Prosthetics and Orthotics Manufacturing Guidelines: Lower limb Orthotics: Knee-Ankle-Foot-Orthosis

8/9/2019 Prosthetics and Orthotics Manufacturing Guidelines: Lower limb Orthotics: Knee-Ankle-Foot-Orthosis

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Physical Rehabilitation Programme

knee-ankle-Foot orthosis

Manufacturing guidelines


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International Committee of the Red Cross

19 Avenue de la Paix1202 Geneva, SwitzerlandT + 41 22 734 60 01 F + 41 22 733 20 57E -mail: [email protected] .icrc.org ICRC, September 2006All photographs: ICRC/PRP


3/20Manufacturing GuidelinesKnee-Ankle-Foot Orthosis

Ta o co t t

Foreword 2

Introduction 41. Casting, measurement and recti cation 4

2. Preparation o rein orcements 6

3. Polypropylene draping and vacuum moulding 7

4. Position o the side bars 9

5. rim lines 11

6. Assembly and parallelism 12

7. Initial ttings 13

8. Finishing 149. KAFO options 15

List o components and materials 16


4/20ICRCPhysical Rehabilitation Programme

For wor

T ICRC po prop t c o o

Since its inception in 1979, the ICRCs Physical Rehabilitation Programme has promoted the useo technology that is appropriate to the speci c contexts in which the organization operates,i.e., countries a ected by war and low-income or developing countries.

Te technology must also be tailored to meet the needs o the physically disabled in the countriesconcerned.

Te technology adopted must there ore be:

durable, com ortable, easy or patients to use and maintain; easy or technicians to learn, use and repair; standardized but compatible with the climate in di erent regions o the world; low-cost but modern and consistent with internationally accepted standards; easily available.

Te choice o technology is o great importance or promoting sustainable physical rehabilitationservices.

For all these reasons, the ICRC pre erred to develop its own technique instead o buying ready-madeorthopaedic components, which are generally too expensive and unsuited to the contexts in whichthe organization works. Te cost o the materials used in ICRC prosthetic and orthotic devices

is lower than that o the materials used in appliances assembled rom commercial ready-madecomponents.

When the ICRC launched its physical rehabilitation programmes back in 1979, locally availablematerials such as wood, leather and metal were used, and orthopaedic components weremanu actured locally. In the early 1990s the ICRC started the process o standardizing thetechniques used in its various projects around the world, or the sake o harmonization between theprojects, but more importantly to improve the quality o services to patients.

Polypropylene (PP) was introduced into ICRC projects in 1988 or the manu acture o prostheticsockets. Te rst polypropylene knee-joint was produced in Cambodia in 1991; other componentssuch as various alignment systems were rst developed in Colombia and gradually improved. Inparallel, a durable oot, made initially o polypropylene and EthylVinylAcetate (EVA), and now opolypropylene and polyurethane, replaced the traditional wooden/rubber oot.

In 1998, a er care ul consideration, it was decided to scale down local component production inorder to ocus on patient care and training o personnel at country level.



O j cti o t a a

Te ICRCs Manu acturing Guidelines are designed to provide the in ormation necessary orproduction o high-quality assistive devices.

Te main aims o these in ormative manuals are as ollows:

o promote and enhance standardization o ICRC polypropylene technology; o provide support or training in the use o this technology; o promote good practice.

Tis is another step orward in the e ort to ensure that patients have access to high-quality services.

ICRCAssistance Division/Health UnitPhysical Rehabilitation Programme



I tro ctio

Te aim o this document is to describe a method or producingknee-ankle-foot orthoses (KAFO) ,working with polypropylene technology and commercial upright sidebars with drop locks as used atthe ICRCs physical rehabilitation centres.

Te casting and recti cation methods used correspond to international prosthetic and orthotic(P&O) standards o practice and are there ore not described in these ICRC manu acturing guidelines.

Some important points should neverthelessbe taken into account:

1.1 A ato a a ark

4 Malleoli

4 Te 1 st and 5th metatarsal heads

4 Navicular bone

4 Base o 5th metatarsal, i prominent

4 Great trochanter

4 Medial tibial plateau

4 Head o bula

CAsTIng, meAsuRemenT And ReC TIFICATIOn1



1.2 Ca t r ctifcatio t o

Once recti cation is completed, check the ollowing:

4 Te posterior line passes through

1. the middle o the thigh2. the middle o the knee3. the middle o the ankle

4 Heel and ore oot are fat on the ground

4 Te lateral line passes rom the great trochanter tothe middle o the lateral malleolus



1.3 m c a ica k joi t ocatio

4 Mechanical axes are de ned in accordance withP&O practice, as shown here.

Te positive plaster remains in a vertical position:

4 Drive two nails into the mouldat the mechanical knee axis (theyshould protrude about 5 mm)

4 Pull a nylon or cotton stocking

over the mould

4 Fix the EVA rein orcementaccording to the measurementcard and requirements

4 Dust the stocking with talcumpowder

PRePARATIOn OF ReInFORCemenTs2



POlyPROPylene dRAPIng And vACuum mOuldIng3

Cut a 5 mm sheet o polypropylene (PP) as ollows:

4 Heat the polypropylene at180 or 20 to 25 minutes,depending on the thicknesso the polypropylene and theper ormance o the oven.

Drape the polypropylene overthe plaster model. Lay thepolypropylene over the mouldwithout stretching it.

Clean the PP sheet.

4 Upper circum erence+10 cm

4 otal length+20 cm

4 Lowercircum erence+15 cm

3

1

2

3

2

1

Drape it rst over the ankle towardsthe middle anterior part o the orthosismould.Ten pull it around the ore oot.



4 Stick it together along theanterior side.

4 ighten the polypropylene

around the suction cone witha rope or something similar.

Open the vacuum valve.

4 With scissors or a kni e, cuto the excess polypropylenealong the welding seam whileit is still hot.



R ark

I the polypropylene sheet cut according to the measurements o the plaster is too big to t into theoven, prepare two PP sheets instead o one.

Drape the PP around the plaster mould.

Pay attention to the overlap area, pulling the PP gradually and care ully; otherwise it will bestretched too thinly and be too weak.

Open the vacuum valve and remove the excess PP along the seam.

POsITIOn OF The sIde bARs4

4 On the bench, the positive mouldis installed as ollows:

4 Te position o the knee axisshould be marked in relation tothe vertical line indicating thelocation o the mechanical knee joint.

knee axis


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4 Te uprights are cut to therequired length, bent andadjusted ollowing the curves othe PP shells.



4 During adjustment o the side bars, theposition and parallelism o the knee axismust be respected.

Axis location and trim lines

4 rim lines depend on the type o correctionrequired and the unction o the KAFO.

In most cases, trim lines should be drawnaccording to international P&O standards, asshown here:

TRIm lInes5



4 Te polypropylene is cut o and the trim line contoursare ground and polished be ore temporary assembly othe KAFO or trial.

Assembly And PARAllelIsm6

4 Te side bars are temporarily xed on thepolypropylene shells with M3 screws andnuts.

Precise parallelism o the knee joint is o the utmost importance and must be ensured be ore the rstting as ollows:

4 m t o 1: Using a Vernier calliper


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InITIAl FITTIngs7

Manufacturing GuidelinesKnee-Ankle-Foot Orthosis

4 m t o 2: Using the centring pin

4 Strap the KAFO on the patients lower limb.

4 Check the trim lines be ore the patientstands up.

Once the shoes are on, the patient standsup and gait training can begin.



FInIshIng8

4 Te straps are xed with tubular rivets

4 Te trim lines are care ullypolished

4 Te uprights can be covered with neleather

4 Te parallelism o the knee joint ischecked again

4 Te uprights are xed with copperrivets


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KAFO OPTIOns9

Manufacturing GuidelinesKnee-Ankle-Foot Orthosis

4 Te KAFO is ready or delivery

4 Some patientsneed an ischialseat support.In this case thebrim has ananterior opening.Te shape issimilar to thato quadrilateral

socket prosthesis.

4 Te KAFO can betted with di erent

orthotic joints(Swiss lock, droplock, ree o set,etc.).



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 1

For 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

li t o co po t a at ria


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MISSION

The International Committee of the Red Cross (ICRC) is an impartial, neutral andindependent organization whose exclusively humanitarian mission is to protect thelives and dignity of victims of war and internal violence and to provide them withassistance. It directs and coordinates the international relief activities conductedby the Movement in situations of con ict. It also endeavours to prevent sufferingby promoting and strengthening humanitarian law and universal humanitarianprinciples. Established in 1863, the ICRC is at the origin of the International RedCross and Red Crescent Movement.

Acknowledgements:

Jean Franois GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard Matagne

Joel NiningerGuy NuryPeter Poet s maHmayak Tarakhchyan

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


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Prosthetics and Orthotics Manufacturing Guidelines: Lower limb Orthotics: Knee-Ankle-Foot-Orthosis

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