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Frossard, Laurent A., Merlo, Gregory, Quincey, Tanya, Berg, Debra, &Burkett, Brendan(2015)Cost-effectiveness of bone-anchored prosthesis: the Queensland experi-ence. InAustralian Orthotic Prosthetic Association (AOPA) Congress, 25 Septem-ber 2015, Adelaide, S.A.
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Cost-effectiveness of bone-anchored prosthesis: the Queensland experience
2015. Australian Orthotic Prosthetic Association (AOPA) Congress Page 1 of 4
Cost-effectiveness of bone-anchored prosthesis: the Queensland experience
Laurent Frossard(1,2)
, Gregory Merlo(1,3)
, Tanya Quincey(4)
, Debra Berg(4)
, Brendan Burkett(2)
(1)
Queensland University of Technology, Brisbane, QLD, Australia (2)
University of the Sunshine Coast, Maroochydore, QLD, Australia (3)
Australian Centre for Health Services and Innovation, QLD, Australia (4)
Queensland Health, Queensland Artificial Limb Service, QLD, Australia
Frossard L, Merlo G, Quincey T, Berg D, Burkett B. Cost-effectiveness of bone-anchored
prosthesis: the Queensland experience. Australian Orthotic Prosthetic Association (AOPA)
Congress. 2015. Adelaide, Australia. p 13
Biography
Dr Laurent Frossard is currently an
adjunct Professor of Biomechanics at the
Queensland University of Technology
(QUT) and University of Sunshine Coast
(USC) as well as the Chief Scientist Officer
at YourResearchProject. As project leader
and active researcher, his expertise in
Biomechanics relates to the development of
biomechanical tools and improvement of
basic knowledge of the locomotion and
rehabilitation of individuals with lower limb
loss fitted with osseointegrated implant and
socket. He is one of the very few
independent experts in the clinical benefits
of bone-anchorage prostheses. His academic
track record includes over 120 publications,
multiple grants, several supervisions of
postgraduate students and international
collaborations (More information:
www.LaurentFrossard.com)
Summary
Individuals with limb amputation
fitted with conventional socket-suspended
prostheses often experience socket-related
discomfort leading to a significant decrease
in quality of life. Bone-anchored prostheses
are increasingly acknowledged as viable
alternative method of attachment of artificial
limb. In this case, the prosthesis is attached
directly to the residual skeleton through a
percutaneous fixation.
To date, a few osseointegration
fixations are commercially available.
Several devices are at different stages of
development particularly in Europe and the
US. [1-15]
Clearly, surgical procedures are
currently blooming worldwide. Indeed,
Australia and Queensland, in particular,
have one of the fastest growing populations.
Previous studies involving either
screw-type implants or press-fit fixations for
bone-anchorage have focused on
biomechanics aspects as well as the clinical
benefits and safety of the procedure. [16-25]
In principle, bone-anchored
prostheses should eliminate lifetime
expenses associated with sockets and,
consequently, potentially alleviate the
financial burden of amputation for
governmental organizations.
Unfortunately, publications focusing
on cost-effectiveness are sparse. In fact,
only one study published by Haggstrom et al
(2012), reported that “despite significantly
fewer visits for prosthetic service the annual
mean costs for osseointegrated prostheses
were comparable with socket-suspended
prostheses”.[26]
Consequently, governmental
organizations such as Queensland Artificial
Limb Services (QALS) are facing a number
of challenges while adjusting financial
assistance schemes that should be fair and
Cost-effectiveness of bone-anchored prosthesis: the Queensland experience
2015. Australian Orthotic Prosthetic Association (AOPA) Congress Page 2 of 4
equitable to their clients fitted with bone-
anchored prostheses.
Clearly, more scientific evidence
extracted from governmental databases is
needed to further consolidate the analyses of
financial burden associated with both
methods of attachment (i.e., conventional
sockets prostheses, bone-anchored
prostheses).
The purpose of the presentation will be
to share the current outcomes of a cost-
analysis study lead by QALS. The specific
objectives will be:
To outline methodological avenues
to assess the cost-effectiveness of
bone-anchored prostheses compared
to conventional sockets prostheses,
To highlight the potential obstacles
and limitations in cost-effectiveness
analyses of bone-anchored
prostheses,
To present cohort results of a cost-
effectiveness (QALY vs cost)
including the determination of fair
Incremental cost-effectiveness
Ratios (ICER) as well as cost-
benefit analysis focusing on the
comparing costs and key outcome
indicators (e.g., QTFA, TUG,
6MWT, activities of daily living)
over QALS funding cycles for both
methods of attachment.
References
1. Kang, N.V., D. Morritt, C.
Pendegrass, and G. Blunn, Use of
ITAP implants for prosthetic
reconstruction of extra-oral
craniofacial defects. J Plast Reconstr
Aesthet Surg, 2013. 66(4): p. 497-
505.
2. Kang, N.V., C. Pendegrass, L.
Marks, and G. Blunn,
Osseocutaneous integration of an
intraosseous transcutaneous
amputation prosthesis implant used
for reconstruction of a transhumeral
amputee: Case report. The Journal of
Hand Surgery, 2010. 35(7): p. 1130-
1134.
3. Pendegrass, C., C. Fontaine, and G.
Blunn, Intraosseous transcutaneous
amputation prostheses vs dental
implants: a comparison between
keratinocyte and gingival epithelial
cell adhesion in vitro. Journal of
Bone & Joint Surgery, British
Volume, 2012. 94-B(SUPP
XXXVI): p. 10.
4. Aschoff, H.H., R.E. Kennon, J.M.
Keggi, and L.E. Rubin,
Transcutaneous, distal femoral,
intramedullary attachment for above-
the-knee prostheses: an endo-exo
device. J Bone Joint Surg Am, 2010.
92 Suppl 2(Supplement 2): p. 180-6.
5. Aschoff, H.-H. and R. McGough,
The Endo-Exo Femoral Prosthesis: a
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Bone & Joint Surgery, British
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XXXIX): p. 77.
6. Hillock, R., J. Keggi, R. Kennon, E.
McPherson, T. Clyburn, D. Brazil,
and T. McTighe, A Global
Collaboration - Osteointegration
Implant (OI) for Transfemoral
Amputation - Case Report.
Reconstructive review - Joint
Implant Surgery & Research
Foundation, 2013. 3(2): p. 50-54.
7. Rubin, L., L. Kennon, J. Keggi, and
H. Aschoff, Surgical management
of trans-femoral amputation with a
transcutaneous, press-fit distal
femoral intra-medullary device:
analysis with minimum 2 year
follow-up. Journal of Bone & Joint
Surgery, British Volume, 2012. 94-
B(SUPP XXI): p. 95.
8. Van de Meent, H., M.T. Hopman,
and J.P. Frolke, Walking ability and
Cost-effectiveness of bone-anchored prosthesis: the Queensland experience
2015. Australian Orthotic Prosthetic Association (AOPA) Congress Page 3 of 4
quality of life in subjects with
transfemoral amputation: a
comparison of osseointegration with
socket prostheses. Arch Phys Med
Rehabil, 2013. 94(11): p. 2174-2178.
9. Tomaszewski, P.K., B. Lasnier, G.
Hannink, G.J. Verkerke, and N.
Verdonschot, Experimental
assessment of a new direct fixation
implant for artificial limbs. J Mech
Behav Biomed Mater, 2013. 21: p.
77-85.
10. Tomaszewski, P.K., M. van Diest,
S.K. Bulstra, N. Verdonschot, and
G.J. Verkerke, Numerical analysis of
an osseointegrated prosthesis
fixation with reduced bone failure
risk and periprosthetic bone loss. J
Biomech, 2012. 45(11): p. 1875-80.
11. Tomaszewski, P.K., N. Verdonschot,
S.K. Bulstra, J.S. Rietman, and G.J.
Verkerke, Simulated bone
remodeling around two types of
osseointegrated implants for direct
fixation of upper-leg prostheses. J
Mech Behav Biomed Mater, 2012.
15(0): p. 167-75.
12. Tomaszewski, P.K., N. Verdonschot,
S.K. Bulstra, and G.J. Verkerke, A
New Osseointegrated Fixation
Implant for Amputated Patients.
Journal of Biomechanics, 2012.
45(0): p. S322.
13. Jeyapalina, S., J.P. Beck, K.N.
Bachus, O. Chalayon, and R.D.
Bloebaum, Radiographic Evaluation
of Bone Adaptation Adjacent to
Percutaneous Osseointegrated
Prostheses in a Sheep Model. Clin
Orthop Relat Res, 2014: p. 1-12.
14. Shelton, T.J., J.P. Beck, R.D.
Bloebaum, and K.N. Bachus,
Percutaneous osseointegrated
prostheses for amputees: Limb
compensation in a 12-month ovine
model. J Biomech, 2011. 44(15): p.
2601-6.
15. Shevtsov, M.A., O.V. Galibin, N.M.
Yudintceva, M.I. Blinova, G.P.
Pinaev, A.A. Ivanova, O.N.
Savchenko, D.N. Suslov, I.L.
Potokin, E. Pitkin, G. Raykhtsaum,
and M.R. Pitkin, Two-stage
implantation of the skin- and bone-
integrated pylon seeded with
autologous fibroblasts induced into
osteoblast differentiation for direct
skeletal attachment of limb
prostheses. J Biomed Mater Res A,
2014. 102(9): p. 3033-48.
16. Frossard, L., D.L. Gow, K. Hagberg,
N. Cairns, B. Contoyannis, S. Gray,
R. Branemark, and M. Pearcy,
Apparatus for monitoring load
bearing rehabilitation exercises of a
transfemoral amputee fitted with an
osseointegrated fixation: a proof-of-
concept study. Gait Posture, 2010.
31(2): p. 223-8.
17. Frossard, L., K. Hagberg, E.
Haggstrom, and R. Branemark,
Load-relief of walking aids on
osseointegrated fixation: instrument
for evidence-based practice. IEEE
Trans Neural Syst Rehabil Eng,
2009. 17(1): p. 9-14.
18. Frossard, L., K. Hagberg, E.
Häggström, D.L. Gow, R.
Brånemark, and M. Pearcy,
Functional Outcome of Transfemoral
Amputees Fitted With an
Osseointegrated Fixation: Temporal
Gait Characteristics. JPO Journal of
Prosthetics and Orthotics, 2010.
22(1): p. 11-20.
19. Frossard, L., N. Stevenson, J.
Smeathers, E. Haggstrom, K.
Hagberg, J. Sullivan, D. Ewins, D.L.
Gow, S. Gray, and R. Branemark,
Monitoring of the load regime
applied on the osseointegrated
fixation of a trans-femoral amputee:
a tool for evidence-based practice.
Cost-effectiveness of bone-anchored prosthesis: the Queensland experience
2015. Australian Orthotic Prosthetic Association (AOPA) Congress Page 4 of 4
Prosthet Orthot Int, 2008. 32(1): p.
68-78.
20. Frossard, L., N. Stevenson, J.
Smeathers, D. Lee Gow, S. Gray, J.
Sullivan, C. Daniel, E. Häggström,
K. Hagberg, and R. Brånemark,
Daily activities of a transfemoral
amputee fitted with osseointegrated
fixation: continuous recording of the
loading for an evidence-based
practice. Kinesitherapie Revue,
2006. 6(56-57): p. 53-62.
21. Frossard, L., R. Tranberg, E.
Haggstrom, M. Pearcy, and R.
Branemark, Fall of a transfemoral
amputee fitted with osseointegrated
fixation: loading impact on
residuum. Gait & Posture, 2009.
30(Supplement 2): p. S151-S152.
22. Frossard, L.A., R. Tranberg, E.
Haggstrom, M. Pearcy, and R.
Branemark, Load on osseointegrated
fixation of a transfemoral amputee
during a fall: loading, descent,
impact and recovery analysis.
Prosthet Orthot Int, 2010. 34(1): p.
85-97.
23. Lee, W., L. Frossard, K. Hagberg, E.
Haggstrom, and R. Brånemark,
Kinetics analysis of transfemoral
amputees fitted with osseointegrated
fixation performing common
activities of daily living. Clinical
Biomechanics, 2007. 22(6): p. 665-
673.
24. Lee, W.C., L.A. Frossard, K.
Hagberg, E. Haggstrom, D.L. Gow,
S. Gray, and R. Branemark,
Magnitude and variability of loading
on the osseointegrated implant of
transfemoral amputees during
walking. Med Eng Phys, 2008.
30(7): p. 825-833.
25. Vertriest, S., P. Coorevits, K.
Hagberg, R. Branemark, E.
Haggstrom, G. Vanderstraeten, and
L. Frossard, Static load bearing
exercises of individuals with
transfemoral amputation fitted with
an osseointegrated implant:
reliability of kinetic data. IEEE
Trans Neural Syst Rehabil Eng,
2015. 23(3): p. 423-30.
26. Haggstrom, E.E., E. Hansson, and K.
Hagberg, Comparison of prosthetic
costs and service between
osseointegrated and conventional
suspended transfemoral prostheses.
Prosthet Orthot Int, 2013. 37(2): p.
152-60.
Laurent Frossard (1,2), Gregory Merlo (1,3), Tanya Quincey (4), Debra Berg (4), Brendan Burkett (2)
Adelaide, Australia – 25/09/2015
(1) Queensland University of Technology, Brisbane, QLD, Australia
(2) University of the Sunshine Coast, Maroochydore, QLD, Australia
(3) Australian Centre for Health Services and Innovation
(4) Queensland Artificial Limb Service, QLD, Australia
Cost-effectiveness of bone-anchored prosthesis: the Queensland experience
www.LaurentFrossard.com
The Australian Orthotic Prosthetic Association (AOPA) Congress 2015
Background
[1] http://opraosseointegration.com/[2] Al Muderis et Al, ISPO-2012, Al Muderis et Al, Personal communication, 2015[3] Hillock et Al, Joint Implant Surgery & Research Foundation. 2013;3:50-54
Nearly ¼ of the population
worldwide live in Australia
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Background
[1] Al Muderis et Al, ISPO-2012, Al Muderis et Al, Personal communication, 2015
Background
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Funding organizations are facing a number of challenges while adjusting financial assistance
schemes that should be fair and equitable to their clients fitted with bone-anchored prostheses
Challenge
Government Insurance Etc…
State
Federal National Disability Insurance Scheme (NDIS) & DVA
Queensland Artificial Limb Services (QALS)QLD
WorkCover
Challenge
Queensland Artificial Limb Services (QALS)State QLD
Funding organizations are facing a number of challenges while adjusting financial assistance
schemes that should be fair and equitable to their clients fitted with bone-anchored prostheseseP
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Queensland Artificial Limb Services (QALS)
Challenge
Funding organizations are facing a number of challenges while adjusting financial assistance
schemes that should be fair and equitable to their clients fitted with bone-anchored prostheses
Queensland Artificial Limb Services (QALS)QLD2013
Research project
will
Cost-effectiveness analysis
Literature review
Haggstrom, E.E., E. Hansson, and K. Hagberg, Comparison of prosthetic costs and service between osseointegrated and conventional suspended transfemoral prostheses. Prosthet Orthot Int, 2013. 37(2): p. 152-60.
Cost-effectiveness analysis
2013
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Literature review
Cost-effectiveness analysis
Fewer QALYs
More QALYs
Higher cost
Lower cost
ICER2013
Literature review
Cost-effectiveness analysis
2013
Fewer QALYs
More QALYs
Higher cost
Lower cost
ICER
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Purpose
Cost-effectiveness analysis
2014
Fewer QALYs
More QALYs
Higher cost
Lower cost
ICER
Purpose
Cost-effectiveness analysis
2015
Fewer QALYs
More QALYs
Higher cost
Lower cost
ICER
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Methods – Participants - Selection
QALS clients N=2,700 between 1998 and 2015
TFA N=540 (20%)
TTA N=1,520 (57%)
OtherN=620 (23%)
Methods – Participants - Selection
QALS clients N=2,700 between 1998 and 2015
TFA N=540 (20%)
TTA N=1,520 (57%)
OtherN=620 (23%)
SocketN=522 (20%)
BAPN=12 (1%)
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Methods – Participants - Selection
QALS DVAN=4
QALS MixtN=2
QALS onlyN=6
QALS clients N=2,700 between 1998 and 2015
TFA N=540 (20%)
TTA N=1,520 (57%)
OtherN=620 (23%)
SocketN=522 (20%)
BAPN=12 (1%)
Methods – Participants - Selection
QALS DVAN=4
QALS MixtN=2
QALS onlyN=6
QALS clients N=2,700 between 1998 and 2015
TFA N=540 (20%)
TTA N=1,520 (57%)
OtherN=620 (23%)
SocketN=522 (20%)
BAPN=12 (1%)
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Methods – Participants - Selection
Clients with socket Clients with fixationQALS only
Secondary attachmentSocket before
Methods – Participants - Selection
�c
N = 12
Clients with socket Clients with fixation
N = 12
N = 16N = 16
N = 6 N = 6
N = 6
N = 0
N = 6
N = 0
QALS only
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Methods – Data collection
Clients with socket Clients with fixation
Y1 Date of last voucher
Y2 Y3 Y4 Y5 Y6
Y1 Y2 Y3 Y4 Y5 Y6Y1 Y2 Y3 Y4 Y5 Y6 S1
Y1 Y2 Y3 Y4 Y5 Y6S1
6 years 6 years
QALS only
11 12 13 14 15 16
11 12 13 14 15 16Y1 Y2 Y3 Y4 Y5 Y6
Methods – Data collection
Y1
Clients with socket Clients with fixation
Date of last voucher
Y2 Y3 Y4 Y5 Y6
S1
S1
6 years 2-3 years
QALS only
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Methods – Calculation ICER
Cost-utility analysis
Fewer QALYs
More QALYs
Higher cost
Lower cost
ICER
Methods – Calculation ICER - QALYs
Cost-utility analysis
Fewer QALYs
More QALYs
Higher cost
Lower cost
ICER
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Methods – Calculation ICER - QALYs
SF36
Mapping algorithm
EQ 5D
QALYs
Methods – Calculation ICER - Costs
Cost-utility analysis
Fewer QALYs
More QALYs
Higher cost
Lower cost
ICER
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Methods – Calculation ICER - Costs
Case 0
Methods – Calculation ICER - Costs
Case 0
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Methods – Calculation ICER - Costs
Methods – Calculation ICER - Costs
Cost with socket Cost with fixation
Y1 Y2 Y3 Y4 Y5 Y6
Y1 Y2 Y3 Y4 Y5 Y6Y1 Y2 Y3 Y4 Y5 Y6 S1
Y1 Y2 Y3 Y4 Y5 Y6S1
6 years 6 years
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Methods – Calculation ICER - Costs
Cost with socket Cost with fixation
Y1 Y2 Y3 Y4 Y5 Y6
Y1 Y2 Y3 Y4 Y5 Y6Y1 Y2 Y3 Y4 Y5 Y6 S1
Y1 Y2 Y3 Y4 Y5 Y6S1
6 years 6 years
Real
Methods – Calculation ICER - Costs
Cost with socket Cost with fixation
Y1 Y2 Y3 Y4 Y5 Y6
Y1 Y2 Y3 Y4 Y5 Y6Y1 Y2 Y3 Y4 Y5 Y6 S1
Y1 Y2 Y3 Y4 Y5 Y6S1
6 years 6 years
Real
Projected
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Methods – Calculation ICER - Costs
Cost with socket Cost with fixation
Y1 Y2 Y3 Y4 Y5 Y6
Y1 Y2 Y3 Y4 Y5 Y6Y1 Y2 Y3 Y4 Y5 Y6
Y1 Y2 Y3 Y4 Y5 Y6
6 years 6 years
Real
Projected
Accuracy
÷
=
Methods – Calculation ICER - Costs
Cost with socket Cost with fixation
Y1 Y2 Y3 Y4 Y5 Y6
Y1 Y2 Y3 Y4 Y5 Y6Y1 Y2 Y3 Y4 Y5 Y6
Y1 Y2 Y3 Y4 Y5 Y6
6 years 6 years
Real
Projected
+
=
1 Cycle
Total cost
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Methods – Calculation ICER - Costs
Cost with socket Cost with fixation
Y1 Y2 Y3 Y4 Y5 Y6
Y1 Y2 Y3 Y4 Y5 Y6Y1 Y2 Y3 Y4 Y5 Y6
Y1 Y2 Y3 Y4 Y5 Y6
12 years 12 years
Real
Projected
+
=
2 Cycles
Total cost
X
2
Results
$15K / cycle
1.71 years
ICER
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Discussion - Outcomes
$14,340
$8,587
$30,000
$0
$625
Discussion - Outcomes
$14,340
$8,587
$30,000
$0
$625
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Discussion - Limitation
• Small sample size
• Matched (N=6)More case series
than study!
Discussion - Limitation
• Small sample size
o Matched (N=6)• Moderate to low accuracy in cost estimation
o Timelineo Short history of surgery
• Sensibility of SF36 data o Immediate historyo Adverse eventseP
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Discussion – Future directions• For TFAs and TTAs
o Increase sample size o Monitoring up coming years (�accuracy)o Look at cost-benefits:
� Functional outcomes (TUG, 6MWT)� Activity of daily living (SenseWear)� Return to work
o Study ICER for OI as primary intervention
Most unlikely
Conclusion
Fewer QALYs
More QALYs
Higher cost
Lower cost
Likely
ICER
Very unlikely Likely
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AcknowledgmentsLaurent and Brendan would like to express their gratitude to :
• Debra Berg• Tanya Quincey
• Danielle Formosa• Barry Leech• Michele Mahoney• Luke Lorenzin• Munjed Al Muderis
Laurent Frossard (1,2), Gregory Merlo (1,3), Tanya Quincey (4), Debra Berg (4), Brendan Burkett (2)
Adelaide, Australia – 25/09/2015
(1) Queensland University of Technology, Brisbane, QLD, Australia
(2) University of the Sunshine Coast, Maroochydore, QLD, Australia
(3) Australian Centre for Health Services and Innovation
(4) Queensland Artificial Limb Service, QLD, Australia
Cost-effectiveness of bone-anchored prosthesis: the Queensland experience
www.LaurentFrossard.com
The Australian Orthotic Prosthetic Association (AOPA) Congress 2015eP
rint V
ers
ion