Meniscal repair by all-inside technique with Fast-Fix device

w w w . r b o . o r g . b r

Original

Article

Meniscal

repair

by

all-inside

technique

with

Fast-Fix

device

夽

Leonardo

José

Bernardes

Albertoni

_,

_Felipe

_Conrado

_Schumacher

_,

Matheus

Henrique

Araújo

Ventura

_,

_Carlos

_Eduardo

_da

_Silveira

_Franciozi

_,

Pedro

Debieux

_,

_Marcelo

_Seiji

_Kubota

_,

_Geraldo

_Sérgio

_de

_Mello

_Granata

_Júnior

_,

Marcus

Vinícius

Malheiros

Luzo

_,

_Antônio

_Altenor

_Bessa

_de

_Queiroz

_,

Mario

Carneiro

Filho

a_{MSc,PhysicianintheKneeGroup,DepartmentofOrthopedicsandTraumatology,EscolaPaulistadeMedicina,UniversidadeFederalde}

SãoPaulo(EPM-UNIFESP),SãoPaulo,SP,Brazil

b_{Third-yearResidentPhysicianintheDepartmentofOrthopedicsandTraumatology,EPM-UNIFESP,SãoPaulo,SP,Brazil} c_{PhD,PhysicianintheKneeGroup,DepartmentofOrthopedicsandTraumatology,EPM-UNIFESP,SãoPaulo,SP,Brazil} d_{PhysicianintheKneeGroup,DepartmentofOrthopedicsandTraumatology,EPM-UNIFESP,SãoPaulo,SP,Brazil}

e_{PhD,AffiliatedProfessorandPhysicianintheKneeGroup,DepartmentofOrthopedicsandTraumatology,EPM-UNIFESP,SãoPaulo,SP,}

Brazil

f_{PhD,AffiliatedProfessorandHeadoftheKneeGroup,DepartmentofOrthopedicsandTraumatology,EPM-UNIFESP,SãoPaulo,SP,}

Brazil

a

r

t

i

c

l

e

i

n

f

o

Articlehistory:

Received20June2012

Accepted22August2012

Keywords:

Arthroscopy

Meniscitibial

Suturetechniques

a

b

s

t

r

a

c

t

Objective:The objectiveofthisstudy isto evaluatetheresults andeffectivenessofthe

techniqueofmeniscalrepairtypeall-insideusingFast-Fixdevice.

Methods:Aretrospectivecohortstudyevaluating22patientswithmeniscalsurgerybetween

January2004andDecember2010underwentmeniscalrepairtechniqueforall-insidewith

theFast-FixdevicewithorwithoutACLreconstruction.Functionandqualityoflifeoutcomes

werechosenbytheIKDCandLysholmscore,beforeandpostoperatively,andreoperation

rates,relyingtothetimeoffinalfollow-up.Statisticalanalysiswasperformedusingthe

Student’sttest.

Results:Themeanfollow-upwas59months(16–84).TheLysholmscoreshowed72%(16

patients)ofexcellentandgoodresults(84–100points),27%(6patients)fair(65–83points)

andnocasesclassifiedaspoor(<64points).AccordingtotheIKDC:81%(18patients)of

excellentandgoodresults(75–100points),18%ofcasesregular(50–75points)andnopatient

hadpoorresults(<50points).Therewerenofailuresorcomplications.

Conclusion:Thetechniqueofmeniscalrepairtypeall-insideusingtheFast-Fixdeviceissafe

andeffectiveforthetreatmentofmeniscallesionsintheredzoneorred-whitewithor

withoutsimultaneousACLreconstruction,withgoodandexcellentresultsinmostpatients

Level4Study.

©2013SociedadeBrasileiradeOrtopediaeTraumatologia.PublishedbyElsevierEditora

Ltda.Allrightsreserved.

夽

StudyconductedattheDepartmentofOrthopedicsandTraumatology,EscolaPaulistadeMedicina,UniversidadeFederaldeSãoPaulo,

SãoPaulo,SP,Brazil.

∗ _{Correspondingauthorat:UniversidadeFederaldeSãoPaulo,EscolaPaulistadeMedicina,DepartamentodeOrtopediaeTraumatologia,}

RuaBorgesLagoa,783,5◦_{.andar,VilaClementino,SãoPaulo,SP,CEP04038-032,Brazil.Tel.:+551155716621.}

E-mail:[email protected](C.E.daSilveiraFranciozi).

Sutura

do

menisco

pela

técnica

a

ll-inside

_com

_o

_dispositivo

_Fast-Fix

Palavras-chave:

Artroscopia

Meniscostibiais

Técnicasdesutura

r

e

s

u

m

o

Objetivo: Avaliarosresultadoseaeficáciadatécnicadereparomeniscaltipoall-insidecom

ousododispositivoFasT-Fix.

Métodos: Estudodecoorteretrospectivocomavaliac¸ãode22pacientescomlesãomeniscal

operadosentrejaneirode2004edezembrode2010,submetidosaoreparomeniscalpela

técnicaall-insidecomodispositivoFasT-Fixeassociadosounãoàreconstruc¸ãodoLCA.

Func¸ãoequalidadedevidaforamosdesfechosescolhidospormeiodosquestionáriosde

LysholmeIKDC,préepós-operatoriamente,alémdastaxasdereoperac¸ão,relevando-seo

tempodeseguimentofinal.AanáliseestatísticafoifeitacomousodotestetdeStudent.

Resultados: Otempomédiodeseguimentofoide59meses(16–84).OescoredeLysholm

apresentou73%(16pacientes)deexcelentesebonsresultados(84–100pontos),27%(seis

pacientes)regulares(65–83pontos)enenhumcasoclassificadocomoruim(<64pontos).

SegundooIKDC:82%(18pacientes)deexcelentesebonsresultados(75–100pontos);18%

decasosregulares(50–75pontos)enenhumpacienteobteveresultadosruins(<50pontos).

Nãoocorreramfalhasoucomplicac¸ões.

Conclusão:Atécnicadereparomeniscaltipoall-insidecomousododispositivoFasT-Fix,nos

pacientesavaliados,semostroueficazeseguraparaotratamentodaslesõesdemeniscona

zonavermelhaouzonavermelho-brancaassociadaounãoàreconstruc¸ãosimultâneado

LCAeapresentouresultadosbonseexcelentesnamaioriadospacientes.

©2013SociedadeBrasileiradeOrtopediaeTraumatologia.PublicadoporElsevier

EditoraLtda.Todososdireitosreservados.

Introduction

Themenisciarefibrocartilaginousstructureinthekneethat

performimportantfunctionssuch asload absorption1 _and

transmission,2 _{synovial fluid distribution and lubrication,}3

improvementoffemorotibialjointcongruence,4_{stabilization}5

andprotectionofthejointcartilagewhensubjectedtoaxial

loads.1,4,5 _{Absence of the menisci is associated with joint}

instabilityandtoincreasedcartilagedegeneration.6,7

There-fore,meniscalrepairshouldbepreferabletomeniscectomy,

wheneverfeasible.5,8

Meniscalsutureshavealreadybeen performedformore

thanacentury.Theywerefirstdescribed andperformedas

openproceduresbyAnnandale,in1883,andKatzenstein,in

1908.Sincethen,avarietyoftechniquesforperforming

menis-calsutureshavebeen putforward,and thesehaveevolved

fromsuturesperformedasopenprocedurestoarthroscopic

repair techniques of inside-out, outside-in and all-inside

types.

Sincetheclassicstudyonvascularizationofthemenisci

conductedbyArnoczkyandWarren9_in1982,which

demon-stratedthepossibilityofachievingmeniscalhealing,

arthro-scopic techniquesand particularly those of all-inside type

havegainedwidespreaduseamongphysicians.

Theall-inside arthroscopic suturing technique presents

theadvantageofnotrequiringsecondarysafetyincisionsfor

performingmeniscalsutures,whichdiminishesthemorbidity

oftheprocedure.10,11_{Thistechniquepresentslessdifficulty,a}

lowcomplicationrateandresultssimilartothosefromthe

classicalsuturingtechniques.11–13

Theobjectiveofthisstudywastoevaluatetheresultsand

effectivenessoftheall-insidemeniscalrepairtechnique,using

the Fast-Fix device (Smith & Nephew, Andover, MA, USA),

whichwastheprecursorofthefourthgenerationofmeniscal

suturing.

Material

and

method

In a retrospective cohort study, 22 patients with meniscal

injurieswhounderwentmeniscalrepairusingtheall-inside

technique with the Fast-Fix device with or without

ante-riorcruciateligament(ACL)reconstruction(usingtheflexor

tendons)betweenJanuary2004andDecember2010were

eval-uated.Alltheprocedureswereperformedbythesamesurgeon

(LJBA). Out ofthe 22 patients, 16 underwent simultaneous

reconstruction of the ACL and six underwent arthroscopic

suturingofameniscalinjuryalone.

ThepatientswereevaluatedthroughapplyingtheLysholm

questionnaire14_{andthatoftheInternationalKnee}

Documen-tationCommittee(IKDC).15_{Evaluationsweremadebeforeand}

aftertheoperation,withaminimumof16monthsof

postop-erativeevaluationuntilthetimeofthefinalfollow-up.

The inclusion criteria were that the injuries should be

unstable longitudinal peripheral injuries of the meniscus,

locatedinthered-redorred-whitezones,9_{whichwere10mm}

ormoreinlength,andthatthepatientsshouldanswer the

assessment questionnaires completely. Patients with

con-comitantACL injuryorfailureunderwentreconstructionof

thisligamentusingflexortendons,duringthesamesurgical

procedure.

Theexclusion criteriawere thatthere shouldnotbean

Outerbridgegrade3or4chondrallesioninthesame

compart-ment;meniscalinjurieswithhybridtreatment,i.e.inwhich

themeniscuswaspartiallysuturedandpartiallyresected;and

meniscalinjuriesthatweresuturedusingrepairtechniques

Fig.1–Insertionofthefirstimplant,withtheneedle startingintheexternalportionofthemeniscusand crossingthecapsule.

patientswhodidnotanswerthequestionnairescompletelyor

whowerelostfromthefollow-upwereexcluded,aswerethose

whose meniscal injurieswere “unrepairable”(in the white

zone, complex,radial orhorizontal),osteoarthriticpatients

andthosewithinflammatorydiseases.

Thesurgicaltechniqueconsistedfirstlyofstimulatingthe

bordersofthemeniscalinjurybyabradingthemwithashaver

orspecificrasps,andsubsequentlydrillingthemostexternal

portionofthemeniscususingaJelcono.14,withtheaimof

creatingchannelsforthevascularaccess.Thesetwo

proce-duresareveryimportant,becausetheyfacilitateandstimulate

healingofthemenisci.Themeniscalsutureinthetruesense

beganwithintroductionoftheFast-Fixdeviceintotheknee

withinits protectivesleeve. For suturesofthe body ofthe

meniscus,theanteriorportalofthecompartmentopposite

tothatoftheinjuredmeniscuswasused.Ontheotherhand,

forsuturinginjuriestotheposteriorcornuofthemeniscus,

theanteriorportalofthesamecompartmentwasused.The

Fast-Fixdevicewasintroducedintothemeniscustwice,soas

tocrossmeniscalinjuryhorizontally,verticallyorobliquely,

accordingtothemorphologyoftheinjury.Inthismanner,the

meniscuswasadvancedasfarasthejointcapsulesuchthat

twoanchorscouldgripthemeniscusaroundthecapsule,thus

stabilizingit.Thedevicewasthenremovedfromthekneeand

theknot,whichhadbeenpre-assembled,wastensionedby

meansofa“knot-pulling”device,whichalsoservedforcutting

theexcessthread(Figs.1–4).

Aftertheoperation,thepatientsremainedwithout

weight-bearingforsixweeks,followedbyanothertwoweeksofpartial

weight-bearing.Thus,theywerereleasedfromusingcrutches

aftereightweeks.Flexionwasrestrictedto90degrees

dur-ingthefirstfourweeksandwasthenprogressivelyallowedto

increase.Thesameprotocolwasusedforthepatientswith

bothACL reconstruction and meniscalrepair. Thepatients

wereallowedtoreturntosportsactivitywhentheoperated

limbhadrecoveredatleast70%ofitsextensormechanism

strength,inrelationtothecontralaterallimb.However,this

wasneverlessthansixmonthsaftertheoperation.

Fig.2–Insertionofthesecondimplant,withtheneedle enteringtheinternalportionofthemeniscusandcrossing thecapsule.

Failureoftheprocedurewasdefinedastheneedforanew

surgical procedure (partial meniscectomy), the presenceof

mechanicalsymptoms(suchasjointblockage)orpoorresults

accordingtothequestionnaires(Lysholmscore<64orIKDC

score<50).

ThestatisticalanalysiswasdoneusingStudent’sttest,

irre-spectiveofstatisticalsignificance.Arelationshipbetweenage

and/or timeelapsedafterthe operationand the functional

resultwassought.

Results

The data resulting from the individual questionnaires

answeredbyeachpatientareshowninTable1.

Fig.4–Tensioningofthesuture,usinga“knotpusher”, whichservedforcuttingthethreadlateron.

Twenty-twopatientswho underwentall-insidemeniscal

suturingwereevaluatedwithregardtotheresultsfromthe

LysholmandIKDCscalesandreoperationrate,aspresented

inthetableforthetotalsample.Themeanlengthoffollow-up

was59months(16–84).

In the Lysholm scale, the results are considered to be

excellent/goodwhenthescoreisbetween84and100points;

fairresultshavescoresbetween65and83;andpoorresults

arethosewithscoresof64orless.Amongourresults,73%

(16patients)hadexcellentorgoodLysholmscores,27%(six

patients)hadfairscoresandnoneofthepatientshad poor

results(score<64).

Inturn,inthe IKDC,resultsare consideredtobe

excel-lent/goodwhenthescoreis75pointsorover;fairresultshave

scoresbetween 50and 74; andthe results are takento be

poorwhenthescoresdonotreach50 points.According to

Table2–Evaluationofthequestionnairesbeforeand aftertheoperation.

Variable Mean SD N p

Lysholmbefore 55.82 19.72 22 <0.001 Lysholmafter 89.95 10.39 22

IKDCbefore 48.32 21.03 22 <0.001 IKDCafter 87.05 11.24 22

SD,standarddeviation;N,sample;p,statisticalsignificance.

thisscale,82%ofthecases(18patients)wereconsideredto haveexcellentresults,18%werefairandnonewerepoor.

The Kolmogorov–Smirnov test was used to determine whetherthescalescorespresentednormaldistribution.This assumptionwassatisfiedforbothscales(p>0.05).Thepaired Student’sttestwasusedtocomparethescalesfrombeforeto aftertheoperation,asshowninTable2.

There wasastatisticallysignificant improvementinthe

scale scoresincomparingfunctionfrombeforetoafterthe

operation(p<0.05).

Neitheragenortimeelapsedsincetheoperationshowed

anystatisticallysignificantcorrelationwithimprovementon

the functional scales (p>0.05). There was only a

statisti-cally significant correlation between the improvements on

thescales,i.e.thegreatertheimprovementobservedonthe

Lysholmscalewas,thegreatertheimprovementontheIKDC

scalealsowas(r=0.877andp<0.001),asshowninTable3.

TheabsoluteandrelativechangesintheLysholmandIKDC

scales were compared between the group that underwent

simultaneousreconstructionoftheACL(73%)andthegroup

thatonlyunderwentmeniscalsuturing(27%).Theresults

sug-gestedthattherewasagreaterchangebetweenthepreand

postoperative assessmentsinthegroup withsimultaneous

Table1–Fullsample.

Patient Sex Age Timeelapsedsince operation(months)

Lysholmbefore operation

Lysholmafter operation

IKDCbefore operation

IKDCafter operation

ABF ♂ 21 26 60 100 49.4 92

AM ♂ 39 55 48 76 46 78.2

AMA ♀ 39 52 55 79 50.6 62.1

AN ♂ 28 77 50 72 44.8 73.6

BG ♀ 21 69 33 91 26.4 87

CSC ♂ 50 75 48 95 36.8 80.5

ED ♂ 44 47 82 100 69 97.7

FF ♂ 32 74 50 100 42.5 100

FFS ♂ 40 54 43 90 28.7 73.6

FKIM ♂ 28 65 63 95 59.8 81.6

GL ♂ 32 53 40 94 35.6 90.8

GR ♂ 24 53 70 100 58.6 100

LF ♀ 19 16 48 81 49.4 78.2

LHSL ♂ 41 63 62 70 57.5 78.2

RC ♂ 35 55 11 91 5.7 89.7

RCR ♂ 30 84 100 100 100 100

RLJL ♂ 21 72 86 84 87.4 71.3

RN ♂ 38 52 42 100 28.7 94.3

RV ♂ 28 66 45 75 29.9 93.1

SJS ♂ 39 62 56 86 37.9 94.3

TSM ♂ 29 60 52 100 48.3 100

Table3–Correlationbetweenthequestionnaires,ageandtimeelapsedafteroperation.

Correlation Age Timeelapsedafter

operation(months)

ChangeonLysholm

Timeelapsedafteroperation(months)

r 0.178

p 0.428

N 22

Lysholmscore

r 0.108 −0.232

p 0.631 0.298

N 22 22

IKDCscore

r 0.142 −0.155 0.877

p 0.530 0.490 <0.001

N 22 22 22

r,relationalstrength;N,numberofpatientsinthesample;p,statisticalsignificance.

ACL reconstruction, but without statistical significance (Table4).

Noneedfornewsurgery(forpartialmeniscectomy),orany

presenceofmechanicalsymptomssuchasjointblockage,was

observedinanyofthepatientsevaluated,aftertheoperation.

Therewerenoneurovascularcomplicationsoranyimplant

migrationinanyofthepatientsevaluated.

Discussion

Suturingofthemeniscuswasintroducedwiththeaimof

pre-servingthistissue,soastopreventthedeleteriousalterations

resultingfromitsresection,evenifdoneonlypartially.Such

alterationshaveaneffectinrelationbothtodegenerationand

toinstabilityoftheknee.Althoughmeniscalrepairpresents

ahigherreoperationrate,ithasbetterlong-termresultsthan

partialmeniscectomy.6,7,16

Atthe beginning ofthe developmentofmeniscal

sutur-ing techniques, the first generation was based on the

inside-out procedure of Henning.17 _{This was followed by}

thesecond generationofoutside-inprocedures,whichwas

introducedbyWarren18_{withtheaimofdiminishingtheriskof}

fibularnerveinjuryinlateralmeniscalrepairs.Alsofocusing

on preventingneurovascular injury, the all-insidemeniscal

repairtechniquewas introduced.Thistypeofsuturing

ini-tiallyconsistedofusingbioabsorbabledevicessuchasarrows,

dartsorstaples,andbecamethethirdgenerationof

menis-calsuturing.Itpresentedpotentialbenefitssuchaseaseof

use,adaptabilitytodifferenttypesofinjury,reducedduration

ofoperationsanddiminishedmorbidity.However,itwasnot

freefromcomplications,suchasearlyfailure(dueto

break-ageoftheimplant)andrepairresistancethatwasinferiorto

that oftheprevious techniques(inside-outandoutside-in),

which presentedmore than twicethe resistance tosuture

tear forces.19,20 _{To surmount these deficiencies of the}

ini-tial implantsoftheall-insidethirdgeneration,theFast-Fix

devicewasdevelopedasamodificationoftheSmith&Nephew

T-Fix device, with the mainaim ofachieving suture

resis-tance equaltothatprovidedbytheinside-outtechnique.12

Theseinside-outsuturingdevicesusingresistantthreadhave

becomeknown asthefourthgeneration,amongwhich the

Fast-Fix device is the precursor.Today, the all-inside

tech-niqueperformed usingfourth-generationimplants and the

inside-outtechniquepresentsimilarsuccessand

complica-tionrates.21

Table4–EvaluationofmeniscalsuturingperformedsimultaneouslywithACLreconstruction.

Variable ACL

Withoutreconstruction Withreconstruction p

Mean SD N Mean SD N

Lysholmbefore 67.7 21.6 6 51.4 17.7 16

Lysholmafter 93.3 10.6 6 88.7 10.4 16

ChangeinLysholm(after-before) 25.7 22.5 6 37.3 19.0 16 0.236 ChangeinLysholm%(after-before)/before 48.5 43.9 6 114.5 169.9 16 0.366

IKDCbefore 63.8 24.1 6 42.5 17.1 16

IKDCafter 91.6 13.2 6 85.4 10.4 16

ChangeinIKDC(after-before) 27.8 29.5 6 42.8 20.0 16 0.182 ChangeinIKDC%(after-before/before 60.8 59.7 6 194.3 348.7 16 0.369

Withbettercomprehensionoftheimportanceof

menis-calsuturing,therehasbeenrapiddevelopmentoftherepair

techniquesoverthelast25years.Theseimprovementshave

beenaimedmainlytowardmakingsurgeryeasier,andhave

ledtoincreaseduseofthisprocedure.12,22_{Unfortunately,in}

Brazilthepopularityofmeniscalrepairstillseemstobefar

behindwhathasbeenreachedinotherregions,suchasthe

UnitedStatesandEurope.Thiscanbedemonstrated partly

bytherelativescarcity ofstudiespublishedintheBrazilian

literatureon this topic and partlyby the difficulty of

hav-ingthesedevicesreleasedforusethroughhealthcareservice

agreementsandwithintheBrazilianNationalHealthSystem

(SUS),giventhattheymakethefinalcostofsurgeryhigher.

Auditors and managers do not understand the real

bene-fit that this increasedexpenditure bringsfor patients and

consequently denyrequests to use these devices.23–25 _The

technologicalgapthatexistsbetweenBrazilandmore

devel-opedcountriesshould alsobementioned,consideringthat

approvalfordevicesdevelopedoutsideofBrazilthataremore

advancedendsupbeingdelayedbycontrollingbodies.

Fur-thermore,theBrazilianmaterialsareoftenwellbelowwhatis

desired,andaresometimesevenimproperforuse.

Inconsideringtreatmentfailuretobetheneedforanew

surgicalprocedure,thepresenceofmechanicalsymptomsora

Lysholmscorelessthan64orIKDClessthan50,wewereable

toconcludethatinourstudytherewerenocasesoffailure

andthatnocomplicationswerediagnosed.However,itneeds

tobeborneinmindthatinthepresentstudy,thesamplewas

relativelysmallandthatthismayhaveinfluencedtheresult.

Inaddition,themeandurationofpostoperativeassessment

was59months(mediumterm).Ifweweretoevaluatethese

patientsagain, overalonger term,wewouldprobablyfind

casesoffailurewiththeneedforanewsurgicalprocedure.

Instratifyingtheresultsaccordingtothescoresobtained,the

Lysholmscaleshowedthat73%oftheresultswereexcellent

andgoodand27%werefair.Noneofthepatientswere

clas-sifiedaspoor.AccordingtotheIKDC,82%oftheresultswere

excellentandgoodand18%werefair.Onceagain,noneofthe

resultswereclassifiedaspoor.

Inthe literature,the clinical success rates formeniscal

sutures are between 83% and 96.4%, when done together

withACLreconstruction,26–28 _{and84%whentheprocedures}

aredoneatdifferenttimes.29_{Ontheotherhand,therateof}

goodresultsfromconservativetreatmentformeniscalinjuries

in association with ACL reconstruction has been found to

be50–61%.30 _{When the meniscal repairisdone separately,}

withoutassociationwithACLreconstruction,afailurerateof

17–19%hasbeenreported.21

The greater success rate presented here can be partly

explainedbyalessrigorousassessmentcriterion,giventhat

insomeofthestudiespresented,thesuturedmeniscuswas

evaluatedbymeansofasecondarthroscopyprocedureand,

incertaincases,meniscal injurieswereseen tobepresent

inclinicallysymptomlesspatients,whichincreasedtherigor

oftheresults.Otherpotentialfactorswerethesmallsample

sizeand thegreater rigorinchoosingthe suturedinjuries.

Inthe present study,alsodiffering from the literature,the

success rate from meniscal repair when associated with

ACLreconstruction wasnotseen tobegreater than inthe

sameproceduredoneseparately.Theexplanationforthisis

probablyrelatedtothesmallnumberofpatients,giventhat

despitethe lackofstatistical significance,therewas a

ten-dencyforpatientswithsimultaneousACLreconstructionto

presentbetterpreandpostoperativeevaluations.

Conclusion

Amongthe patients studied, the all-insidemeniscal repair

techniqueusingtheFast-Fixdevicewaseffectiveandsafefor

treatingmeniscalinjuriesintheredzoneorred-whitezone,

withorwithoutsimultaneousACLreconstruction, and

pre-sentedgoodorexcellentresultsinthemajorityofthepatients.

Conflicts

of

interest

Dr. Leonardo José Bernardes Albertoni is a consultant for

Pró-CirurgiaEspecializada(PCE),thedistributorforSmith &

NephewinBrazil,buthedeclaresthathedidnotreceiveany

incentivetocarryingoutthisstudy.Theauthorsdeclarethat

therewerenoconflictsofinterest.

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