurgeryand78%ofpa(entsat42monthsaOersurgery,withsubstanSalfuncSonalimprovement.
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Patch Interposition Outcomes Level of Evidence 4
Long-termsuccessfularthroscopicrepairoflargeandmassiverotatorcufftearswithafunc(onalanddegradablereinforcementdevice.ChristopherS.ProctorMDJournalofShoulderandElbowSurgery,2014-10-01,Volume23,Issue10,Pages1508-1513
• Thepoly-l-lacScacidbioabsorbablepatchdesignedspecificallytoreinforcethesurgicalrepairoftendonssupportedsuccessfulrepairoflargetomassiverotatorcufftearsin83%ofpa(entsat12monthsaOersurgeryand78%ofpa(entsat42monthsaOersurgery,withsubstanSalfuncSonalimprovement.
Rotatorcuffrepairaugmenta(onusinganovelpolycarbonatepolyurethanepatch:preliminaryresultsat12months'follow-up.IvanEncalada-DiazMD,BrianJ.ColeMD,MBA,JohnD.MacGillivrayMD,MichellRuiz-SuarezMD,MS,JamesS.KercherMD,NicoleA.FrielMSandFernandoValero-GonzalezMDJournalofShoulderandElbowSurgery,2011-07-01,Volume20,Issue5,Pages788-794
• ThepolycarbonatepolyurethanepatchwasdesignedtosupportSssueingrowthandenhancehealingasshownbypreclinicalanimalstudies.Clinically,thepatchiswelltoleratedandshowspromisingefficacy,witha10%retearrateatthe12-month(mepoint.
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Patch Extension Outcomes Level of Evidence 4
Aprospec(ve,mul(centerstudytoevaluateclinicalandradiographicoutcomesinprimaryrotatorcuffrepairreinforcedwithaxenograOdermalmatrix.EvanS.LedermanMD,AlisonP.TothMD,GregoryP.NicholsonMD,RobertJ.NowinskiDO,GeorgeK.BalMD,GeraldR.WilliamsMDandJosephP.IannobMD,PhD.JShoulderElbowSurg.2016Apr26Epubaheadofprint
• RepairoflargerotatorcufftearsstructurallyreinforcedwithxenograOECMresultedinimprovedfunc(onaloutcomesscoresandstrength.Adverseeventswereuncommon,andtherateofrevisionsurgerywaslow.
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Patch Extension Outcomes Level of Evidence 4
Aprospec(ve,mul(centerstudytoevaluateclinicalandradiographicoutcomesinprimaryrotatorcuffrepairreinforcedwithaxenograOdermalmatrix.EvanS.LedermanMD,AlisonP.TothMD,GregoryP.NicholsonMD,RobertJ.NowinskiDO,GeorgeK.BalMD,GeraldR.WilliamsMDandJosephP.IannobMD,PhD.JShoulderElbowSurg.2016Apr26Epubaheadofprint
• RepairoflargerotatorcufftearsstructurallyreinforcedwithxenograOECMresultedinimprovedfunc(onaloutcomesscoresandstrength.Adverseeventswereuncommon,andtherateofrevisionsurgerywaslow.
Dermal(ssueallograOfortherepairofmassiveirreparablerotatorcufftears.AnilK.Gupta,KevinHug,DavidJ.Berkoff,BlakeR.Boggess,MollyGavigan,PaulC.MalleyandAlisonP.TothAmJSportsMed.2012Jan;40(1):141-7
• Inourseriesofcarefullyselectedcandidates,allpa(entsdemonstratedasignificantimprovementinpain,rangeofmo(on,andstrength.SubjecSveoutcomemeasures,includingmeanASESandSF-12scores,alsodemonstratedsignificantimprovementatanaverage3-yearfollow-up.
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Patch Extension Outcomes Level of Evidence 3
• ThebenefitofsyntheScversusbiologicalpatchaugmentaSonintherepairofposterosuperiormassiverotatorcufftears:a3-yearfollow-upstudy.
PietroCiampi,CelesteScon,AlessandroNonis,MaIeoVitali,CleliaDiSerio,GiuseppeM.PerenandGianfrancoFraschini.AmJSportsMed.2014May;42(5):1169-75
• CONCLUSION:• Polypropylenepatchaugmenta(onofrotatorcuffrepairwas
demonstratedtosignificantlyimprovethe36-monthoutcomeintermsoffunc(on,strength,andretearrate.
• Re-tearRates:Control41% CollagenPatch51% Polypropelyne17%
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Growth Factors
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PRPincludesmanygrowthfactorsidenSfiedascrucialinnormalbone-to-tendonhealing:TGF-β,bFGF,PDGF,vascularendothelialgrowthfactor,connecSveSssuegrowthfactor,andepidermalgrowthfactor.HighPlateletConcentraSon
butalsolowWBCconcentra(onimportant
Growth Factors Tenocytesofchronicrotatorcufftendontearscanbes(mulatedbyplatelet-releasedgrowthfactors.HoppeS,AliniM,BennekerLM,MilzS,BoileauP,ZumsteinMA.JShoulderElbowSurg.2013Mar;22(3):340-9
• CLINICALRELEVANCE:• Biologicaugmenta(onof
repairedrotatorcuffswithPRGFmayenhancetheproper(esoftherepair(ssue.However,furtherstudiesareneededtodetermineifapplicaSonofPRGFremainssafeandeffecSveinlong-termclinicalstudies.
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TGF-B2minutesBMP-2<16minutesPDGFA-Chain2.4hoursFGF-2<14hours
GrowthFactorHalfLife
Where does the GF go?
• Ontopofthetendon– LiquidPRP
• GFgonein7-12hours
• Betweentendonandbone– Fibrinconstruct
• GFreleasedoverapprox.7days
• Nexttothetendon– CrimsonDuvet
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PRPFM (PRP with fibrin matrix)
Theeffectofplatelet-richfibrinmatrixonrotatorcufftendonhealing:aprospec(ve,randomizedclinicalstudy.RodeoSA,DelosD,WilliamsRJ,AdlerRS,PearleA,WarrenRF.AmJSportsMed.2012Jun;40(6):1234-41
• LevelofEvidence2
• Platelet-richfibrinmatrixappliedtothetendon-boneinterfaceattheSmeofrotatorcuffrepairhadnodemonstrableeffectontendonhealing,tendonvascularity,manualmusclestrength,orclinicalra(ngscales.Infact,theregressionanalysissuggeststhatPRFMmayhaveanega(veeffectonhealing.FurtherstudyisrequiredtoevaluatetheroleofPRFMinrotatorcuffrepair.
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PRPFM (PRP with fibrin matrix)
Theeffectofplatelet-richfibrinmatrixonrotatorcufftendonhealing:aprospec(ve,randomizedclinicalstudy.RodeoSA,DelosD,WilliamsRJ,AdlerRS,PearleA,WarrenRF.AmJSportsMed.2012Jun;40(6):1234-41
• LevelofEvidence2
• Platelet-richfibrinmatrixappliedtothetendon-boneinterfaceattheSmeofrotatorcuffrepairhadnodemonstrableeffectontendonhealing,tendonvascularity,manualmusclestrength,orclinicalra(ngscales.Infact,theregressionanalysissuggeststhatPRFMmayhaveanega(veeffectonhealing.FurtherstudyisrequiredtoevaluatetheroleofPRFMinrotatorcuffrepair.
Platelet-richplasmaaugmenta(onforarthroscopicrotatorcuffrepair:arandomizedcontrolledtrial.CastriciniR,LongoUG,DeBenedejoM,PanfoliN,PiraniP,ZiniR,MaffulliN,DenaroV.AmJSportsMed.2011Feb;39(2):258-65
• LevelofEvidence1
• OurstudydoesnotsupporttheuseofautologousPRFMforaugmenta(onofadouble-rowrepairofasmallormediumrotatorcuffteartoimprovethehealingoftherotatorcuff.Ourresultsareapplicabletosmallandmediumrotatorcufftears;itispossiblethatPRFMmaybebeneficialforlargeandmassiverotatorcufftears.Also,giventheheterogeneityofPRFMpreparaSonproductsavailableonthemarket,itispossiblethatotherprepara(onsmaybemoreeffec(ve.
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Review of GFs
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• RESULTS:• Regularbone-to-tendonhealingformsafibrousjuncSonbetween
tendonandbonethatisdisSnctfromtheoriginalbone-to-tendonjuncSon.TendonaugmentaSonwithcellularcomponentsservesasscaffoldingforfibroblasSccellsandapossiblesourceofgrowthfactorsandfibroblasSccells.ExtracellularmatricesprovideascaffoldforincomingfibroblasSccells,althoughcurrentresearchdoesnotconclusivelyconfirmwhichifanyofthesescaffoldsenhancerepairowinginparttointer-manufacturervaria(onsandthelimitedhumanresearch.Growthfactorsandplatelet-rich-plasmaareestablishedinotherfieldsofresearchandmayenhancerepairbuthavenotbeenrigorouslytested.
• CONCLUSIONS:• ThereispotenSalapplicaSonofbiologic
augmentaSontoimprovehealingaaerrotatorcuffrepair.However,researchinthisfieldiss(llinconclusiveandhasnotbeensufficientlydemonstratedtomeritregularclinicaluse.FuturehumantrialscanelucidatetheuseofbiologicaugmentaSoninrotatorcuffrepairs.
Strategiesinbiologicaugmenta(onofrotatorcuffrepair:areview.CheungEV,SilverioL,SperlingJW.ClinOrthopRelatRes.2010Jun;468(6):1476-84
Liquid vs. Solid PRP
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Crimson Duvet
Mul(plechannelingimprovesthestructuralintegrityofrotatorcuffrepair.JoCH,ShinJS,ParkIW,KimH,LeeSY.AmJSportsMed.2013Nov;41(11):2650-7.
• CONCLUSION:• Thefindingsofthestudyshowedthat
mul(plechannelingsignificantlydecreasedthere-tearrateaOerarthroscopicrotatorcuffrepair,probablyviatherecruitmentofendogenousMSCsfromtheproximalhumerus.Althoughtheresultsdidnotshowsignificantdifferencesintheclinicaloutcomesbetweenthe2groups,bejerclinicaloutcomesmightbean(cipatedinthemulSplechannelinggroupviaimprovedstructuralintegrityinalong-termfollow-up.
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Crimson Duvet
Mul(plechannelingimprovesthestructuralintegrityofrotatorcuffrepair.JoCH,ShinJS,ParkIW,KimH,LeeSY.AmJSportsMed.2013Nov;41(11):2650-7.
• CONCLUSION:• Thefindingsofthestudyshowedthat
mul(plechannelingsignificantlydecreasedthere-tearrateaOerarthroscopicrotatorcuffrepair,probablyviatherecruitmentofendogenousMSCsfromtheproximalhumerus.Althoughtheresultsdidnotshowsignificantdifferencesintheclinicaloutcomesbetweenthe2groups,bejerclinicaloutcomesmightbean(cipatedinthemulSplechannelinggroupviaimprovedstructuralintegrityinalong-termfollow-up.
Bonemarrows(mula(onatthefootprintofarthroscopicsurface-holdingrepairadvancescuffrepairintegrity.TaniguchiN,SuenagaN,OizumiN,MiyoshiN,YamaguchiH,InoueK,ChosaE.JShoulderElbowSurg.2015Jun;24(6):860-6.
• CONCLUSIONS:• Thesefindingsdemonstrate
thatapplyingBMStothefootprintduringASHrepairresultsinimprovedcuffrepairintegrity,par(cularlyinlarge-massivetears,andsuggesttheimportanceofbiologictreatmentforrotatorcuffhealingaaerarthroscopicrotatorcuffrepair.
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Outcomes of Combined Bone Marrow Stimulation and Patch Augmentation for Massive Rotator Cuff Tears.
YoonJP,ChungSW,KimJY,LeeBJ,KimHS,KimJE,ChoJH.AmJSportsMed.2016Apr;44(4):963-71.
• LevelofEvidence3 • CONCLUSION:• Concomitantbonemarrow
s(mula(onandpatchaugmenta(onsignificantlyreducedre-tearandmedial-rowfailureratesinthearthroscopicrepairofmassiverotatorcufftears.
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Role of Acromioplasty ReleaseofgrowthfactorsaOerarthroscopicacromioplasty.RandelliP,Margheri(niF,CabitzaP,DogliobG,CorsiMM.KneeSurgSportsTraumatolArthrosc.2009Jan;17(1):98-101.
• ConcentraSonshigherofTGF-beta1,PDGF-AB,andbFGF.
• Therearehighconcentra(onsofseveralgrowthfactorsinthesubacromialspaceaOeracromioplasty.
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Stem Cells Effectoftheadipose-derivedstemcellfortheimprovementoffajydegenera(onandrotatorcuffhealinginrabbitmodel.OhJH,ChungSW,KimSH,ChungJY,KimJY.JShoulderElbowSurg.2014Apr;23(4):445-55
• RESULTS:
• ThedegreeoffatstainingincreasedfromtheADSC+repairgroup(unclearorweak)tothesaline-onlygroup(stronglypresent).
• CONCLUSION:
• Localadministra(onofADSCsmighthavethepossibilitytoimprovemusclefunc(onandtendonhealinganddecreasefajyinfiltra(onaOercuffrepair.
Adiposederivedstemcells
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Take Home Messages
• Preclinicaltrialsdonotalwaystranslatetogoodresults.
• PatcheshavebeengainingtracSonbuttechniques,costandreimbursementareproblems.Synthe'candpermanent…thefuture?
• LiquidPRPmaybeeffecSvebutsolidPRPappearstogivebeIerhealing.
• MarrowSSmulaSontechniquesarelowcostandcanbeeffecSve
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Take Home Messages
• BonemarrowaspiratesshowveryliIleevidenceatthispoint.
• StemCells???• Minimalevidencepresentasfarasdosage,Smingandfrequency.
• Mostclinicaltrialsforgrowthfactorscost30-50milliondollars,sotheseareverydifficultproductstodevelopforthehopethatitworks!
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Thank You!
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References • 1.BrianJ.ColeMD,MBA,L.PearceMcCartyMD,RichardW.KangMD,MS,WinslowAlfordMD,PaulB.LewisMD,MSandJenniferK.HaydenMSN,RN.JournalofShoulderandElbowSurgery,
2007-09-01,Volume16,Issue5,Pages579-585• 2.GalatzL.M.,BallC.M.,TeefeyS.A.,MiddletonW.D.,andYamaguchiK.Theoutcomeandrepairintegrityofcompletelyarthroscopicallyrepairedlargeandmassiverotatorcufftears.JBoneJoint
SurgAm2004;86:pp.219-224• 3.StructuralIntegrityAaerRotatorCuffRepairDoesNotCorrelatewithPaSentFuncSonandPain:AMeta-Analysis.Russell,RobertDMD;Knight,JusSnRMD;Mulligan,EdwardDPT;Khazzam,
MichaelSMD.JournalofBone&JointSurgery-AmericanVolume.96(4):265-271,February2014.• 4.BiomechanicalanalysisofgapformaSonandfailuremechanicsofaxenograa-reinforcedrotatorcuffrepairinacadavericmodel.KevinP.SheaMD,ElimoObopilweMS,JohnW.SperlingMD,MBA
andJosephP.IannonMD,PhD.JournalofShoulderandElbowSurgery,2012-08-01,Volume21,Issue8,Pages1072-1079• 5.ReconstrucSonoflargerotator-cufftearswithacellulardermalmatrixgraasinrats.JunjiIdeMD,KenshiKikukawaMD,JunHiroseMD,Ken-ichiIyamaMD,HidetoshiSakamotoDrEngandHiroshi
MizutaMD.JournalofShoulderandElbowSurgery,2009-03-01,Volume18,Issue2,Pages288-295• 6.Rotatorcuffrepairusinganacellulardermalmatrixgraa:aninvivostudyinacaninemodel.AdamsJE1,ZobitzME,ReachJSJr,AnKN,SteinmannSP.Arthroscopy.2006Jul;22(7):700-9.• 7.RotatorCuffRepairUsinganAcellularDermalMatrixGraa:AnInVivoStudyinaCanineModel.JulieE.Adams,M.D.a,MarkE.Zobitz,M.S.b,JohnS.ReachJr,M.D.a,Kai-NanAn,Ph.D.b,ScoIP.
Steinmann,M.D.Arthroscopy.Volume22,Issue7,July2006,Pages700–709• 8.Long-termsuccessfularthroscopicrepairoflargeandmassiverotatorcufftearswithafuncSonalanddegradablereinforcementdevice.ChristopherS.ProctorMD.JournalofShoulderandElbow
Surgery,2014-10-01,Volume23,Issue10,Pages1508-15139.• 9.RotatorcuffrepairaugmentaSonusinganovelpolycarbonatepolyurethanepatch:preliminaryresultsat12months'follow-up.IvanEncalada-DiazMD,BrianJ.ColeMD,MBA,JohnD.MacGillivray
MD,MichellRuiz-SuarezMD,MS,JamesS.KercherMD,NicoleA.FrielMSandFernandoValero-GonzalezMD.JournalofShoulderandElbowSurgery,2011-07-01,Volume20,Issue5,Pages788-794• 10.AprospecSve,mulScenterstudytoevaluateclinicalandradiographicoutcomesinprimaryrotatorcuffrepairreinforcedwithaxenograadermalmatrix.EvanS.LedermanMD,AlisonP.TothMD,
GregoryP.NicholsonMD,RobertJ.NowinskiDO,GeorgeK.BalMD,GeraldR.WilliamsMDandJosephP.IannonMD,PhD.JShoulderElbowSurg.2016Apr26Epubaheadofprint• 11.DermalSssueallograafortherepairofmassiveirreparablerotatorcufftears.AnilK.Gupta,KevinHug,DavidJ.Berkoff,BlakeR.Boggess,MollyGavigan,PaulC.MalleyandAlisonP.TothAmJ
SportsMed.2012Jan;40(1):141-7• 12.ThebenefitofsyntheScversusbiologicalpatchaugmentaSonintherepairofposterosuperiormassiverotatorcufftears:a3-yearfollow-upstudy.PietroCiampi,CelesteScon,AlessandroNonis,
MaIeoVitali,CleliaDiSerio,GiuseppeM.PerenandGianfrancoFraschini.AmJSportsMed.2014May;42(5):1169-75• 13.TenocytesofchronicrotatorcufftendontearscanbesSmulatedbyplatelet-releasedgrowthfactors.HoppeS,AliniM,BennekerLM,MilzS,BoileauP,ZumsteinMA.JShoulderElbowSurg.2013
Mar;22(3):340-9• 14.StrategiesinbiologicaugmentaSonofrotatorcuffrepair:areview.CheungEV,SilverioL,SperlingJW.ClinOrthopRelatRes.2010Jun;468(6):1476-84• 15.Theeffectofplatelet-richfibrinmatrixonrotatorcufftendonhealing:aprospecSve,randomizedclinicalstudy.RodeoSA,DelosD,WilliamsRJ,AdlerRS,PearleA,WarrenRF.AmJSportsMed.
2012Jun;40(6):1234-41• 16.Platelet-richplasmaaugmentaSonforarthroscopicrotatorcuffrepair:arandomizedcontrolledtrial.CastriciniR,LongoUG,DeBenedeIoM,PanfoliN,PiraniP,ZiniR,MaffulliN,DenaroV.AmJ
SportsMed.2011Feb;39(2):258-65• 17.MulSplechannelingimprovesthestructuralintegrityofrotatorcuffrepair.JoCH,ShinJS,ParkIW,KimH,LeeSY.AmJSportsMed.2013Nov;41(11):2650-7.• 18.BonemarrowsSmulaSonatthefootprintofarthroscopicsurface-holdingrepairadvancescuffrepairintegrity.TaniguchiN,SuenagaN,OizumiN,MiyoshiN,YamaguchiH,InoueK,ChosaE.J
ShoulderElbowSurg.2015Jun;24(6):860-6.• 19.OutcomesofCombinedBoneMarrowSSmulaSonandPatchAugmentaSonforMassiveRotatorCuffTears.YoonJP,ChungSW,KimJY,LeeBJ,KimHS,KimJE,ChoJH.AmJSportsMed.2016Apr;
44(4):963-71.• 20.Releaseofgrowthfactorsaaerarthroscopicacromioplasty.RandelliP,MargheriSniF,CabitzaP,DoglionG,CorsiMM.KneeSurgSportsTraumatolArthrosc.2009Jan;17(1):98-101.• 21.Effectoftheadipose-derivedstemcellfortheimprovementoffaIydegeneraSonandrotatorcuffhealinginrabbitmodel.OhJH,ChungSW,KimSH,ChungJY,KimJY.JShoulderElbowSurg.
2014Apr;23(4):445-55
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