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Physical Rehabilitation Programmeknee-ankle-Foot orthosis
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Manufacturing guidelines
International Committee of the Red Cross19 Avenue de la Paix1202 Geneva, SwitzerlandT + 41 22 734 60 01 F + 41 22 733 20 57E-mail: [email protected]© ICRC, September 2006All photographs: ICRC/PRP
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.
�Manufac tur ing Guidel ines Knee -Ankle -Foot O r thosis
Table of contents
Foreword 2Introduction 41.Casting,measurementandrectification 42.Preparationofreinforcements 63.Polypropylenedrapingandvacuummoulding 74.Positionofthesidebars 95.Trimlines 116.Assemblyandparallelism 127.Initialfittings 138.Finishing 149.KAFOoptions 15Listofcomponentsandmaterials 16
� ICRC Physical Rehabi l i tat ion Programme
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.
�Manufac tur ing Guidel ines Knee -Ankle -Foot O r thosis
Objective of the manuals
TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.
Themainaimsoftheseinformativemanualsareasfollows:
• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.
Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.
ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme
� ICRC Physical Rehabi l i tat ion Programme
Introduction
Theaimofthisdocumentistodescribeamethodforproducingknee-ankle-foot orthoses (KAFO),workingwithpolypropylenetechnologyandcommercialuprightsidebarswithdroplocksasusedattheICRC’sphysicalrehabilitationcentres.
Thecastingandrectificationmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsofpracticeandarethereforenotdescribedintheseICRCmanufacturingguidelines.
Someimportantpointsshouldneverthelessbetakenintoaccount:
1.1 Anatomy and landmarks
4Malleoli
4The1stand5thmetatarsalheads
4Navicularbone
4Baseof5thmetatarsal,ifprominent
4Greattrochanter
4Medialtibialplateau
4Headoffibula
CAsTIng, meAsuRemenT And ReCTIFICATIOn1
�Manufac tur ing Guidel ines Knee -Ankle -Foot O r thosis
1.2 Cast rectification method
Oncerectificationiscompleted,checkthefollowing:
4Theposteriorlinepassesthrough
1.themiddleofthethigh2.themiddleoftheknee3.themiddleoftheankle
4Heelandforefootareflatontheground
4Thelaterallinepassesfromthegreattrochantertothemiddleofthelateralmalleolus
� ICRC Physical Rehabi l i tat ion Programme
1.3 mechanical knee joint location
4MechanicalaxesaredefinedinaccordancewithP&Opractice,asshownhere.
Thepositiveplasterremainsinaverticalposition:
4Drivetwonailsintothemouldatthemechanicalkneeaxis(theyshouldprotrudeabout5mm)
4Pullanylonorcottonstockingoverthemould
4FixtheEVAreinforcementaccordingtothemeasurementcardandrequirements
4Dustthestockingwithtalcumpowder
PRePARATIOn OF ReInFORCemenTs2
�Manufac tur ing Guidel ines Knee -Ankle -Foot O r thosis
POlyPROPylene dRAPIng And vACuum mOuldIng3
Cuta5mmsheetofpolypropylene(PP)asfollows:
4Heatthepolypropyleneat180°for20to25minutes,dependingonthethicknessofthepolypropyleneandtheperformanceoftheoven.
Drapethepolypropyleneovertheplastermodel.Laythepolypropyleneoverthemouldwithoutstretchingit.
CleanthePPsheet.
4Uppercircumference+10cm
4Totallength+20cm
4Lowercircumference+15cm
3
1
2
3
2
1
Drapeitfirstovertheankletowardsthemiddleanteriorpartoftheorthosismould.Thenpullitaroundtheforefoot.
� ICRC Physical Rehabi l i tat ion Programme
4Stickittogetheralongtheanteriorside.
4Tightenthepolypropylenearoundthesuctionconewitharopeorsomethingsimilar.
Openthevacuumvalve.
4Withscissorsoraknife,cutofftheexcesspolypropylenealongtheweldingseamwhileitisstillhot.
�Manufac tur ing Guidel ines Knee -Ankle -Foot O r thosis
Remarks
Ifthepolypropylenesheetcutaccordingtothemeasurementsoftheplasteristoobigtofitintotheoven,preparetwoPPsheetsinsteadofone.
DrapethePParoundtheplastermould.
Payattentiontotheoverlaparea,pullingthePPgraduallyandcarefully;otherwiseitwillbestretchedtoothinlyandbetooweak.
OpenthevacuumvalveandremovetheexcessPPalongtheseam.
POsITIOn OF The sIde bARs4
4Onthebench,thepositivemouldisinstalledasfollows:
4Thepositionofthekneeaxisshouldbemarkedinrelationtotheverticallineindicatingthelocationofthemechanicalkneejoint.
kneeaxis
�0 ICRC Physical Rehabi l i tat ion Programme
4Theuprightsarecuttotherequiredlength,bentandadjustedfollowingthecurvesofthePPshells.
��Manufac tur ing Guidel ines Knee -Ankle -Foot O r thosis
4Duringadjustmentofthesidebars,thepositionandparallelismofthekneeaxismustberespected.
Axislocationandtrimlines
4TrimlinesdependonthetypeofcorrectionrequiredandthefunctionoftheKAFO.
Inmostcases,trimlinesshouldbedrawnaccordingtointernationalP&Ostandards,asshownhere:
TRIm lInes5
�� ICRC Physical Rehabi l i tat ion Programme
4ThepolypropyleneiscutoffandthetrimlinecontoursaregroundandpolishedbeforetemporaryassemblyoftheKAFOfortrial.
Assembly And PARAllelIsm6
4ThesidebarsaretemporarilyfixedonthepolypropyleneshellswithM3screwsandnuts.
Preciseparallelismofthekneejointisoftheutmostimportanceandmustbeensuredbeforethefirstfittingasfollows:
4method 1:UsingaVerniercalliper
��
InITIAl FITTIngs7
Manufac tur ing Guidel ines Knee -Ankle -Foot O r thosis
4method 2:Usingthecentringpin
4StraptheKAFOonthepatient’slowerlimb.
4Checkthetrimlinesbeforethepatientstandsup.
Oncetheshoesareon,thepatientstandsupandgaittrainingcanbegin.
�� ICRC Physical Rehabi l i tat ion Programme
FInIshIng8
4Thestrapsarefixedwithtubularrivets
4Thetrimlinesarecarefullypolished
4Theuprightscanbecoveredwithfineleather
4Theparallelismofthekneejointischeckedagain
4Theuprightsarefixedwithcopperrivets
��
KAFO OPTIOns9
Manufac tur ing Guidel ines Knee -Ankle -Foot O r thosis
4TheKAFOisreadyfordelivery
4Somepatientsneedanischialseatsupport.Inthiscasethebrimhasananterioropening.Theshapeissimilartothatofquadrilateralsocketprosthesis.
4TheKAFOcanbefittedwithdifferentorthoticjoints(Swisslock,droplock,freeoffset,etc.).
�� ICRC Physical Rehabi l i tat ion Programme
ICRC Code Description Unit of measure Quantity
For negative and positive cast :ODROSTOCOT60 Tubular stockinet, 60 cm Cm 135MDREBANDP10-12-15 Plaster of Paris bandages10, 12 or 15 cm x 3 m Piece 6 to 7OTOOPLASPW40 Plaster of Paris powder Each As requiredFor EVA and plastic moulding :OPLAEVAFKIN06 EVA FOAM 6 mm x 0.95 m x 0.95 m, 0.90 m2, skin colour Sheet 0OPLAPOLYSKIN 04 HOMOPOLYMER 4 mm or 5 mm x 1 m x 2 m 7.5 kg, beige colour Sheet 0.5For components/ sidebars:OCPOKNEEB20DL/16DL ORTHOSIS, ADULT, 20 mm or 16 mm side bar knee joint w.drop lock (pairs) Pair 1OCPOKNEEBO20SL/16SL ORTHOSIS, ADULT, 20 mm or 16 mm side bar knee joint, Swiss lock (pairs) Pair 1OCPOKNEEBO20DL/16DL ORTHOSIS, ADULT, 20 mm or 16 mm side bar knee joint w.drop lock (pairs) Pair 1For straps and rivets:OSBOVSBO26 ELASTIC STRAP 25 mm x 25 m Roll 0.02EHDWZBAKGLUE01 GLUE, SYNTHETIC Litre 0.2OSBOVSBO36 LOOP 35 mm x 100 pcs Box 0.04EBUIZBAKPOPPOWD PLASTER POWDER Kg 12EHDWOHPW45 RIVET (COPPER) 4 mm x 20 mm x 1,000 pcs Box 0.012EHDWOHDW40 RIVET (TUBULAR) 13 mm x 12 mm x 1,000 pcs Box 0.012ORTOZBAKSPAR SANDPAPER 15 x 15 Piece 1OSBOVSBO29 STRAP (PROSTHESIS) 35 mm x 50 m Roll 0.02OSBOVSBO25 STRAP (VELCRO) 30 mm M 1OOMAALIGORTH CENTRING PIN FOR ORTHOSIS 1 30ETOOMEASC15 VERNIER CALLIPER 1 35Special hand tools:OTOOMEASCIR4 _ 7 COUNTOURING INSTRUMENT, ROUND BEAK Each 2OTOOMEASCFL COUNTOURING INSTRUMENT, FLAT Each 2OOMAALIGORTHX CENTRING PIN FOR ORTHOSIS Each 1ETOOMEASC15 VERNIER CALLIPER Each 1
list of components and 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: [email protected]© ICRC, September 2006All photographs: ICRC/PRP
Physical Rehabilitation Programmeankle-Foot orthosis
Manufacturing guidelines
0868
/002
0
9/20
06
200
