Cost and effectiveness of a
physiotherapist- manufactured
Temporary Prosthesis Program
Fitzsimons TR1, Jones ME2, Collins R3
1
Nepean Hospital, Sydney 2 Port Kembla Hospital, Wollongong
3 Prince of Wales Hospital, Sydney
Gerontology 736
Australian Physiotherapy Conference Week 2009
1 – 5 October 2009 Sydney Convention Centre
NATURE OF THE PROBLEM
Viability of the Temporary Prosthesis Program
was at risk
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Therapeutic Goods Administration
NSW Health Policy Directive
Paucity of documented evidence of costs and
outcomes
Patient population with many variables
EXTENT OF THE PROBLEM
 21,518 amputees in Australia, 57.41% TTA,
54% >60years, 43% circulatory (Rehabtech,
2000)
 Benefits of early prosthetic training (Wu et al
1979, Jones et al 2001)
 Interim prosthesis pilots in Newcastle and
Westmead
Longitudinal study
 Human Experimentation Ethics approval
at each of the six participating public
hospitals
 Two year longitudinal prospective study
of transtibial amputees in temporary
prosthesis program
AIM
The aim of this project was
to validate the cost, safety
and effectiveness of the
plaster temporary
prostheses manufactured by
physiotherapists in six
public hospitals from 2005
to 2007.
Informed Participants

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Transtibial amputees (n=42)
Average age 63.4 years
71.4% male
Etiology: peripheral vascular disease (48%), diabetes
(33%), trauma (10%), cancer (2%) and other (7%).
 Co-morbidities included cardiac, respiratory,
emotional and previous amputations.
 Pre-morbid independence was 94%, 77% with
walking aids
 Post operative complications reported were stump
breakdown in 26%, cardiac events in 11.9%.
Interventions – stump preparation
type
frequency
cost
Rigid
Dressings
4 (10%)
Removable
Rigid
Dressings
Stump
shrinker
Stump
bandaging
13 (42%)
$30
23 (55%)
$60
21 (50%)
$21
Intervention - Prosthetic Assembly
Plaster sockets made for this cohort n= 76
Intervention - Dynamic Alignment
 Biomechanical analysis and alterations
for


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Leg length
Ground force reaction in sagittal and
frontal planes
Heel and toe levers in respect to the
initial contact through loading
response
Heel and toe levers in respect to the
midstance through preswing phase of
gait
Location of the trochanter-knee-ankle
line for inherent knee stability
Intervention - Prosthetic Training
Mobility Milestones (days)
Ave
19.79
1st Mob Ind no
prosth
21.45
46.88
Count
29
29
25
35
30
Min
1
2
2
19
21
Max
362
365
365
197
409
SD
67.06
67.46
85.70
40.34
74.93
5
21
42
68
SOOB
Median 3
First
Temp
57.66
Ind with
prosth
85.1
Physiotherapy Treatments
IP acute
IP rehab
OP rehab Prosthetic
Ave
16.04
34.58
15.08
6.57
Count
24
26
37
28
Min
4
0
0
1
Max
53
111
35
26
SD
12.95
33.69
10.78
5.71
Median
11.5
29.5
15
5
Second Temporary and Definitive
2nd Temp
1st Definitive 2nd Definitive
Ave
187.2
224.24
386.31
Count
25
34
13
Min
28
59
173
Max
450
1379
1498
SD
94.07
231
352.57
median
79.5
126
252
Average cost to the patient
 21 days to start mobilising,
 42 days to begin prosthetic training with the temporary
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prosthesis,
68 days to become independently mobile with the
temporary prosthesis,
126 days to get the definitive prosthesis,
7 months of outpatient care,
11 months from amputation to discharge from the
Temporary Prosthesis Program.
Physiotherapy costs
 Occasions of service
 16 acute,
 34.6 rehabilitation inpatient,
 15 outpatient.
 Temporary prosthesis
 disposables and labor $200;
 all prosthetic components were re-usable due to
composition of stainless steel/ titanium and short
duration use. ($600 to $1000 if new components)
 average number of temporary sockets was 1.89 per
patient.
Prosthetic Costs
 7 prosthetist appointments.
 Definitive prosthesis costs ranged from $2891
to $3127 from the Artificial Limb Service.
 For those with
compensation claims,
high tech components
were provided by the
insurer.
Average Patient Outcomes:
 93% discharged home,
 84.6% walked independently,
 34.2% needed no walking aid
 walking velocity only slightly slower than
normal (18.7s/10m, range 4 - 60),
 59.5% ascended stairs with one rail.
Safety Outcomes
 Temporary prosthesis success in 94.2%,
 No need for definitive socket replacement
<6months (83%).
 socket abrasions (none),
 component failure (three with cracks in
plaster, no failure of prefabricated parts, all
grub screws monitored closely).
In Conclusion
Physiotherapist-manufactured
temporary prostheses were a safe
and cost effective means of
initiating prosthetic rehabilitation to
transtibial amputees.
Thank you . . .
for the first step in getting on with life.
TGA Australian Medical Devices
Guidance Document December 2008
 Manufacturer:


the person who assembles the device
Assigns its purpose by means of instructions for its use
 Medical Device is any instrument intended for:

Investigation, replacement or modification of the anatomy or
physiological process
 Custom made medical device means that it is


specifically made in accordance with a request by health
professional specifying design characteristics
Is intended to be used only in relation to a particular
individual
Custom Made Medical Device
Essential Principles Checklist
 Risk management
 Documentation of verification, compliance,
manufacturing records
 Labelling and Instructions for use
 Adverse event reporting
 Monitoring of product performance
 www.tga.gov.au