Prosthetics and Orthotics Manufacturing Guidelines: Lower Limb Prosthetics: Trans-Tibial Prosthesis

Manufacturing Guidelines
Trans-Tibial Prosthesis
200
0868/002 09/2006 Physical Rehabilitation Programme
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 Gallay
Leo Gasser
Pierre Gauthier
Frank Joumier
International Committee of the Red Cross Jacques Lepetit
19 Avenue de la Paix Bernard Matagne
1202 Geneva, Switzerland Joel Nininger
Guy Nury
T + 41 22 734 60 01 F + 41 22 733 20 57
Peter Poestma
E-mail: [email protected] Hmayak Tarakhchyan
www.icrc.org
© ICRC, September 2006 and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.
All photographs: ICRC/PRP
Table of contents
Foreword 2
Introduction 4
1. Raw materials and components 4
2. Measurements and soft socket manufacture 6
3. Trans-tibial cup alignment and socket manufacture 11
4. Building up the prosthesis and bench alignment 17
5. Polypropylene cosmetic manufacture 26
5.1 Cosmetic with upper part of socket removed 26
5.2 Cosmetic with complete PP socket 34
6. EVA cosmetic manufacture 41
Reference list of materials 46
Standard cuts of polypropylene sheets for lower-limb prostheses 48
Manufacturing Guidelines Trans-Tibial Prosthesis

Foreword
The ICRC polypropylene technology
Since its inception in 1979, the ICRC’s Physical Rehabilitation Programme has promoted the
use of technology that is appropriate to the specific contexts in which the organization operates,
i.e., countries affected by war and low-income or developing countries.
The technology must also be tailored to meet the needs of the physically disabled in the countries
concerned.
The technology adopted must therefore be:
• durable, comfortable, easy for patients to use and maintain;

• easy for technicians to learn, use and repair;
• standardized but compatible with the climate in different regions of the world;
• low-cost but modern and consistent with internationally accepted standards;
• easily available.
The choice of technology is of great importance for promoting sustainable physical rehabilitation
services.
For all these reasons, the ICRC preferred to develop its own technique instead of buying ready-made
orthopaedic components, which are generally too expensive and unsuited to the contexts in which
the organization works. The cost of the materials used in ICRC prosthetic and orthotic devices
is lower than that of the materials used in appliances assembled from commercial ready-made
components.
When the ICRC launched its physical rehabilitation programmes back in 1979, locally available
materials such as wood, leather and metal were used, and orthopaedic components were
manufactured locally. In the early 1990s the ICRC started the process of standardizing the
techniques used in its various projects around the world, for the sake of harmonization between the
projects, but more importantly to improve the quality of services to patients.
Polypropylene (PP) was introduced into ICRC projects in 1988 for the manufacture of prosthetic
sockets. The first polypropylene knee-joint was produced in Cambodia in 1991; other components
such as various alignment systems were first developed in Colombia and gradually improved. In
parallel, a durable foot, made initially of polypropylene and EthylVinylAcetate (EVA), and now of
polypropylene and polyurethane, replaced the traditional wooden/rubber foot.
In 1998, after careful consideration, it was decided to scale down local component production in
order to focus on patient care and training of personnel at country level.
ICRC Physical Rehabilitation Programme

Objective of the manuals
The ICRC’s “Manufacturing Guidelines” are designed to provide the information necessary for
production of high-quality assistive devices.
The main aims of these informative manuals are as follows:
• To promote and enhance standardization of ICRC polypropylene technology;

• To provide support for training in the use of this technology;
• To promote good practice.
This is another step forward in the effort to ensure that patients have access to high-quality services.
ICRC
Assistance Division/Health Unit
Physical Rehabilitation Programme

Introduction
The aim of this document is to describe a method for manufacturing trans-tibial (TT) prostheses
using the ICRC’s polypropylene technology as applied in ICRC projects worldwide.
The casting, rectification and alignment methods used correspond to international prosthetic and
orthotic (P&O) standards of practice and are therefore not described in these ICRC manufacturing
guidelines.
1 Raw materials and components
For short and medium stump, adult
The alignment system and foot components are available in adult and child sizes.
4Description:
1 Convex ankle
2 Two concave cylinders
3 Convex disc
4 Cylindrical TT cup
5 Flat steel washer and countersunk head bolt
6 Solid Ankle Cushion Heel (SACH) foot
7 Hexagonal head bolt and lock washer

For long stump
The alignment system and foot components are available only in adult size.
4Description:
1 Concave ankle
2 Convex disc
3 Cylindrical TT cup
4 Flat steel washer
5 Solid Ankle Cushion Heel (SACH) foot
6 Countersunk head M10 bolt and the lock

washer
Socket design
4PTB (patellar-tendon-bearing) socket secured with

a cuff suspension. The suspension can be adjusted.
In case of medio-lateral instability of the knee or

for a strong hyperextension, a thigh corset with
sidebars is suitable.
This can be made with or without a soft liner.

6PTB-SC (supra-condylar) 6PTB-SCSP (supra-condylar, supra-patellar)
Should be made with a soft liner. Must be made with a soft liner.
2 Measurements and soft socket manufacture
6The patient is assessed, a prescription is made, measurements are taken and moulding and
rectification are performed according to best P&O practice.

Soft liner manufacture
4Measure the plaster mould. Note the:

• smallest circumference;
• largest circumerence;
• length.
6Draw a trapezoid on a sheet of 6 mm EVA according to the measurements taken but adding 3 cm
to the length on the short side of the trapezoid.
Cut the EVA and skive the lateral and the distal sides (about 12 mm).

6Apply glue on both skived sides and form a cone. Keep the trimmed distal side on the outside of
the cone and leave it free of glue.
Apply talcum powder inside the cone and on the plaster model.
Thermoforming is done using the vacuum pump, on a vertical suction hose.
Heat the EVA cone in the oven at 120°C.

6Pull the EVA cone over the plaster mould, keeping the glued line on the posterior side, until the
trimmed distal side coincides with the tip of the plaster mould.
Cover the mould with a plastic bag, close it securely below the mould with an elastic strap and
switch on the vacuum pump.
4Allow the soft liner to cool down for few

minutes.
Remove the plastic bag.
Prepare a piece of 6 mm EVA to cover the

bottom edge.
Apply glue to the trimmed edge and the

cover cap.
Heat the cap in the oven and mould it on

the socket.
Cut off the extra EVA and grind till smooth.
Add padding above the medial condyle and

other areas if required.

4Cover the soft socket with a tubular
cotton stocking and glue.
4Prepare a sheet of 3 mm EVA to cover

the cotton.
Skive one side of the EVA, apply glue to

the entire surface of the EVA including
the skived side, and place it in the oven
at 120°C.
Cover the soft liner, starting from the

posterior side. Remove the excess EVA
and grind the posterior side and the
distal part till smooth.
10 ICRC Physical Rehabilitation Programme

4Lastly, cover the distal part with a
3 mm or 6 mm EVA “cap” and
grind till smooth.
3 Trans-tibial cup alignment and socket manufacture
4Grind the edge of the socket cup.
Manufacturing Guidelines Trans-Tibial Prosthesis 11

Alignment of the trans-tibial cup
4Fix the nail at the bottom of the mould, where the

cup will be attached.
Place the TT mould on the CR alignment jig;

align according to the instructions on the use of
the jig (separate manual). Perform the alignment
in accordance with the measurement card. Fix the
cup to the socket with plaster.
4From the middle of the

condyle, the plumb line
should pass about 1 cm
in front of the cup axis.

4When the plaster has set,
smooth it.
4Cover the soft liner with a nylon

or cotton stocking. Remove the
nylon covering the cup.
Manufacture of the socket (4 mm polypropylene)
Measurements
4Add 15 cm to the measurement

taken at patella level.

4Add 15 cm to the measurement
taken at the distal part.
4Add 15 cm to the measured

length of the socket.
4Fix a round piece of EVA

(12 + 6 mm) with a nail inside the
opening of the cup.

4Cut a sheet of 4 mm PP corresponding
to these measurements. Clean the PP
sheet and the Teflon in the oven with
thinner.
Put the PP in the oven at 180°C .
4Switch on the vacuum pump;

drape the PP around the socket.
Welding seam position:

• for PP cosmetic: lateral or medial
• for EVA cosmetic: posterior
Cut off the excess PP while it is

still hot.
Leave the vacuum on until the

PP cools down.

6Cut the PP according to the trim lines, remove the plaster without damaging the socket liner and
PP socket, and grind the welding seam down to 3 mm.
6Once the plaster is removed, use a screwdriver to remove the piece of EVA.
6Grind the distal part and check that the surface is flat.
For maximum strength, keep a minimum PP thickness of 2 to 3 mm under the cup.

4 Building up the prosthesis and bench alignment
Steps to follow:
• Ankle-foot build-up and alignment;

• Socket build-up;
• Adjustment of length and welding of concave cylinder butt;
• Final bench alignment.
6The foot, the convex ankle and the concave cylinder are attached together.
The window in the concave cylinder must be anterior.

Ankle-foot alignment
An extra 4 mm plate must be attached to the convex ankle. Drill two holes as shown on the
illustration below and fix the two components together with a PP welding rod. This will prevent
breakage of the foot bolt.
Components

Preparation before fixation
Attach the concave cylinder (with the opening in front) to the foot and the convex ankle.
The heel height is adjusted according to the patient’s shoe; the concave cylinder must be
perpendicular to the ground.
The foot has a heel height of 10 mm (maximum heel height: 15 to 20 mm).
• The ankle alignment system allows antero-posterior movements (flexion, extension).

• This alignment system is used to adjust the angulation of the prosthesis according
to heel height.
• In any event, the concave cylinder must remain perpendicular to the ground.

6The foot is adjusted in 5° to 8° 6Check the alignment once again
external rotations. with the patient’s shoe on the foot.
6The opening in the concave cylinder

6The socket is attached to the remains in front. The alignment
concave cylinder with the convex system is in neutral position for the
disc in between. first fitting.

4Adjust the length
according to the
measurements taken on
the patient.
Mark the concave cylinder

and saw off the excess.
Cut the concave cylinder at

an angle of 90°.
4Set the temperature of the

mirror welder between
185° and 200°C.
6Hold the concave cylinders on the mirror welder until a roll of melted PP forms.

6Carefully bring the cylinders together and apply slight pressure.
Concave cylinders correctly welded

Concave cylinders incorrectly welded
Socket alignment
The socket is connected to a concave cylinder with a convex disk in between. The connection is
secured by a countersunk head bolt and flat washer inside the socket, with the T-nut inside the
concave cylinder.
Shifting can occur in all directions: anterior, posterior, medial, lateral and combined movements,
with a range of 10 mm in all directions
Anterior shifting Initial position Posterior shifting

6The alignment system also allows flexion, extension, abduction, adduction and rotation.
6Bench alignment is performed according to P&O practice and adjusted during fitting and during
the gait training period.

6Before the cosmetic is made, all the components must be welded together.

5 Polypropylene cosmetic manufacture
There are two ways of manufacturing a PP cosmetic.
5.1 Cosmetic with upper part of socket removed
Adjustment of ankle part
6Draw a line following the shape of the foot, then disassemble the foot.

4Check your mark and grind it carefully.
Check once more against the foot.
4Stick adhesive tape on the foot and draw

a line with a permanent marker on the
top of the convex ankle and on the tape.
4Disassemble the foot and draw a line all

around the plate 4 mm from the edge. Minus
4 mm
Grind the edge carefully.

4Check again with the foot.
Weld the two plates together, first using the

welding iron to make a groove and then
welding with the hot-air welding gun.
Grind again carefully.
Manufacture of cosmetic shell
6Cut across the prosthesis below the level of the hamstring tendons and remove the upper part.
4Skive the PP edge carefully.

4Add plaster to shape the shank.
4Reduce the circumference of the shank

by 3 cm to allow for the thickness of the
4 mm PP sheet.
Smooth the plaster.
Leave the ankle edge free

of plaster for the final welding.
4Fix the 4 mm PP reinforcement plate at

the popliteal level with 2 nails.
4Draw a nylon or cotton stocking

over the plaster.
Add talcum powder.
Heat the 4 mm PP sheet in the oven

at 180° C.

4Glue or nail 5 mm PP under the
ankle plate to compensate for
retraction of the PP after opening.
6Drape the PP under vacuum.
6Cut off the excess PP at the welding seam. Keep the vacuum on until the plastic cools down.

4Grind the posterior seam down to
2 to 3 mm. In three places, leave a
wider overlap of PP for holding the
prosthesis during welding.
4Open the seam carefully with an

oscillating saw to avoid breakage.
6Remove the PP shell from the prosthesis and remove the plaster. Clean the prosthesis thoroughly
to ensure that no pieces of plaster remain. Put the prosthesis back into the shell.

4Hold the prosthesis in a
parallel vice with EVA
or rubber protection
between the vice jaws
and the cosmetic shell.
Close the two sides of
the posterior seam with
lock grips and/or other
suitable tools.
Before welding, make

V-shaped indentations
along the seam with a
welding iron.
4The final welding is

done with a hot-air
welding gun and a
4 mm PP welding rod.
4Weld the ankle to the

shell. After welding,
carefully flatten the
ankle surface.

4Polish with a rasp and/or a
sharp piece of glass.
4Attach the 4 mm PP
reinforcement to the shell
with tubular rivets.
The last step is to fix the foot on the prosthesis.

5.2 Cosmetic with complete PP socket


4Disassemble the foot and draw a line all

around the plate 3 mm from the edge. Minus
3 mm
Grind the edge carefully.

4Check again with the foot.
Once a good fit has been achieved, weld the

two plates together: first make a groove with
the welding iron and then weld with the
hot-air welding gun.
Grind again carefully.
4Roughen the surface of the socket.
4Cover the concave cylinders with adhesive

tape.

4Shape the shank with plaster.
4Draw a nylon or cotton stocking

over the prosthesis.
4Glue or nail 5 mm PP under

the ankle plate to compensate
for shrinkage of the PP after
thermoforming.

6Drape a sheet of 3 mm PP around the mould under vacuum.
4Grind the posterior seam down to

2 to 3 mm. In three places, leave a
wider overlap of PP for holding the
prosthesis during welding.
4Open the seam carefully with an

oscillating saw to avoid breakage.
4Remove the PP shell from the

prosthesis and remove the plaster.
Clean the prosthesis thoroughly
to ensure that no pieces of plaster
remain.

4Hold the prosthesis in a
parallel vice with EVA
or rubber protection
between the vice jaws
and the cosmetic shell.
Close the two sides of
the posterior seam with
lock grips and/or other
suitable tools.
Before welding, make

V-shaped indentations
along the seam with a
welding iron.
4The final welding is done

with a hot-air welding
gun and a 4 mm PP
welding rod.
4Weld the ankle to the shell.

After welding, carefully
flatten the ankle surface.

6Grind the seam down to 2 to 3 mm. Polish with a rasp or a piece of glass.
6Weld the proximal part of the prosthesis.
The last step is to fix the foot back on the prosthesis. Check the flatness of the ankle.

6 EVA cosmetic manufacture


4Dismantle the foot and draw a line all
around the plate, 3 mm from the edge.
4Grind the edge carefully.
4Roughen the surface of the socket.
For heavy patients, reinforce the concave

cylinders with a 3 mm PP sheet.

4Glue layers of EVA on the prosthesis.
4Shape to match the sound leg.
Leave the ankle plate free of EVA for the

final cosmetic.
Bear in mind the fact that an additional

layer of 3 mm EVA will cover the entire
prosthesis, and that this will increase
the circumference of the prosthesis by
about 1 cm. At this stage, check your
circumferences by comparing them with
the measurements noted on the patient’s
technical card, and reduce the size by
1 cm all over.

4Cut a sheet of 3 mm EVA according to the
circumferences measured, but longer than the
measurements.
Skive the side that will be glued on top of the

foot.
Skive one long side of the EVA sheet and apply

glue to that part.
Turn the EVA sheet over, and cover this

reverse side with glue.
4Apply glue to the entire prosthesis (except the

foot).
Heat the 3 mm EVA sheet in the oven at

120°C for a few seconds until it becomes very
flexible. Do not overheat the EVA or you may
accidentally make print marks on it during
manipulation.
Take the 3 mm EVA sheet out of the oven and

glue it over the prosthesis, starting by gluing
the skived edge along the posterior side of the
prosthesis.
4Then start gluing the 3 mm EVA sheet on the

prosthesis by revolving the prosthesis on it,
applying constant tension on the EVA to avoid
air bubbles and folds.

4The last step is to remove the excess EVA and
to grind the seam and the proximal trim line
of the prosthesis smoothly.

Reference list of materials
Components: Trans-tibial module, child
ICRC Code Description Specification Unit of Measure

Trans-tibial module, child
OCPOMODUTTC Countersunk head bolt M8 x 60 mm 1 piece
Flat washer, steel D40 x d10 x H2.5 mm 1 piece
Trans-tibial cup D70 x H26 mm 1 piece
Convex disc 1 piece
Concave cylinder with M8 T-nut dia. 22 mm 2 pieces
Convex ankle 1 piece
Weight per unit of measurement: 285 grams • Quantity per box: 25 sets • Box size: L40 x l30 x H44 cm
Components: Trans-tibial module, adult

Trans-tibial module, adult
OCPOMODUTTA Countersunk head bolt M10 x 60 mm 1 piece
Flat washer, steel D44 x d15 x H3 mm 1 piece
Convex disc 1 piece
Concave cylinder with T-nut M8 dia. 25 mm 2 pieces
Convex ankle 1 piece
Weight per unit of measurement: 490 grams • Quantity per box: 25 sets • Box size: L40 x l30 x H44 cm

Components: Trans-tibial module, long stump prosthesis

Trans-tibial module, long stump prosthesis
OCPOMODUTTLA Flat washer, steel D44 x d15 x H3 mm 1 piece
Convex disc 1 piece
Concave ankle 1 piece
Weight per unit of measurement: 130 grams • Quantity per packet: 1 piece
Components: Feet for prosthesis
ICRC Code Description Specification

Feet for prosthesis
OCPOFOOT... Foot 22 – 28 cm, left and right, Heel, 10 mm
olive and terra colours
When ordering feet from 22 to 28 cm, change the number in the ICRC code and description.
4With all the adult feet a M10 bolt and a M10 lock washer are included.
4Weight per unit: (size 25) 605 grams • Quantity per box: 25 pcs. • Box L40 x l30 x H44 cm
OCPOFOOT... Foot 14 -21 cm, left and right, Heel, 10 mm
olive and terra colours
When ordering feet from 14 to 21 cm, change the number in the ICRC code and description.
4With all child feet a M8 bolt and a M10 lock washer are included.
4Weight per unit: (size 19) 340 grams. • Quantity per packet: 1 pc.

PP, EVA and other consumables
Designation Used for

Materials
POP bandage 15 cm Cast-taking
POP powder Positive mould
Contact glue Soft socket
Soap (demoulding agent) Positive mould
Talcum powder Thermoforming
Vaseline Cast-taking
Nails Positive mould
Colorant for plaster Positive mould
Cotton/nylon stockinet dia. 8 or 10 cm Cast taking and soft socket
Cotton stockinet or sock Stump sock
Welding rod PP dia. 4 mm Welding components
Polypropylene 4 mm Hard socket
EVA 3 mm Soft socket
EVA 6 mm Soft socket
Polypropylene cosmetic
Polypropylene 3 or 4 mm Cosmetic shell
Welding rod dia. 4 mm Welding cosmetic shell
Plaster powder Cosmetic shape
Adhesive tape
Tubular rivets (2) Posterior reinforcement
EVA cosmetic
EVA 3 mm; 6 mm; 12 mm
Contact glue
Standard cuts of polypropylene sheets for lower-limb prostheses

Polypropylene sheet: 2000 mm x 1000 mm
Trans-tibial socket Trans-tibial cosmetic

4 mm 3 mm or 4 mm

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 Gallay
Leo Gasser
Pierre Gauthier
Frank Joumier
International Committee of the Red Cross Jacques Lepetit
19 Avenue de la Paix Bernard Matagne
1202 Geneva, Switzerland Joel Nininger
Guy Nury
T + 41 22 734 60 01 F + 41 22 733 20 57
Peter Poetsma
E-mail: [email protected] Hmayak Tarakhchyan
www.icrc.org
© ICRC, September 2006 and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.
All photographs: ICRC/PRP
Manufacturing Guidelines
Ankle-Foot Orthosis
200
0868/002 09/2006 Physical Rehabilitation Programme

Prosthetics and Orthotics Manufacturing Guidelines: Lower Limb Prosthetics: Trans-Tibial Prosthesis

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Manufacturing Guidelines

Manufacturing Guidelines Trans-Tibial Prosthesis 

The ICRC polypropylene technology

The technology adopted must therefore be:

• durable, comfortable, easy for patients to use and maintain;

 ICRC Physical Rehabilitation Programme

The main aims of these informative manuals are as follows:

• To promote and enhance standardization of ICRC polypropylene technology;

Manufacturing Guidelines Trans-Tibial Prosthesis 

1 Raw materials and components

For short and medium stump, adult

2 Two concave cylinders

5 Flat steel washer and countersunk head bolt

6 Solid Ankle Cushion Heel (SACH) foot

7 Hexagonal head bolt and lock washer

 ICRC Physical Rehabilitation Programme

4 Flat steel washer

5 Solid Ankle Cushion Heel (SACH) foot

6 Countersunk head M10 bolt and the lock

4PTB (patellar-tendon-bearing) socket secured with

In case of medio-lateral instability of the knee or

This can be made with or without a soft liner.

Manufacturing Guidelines Trans-Tibial Prosthesis 

2 Measurements and soft socket manufacture

 ICRC Physical Rehabilitation Programme

4Measure the plaster mould. Note the:

Manufacturing Guidelines Trans-Tibial Prosthesis 

Thermoforming is done using the vacuum pump, on a vertical suction hose.

Heat the EVA cone in the oven at 120°C.

 ICRC Physical Rehabilitation Programme

4Allow the soft liner to cool down for few

Remove the plastic bag.

Prepare a piece of 6 mm EVA to cover the

Apply glue to the trimmed edge and the

Heat the cap in the oven and mould it on

Cut off the extra EVA and grind till smooth.

Add padding above the medial condyle and

Manufacturing Guidelines Trans-Tibial Prosthesis 

4Prepare a sheet of 3 mm EVA to cover

Skive one side of the EVA, apply glue to

Cover the soft liner, starting from the

10 ICRC Physical Rehabilitation Programme

3 Trans-tibial cup alignment and socket manufacture

4Grind the edge of the socket cup.

Manufacturing Guidelines Trans-Tibial Prosthesis 11

4Fix the nail at the bottom of the mould, where the

Place the TT mould on the CR alignment jig;

4From the middle of the

12 ICRC Physical Rehabilitation Programme

4Cover the soft liner with a nylon

Manufacture of the socket (4 mm polypropylene)

4Add 15 cm to the measurement

Manufacturing Guidelines Trans-Tibial Prosthesis 13

4Add 15 cm to the measured

4Fix a round piece of EVA

14 ICRC Physical Rehabilitation Programme

Put the PP in the oven at 180°C .

4Switch on the vacuum pump;

Welding seam position:

Manufacturing Guidelines Trans-Tibial Prosthesis

ICRC Physical Rehabilitation Programme

Manufacturing Guidelines Trans-Tibial Prosthesis

ICRC Physical Rehabilitation Programme

Manufacturing Guidelines Trans-Tibial Prosthesis

ICRC Physical Rehabilitation Programme

Manufacturing Guidelines Trans-Tibial Prosthesis

ICRC Physical Rehabilitation Programme

Manufacturing Guidelines Trans-Tibial Prosthesis