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Frossard, Laurent A.(2014)Are bone-anchored prostheses about to revolutionise the world of pros-thetics? InAustralian Orthotic Prosthetic Association (AOPA) Congress, 2014-10-09- 2014-10-10.
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Are bone-anchored prostheses about to revolutionise the world of prosthetics?
2014 AOPA Congress Page 1 of 5
ARE BONE-ANCHORED PROSTHESES ABOUT TO REVOLUTIONISE
THE WORLD OF PROSTHETICS?
Frossard Laurent (1,2, 3)
(1)
Queensland University of Technology, Brisbane, Australia (2)
University of the Sunshine Coast, Maroochydore, Australia (3)
Marie-Enfant Rehabilitation Center, Canada
Frossard L. Are bone-anchored prostheses about to revolutionise the world of prosthetics?
Australian Orthotic Prosthetic Association (AOPA) Congress. 2014. Melbourne, Australia.
p 2
Biography
Dr Laurent Frossard is currently an adjunct
Professor of Biomechanics at the QUT and
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 100 publications,
multiple grants, several supervisions of
postgraduate students and international
collaborations.
Abstract Individuals with limb amputation fitted with
conventional socket-suspended prostheses
often experience socket related discomfort
leading to a significant decrease in quality of
life. Most of these concerns can be
overcome by surgical techniques enabling
bone-anchored prostheses. In this case, the
prosthesis is attached directly to the residual
skeleton through a percutaneous implant.[1, 2]
The primary aim of this study is to present
the current advances in these surgical
techniques worldwide with a strong focus on
the developments in Australia. The
secondary aim is to provide an overview of
the possible critical changes that may
occurred in the world of prosthetic following
these developments in bone-anchored
prostheses.
The current advances will be extracted from
a systematic literature review including
approximately 40 articles. The outcomes
measured will include the estimation of the
population worldwide as well as the
complications (e.g., infection, loosening,
fractures, breakage) and the benefits (e.g.,
functional outcomes, health-related quality
of life).[3-20]
The population of individuals fitted with a
bone-anchored prosthesis is approximately
500 worldwide. Publications focusing on
infection are sparse. However, superficial
infections are common (80%) while the rate
of deep infection is estimated between 6 to
20%. Loosening and preprosthetic fractures
are fairly uncommon. Breakage of
percutaneous parts occurs regularly mainly
due to fall. All studies reported a significant
improvement in functional level and overall
quality of life.
Several commercial implants are in
developments in Europe and US.[21-28]
The
number of procedures is consistently
growing worldwide. This technique might be
primary way to fit a prosthesis to young and
Are bone-anchored prostheses about to revolutionise the world of prosthetics?
2014 AOPA Congress Page 2 of 5
active amputees by 2025. Interestingly,
Australia is currently on the leading country
worldwide in terms of range of procedures
and level of amputation, choice of implants,
rapid population growth, developments of
governmental reimbursement schemes, etc.
These developments in bone-anchored
prostheses could be potentially a game
changer in the field of prosthetics. The
fitting requirement (e.g., fall prevention) is
challenging the use of K-level
classification.[9, 10, 13, 14, 17, 20, 29-40]
It is
unclear, if the bottom line of prosthetists
would be affected due to the lack of socket
manufacturing. However, clearly prosthetists
could play in key role in referral and follow
up on patients, particularly in safe fitting of
the prosthesis[34]
, replacement of
percutaneous parts and prevention of
superficial and deep infection.
References 1. Branemark, R., P.I. Branemark, B.
Rydevik, and R.R. Myers,
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2. Aschoff, H.H., R.E. Kennon, J.M.
Keggi, and L.E. Rubin,
Transcutaneous, distal femoral,
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the-knee prostheses: an endo-exo
device. J Bone Joint Surg Am, 2010.
92 Suppl 2(Supplement 2): p. 180-6.
3. Hagberg, K., E. Hansson, and R.
Brånemark, Outcome of
percutaneous osseointegrated
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4. Tsikandylakis, G., O. Berlin, and R.
Branemark, Implant Survival,
Adverse Events, and Bone
Remodeling of Osseointegrated
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Orthop Relat Res, 2014: p. 1-10.
5. Branemark, R., O. Berlin, K.
Hagberg, P. Bergh, B. Gunterberg,
and B. Rydevik, A novel
osseointegrated percutaneous
prosthetic system for the treatment of
patients with transfemoral
amputation: A prospective study of
51 patients. Bone Joint J, 2014.
96(1): p. 106-113.
6. Van de Meent, H., M.T. Hopman,
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9. Frossard, L., N. Stevenson, J.
Smeathers, D. Lee Gow, S. Gray, J.
Sullivan, C. Daniel, E. Häggström,
K. Hagberg, and R. Brånemark,
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Are bone-anchored prostheses about to revolutionise the world of prosthetics?
2014 AOPA Congress Page 3 of 5
10. 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
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22(1): p. 11-20.
11. Hagberg, K., R. Branemark, B.
Gunterberg, and B. Rydevik,
Osseointegrated trans-femoral
amputation prostheses: Prospective
results of general and condition-
specific quality of life in 18 patients
at 2-year follow-up. Prosthetics and
Orthotics International, 2008. 32(1):
p. 29 - 41.
12. Hagberg, K. and R. Branemark, One
hundred patients treated with
osseointegrated transfemoral
amputation prostheses-rehabilitation
perspective. J Rehabil Res Dev,
2009. 46(3): p. 331-44.
13. 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.
14. 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.
Prosthet Orthot Int, 2008. 32(1): p.
68-78.
15. Hagberg, K., E. Haggstrom, M.
Uden, and R. Branemark, Socket
versus bone-anchored trans-femoral
prostheses: hip range of motion and
sitting comfort. Prosthet Orthot Int,
2005. 29(2): p. 153-163.
16. 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.
17. 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.
18. Nebergall, A., C. Bragdon, A.
Antonellis, J. Karrholm, R.
Branemark, and H. Malchau, Stable
fixation of an osseointegated implant
system for above-the-knee amputees:
titel RSA and radiographic
evaluation of migration and bone
remodeling in 55 cases. Acta Orthop,
2012. 83(2): p. 121-8.
19. Tillander, J., K. Hagberg, L.
Hagberg, and R. Branemark,
Osseointegrated titanium implants
for limb prostheses attachments:
infectious complications. Clin
Orthop Relat Res, 2010. 468(10): p.
2781-8.
20. 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.
21. 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 (SBIP) seeded with
Are bone-anchored prostheses about to revolutionise the world of prosthetics?
2014 AOPA Congress Page 4 of 5
autologous fibroblasts induced into
osteoblast differentiation for direct
skeletal attachment of limb
prostheses. Journal of Biomedical
Materials Research Part A, 2013: p.
n/a-n/a.
22. 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.
23. Holt, B.M., K.N. Bachus, J.P. Beck,
R.D. Bloebaum, and S. Jeyapalina,
Immediate post-implantation skin
immobilization decreases skin
regression around percutaneous
osseointegrated prosthetic implant
systems. J Biomed Mater Res A,
2013. 101(7): p. 2075-82.
24. Jeyapalina, S., J.P. Beck, R.D.
Bloebaum, and K.N. Bachus,
Progression of Bone Ingrowth and
Attachment Strength for Stability of
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2013: p. 1-9.
25. Shelton, T.J., J.P. Beck, R.D.
Bloebaum, and K.N. Bachus,
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model. J Biomech, 2011. 44(15): p.
2601-6.
26. 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.
27. 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.
28. 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.
29. 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,
2014. In press.
30. Dumas, R., L. Cheze, and L.
Frossard, Loading applied on
prosthetic knee of transfemoral
amputee: comparison of inverse
dynamics and direct measurements.
Gait Posture, 2009. 30(4): p. 560-2.
31. Lee, W.C., J.M. Doocey, R.
Branemark, C.J. Adam, J.H. Evans,
M.J. Pearcy, and L.A. Frossard, FE
stress analysis of the interface
between the bone and an
osseointegrated implant for
amputees--implications to refine the
rehabilitation program. Clin Biomech
(Bristol, Avon), 2008. 23(10): p.
1243-50.
32. Frossard, L., J. Beck, M. Dillon, M.
Chappell, and J.H. Evans,
Development and preliminary testing
of a device for the direct
measurement of forces and moments
in the prosthetic limb of transfemoral
amputees during activities of daily
living. Journal of Prosthetics and
Orthotics, 2003. 15(4): p. 135-142.
33. 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
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2014 AOPA Congress Page 5 of 5
walking. Med Eng Phys, 2008. 30(7):
p. 825-833.
34. Frossard, L., E. Haggstrom, K.
Hagberg, and P. Branemark, Load
applied on a bone-anchored
transfemoral prosthesis:
characterisation of prosthetic
components – A case study Journal
of Rehabilitation Research &
Development, 2013. 50(5): p. 619–
634.
35. Frossard, L., L. Cheze, and R.
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hip joint moments, power and work
on the prosthetic limb of
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Sullivan, M. Uden, and M. Pearcy,
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23(1): p. 2-11.
37. Frossard, L.A., Load on
osseointegrated fixation of a
transfemoral amputee during a fall:
Determination of the time and
duration of descent. Prosthet Orthot
Int, 2010. 34(4): p. 472-87.
38. 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.
39. Helgason, B., H. Palsson, T.P.
Runarsson, L. Frossard, and M.
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Trans Neural Syst Rehabil Eng,
2009. 17(1): p. 9-14.
1
Laurent Frossard (1, 2, 3)
Are bone-anchored prostheses about to revolutionise the world of prosthetics?
Melbourne, Australia –10/10/2014
AOPA Congress 2014
(1) University of the Sunshine Coast, Autralia
(2) Queensland University of Technology, Australia
(3) Marie-Enfant Rehabilitation Center, Canada
http://www.chalmers.se/en/news/Pages/Thought-controlled-prosthesis-is-changing-the-lives-of-amputees.aspx
Are bone-anchored prostheses about to revolutionise the world of prosthetics?
ePrin
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Context
Socket
Attachment
Socket
Socket
Context
Attachment
FixationSocket
Fixation
ePrin
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3
ITAP
Commercial fixationsIntegral Leg Prosthesis Orthodynamics Pty Ltd
UKILP
Dr Horst Aschoff
Lunow, C., K. Staubach, and H. Aschoff, [Endo-exo Femoral Prosthesis]. Zeitschrift Der Unfallchirug, 2010.
OLP
ITAP
Commercial fixations
Dr Munjed Al Muderis
Osseointegrated Prosthesis Limb Med-Italia Biomedica SRL, Italy
Sydney, Australia
http://www.osseointegrationaustralia.com.au/ePrin
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ILP/OPL
ITAP
Commercial fixationsOsseointegrated Prosthesis for Rehabilitation of
Amputees Integrum AB
SwedenOPRA
Dr Rickard Branemark
http://opraosseointegration.com/
ILP/OPL
ITAP
Commercial fixations
Nebergall, A., C. Bragdon, A. Antonellis, J. Kärrholm, R. Brånemark, and H. Malchau, Stable fixation of an osseointegated implant system for above-the-knee amputees. Acta Orthopaedica, 2012. 83(2): p. 121-128
OPRA
X-rays
ePrin
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5
ILP/OPL
ITAP
Commercial fixations
OPRA
Residuum post-op
OPRA
ILP/OPL
ITAP
Commercial fixations
Overview
ILP OPL OPRA
Interface fixation - bone Press-fit Press-fit Screw
ePrin
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6
OPRA
ILP/OPL
ITAP
Commercial fixations
Overview
ILP OPL OPRA
Interface fixation - bone Press-fit Press-fit Screw
Nb of surgeries 2 2 2
Stage 1
Stage 2
OPRA
ILP/OPL
ITAP
Commercial fixations
Overview
ILP OPL OPRA
Interface fixation - bone Press-fit Press-fit Screw
Nb of surgeries 2 2 –> 1 2
Stage 1
Stage 2
ePrin
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7
OPRA
ILP/OPL
ITAP
Commercial fixations
Overview
ILP OPL OPRA
Interface fixation - bone Press-fit Press-fit Screw
Nb of surgeries 2 2 2
Duration rehabilitation * 4 mth 4 mth 9-12 mth
* Estimation
Stage 1
Stage 2
2 months
OPRA
ILP/OPL
ITAP
Commercial fixations
Overview
ILP OPL OPRA
Interface fixation - bone Press-fit Press-fit Screw
Nb of surgeries 2 2 2
Duration rehabilitation * 4 mth 4 mth 9-12 mth
* Estimation
Stage 1
Stage 2
6 months
ePrin
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OPRA
ILP/OPL
ITAP
Commercial fixations
Overview
ILP OPL OPRA
Interface fixation - bone Press-fit Press-fit Screw
Nb of surgeries 2 2 2
Duration rehabilitation * 4 mth 4 mth 9-12 mth
Nb of years since first S1 * 8 2 15
* Estimation
OPRA
ILP/OPL
ITAP
Commercial fixations
Overview
ILP OPL OPRA
Interface fixation - bone Press-fit Press-fit Screw
Nb of surgeries 2 2 2
Duration rehabilitation * 4 mth 4 mth 9-12 mth
Nb of years since first S1 * 8 2 15
Nb of patients *100 80
500180
* Estimation
Most published and acknowledged
ePrin
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Hagberg, K. and R. Branemark, One hundred patients treated with osseointegrated transfemoral amputation prostheses--rehabilitation perspective. J Rehabil Res Dev, 2009. 46(3): p. 331-44.
Screening -6 mth0 12 186
Exclusion criteria
Pre-op
Treatment with OPRA
• Diabetes• Smoking• Severe vascular disease• Peripheral vascular disease• Growing skeleton • Severe learning disability• Lack of compliance• Chemotherapy treatment• Inability to adhere program / pregnancy• Arteriosclerosis• Mental illness
Treatment with OPRA
Hagberg, K. and R. Branemark, One hundred patients treated with osseointegrated transfemoral amputation prostheses--rehabilitation perspective. J Rehabil Res Dev, 2009. 46(3): p. 331-44.
Screening -6 mth0 12 186
Pre-op
Inclusion criteria
• Socket-related problems• Inability to use a conventional prosthesis• Use of prosthesis limited significantly• Short residual limb• Dimension of residual bone• Quality of residual bone• Bilateral amputation• Understanding the risks of complications• Willing to comply with treatment protocol• Following the rehabilitation protocol• Acceptance of disability
K0 to K2
ePrin
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Screening
Treatment with OPRA
Surgery
-6 mth0 12 186
Residuum pre-op
Screening
Treatment with OPRA
Surgery
-6 mth0 12 186
Stage 1 – Insertion medullar part
ePrin
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Screening
Treatment with OPRA
Surgery
-6 mth0 12 186
Stage 2 – Insertion percutaneous parts
Screening
Surgery
Treatment with OPRA
Vertriest S, Coorevits P, Brånemark R, Hagberg K, Brånemark R, Vanderstraeten G, Frossard L. Static load bearing exercises of individuals with transfemoral amputation fitted with an osseointegrated implant: Reliability of kinetic data. IEEE Transactions on Neural Systems and Rehabilitation Engineering. 2014. Accepted minor revisions.
Rehab
-6 mth0 12 186
Load bearing exercises
Bone remodelling =
Right load +
Right time
ePrin
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Screening
Surgery
Treatment with OPRA
Frossard, L., D.L. Gow, K. Hagberg, N. Cairns, B. Contoyannis, S. Gray, R. Brånemark, 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 and Posture, 2010. 31(2): p. 223-228
Rehab
-6 mth0 12 186
Load bearing exercises - Static
Screening
Surgery
Treatment with OPRA
Hagberg, K. and R. Brånemark, One hundred patients treated with osseointegrated transfemoral amputation prostheses - the rehabilitation perspective. Journal of Rehabilitation Research & Development, 2009. 43(3): p. 331-344
Rehab
-6 mth0 12 186
Load bearing exercises - Dynamic
ePrin
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Screening
Surgery
Treatment with OPRA
Rehab
-6 mth0 12 186
Walking aids
Frossard, L., K. Hagberg, E. Haggstrom, and R. Branemark, Load-relief of walking aids on osseointegrated fixation: instrument for evidence-based practice. NSRE, IEEE Transactions on, 2009. 17(1): p. 9-14
Rehab
Screening
Surgery
Treatment with OPRA
-6 mth0 12 186
Choice of components
Frossard, L., E. Haggstrom, K. Hagberg, and P. Branemark, Load applied on a bone-anchored transfemoral prosthesis: characterisation of prosthetic components – A case study Journal of Rehabilitation Research & Development, 2013. 50(5): p. 619–634.
Fitting
ePrin
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Benefits
Branemark, R., O. Berlin, K. Hagberg, P. Bergh, B. Gunterberg, and B. Rydevik, A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J, 2014. 96(1): p. 106-113. Errata : Haddad, Bone Joint J: 2014, 96-B 106-113
Benefits
Health-related quality of life: SF 36
Branemark, R., O. Berlin, K. Hagberg, P. Bergh, B. Gunterberg, and B. Rydevik, A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J, 2014. 96(1): p. 106-113. Errata : Haddad, Bone Joint J: 2014, 96-B 106-113
Benefits
BenefitsHealth-related quality of life: SF 36
ePrin
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Benefits
Benefits
Branemark, R., O. Berlin, K. Hagberg, P. Bergh, B. Gunterberg, and B. Rydevik, A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J, 2014. 96(1): p. 106-113.
Health-related quality of life: Q-TFA
Benefits
Benefits
Branemark, R., O. Berlin, K. Hagberg, P. Bergh, B. Gunterberg, and B. Rydevik, A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J, 2014. 96(1): p. 106-113.
Health-related quality of life: Q-TFA
ePrin
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Benefits
BenefitsSitting
http://www.sahlgrenska.se/su/osseointegrationhttp://osseointeg.ning.com/profile/ErikAx
Benefits
Benefits
Lundberg, M., K. Hagberg, and J. Bullington, My prosthesis as a part of me: a qualitative analysis of living with an osseointegrated prosthetic limb. Prosthetics and Orthotics International, 2011. 35(2): p. 207-214
Body representationN=13
‘‘ The prosthesis (OI-prosthesis) is a part of me since it works so well, and you don’t have to think that it’s a problem and that it should be hard and so forth . . . it’s more like a substitute, my ¨pretend leg ¨ ’’
http://news.bme.com/tag/amputation/
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Benefits
Benefits
Hagberg, K., E. Häggström, S. Jönsson, B. Rydevik, and R. Brånemark, Osseoperception and Osseointegrated Prosthetic Limbs, P. Gallagher, D. Desmond, and M. MacLachlan, Editors. 2008, Springer London. p. 131-140
Osseoperception
Benefits
Benefits
Hagberg, K., E. Häggström, S. Jönsson, B. Rydevik, and R. Brånemark, Osseoperception and Osseointegrated Prosthetic Limbs, P. Gallagher, D. Desmond, and M. MacLachlan, Editors. 2008, Springer London. p. 131-140
Doning and doffing
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Benefits
BenefitsHip range of movement
http://osseointeg.ning.com/profile/ErikAx
Tranberg, R., R. Zügner, and J. Kärrholm, Improvements in hip- and pelvic motion for patients with osseointegrated trans-femoral
prostheses. Gait & Posture, 2011. 33(2): p. 165-168
N=19 N=57
Benefits
Benefits
Frossard, L., K. Hagberg, E. Haggstrom, D. Lee Gow, R. Branemark, and M. Pearcy, Functional outcome of transfemoral amputees fitted with an osseointegrated fixation: Temporal gait characteristics. Journal of Prosthetics and Orthotics, 2010. 22(1): p. 11-20
Walking abilities and functional outcomes
N=12
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Risks
Infections
Risks
[1] Tillander, J., K. Hagberg, L. Hagberg, and R. Branemark, Osseointegrated Titanium Implants for Limb Prostheses Attachments: Infectious Complications. Clinical Orthopaedic Related Research, 2010. 468(10): p. 2781-2788
[2] Branemark, R., O. Berlin, K. Hagberg, P. Bergh, B. Gunterberg, and B. Rydevik, A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J, 2014. 96(1): p. 106-113.
Overview - Deep infectionsInclusion Follow-up
(2-3 yrs) (S2-2 yrs)
Reference [1] [2] [1] [2]
Number of participants in study 39 51 39 51
Definite implant infection / Deep implant infection 5% 11% 15% 6%
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Risks
[1] Tillander, J., K. Hagberg, L. Hagberg, and R. Branemark, Osseointegrated Titanium Implants for Limb Prostheses Attachments: Infectious Complications. Clinical Orthopaedic Related Research, 2010. 468(10): p. 2781-2788
[2] Branemark, R., O. Berlin, K. Hagberg, P. Bergh, B. Gunterberg, and B. Rydevik, A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J, 2014. 96(1): p. 106-113.
Infections Overview - Deep infectionsInclusion Follow-up
(2-3 yrs) (S2-2 yrs)
Reference [1] [2] [1] [2]
Number of participants in study 39 51 39 51
Definite implant infection / Deep implant infection 5% 11% 15% 6%
Short course of antibiotics
Risks
[1] Tillander, J., K. Hagberg, L. Hagberg, and R. Branemark, Osseointegrated Titanium Implants for Limb Prostheses Attachments: Infectious Complications. Clinical Orthopaedic Related Research, 2010. 468(10): p. 2781-2788
[2] Branemark, R., O. Berlin, K. Hagberg, P. Bergh, B. Gunterberg, and B. Rydevik, A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J, 2014. 96(1): p. 106-113.
Infections Overview – Superficial infectionsInclusion Follow-up
(2-3 yrs) (S2-2 yrs)
Reference [1] [2] [1] [2]
Number of participants in study 39 51 39 51
Local soft tissue infection in the skin penetration area / Superficial infection 17% 11% 29% 80%
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Risks
[1] Tillander, J., K. Hagberg, L. Hagberg, and R. Branemark, Osseointegrated Titanium Implants for Limb Prostheses Attachments: Infectious Complications. Clinical Orthopaedic Related Research, 2010. 468(10): p. 2781-2788
[2] Branemark, R., O. Berlin, K. Hagberg, P. Bergh, B. Gunterberg, and B. Rydevik, A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J, 2014. 96(1): p. 106-113.
Infections Overview – Superficial infectionsInclusion Follow-up
(2-3 yrs) (S2-2 yrs)
Reference [1] [2] [1] [2]
Number of participants in study 39 51 39 51
Local soft tissue infection in the skin penetration area / Superficial infection 17% 11% 29% 80%
Cleaning
Risks
Pitkin, M., On the way to total integration of prosthetic pylon with residuum. Journal of Rehabilitation Research & Development, 2009. 46(3): p. 345-360
Infections Discharge
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Infections
Risks
Thompson M. Mechanical analysis of osseointegrated transfemoral implant systems. 2009. Master Thesis. Queen’s University Kingston, Ontario, Canada
Breakage
Activity of daily living
High-impact activities / Falls
Breakage
Infections
RisksTitel RSA and radiographic
Nebergall, A., C. Bragdon, A. Antonellis, J. Kärrholm, R. Brånemark, and H. Malchau, Stable fixation of an osseointegated implant system for above-the-knee amputees. Acta Orthopaedica, 2012. 83(2): p. 121-128
Loosening
N=55
1, 2, 5, 7, 10 years post-op
Strong bonding
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Risks vs Benefits
Benefits Risks
Future developments
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Future developments
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.
ITAP, Stanmore Implant, UKFixation
NHS
Clinical trial
Future developments
http://www.healio.com/orthotics-prosthetics/prosthetics/news/online/%7Bbf5a0e16-eb8c-4e89-aa8b-0e2941bc31fb%7D/researcher-announces-plans-for-fda-study-of-osseointegrated-implants
University of Utah - Orthopaedics DepartmentFixation
FDA
Clinical trial
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TeamsFixation
Future developments
http://www.chalmers.se/en/news/Pages/Thought-controlled-prosthesis-is-changing-the-lives-of-amputees.aspx
Neuromuscular control of prosthesis
Focus
Focus
TeamsFixation
Future developments
Accessible to population with diabetes
Challenges
K. Ziegler-Graham, E. J. MacKenzie, P. L. Ephraim, T. G. Travison, and R. Brookmeyer, "Estimating the prevalence of limb loss in the United States: 2005 to 2050," Arch Phys Med Rehabil, vol. 89, pp. 422-9, Mar 2008.eP
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Focus
TeamsFixation
Future developments
High impact activities
Challenges
http://www.tulsaworld.com/
Focus
TeamsFixation
Future developments
Accessible to low income countries
Challenges
http://projecthopeinthefield.blogspot.ca/2010_04_01_archive.htmlePrin
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Focus
TeamsFixation
Future developments
Pediatric applications
Challenges
http://www.dailymail.co.uk/news/article-1160954/With-pairs-legs-I-feel-10-feet-tall-The-boy-7-doesnt-let-double-amputation-hold-back.html
Australia : leader worldwide
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Australia : leader worldwide
Clinical know-how
• 3rd largest population worldwide• largest population outside Europe
• Fastest growing population worldwide
OPRA500 cases15 years
≈33 cases/year
ILP/OPL80 cases2 years
≈40 cases/year
Population
Population
Australia : leader worldwide
Clinical know-how
Several world firsts
• Broadest range of case-mix
Case-mix
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Population
Case-mix
Australia : leader worldwide
Clinical know-how
• Only two countries where patients have 2 choices of implants
OPRA ILP OPL
• Only country where patients have 3 choices of implants
Choice
Population
Case-mix
Choice
Australia : leader worldwide
• State (QLD) looking at fair and equitable reimbursement scheme
Support government
15K for kit Otto Bock prosthesis
Support
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Population
Case-mix
Choice
Support
Australia : leader worldwide
Unique Clinical Outcome Registry=
Evidence-based treatment
Scientific expertise
Research
Population
Case-mix
Choice
Support
Research
Australia : leader worldwide
• Biggest demand is in Australia
Heat + sweat=
Poor socket fit =
Poor quality of life
Demand Patients
Clinical know-how
Support government
QLDNT
Demand
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Are bone-anchored prostheses about to revolutionise the world of prosthetics?
• BAP works!
• It is happening!
• It is happening now in Australia!
Just some thoughts!
Not yet!
Eligibility criteria
Exclusion
• Diabetes• Smoking• Severe vascular disease• Peripheral vascular disease• Growing skeleton
Safe
No major loss of incomeseP
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Soon, it might!
Eligibility criteria ChangeInclusion
• Diabetes• Smoking• Severe vascular disease• Peripheral vascular disease• Growing skeleton
Possible loss of incomes
Inclusion
Soon, it might!
• Revisiting the use of K-Levels for choice of componentso All patients = K4 regardless of
functional outcomes
• Manufacturing of purposely designed components (e.g., knee)o Larger ROMo Safer (e.g., fall)o Capitalising more on osseoperceptiono Better monitoring of ADL and usage
Developt
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Inclusion
Developt
Soon, it might!
• Before surgeryo Referral of patientso Participate to screening
• After surgeryo Fitting limb Minimise risks of fall Loading profile Fixing / Replacing fixation parts
o Primary care for infection prevention Diagnosis Treatment (e.g., Referral GP, surgeon)
CPO Role
Inclusion
Developt
Soon, it might!
• Assistance from supporting bodies:o E.g. QALS in QLD 23 hours $15K for componentsCPO Role
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Laurent Frossard (1, 2, 3)
Are bone-anchored prostheses about to revolutionise the world of prosthetics?
Melbourne, Australia –10/10/2014
AOPA Congress 2014
(1) University of the Sunshine Coast, Autralia
(2) Queensland University of Technology, Australia
(3) Marie-Enfant Rehabilitation Center, Canada
Website
www.YourResearchProject.com
www.laurentfrossard.com
www.ca.linkedin.com/pub/laurent-frossard/5/4b4/b59/
Google+
www.plus.google.com/#113083134851353167716/about
www.facebook.com/YourResearchProjectePrin
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