Prosthetics and Orthotics Manufacturing Guidelines - 1 ... · PDF fileMISSION The...

Partial Foot ProsthesisPhysical Rehabilitation Programme

Manufacturing guidelines

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MISSION

The International Committee of the Red Cross (ICRC) is an impartial, neutral and independent organization whose exclusively humanitarian mission is to protect the lives and dignity of victims of war and internal violence and to provide them with assistance. It directs and coordinates the international relief activities conducted by the Movement in situations of conflict. It also endeavours to prevent suffering by promoting and strengthening humanitarian law and universal humanitarian principles. Established in 1863, the ICRC is at the origin of the International Red Cross and Red Crescent Movement.

Acknowledgements:

Jean François GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard MatagneJoel NiningerGuy NuryPeter PoestmaHmayak Tarakhchyan

and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.

International Committee of the Red Cross19 Avenue de la Paix1202 Geneva, SwitzerlandT + 41 22 734 60 01 F + 41 22 733 20 57E-mail: icrc.gva@icrc.orgwww.icrc.org© ICRC, September 2006All photographs: ICRC/PRP

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Table of contents

Foreword 2Introduction 41.Footprintofsoundside 52.Castingandrectification 63.Softsocketfabrication 74.Forefootbuild-up 115.Firstfittingofsoftsocket 136.Drapingofpolypropylene 157.Trimlines 178.Fitting 209.Straps 2110.Finishedpartialfootprosthesis 22Listofmanufacturingmaterials 23

Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

Foreword

The ICRC polypropylene technology

Sinceitsinceptionin1979,theICRC’sPhysicalRehabilitationProgrammehaspromotedtheuseoftechnologythatisappropriatetothespecificcontextsinwhichtheorganizationoperates,i.e.,countriesaffectedbywarandlow-incomeordevelopingcountries.

Thetechnologymustalsobetailoredtomeettheneedsofthephysicallydisabledinthecountriesconcerned.

Thetechnologyadoptedmustthereforebe:

• durable,comfortable,easyforpatientstouseandmaintain;• easyfortechnicianstolearn,useandrepair;• standardizedbutcompatiblewiththeclimateindifferentregionsoftheworld;• low-costbutmodernandconsistentwithinternationallyacceptedstandards;• easilyavailable.

Thechoiceoftechnologyisofgreatimportanceforpromotingsustainablephysicalrehabilitationservices.

Forallthesereasons,theICRCpreferredtodevelopitsowntechniqueinsteadofbuyingready-madeorthopaediccomponents,whicharegenerallytooexpensiveandunsuitedtothecontextsinwhichtheorganizationworks.ThecostofthematerialsusedinICRCprostheticandorthoticdevicesislowerthanthatofthematerialsusedinappliancesassembledfromcommercialready-madecomponents.

WhentheICRClauncheditsphysicalrehabilitationprogrammesbackin1979,locallyavailablematerialssuchaswood,leatherandmetalwereused,andorthopaediccomponentsweremanufacturedlocally.Intheearly1990stheICRCstartedtheprocessofstandardizingthetechniquesusedinitsvariousprojectsaroundtheworld,forthesakeofharmonizationbetweentheprojects,butmoreimportantlytoimprovethequalityofservicestopatients.

Polypropylene(PP)wasintroducedintoICRCprojectsin1988forthemanufactureofprostheticsockets.Thefirstpolypropyleneknee-jointwasproducedinCambodiain1991;othercomponentssuchasvariousalignmentsystemswerefirstdevelopedinColombiaandgraduallyimproved.Inparallel,adurablefoot,madeinitiallyofpolypropyleneandEthylVinylAcetate(EVA),andnowofpolypropyleneandpolyurethane,replacedthetraditionalwooden/rubberfoot.

In1998,aftercarefulconsideration,itwasdecidedtoscaledownlocalcomponentproductioninordertofocusonpatientcareandtrainingofpersonnelatcountrylevel.

�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

Objective of the manuals

TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.

Themainaimsoftheseinformativemanualsareasfollows:

• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.

Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.

ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme

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Introduction

Theaimofthisdocumentistodescribeamethodforproducingpartial foot prostheses,workingwiththeICRCpolypropylenetechnologyandorthopaediccomponentsusedattheRegionalPhysicalRehabilitationCentreinBattambang,Cambodia.

Thecasting,rectificationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsofpracticeandarethereforenotdescribedintheseICRCmanufacturingguidelines.

Remarks

• Theproceduredescribedrelatestooneofthemostcommontypesofpartialfootamputation,whichisalsoknownasChoppartormid-footamputation.

• Iffullendbearingisnotpossible,thePatellar-Tendon-Bearing(PTB)designbrimshouldbeused.

ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

FOOTpRInT OF sOund sIde1

6Copythesound-sidefootprintonasheetofpaperandmarkthefootrotation(~10°).

Insertfrontalline.

6Fixthepaperagainstawindowandcopythereversesideofthefootprint.

Theprintwillhelpinpositioningthebuild-upofthefootontheprosthesis.

� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

CasTIng and ReCTIFICaTIOn2

PatientassessmentandcastingareperformedinaccordancewithP&Ostandards.However,thecastistakenwhiletheamputeeissittingdown.Patientswhowillhavetheirfullweightbearingontheprosthesisshouldstandbeforetheplasterbandageshavehardened.Formoresensitivestumpsthepatientshouldstandonalayerofsoftfoam,andifnecessaryaheelwedgemaybeaddedtocompensateforequinuspositionofthestumportheheightoftheshoeheel.

Caremustbetakentoensurethatthecalcaneusisheldinaneutralposition.

RectificationofthepositivecastimpressionisperformedinaccordancewithP&Ostandards.

6Referencelinescanbeaddedonthemouldsandthefootprint.

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ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

sOFT sOCkeT FabRICaTIOn3

MeasurementofEVAfoam:

� Circumference2cmabovetheheadofthefibula.� Circumferencemiddleofthecalcaneus.� Lengthofplastercast.

Cutatrapezoidfromasheetof6mmEVAfoamaccordingtotheabovemeasurements.

� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

4Trima10mmstriponbothlateralsidesoftheEVAfoamtozeromillimetres.

4ApplyNeoprenecontactgluetwiceonbothtrimmedsides.

4Oncetheglueisdry,jointhetwosurfacestoformacone.

�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

4DusttheplasterpositiveandtheinsideoftheEVAconewithtalcumpowdertofacilitatesliding.

4HeattheEVAconeinanovenforabout5minutesat120°Candthenpullitovertheplasterpositive.

4TokeeptheEVAfoaminthesameshapeastheplasterpositive,secureitwithelasticbandagesorplaceitundervacuumuntilithascooleddown.

�0 ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

4TrimthedistalsectionoftheEVAconewithaknifeandsmoothitbygrinding.

4ApplytwolayersofNeoprenecontactgluetothetrimmedsectionandtothe12mmEVAfoamsocketcap.

4Heatthecapfor2to3minutesat120°Cinanovenandglueitontothesoftsocket.

CutoffandgrindtoremovetheexcessEVAfoam.

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

FOReFOOT buIld-up4

4Gluelayersof12mmEVAfoamcorrespondingtothelengthofthesoundfootmeasuredbeforecasting.

4Usethefootprinttakenbeforecastingtodeterminethecorrectfootrotation.

Checktheanterior/posteriorandthelateral/medialalignmentsagainstthemeasurementcard(e.g.heelheight).

6Pre-shapetheforefootwithaknife.

�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

6Finishshapingtheforefootonthegrindingmachine.

Makesurethattheplantarsolebetweenheelandtoesisparalleland,ifnecessary,thattheheelheightiscorrect.Wherepossible,shapethelongitudinalarchsupport.

6Forfinishing,asheetof3mmEVAfoamisdrapedoverthefoot.

FitthesheetofEVAfoamonthefootbycuttingitroundaroundtheankle.

ApplytwolayersofNeoprenecontactglue,thenheatthe3mmEVAfoamintheovenfor2minutesat120°Cbeforedrapingit.Cutandsmooththeedges.Afurthersheetof3mmEVAfoammaybeadded(glued)tothesole.

Thisoperationcanalsobecarriedoutafterthefirstfittingofthesoftsocketontheamputee,describedbelow.

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

FIRsT FITTIng OF sOFT sOCkeT5

4Beforethepolypropyleneisdraped,thesoftsocketmustbecheckedonthepatient.

Thesoftsocketmustberemovedfromtheplasterpositivewithoutbreakingit.

Ontheposteriorside,puncha4mmholejustabovethecalcaneus.ThishelpsavoidtearingoftheEVAfoamwhenthesoftsocketisbeingremovedfromtheplaster.

Drawalineorusearulertomakeastraightcuttinglineuptotheproximalendofthesocket.

Removethesoftsocketcarefullyandkeeptheplasterpositive.

6Tocheckthefit,alignmentandlengthofthesoftsocket,fixitwithtape.

�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

6Checktheheightoftheprosthesisanditsstaticalignment.Makethenecessarymodifications/correctionsbygrindingofforaddingEVAfoam.

6Checkalsothelengthandrotationofthefoot,andadjustitasdescribedabove.

Atthispointitisnotrecommendedthatthepatientbeallowedtowalk,asthesocketandforefootaretooflexible.However,theamputeemaytakesomestepsinsideparallelbarssothatthedynamicalignmentcanbechecked.

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

dRapIng OF pOlypROpylene6

4Putthesoftsocketbackontheplasterpositiveandstapleortapethesidesoftheposteriorseamtogether.

4Measurementofpolypropylenesheet:

Lengthfromproximalpartofplasterpositivetotoes+15cm

Circumferenceofproximalpartofsoftsocket+2cm

Circumferenceofmid-tibialsection+2cm

Circumferenceoffoot-ankle(below

medialmalleoli,includingcalcaneus)+5cm

4Beforedrapingthepolypropylene,pullanylonstockingoverthesoftsocketanddustitwithtalcumpowder.

�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

4Cuta5mmsheetofPPcorrespondingtothemeasurementstakenabove.

HeatthePPinanovenforabout20minutesat180°C.

4LaythePPoverthemouldwithoutstretchingit.

Drapeitfirstovertheankletowardsthemiddleanteriorpartoftheprosthesis.Thenpullitaroundtheforefoot.

4FinishdrapingthePPandstickittogetheralongthemiddleanteriorsideoftheprosthesis.

TightenthePParoundthesuctionconewithabicycleinnertube,aropeorastockingandopenthevacuumvalve.

4Withscissorsoraknife,cutofftheexcessalongtheweldingseamwhilethePPisstillhot.

4Keepthevacuumonforabout5min.,butwaituntilthePPhascompletelycooleddownbeforeremovingthemouldfromthevacuumcone.

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

TRIm lInes7

4Proximaltrimline: 1to2cmbelowthefibulahead.

Lateral/medialtrimlines: On1/3oftheproximaltibialsection,

2to3cmwiderthanthe2/3distaltibialtrimline,whichisdrawnstraightupjustbehindthelateralandmedialmalleoli.

Distal/posteriortrimline: Alongthecalcaneustuberosity.

6Forefoottrimline: 5mmposteriortothe1stmetatarsaltodistalphalanges,butkeepthePPtipforprotectionofthe

EVAfoam.

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4Removethesoftsocketfromtheplasticsocket.BearinmindthatitmightbedifficulttoextractthesoftsocketfromthePPshell.

ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

4Cuttheposterioropeningwithanoscillatingsaw.

4ToavoiddamagingtheEVAfoam,donotcuttheforefootopeningwithanoscillatingsaworknife.Instead,carefullygrinditoff.

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

6GrindtheanteriorPPweldingseamdownto5mmandshapethetrimlinesoftheplasticandsoftsockets.

6Shapealsothetrimlinesoftheforefootopening.

�0 ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

FITTIng8

6Duringfittingandgaittraining,fixtheproximalpartoftheprosthesiswithtape.

Modificationscanstillbemadetothealignment,especiallytocorrecttheeversionorinversionofthefoot,andtotheheelheightbyaddingEVAfoamonthesole.

Iftheprosthesisistoolong,compensateforthedifferenceinlengtheitherinsidetheshoeoronthesoleofthesoundleg.

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

sTRaps9

4PositionaVelcrostrap(width:25or40mm)justbelowthefibulahead.

4FixthelooponthemedialwallandtheVelcrostraponthelateralwallwithtubularrivets.

�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

FInIshed paRTIal FOOT pROsThesIs10

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis

ICRC Code Description Unit of measure Quantity

MDREBANDP12 Plaster bandages 12 cm Each According to stump dimension

OMIS Plaster of Paris Each According to cast dimension

OPLAEVAFERA03OPLAEVAFERA06OPLAEVAFERA12

OPLAEVAFKIN03OPLAEVAFKIN06OPLAEVAFKIN12

OPLAEVAFLIV03OPLAEVAFLIV06OPLAEVAFLIV12

EVA foam 3 mm, terra brownEVA foam 6 mm, terra brownEVA foam 12 mm, terra brown

EVA foam 3 mm, beigeEVA foam 6 mm, beigeEVA foam 12 mm, beige

EVA foam 3 mm, oliveEVA foam 6 mm, oliveEVA foam 12 mm, olive

Each According to cast dimension

OHDWGLUENEO4 Glue, Neoprene contact Each According to soft socketOMIS Tubular nylon stocking 60 mm for PP draping Each 1 length according to

prosthesisOPLAPOLYCHOC05

OPLAPOLYSKIN05

OPLAPOLYLIV05

Polypropylene 5 mm, terra brown

Polypropylene 5 mm, beige

Polypropylene 5 mm, olive

Each According to cast dimension

OSBOSTRVP325

OSBOSTRVP440

Velcro strap with loop 25 mmorVelcro strap with loop 40 mm

Each 1 length according to patient size

OHDWRIVET081

OHDWRIVET131

Tubular rivet 8 mm x 9 mmorTubular rivet 13 mm x 12 mm

Each 2

list of manufacturing materials

MISSION

The International Committee of the Red Cross (ICRC) is an impartial, neutral and independent organization whose exclusively humanitarian mission is to protect the lives and dignity of victims of war and internal violence and to provide them with assistance. It directs and coordinates the international relief activities conducted by the Movement in situations of conflict. It also endeavours to prevent suffering by promoting and strengthening humanitarian law and universal humanitarian principles. Established in 1863, the ICRC is at the origin of the International Red Cross and Red Crescent Movement.

Acknowledgements:

Jean François GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard MatagneJoel NiningerGuy NuryPeter PoetsmaHmayak Tarakhchyan

and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.

International Committee of the Red Cross19 Avenue de la Paix1202 Geneva, SwitzerlandT + 41 22 734 60 01 F + 41 22 733 20 57E-mail: icrc.gva@icrc.orgwww.icrc.org© ICRC, September 2006All photographs: ICRC/PRP

Physical Rehabilitation Programmeankle-Foot orthosis

Manufacturing guidelines

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