1. Cost and effectiveness of a physiotherapist- manufactured Temporary Prosthesis Program Fitzsimons TR 1, Jones ME 2, Collins R 3 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

2. 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

3. 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

4. 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

5. 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.

6. 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%.

7. Interventions – stump preparation typefrequencycost Rigid Dressings 4 (10%) Removable Rigid Dressings 13 (42%)$30 Stump shrinker 23 (55%)$60 Stump bandaging 21 (50%)$21

8. Intervention - Prosthetic Assembly Plaster sockets made for this cohort n= 76

9. 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

10. Intervention - Prosthetic Training

11. Mobility Milestones (days) SOOB1 st MobInd no prosth First Temp Ind with prosth Ave19.7921.4546.8857.6685.1 Count29 253530 Min1221921 Max362365 197409 SD67.0667.4685.7040.3474.93 Median35214268

12. Physiotherapy Treatments IP acuteIP rehabOP rehabProsthetic Ave16.0434.5815.086.57 Count24263728 Min4001 Max531113526 SD12.9533.6910.785.71 Median11.529.5155

13. Second Temporary and Definitive 2 nd Temp1 st Definitive2 nd Definitive Ave187.2224.24386.31 Count253413 Min2859173 Max45013791498 SD94.07231352.57 median79.5126252

14. 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.

15. 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.

16. 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.

17. 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.

18. 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).

19. In Conclusion Physiotherapist-manufactured temporary prostheses were a safe and cost effective means of initiating prosthetic rehabilitation to transtibial amputees.

20. Thank you... for the first step in getting on with life.

21. 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

22. 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