This may be the author s version of a work that was submitted/accepted for publication in the following source:

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This may be the author’s version of a work that was submitted/accepted for publication in the following source:

Frossard, Laurent A.

(2015)

Bone-anchored prosthesis: Current developments worldwide and chal-lenges.

XV World Congress of the International Society for Prosthetics and Or-thotics (ISPO), 2015.

[Article]

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Bone-anchored prosthesis: current developments worldwide and challenges

2015. XV World Congress of the ISPO, Lyon Page 1 of 7

ISPO 2015, Lyon, France

Scientific Symposium on

Bone-anchored prosthesis: update in international developments

Chairman: Adj/Prof Laurent Frossard (PhD)

Queensland University of Technology, Brisbane, QLD, Australia University of the Sunshine Coast, Maroochydore, QLD, Australia

Speaker Title

1-Frossard, L [1-38] Bone-anchored prosthesis: current developments worldwide and challenges

2-Pitkin, M [39-50] Design features of the implants for direct skeletal attachment addressing anisotropy of tissues regeneration

3-Hagberg, K [5-10, 16, 18, 19, 51-62] Rehabilitation outcome for patients treated with the OPRA system in Sweden

4-Bachus, K [63-71] Osseointegration pathway in the United States

5-Van De Meent, H [72, 73] Rehabilitation outcome of osseo-integrated prosthesis compared to socket prosthesis for lower limb amputees-The Deutch experience

6-Al Muderis, M [32-36, 74-76] Innovation of the Osseointegration Group of Australia Accelerated Protocol (OGAAP)

Presentation 1

Title

Bone-anchored prosthesis: current developments worldwide and challenges

Presenters

Laurent Frossard(1,2) (1)

Queensland University of Technology, Brisbane, QLD, Australia (2)

University of the Sunshine Coast, Maroochydore, QLD, Australia

Reference

Frossard L. Bone-anchored prosthesis: current developments worldwide and challenges. XV World Congress of the International Society for Prosthetics and Orthotics (ISPO). 2015. Lyon, France. SYMP-Session 7-1

Abstract

Background

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

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2015. XV World Congress of the ISPO, Lyon Page 2 of 7 directly to the residual skeleton through a percutaneous implant (e.g., screw type fixation, press-fit implant).[46, 48, 51, 52, 77, 78]

The aim of this study is to present the current advances in these surgical techniques worldwide with a strong focus on the current challenges.

Methods

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, and breakage) and the benefits (e.g., functional outcomes, health-related quality of life).[5-19, 51-53, 55, 57, 58, 62, 73, 79]

Results

The population of individuals fitted with a bone-anchored prosthesis is approximately 550 worldwide. Publications focusing on infection are sparse. However, the rate of superficial infection is estimated at 20%. Deep infection occurs rarely. Loosening and peri-prosthetic fractures are fairly uncommon. Breakage of implant parts occurs regularly mainly due to fall. All studies reported a significant improvement in functional level and overall quality of life.

Conclusions

Several commercial implants are in developments in Europe and US. The number of procedures is

consistently growing worldwide. This technique might be primary way to fit a prosthesis to young and active amputees by 2025.

References

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amputee: comparison of inverse dynamics and direct measurements. Gait Posture, 2009. 30(4): p. 560-2.

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2015. XV World Congress of the ISPO, Lyon Page 3 of 7 osseointegrated fixation of a trans-femoral amputee: a tool for evidence-based practice. Prosthet Orthot Int, 2008. 32(1): p. 68-78.

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Adj/Prof Laurent Frossard (PhD)

Lyon, France 25/06/2015

Queensland University of Technology, Brisbane, QLD, Australia University of the Sunshine Coast, Maroochydore, QLD, Australia

Bone-anchored prosthesis: current

developments worldwide and

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Bone-anchored prosthesis

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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

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HRQoL

Q-TFA

Sitting

SF-36

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 representation

N=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/

Image

HRQoL

Q-TFA

Sitting

Image

SF-36

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

OIperception

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HRQoL

Q-TFA

Sitting

Image

SF-36

OIperception

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

Attachment

HRQoL

Q-TFA

Sitting

Image

Attachment

SF-36

OIperception

Benefits

Hip range of movement

http://osseointeg.ning.com/profil e/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

Hip ROM

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HRQoL

Q-TFA

Sitting

Image

OIperception

Attachment

Hip ROM

SF-36

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

Walking

Risks

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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 infections

Inclusion 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%

Risks

Infections

Overview - Deep infections

(2-3 yrs) (S2-2 yrs)

Reference [1] [2] [1] [2]

Definite implant infection / Deep implant

infection 5% 11% 15% 6%

Short course of antibiotics

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Risks

Infections

Overview – Superficial infections

(2-3 yrs) (S2-2 yrs)

Reference [1] [2] [1] [2]

Local soft tissue infection in the skin

penetration area / Superficial infection 17% 11% 29% 80%

Risks

Infections

Overview – Superficial infections

(2-3 yrs) (S2-2 yrs)

Reference [1] [2] [1] [2]

Local soft tissue infection in the skin

penetration area / Superficial infection 17% 11% 29% 80%

Cleaning

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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

Risks

Titel 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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Benefits vs harms

Benefits

Harms

Bone-anchored prosthesis:

current

developments worldwide

and

challenges

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Centres in the world

Country Number of centres Centres

Australia 2 Melbourne, Sydney

Netherlands 2 Linden, Nijmegen

Belgium 1 Ghent Chile 1 Santiago Denmark 1 Aarhus France 1 Montpellier Germany 1 Lubeck Spain 1 Barcelona Sweden 1 Gothenburg UK 1 London

USA 1 Las Vegas

Total 13 - 16

[1]http://opraosseointegration.com/in 2013

[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

Number

Cases worldwide

Country Rank Total TTA1 TTA2 TFA1 TFA2 TRA1 THA1 THA2 THB MTD

Sweden 1 205 2 0 141 9 15 0 22 0 15 Australia 2 124 17 0 87 4 0 0 5 1 5 Germany 3 78 6 2 66 4 0 0 0 0 0 Netherlands 4 40 3 0 37 0 0 0 0 0 0 Chile 5 27 0 0 22 0 0 0 5 0 0 Denmark 6 23 0 0 21 0 0 0 1 0 1 UK 7 18 0 0 18 0 0 0 0 0 0 France 8 14 3 0 10 1 0 0 0 0 0 Spain 9 8 0 0 7 1 0 0 0 0 0 Belgium 10 3 0 0 1 1 0 0 1 0 0 USA 11 1 0 0 1 0 0 0 0 0 0 Total 540 31 2 410 20 15 0 34 1 21 [1]http://opraosseointegration.com/in 2013

Number

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Number

Cases worldwide

Sweden 1 75 0 0 26 2 3 0 4 0 3 Australia 2 3 0 16 1 0 0 1 0 1 Germany 3 1 0 12 1 0 0 0 0 0 Netherlands 4 7 1 0 7 0 0 0 0 0 0 Chile 5 5 0 0 4 0 0 0 1 0 0 Denmark 6 4 0 0 4 0 0 0 0 0 0 UK 7 3 0 0 3 0 0 0 0 0 0 France 8 3 1 0 2 0 0 0 0 0 0 Spain 9 1 0 0 1 0 0 0 0 0 0 Belgium 10 1 0 0 0 0 0 0 0 0 0 USA 11 0 0 0 0 0 0 0 0 0 0 Total 100 6 0 76 4 3 0 6 0 4 [1]http://opraosseointegration.com/

Percent

Number

Cases worldwide

[1]http://opraosseointegration.com/

Percent

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Number

Cases worldwide

[1]http://opraosseointegration.com/

Percent

Case mix

Australia 1 7 Y N Y Y N Y Y Y Y Sweden 1 7 Y N Y Y Y Y N Y Y Germany 4 4 Y Y Y Y N N N N N Belgium 5 3 N N Y Y N Y N N N Denmark 5 3 N N Y N N Y N Y N France 5 3 Y N Y Y N N N N N Chile 9 2 N N Y N N Y N N N Netherlands 9 2 Y N Y N N N N N N Spain 9 2 N N Y Y N N N N N UK 14 1 N N Y N N N N N N USA 14 1 N N Y N N N N N N [1]http://opraosseointegration.com/

Number

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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, UK

Fixation

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 Department

Fixation

FDA

Clinical

trial

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Future developments

Pitkin, M., C. Cassidy, R. Muppavarapu, R. J, M. Shevtsov, O. Galibin, and S. Rousselle, New method of fixation of in-bone implanted prosthesis. J Rehabil Res Dev, 2013. 50(5): p. 709-722.

Tuft University

Fixation

Future developments

Single stage surgery

Focus

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Fixation

Future developments

Single stage surgery

Focus

Nb of surgeries before 2014 2 2 2 Nb of surgeries after 2014 1 1 1

Fixation

Future developments

Primary intervention

Focus

http://www.smh.com.au/news/national/lplate-collision-kills-policewoman/2008/04/20/1208629736691.html

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Fixation

Future developments

Isaacson, B.M., J.G. Stinstra, R.D. Bloebaum, P.F. Pasquina, and R.S. MacLeod, Establishing multiscale models for simulating whole limb estimates of electric fields for osseointegrated implants. IEEE Trans Biomed Eng, 2011. 58(10): p. 2991-4.

Electrical field for osseointegration

Focus

Fixation

Surgical methods

Future developments

Focus

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Fixation

Future developments

http://www.chalmers.se/en/news/Pages/Thought-controlled-prosthesis-is-changing-the-lives-of-amputees.aspx

Neuromuscular control of prosthesis

Focus

Fixation

Future developments

Cost-effectiveness

Frossard L, Formosa D, Quincey T, Berg D, Burkett B. Cost effectiveness of osseointegration. 2nd Australasian Osseointegrated for Amputees Conference. 2015. Brisbane, Australia. p 3

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(32)

Focus

Fixation

Future developments

Common evaluation framework - Registry

Bone-anchored prosthesis: current

developments worldwide and

challenges

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Focus

Fixation

Challenges

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.

Focus

Teams

Fixation

Challenges

High impact activities

http://www.tulsaworld.com/

Challenges

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Focus

Teams

Fixation

Challenges

Accessible to low income countries

http://projecthopeinthefield.blogspot.ca/2010_04_01_archive.html

Challenges

Focus

Teams

Fixation

Challenges

http://online.publicationprinters.com/launch.aspx?eid=202f0de3-6dd9-4208-8677-4c273a37b5d3

Challenges

Pediatric applications

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Focus

Teams

Fixation

Challenges

Pediatric applications

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

Challenges

Focus

Teams

Fixation

Challenges

Accessible after natural disasters

http://www.msf.org.uk/teaching-resources-level-geography

Challenges

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Bone-anchored prosthesis: current

developments worldwide and

challenges

Demand Patients Clinical know-how Support government Scientific expertise

2000-2012

2015-2020

2020-…

Conclusions

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Conclusions

Adj/Prof Laurent Frossard (PhD)

Lyon, France 25/06/2015

Queensland University of Technology, Brisbane, QLD, Australia University of the Sunshine Coast, Maroochydore, QLD, Australia

Bone-anchored prosthesis: current

developments worldwide and

challenges

www.LaurentFrossard.com

2015 ISPO World Congress

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