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Cost and effectiveness of a physiotherapist- manufactured Temporary Prosthesis Program
Fitzsimons TR1, Jones ME2, Collins R3
1 Nepean Hospital, Sydney 2 Port Kembla Hospital, Wollongong3 Prince of Wales Hospital, Sydney
Gerontology 736Australian Physiotherapy Conference Week 20091 – 5 October 2009 Sydney Convention Centre
NATURE OF THE PROBLEM
Viability of the Temporary Prosthesis Program was at risk 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
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
13 (42%) $30
Stump shrinker
23 (55%) $60
Stump bandaging
21 (50%) $21
Intervention - Prosthetic Assembly
Plaster sockets made for this cohort n= 76
Intervention - Dynamic Alignment
Biomechanical analysis and alterations for
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)
SOOB 1st Mob Ind no prosth
First Temp
Ind with prosth
Ave 19.79 21.45 46.88 57.66 85.1
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
Median 3 5 21 42 68
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
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