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