A decision-making tool to prescribe knee orthoses in daily practice for patients with osteoarthritis

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A decision-making tool to prescribe knee orthoses in

daily practice for patients with osteoarthritis

Emmanuel Coudeyre, Christelle Nguyen, Aurore Chabaud, Bruno Pereira,

Johann Beaudreuil, Jean-Marie Coudreuse, Philippe Deat, Frédéric Sailhan,

Alain Lorenzo, François Rannou

To cite this version:

Emmanuel Coudeyre, Christelle Nguyen, Aurore Chabaud, Bruno Pereira, Johann Beaudreuil, et al..

A decision-making tool to prescribe knee orthoses in daily practice for patients with

osteoarthri-tis.

Annals of Physical and Rehabilitation Medicine, Elsevier Masson, 2018, 61 (2), pp.92-98.

Original

article

A

decision-making

tool

to

prescribe

knee

orthoses

in

daily

practice

for

patients

with

osteoarthritis

Emmanuel

Coudeyre

*

,

Christelle

Nguyen

,

Aurore

Chabaud

,

Bruno

Pereira

,

Johann

Beaudreuil

_,

_Jean-Marie

_Coudreuse

_,

_Philippe

_Deat

_,

_Fre´de´ric

_Sailhan

_,

Alain

Lorenzo

,

Franc¸ois

Rannou

a

INRA,servicedeme´decinephysiqueetdere´adaptation,CHUClermont-Ferrand,universite´ Clermont-Auvergne,63000Clermont-Ferrand,France b

Universite´ ParisDescartes,faculte´ deme´decineParisDescartes,SorbonneParisCite´,75006Paris,France c

InsermUMR1124,faculte´ dessciencesfondamentalesetbiome´dicales,centreuniversitairedesSaints-Pe`res,75006Paris,France d

Servicedere´e´ducationetdere´adaptationdel’appareillocomoteuretdespathologiesduRachis,hoˆpitauxuniversitairesParisCentre,groupehospitalier Cochin,AP–HP,75014Paris,France

e

De´le´gationrecherchecliniqueetinnovation,CHUdeClermont-Ferrand,Clermont-Ferrand,France

f_{Servicesderhumatologie,me´decinephysiqueetdere´adaptation,hoˆpitalLariboisie`re–Fernand-Widal,universite´ Paris7,AP–HP,75010Paris,France} g

Unite´ deme´decinedusport,poˆledeme´decinephysiqueetdere´adaptation–me´decinedusport,hoˆpitalSalvator,AP–HM,249,boulevardSainte-Marguerite, 13009Marseille,France

h

InstitutdeformationenMassokine´sithe´rapie,Vichy,universite´ Clermont-Auvergne,Clermont-Ferrand,France i

Serviced’orthope´die,hoˆpitauxuniversitairesParisCentre,groupehospitalierCochin,AP–HP,75014Paris,France j

De´partementdeme´decinege´ne´rale,universite´ ParisDescartes,Paris,France

1. Introduction

Becauseofpopulationageing,osteoarthritis(OA)hasbecomea majorpublichealthproblem.OAisoneofthe10mostdisabling chronicdiseasesindevelopedcountries.OAaffects 9.6%ofmen

and18%ofwomenintheworld[1].Lower-limbOAreducesmotion for80%ofpatientsandlimitsactivitiesofdailyliving[1],suchas walking,climbing stairs, doing householdchoresor getting up fromsitting[2]for25%ofthem.Disabilityismostlyduetoknee pain and decreasedrange of motion [3] andis associated with

ARTICLE INFO Articlehistory: Received19September2017 Accepted3January2018 Keywords: Kneeosteoarthritis Orthosis Braces Decision-makingtool Guidelines ABSTRACT

Objective:Todevelopadecision-makingtool(DMT)tofacilitatetheprescriptionofkneeorthosesfor patientswithosteoarthritis(OA)indailypractice.

Methods:AsteeringcommitteegatheredamultidisciplinarytaskforceexperiencedinOAmanagement/ clinicalresearch.Twomembersperformedaliteraturereviewwithqualitativeanalysisofthe highest-qualityrandomizedcontrolledtrialsandpracticeguidelinestoconfirmevidenceconcerningkneeorthosis forOA.AfirstDMTdraftwaspresentedtothetaskforceina1-daymeetinginJanuary2016.Thefirstversion oftheDMTwascriticizedanddiscussedregardingeverydaypracticeissues.Everystepwasdiscussedand amendeduntilconsensusagreementwasachievedwithinthetaskforce.Then4successiveconsultation roundsoccurredby electroniccommunication, firstwith primary-andsecondary-care physicians, then with internationalexperts.Allcorrectionsandsuggestionsbyeachmemberweresharedwiththerestofthetask forceandincludedtoreachfinalconsensus.Thefinalversionwasvalidatedbythesteeringcommittee. Results:Thedefinitionandindicationofseveraltypesofkneeorthoses(sleeve,patello-femoral,hingedor unicompartmentaloffloadingbraces)weredetailed.Orthosesmaybeproposedinadditiontofirst-line non-pharmacologicaltreatmentifpatientacceptanceisconsideredgood.Ateverystep,aspecificclinical assessmentisneeded.

Discussion/conclusion:Basedonthelatesthigh-levelevidence,practiceguidelines,andanexpertpanel,a DMTtofacilitatedailypracticeprescriptionofkneeorthosesforOApatientswasdesigned.Anevaluation ofDMTimplementationinawiderangeofhealthprofessionalsisstillneeded.

C2018TheAuthor(s).PublishedbyElsevierMassonSAS.ThisisanopenaccessarticleundertheCC BY-NC-NDlicense(http://creativecommons.org/licenses/by-nc-nd/4.0/).

* Correspondingauthor.Servicedeme´decinephysiqueetre´adaptation,hoˆpitalNord,CHUClermont-Ferrand,routedeChateaugay,BP30056,63118Ce´bazat,France. E-mailaddress:ecoudeyre@chu-clermontferrand.fr(E.Coudeyre).

Available

online

at

ScienceDirect

www.sciencedirect.com

https://doi.org/10.1016/j.rehab.2018.01.001

1877-0657/C_{2018TheAuthor(s).PublishedbyElsevierMassonSAS.ThisisanopenaccessarticleundertheCCBY-NC-NDlicense(}

reducedhealth-relatedqualityoflifeandimportantpsychological distress[4].

Internationalpracticeguidelines advocatevarious non-phar-macologicaltreatments, includingexercisetherapy,information and education, weight loss and active lifestyle as first-line treatmentsofOA[5–11].Kneebracesareconsideredsecond-line non-pharmacological treatments of knee OA and are often presentedin anundetailed wayasbiomechanical interventions

[12].TheefficiencyofkneeorthosesforOApatientsisadvocatedby internationalpracticeguidelinesandtheliterature,particularlyfor kneesleeves[5,13]andunloaderkneebraces[11].

Knee sleeves are elastic non-adhesive orthoses associated or not with various devicesaimed at patellar alignment or frontal tibiofemoral stabilization. Unloading braces consist of external stems,hingesandstraps.Theyaimtodecreasecompressiveloads transmittedtothejointsurfaces,inthemedialorlateraltibiofemoral compartments,dependingon thevalgusorvaruspositionofthe device (Appendix 1). Unloading braces can be prefabricated or custom-madebyhealthcareprofessionalsandallowsforselecting differentanglevariationsinthevarus/valgusposition.

Asurveyof1800Frenchgeneralpractitioners(GPs),conductedin 2005,indicated that only10% of them usuallyprescribe knee orthoses forpatients with kneeOA [14]. Surveysof rheumatologistsand specialistsinphysicalmedicineandrehabilitation(PMR)indicate highvariabilityinpracticedependingonthemedicalspecialtyand thetypeofdevice[5].Amongsplints,tapes,sleevesandunloading knee braces, elastic sleeves are the most frequently prescribed orthoses [5].On the whole, 25% of PMR physicians and 35% of rheumatologistsdeclaredthattheyoftenprescribeakneesleeve, whereas19%ofPMRphysiciansand9%ofrheumatologistsprescribe anunloadingkneebrace[5].Altogether,thesefindingsindicatea discrepancybetweenpracticeguidelinesbasedonevidencedataand expertadviceandeverydayprescriptionforOA[15],particularlyfor kneeorthoses.Thisgapmaybeexplainedinpartbythevariablecost andinconsistentavailability ofthesekindsofdevices. Oneother reasonisthelackofuser-friendlytoolsspecificallydesignedtohelp physiciansmakedecisionsinprimaryandsecondarycare.

Toourknowledge,onlyonealgorithmforkneeOAhasbeen proposed by the European Society for Clinical and Economic Aspects of Osteoporosis and OA (ESCEO) [9]. However, this algorithmis toounspecifictobeimplementedindaily practice toprescribeknee bracesbecauseof missingdetailsand specifi-cationsofthekindoforthoses.

Closing the gap between international guidelines based on evidence-baseddataandeverydaypracticeisarealchallengethat canimprovepatientcare.Theaimofourstudywastodesigna decision-makingtool(DMT)toimprovetheprescriptionofknee orthosesforpatientswithkneeOAindailypractice,aspartofa non-pharmacological management strategy, by using a mixed methodologicalapproachbasedonbothevidence-baseddataand expertadvice[9].

2. Methods

In theabsence of referencemethodology, we built a 6-step methodology(Fig.1)inspiredbythatproposedbytheESCEO[9]. 2.1. Extractionofevidence-baseddata

Because the aim of our study was not to comprehensively analyzeefficacyorsafetyoutcomesofclinicaltrials,wethought that a systematic literature search of all available electronic databasesfromtheirinceptionwouldaddverylittleinformation (Fig.2).Therefore,welimitedourliteraturesearchtothe3most recent systematic reviews with meta-analysis of randomized

controlledtrialscomparingkneeorthosistootherinterventionsor nointerventionpublisheduptoJanuary2016[16–18].Additional clinicaltrialspublishedfromJanuary2014toJanuary2016were searchedonPubMedbyusingthekeywords(‘‘kneebrace’’or‘‘knee orthosis’’or‘‘kneebracing’’)and‘‘osteoarthritis’’.ThelatestFrench and internationalpractice guidelinesfromOA Research Society International (OARSI) [11], National Institute for Health and Clinical Excellence (NICE) [10], ESCEO [9], European League Against Rheumatism(EULAR) [7], AmericanAcademyof Ortho-paedic Surgeons(AAOS)[8],AmericanCollegeofRheumatology (ACR)[6]andFrenchSocietyofPhysicalMedicineand Rehabilita-tion(SOFMER)[5]werealsoreviewed.Relevantreferenceswere extracted from the 3 sources and assessed independently by 2reviewers(CNandAC)inanunstandardizedqualitativemanner. References were eventually considered if they werepublished, full-length papers of randomized controlled trials or practice guidelines investigating orthoticinterventions in patients with kneeOA.Referenceswereexcludediftheywerenotrandomized controlledtrialsorpracticeguidelines,ifnoabstractwereavailable oriftheywerewritteninlanguageotherthanEnglish.Duplicated referenceswereremovedafteralldatabasesweresearched. 2.2. DevelopmentoftheDMT

Weuseda6-stepmethodologicalapproachtodesigntheDMT (Fig. 1). A preliminary version of the DMT using data from the literature was drafted before the first meeting by the principal investigator(EC)andtheinvestigatorswhoreviewedevidencefrom theliterature(CN,AC).Thesteeringcommitteewascomposedof 3clinicians(JB,EC,andFR)whohadpreviouslybeeninvolvedin

Fig.1.Successivestepsofthedecision-makingtool(DMT)elaboration. E.Coudeyreetal./AnnalsofPhysicalandRehabilitationMedicine61(2018)92–98 93

internationalguidelinesforOA[5,11]andamethodologist(BP).The steeringcommittee firstdecidedthe composition ofthe experts’ panel,withatleastonephysicianineachspecialityfromprimaryand secondarycare,allinvolvedinkneeOAcareinFrance(PMRphysician, sport-medicinephysician,rheumatologist,GP,orthopaedicsurgeon, physiotherapist, pharmacist) but also in other countries (PMR physician, rheumatologist, orthopaedic surgeon). To take into account theclinicalexperienceofdifferent healthcareprofessionals(PMR physician,sportmedicinephysician,rheumatologist,GP,orthopaedic surgeon, physiotherapist) involved in the management of OA patients, thefirstschematicDMTwasvalidatedina1-daymeetinginJanuary 2016. The multidisciplinary panel reviewed the preliminary version of theDMTtakingintoaccounteverydaypractice,patientexpectations andmedical patientpathways during a detailed discussion. The preliminaryversionoftheDMTwasmodifiedaccordingly.Everystep wasdiscussedandamendeduntilconsensuswasachievedwithinthe taskforce.

2.3. ValidationoftheDMT

AllexpertswhoagreedtobepartofthestudyreceivedtheDMT; theyhadtocarefullyreadtheDMTandgivetheiradvice.Wechose not to use close-ended questions but preferred to use semi-structuredinterviews (qualitative method). In thisway, all 10experts answeredthequestionsasked.Foursuccessiveroundsofreviewof the DMT by a multidisciplinary panel of French primary and secondary physicians(PMRphysician,sport-medicinephysician, rheumatolo-gist,GP,orthopaedicsurgeon,physiotherapist,andpharmacist)and internationalexperts(PMRphysician,rheumatologist,and orthopae-dicsurgeon)wereusedtoachieveconsensus.Firstandlastrounds weredraftedbythesteeringcommittee,thesecondroundbyprimary andsecondarycarephysicians,andthefourthroundbyinternational experts. All physicians and experts commented on the content anddesignof theDMT.Thenumber ofadaptations toobtainan acceptablefinalversionwasbasedonastep-by-stepmethod. 3. Results

3.1. Literaturesearch

LiteraturerelevantforthedesignoftheDMTincludeddatafrom 7 national and international practice guidelines (Table 1) and

9randomizedcontrolledtrialsincludedinthe3latestpublished systematic reviewswith meta-analysis published until January 2018.AsearchofPubMedconductedfromJanuary2014toJanuary 2016didnotyieldanyadditionalreferences(Table2).

3.2. Reviewofevidenceandpracticeguidelines

The literature search allowed for identifying several types of orthosesdependingontheirbiomechanicalproperties,materialand stiffnesssuchasneutralorpatello-femoralsleeve, unicompartmen-taloffloadingbrace,andhingedbraceforstabilization.Theliterature guidelineswerenothomogeneousregardingtheuseoforthotics.

Thefirst-line use of a sleevehad been proposed by SOFMER guidelinesbasedonliteraturedataandexperts’opinion[5],andits efficiencyonpainanddisabilitywasconfirmedbyarecent meta-analysispublished in 2017 [13]. TheACR guidelines[6] propose ‘‘taping’’;therearenoitemsonthistopicinEULARguidelines[7].The toleranceoftapingisgoodandappearstohaveashort-termeffecton pain.IntheNICEguidelines[10],theuseoforthotics,inadditionto the coretreatmentfortheirOA,mustbementionedforpatientswhose painoriginisbiomechanicalorthatexhibitsinstability.TheOARSI guidelines [11]includeorthoticsin thecontextof biomechanical treatmentsthat mustbe proposedby a specialist withoutmore details. TheESCEO guidelines [9] aremore preciseand position orthotics as a second-line treatment aimed at patients with predominantlyunicompartmental femoraltibialOA.A profileofa goodpotentialresponderisproposed:relativelyyoung,physically active,withoutmajorobesity,withunicompartmentalfemorotibial medialinvolvementandalower-limbreduciblemalalignment(varus orvalgus) on clinicalexamination.Ofnote, inallguidelines,the typologyoforthoticsproposedisoftenratherinaccurate.Publications ofrecentoriginalworksfororthosesofunicompartmentalunloading orwithfemoro-patellaraimsincludemoreelements[19,20]. 3.3. ProposedDMT

ApreliminaryversionoftheDMTusingdatafromtheliterature wasdraftedbeforethefirstmeetingbytheprincipalinvestigator (EC) and the investigators who reviewed evidence from the literature(CN,AC)(Fig.3).Thispreliminaryversionwasbasedon theclinicalpracticeofmembersofthecommittee,with primary-andsecondary-careproposals.

Fig.2.Flowdiagramforextractionofevidence-baseddata.AAOS:AmericanAcademyofOrthopaedicSurgeons;ACR:AmericanCollegeofRheumatology;ESCEO:European SocietyforClinicalandEconomicAspectsofOsteoporosisandOsteoarthritis;EULAR:EuropeanLeagueAgainstRheumatism;NICE:NationalInstituteforHealthandClinical Excellence;OARSI:OsteoarthritisResearchSocietyInternational;SOFMER:Socie´te´ Franc¸aisedeMe´decinePhysiqueetdeRe´adaptation.

Elasticbracesmaybeproposed inadditiontofirst-line non-pharmacologicaltreatment (information/education,exerciseand physicalactivity,weightreduction)inpatientswithkneeOA,when therapeuticresponseisinsufficient,and ifpatientacceptanceis consideredgood.Thisfirststepisbasedonevidence-baseddata

[5,13]andphysicians’practice[5].Patientsmustbeaskedwhether theythinktheyareabletowearanorthosisbeforeprescription.If not,anorthosisprescriptionmightbeuseless.

Aclinicalassessmentofthepatello-femoralcomponentisneeded toprovideaneutralorpatellofemoralbracebecauseweconsidered thatthe kindoforthosesmightdiffer evenifliteraturedataare controversialconsideringfemoro-patellainvolvement[21–23].

Morerigidbracesmaybeproposedafterfinebiomechanical clinicaland imaging analysis and shouldtake into account the affectedcompartment,lower-limbmalalignment(varusorvalgus) andtheirreducibility,jointstability,andpatients’willingnessand relative contraindications. If femorotibial OA predominates, a unicompartmentaltibiofemoralunloadingbracecanbeproposed for unicompartmental OA and a hinged stabilizing brace for bicompartmentaltibiofemoralOA associatedwithinstability.In case of femorotibialand patellofemoral combination, the most symptomaticcompartmentmustbetakenintoaccount.

Thislaststepisbasedonseveralstudiesofunloadingorthoses (Table2)andonphysicians’experienceforbicompartmentalOA withorwithoutinstabilityand femorotibialand patellofemoral combinedOA.

3.4. ValidationoftheproposedDMT

Foursuccessiveroundsofconsultationoccurredbyelectronic communication between January and August 2016, first with Frenchphysicians,thenwith3internationalexpertswiththeDMT. Theinternationalexperts’panelwasamultidisciplinarypanel consistingof3differentphysiciansspecializedinPMR, orthopae-dic surgery and rheumatology with previous activities and publications in OA or orthoses fields. All corrections and suggestions byeachmemberwere sharedwiththerestof the taskforceandincludedtoreachfinalconsensus.Thefinalversion wasvalidated bythesteering committee.Thefinalconsensual versionwastranslatedbyaprofessionaltranslatorandculturally adaptedbyahealthcareprofessionalforeachcountrytoensure goodunderstanding.TheDMTisavailableonlinein6languages (English, French, Spanish, Dutch, German, and Chinese) (Fig. 4e-component).

4. Discussion

A mixed methodological approach allowed for building an originalDMTdesignedtohelphealthcareprofessionalsprescribe kneeorthosesforpatientswithkneeOAindailypractice.Toour knowledge,thisDMTisthefirstavailablein6languages.Thistool couldhelpphysicianstoimprovethequalityoftheirprescriptions ofkneeorthoses.

Table1

Nationalandinternationalpracticeguidelinesconsideredforthepurposeofthestudy.

Guidelines Recommendation Evidence

OARSI(2014) ‘‘Werecommenduseofbiomechanicalinterventionsasdirectedbyanappropriatespecialist.’’ ‘‘Fair’’ NICE(2014) ‘‘Peoplewithosteoarthritiswhohavebiomechanicaljointpainorinstabilityshouldbeconsideredforassessmentfor

bracing/jointsupports/insolesasanadjuncttotheircoretreatments.’’

‘‘Some’’ ESCEO(2014) ‘‘Thereisatheoreticalrationaleforusingbiomechanicalinterventionssuchasbracesorinsolesinpatientswith

unicompartmentaltibiofemoralOAtoreducemalalignment,toreducetheconsequentarticularstress,andthusto improvepainandfunction[...].’’

‘‘Reasonable’’

‘‘ThereisinsufficientevidencetodeterminewhetherbracesorinsolesaffecttheprogressionofkneeOA.’’ ‘‘Idealpatientsforbracingareyoungerindividuals,morephysicallyactive,notseverelyobese,withunicompartmental symptomatictibiofemoralOAandmalalignmentthatisreduciblebyvalgusorvarusstressmaneuversonphysical examination.’’

EULAR(2013) ‘‘Allpeoplewithknee/hiposteoarthritisshouldreceiveanindividualisedmanagementplan(apackageofcare)that includesthecorenon-pharmacologicalapproaches,specifically:[...]e*reductionofadversemechanicalfactors(e.g., appropriatefootwear);*fconsiderationofwalkingaidsandassistivetechnology.’’

‘‘Ib’’

AAOS(2013) ‘‘Weareunabletorecommendfororagainsttheuseofavalgusdirectingforcebrace(medialcompartmentunloader) forpatientswithsymptomaticosteoarthritisoftheknee.’’

‘‘Inconclusive’’ ACR(2012) ‘‘Wehavenorecommendationsregardingthefollowing[...]wearingkneebraces[...].’’ Notassessed SOFMER(2009) Kneesleeves

‘‘Kneesleevesappeartohaveanantalgiceffectonkneeosteoarthritis,independentofanylocalheatingaction.’’ ‘‘GradeB ‘‘Theiruseisassociatedwithsubjectiveimprovementandtheireffectonphysicaldisabilityisnotdemonstrated.’’ ‘‘GradeB’’ ‘‘Highqualityclinicaltrials—level-1or-2ANAESscore,withparticularattentiontopotentialconflictofinterest—are

stillnecessary.Thefollowingdesignissuggested:withandwithoutkneesleevesandkneesleeveswithandwithout peripatellaralignmentorfrontalstabilizingdevices.’’

‘‘GradeC’’ Unloadingvalguskneebraces ‘‘GradeB’’

‘‘Unloadingvalguskneebracescanbeusedforsymptomaticmedialfemoro-tibialOAbecauseofshort-andmid-term reductionofpainanddisability.’’

‘‘GradeB’’ ‘‘Theyappeartobemoreeffectivethanneoprenekneesleevesandimprovequalityoflifeintheshort-term.’’ ‘‘GradeC’’ ‘‘Theyfavorablymodifycompressiveloadsinthemedialtibiofemoralcompartment,jointproprioception,isokinetic

strengthofquadriceps,gaitsymmetryandperhapsverticalpropulsiveforce.’’

‘‘GradeC’’ ‘‘Theresultsofobservationandresponsivenesstounloadingkneebracesremaininconsistent.’’ ‘‘GradeC’’ ‘‘Sideeffectsarevarious.Themostseriousarevenousthromboembolicevents.’’ ‘‘GradeC’’ ‘‘Safety,observance,andresponsivenessarethereforeimportantconsiderationsbeforeproposingunloadingknee

bracingforkneeOA.’’

‘‘GradeC’’ ‘‘Moststudiesofunloadingorthosisareoflowquality,namelylevel-4ANAESscore.High-qualitytrialsaretherefore

necessary.’’

‘‘Thefollowingfieldsshouldbeinvestigated:clinicalpredictivefactorsforsafety,observanceandresponsiveness; optimaldurationoforthosiswear;biomechanicalwaysofactions,consideringespeciallythepreviousconflicting resultsandcriteriasuchasfemoro-tibialangle,adductormoment,footstrikeforceandverticalpropulsiveforce.’’

AAOS:AmericanAcademyofOrthopaedicSurgeons;ACR:AmericanCollegeofRheumatology;ESCEO:EuropeanSocietyforClinicalandEconomicAspectsofOsteoporosis andOsteoarthritis;EULAR:EuropeanLeagueAgainstRheumatism;GradeB:scientificpresumption;GradeC:lowlevelofevidence;Ib:atleastonerandomizedcontrolled trial;NICE:NationalInstituteforHealthandClinicalExcellence;OARSI:OsteoarthritisResearchSocietyInternational;SOFMER:Socie´te´ Franc¸aisedeMe´decinePhysiqueetde Re´adaptation.

Table 2

Summary of the 9 randomized controlled trials (RCTs) considered for the purpose of the study.

Author Design Sample Patients Intervention Control Primary outcome Results COI

Jones et al. (UK, 2013)

RCT Cross-over

28 Unilateral OA

KL II/III

Valgus knee brace (DonJoy

OAdjuster1

) For 2 weeks

Lateral wedge insole For 2 weeks

KAM For 6 weeks

Brace  insole # Early stance KAM

Braces provided by DonJoy Hunter et al. (USA, 2012) RCT Cross-over 80 ACR criteria MTF OA KL II/III/IV

Valgus knee brace (DonJoy

OAdjuster1

)

+ Custom-made neutral foot orthoses

+ Shoes designed for motion control (NB 830)

For 12 weeks

Neutral knee brace (DonJoy

Montana1

)

+ Flat unsupportive foot orthoses

+ Shoes with a flexible mid-sole (NB 505) For 12 weeks Pain Functiona For 30 weeks # Pain  Function Supported by the NIDRR and Donjoy Braces provided by DonJoy

Shoes provided by NB

Sattari et al. (Iran, 2011) RCT 3 parallel groups 60 Knee pain Genu varum KL III/IV

Custom-made valgus knee brace

For 9 months

Lateral wedge insole or no intervention For 9 months Pain Walking distance X-ray JSN At 9 months Brace  insole or no intervention # Pain " Walking distance # JSN None declared

Van Raaij et al. (Netherlands, 2010) RCT 2 parallel groups 91 MTF OA KL I/II/III/IV

Valgus knee brace (Bauerfeind

MOS Genu1

) For 6 months

Lateral wedge insole For 6 months

Pain At 6 months

 Pain None declared

Brouwer et al. (Netherlands, 2006) RCT 2 parallel groups 117 Unicompartmental MTF or LTF OA Ahlba¨ck score > 0

Unloading knee brace (OAsys1

) + Standard care For 12 months Standard care For 12 months Pain Functionb At 3, 6 and 12 months # Pain " Function At all timepoints Supported by the Revolving Fund of the Erasmus University Medical Centre Draganich et al. (USA, 2006) RCT Cross-over 10 Altman criteria MTF pain MTF JSN Varus > 08 Custom-made patient-adjustable valgus knee brace (DonJoy Adjustable OA

Defiance1

) For 4–5 weeks

Off-the-shelf patient-adjustable valgus knee brace

(DonJoy OAdjuster1 ) For 4–5 weeks Pain Stiffness Functiona Gait Stair-stepping For 8–10 weeks Custom-made  off-the-shelf # Stiffness " Function

# KAM during gait and stair-stepping

# Varus angulation

Funded by DonJoy

Richards et al. (UK, 2005)

RCT Cross-over

12 MTF OA

Larsen II/III/IV

Valgus knee brace (GII Orthotics, Generation II ADJ

Unloader1

) For 6 months

Hinged knee brace (Camp Healthcare, Bilateral uniaxial hinge B11 ) For 6 months Knee kinematics Ground reaction Forces Pain Function HSS score For 12 months

Valgus  hinged knee brace # Pain " Function None declared Kirkley et al. (Canada, 1999) RCT 3 parallel groups 119 MTF OA KL II/III/IV

Valgus knee brace (GII Orthotics, Generation II

Unloader1

) + Medical treatment

For 6 months

Neoprene knee sleeve + Medical treatment or medical treatment alone For 6 months Functiona,c 6MWT 32-stair-climbing At 6 months

Brace  medical Treatment " Function

" 6MWT #32-stair-climbing Brace  sleeve

# Pain after 6MWT and 32-stair-climbing

" Function

Funded by Generation II Orthotics

Horlick and Loomer (Canada, 1993)

RCT Cross-over

39 MTF OA Off-the-shelf valgus knee brace

(valgus knee brace) (GII Orthotics, Generation II

Unloader1

) For 6 weeks

Neutral knee brace (GII Orthotics, Generation II1 ) For 6 weeks Pain Function X-ray JSN For 12 weeks # Pain Funded by Generation II Orthotics

: no difference; ": reduction; ": increase;; 6MWT: 6-minute walk test; ACR: American College of Rheumatology; COI: conflict of interest; KAM: knee adduction moment; JSN: joint space narrowing; KL: Kellgren and Lawrence X-ray

grade; LTF: lateral tibiofemoral; MTF: medial tibiofemoral; NB: New Balance1

; NIDRR: National Institute on Disability and Rehabilitation Research; OA: osteoarthritis. a

WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index. b _{Hospital for Special Surgery Score.}

c _{MACTAR: McMaster-Toronto Arthritis Patient Preference Disability Questionnaire.}

E. Coudeyre et al. / Annals of Physical and Rehabilitation Medicine 61 (2018) 92–98

TheDMTproposesfirsttotryasleevefor2mainreasons.The first-lineuseofasleevehadbeenproposedbySOFMERguidelines basedonliteraturedataandexperts’opinion[5]anditsefficiency onpainand disabilitywasconfirmedbyarecentmeta-analysis

[13].Manypatients hadtriedsleevesbecausetheyarelowcost

(from10to30euros);theyboughttheminapharmacyoverthe counterorinasportsshop.

Orthoses with biomechanical effects are proposed secondarily becausewecanhonestlyconsiderthatifpatientsacceptasleeveasa first-line treatment,theyare more open to consider more rigidorthoses.

Fig.3.Decision-makingtool(Englishversion).

We didnotfindanycost-effectivenessevaluationscomparing kneesleevesversusrigidorthosesintheinternationalliterature,but thelowcostofkneesleevescomparedtounloadingorthosesiswell documentedandfavorssleevesasafirst-intentionorthosis.

Evidence-based data are lacking for specific patello-femoral braces,withcontradictorystudiesincludingdifferentphenotypesof patients[21–23],bythewayweaccountedforexperts’advice.

The first limitation of this study is a methodological one, becausealimitednumberofexpertswereinvolvedintheprocess. Weaskedalimitednumberofexperts,butwepaidattentionto mixdifferentprimaryandsecondaryhealthcareprofessionalsfrom Franceandothercountries.ThisDMTisbasedononlyliterature data, practice guidelines and expert advice. A patient-based qualitative approach may add relevant information toimprove theefficacyofthe DMTbybettertaking intoaccount patients’ perspectivesandenhancingpatients’empowerment.

The DMTis still preliminary.A prospectivevalidation of the DMTandanevaluationofitsimplementationinawiderangeof health professionals in primary and secondary care are still needed.Wecouldalsoassesswhethertheuseofthistoolmodifies prescriberbehavior.Thistoolcanbeusefulforphysicianeducation on OA management. Another perspective is the possibility to convertthisDMTtoasmartphoneapplicationforauser-friendly everydaypracticeuse.

5. Conclusions

WeusedamixedmethodologytodevelopanapplicableDMT forOAroutinemanagement.Aprospectivevalidationinprimary andsecondarycareis needed,followed byanevaluationof the implementation in a wide range of health professionals to definitivelyvalidatetheDMT.

Grantsandfundings

Allcontributorsofthis publicationreceivedfeesoflessthan 5000USDfromTHUASNE.THUASNEwasimplicatedfortechnical supportandnothingelse.

Disclosureofinterest

Theauthorsdeclarethattheyhavenocompetinginterest. Acknowledgments

We warmly thankall thecolleaguesand experts whomade usefulcommentstoimprovetheDMT.

One-day meeting experts’ panel: Dr A Chabaud (general practitioner),DrJMCoudreuse(sportmedicine),PDeat (physio-therapist),DrALorenzo(generalpractitioner),DrCNguyen(PMR), DrFSailhan(orthopaedicsurgeon).

Primary- and secondary-care healthcare professionals: Dr A Boyer(pharmacist), Dr B Eschalier (general practitioner), Dr M Fechtenbaum (rheumatologist), Dr PL Fournier (orthopaedic surgeon),MrS Girold(physiotherapist), Dr MGiustiniani(PMR andsportmedicine),DrCMorel(PMRandsportmedicine).

Internationalexperts:PrASautet(orthopaedicsurgeon),PrDJ Hunter(rheumatology),PrPThoumie(PMR).

AppendixA. Supplementarydata

Supplementary data associated with this article can be found,in theonlineversion,athttps://doi.org/10.1016/j.rehab. 2018.01.001.

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