This may be the author’s version of a work that was submitted/accepted for publication in the following source: Frossard, Laurent A. (2014) Are bone-anchored prostheses about to revolutionise the world of pros- thetics? In Australian Orthotic Prosthetic Association (AOPA) Congress, 2014-10-09 - 2014-10-10. This file was downloaded from: https://eprints.qut.edu.au/77999/ c© Copyright 2014 [please consult the author] This work is covered by copyright. Unless the document is being made available under a Creative Commons Licence, you must assume that re-use is limited to personal use and that permission from the copyright owner must be obtained for all other uses. If the docu- ment is available under a Creative Commons License (or other specified license) then refer to the Licence for details of permitted re-use. It is a condition of access that users recog- nise and abide by the legal requirements associated with these rights. If you believe that this work infringes copyright please provide details by email to qut.copyright@qut.edu.au Notice: Please note that this document may not be the Version of Record (i.e. published version) of the work. Author manuscript versions (as Sub- mitted for peer review or as Accepted for publication after peer review) can be identified by an absence of publisher branding and/or typeset appear- ance. If there is any doubt, please refer to the published source. 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, Osseointegration in skeletal reconstruction and rehabilitation: a review. J Rehabil Res Dev, 2001. 38(2): p. 175-81. 2. 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. 3. Hagberg, K., E. Hansson, and R. Brånemark, Outcome of percutaneous osseointegrated prostheses for patients with unilateral transfemoral amputation at two-year follow-up. Archives of Physical Medicine and Rehabilitation, 2014(0). 4. Tsikandylakis, G., O. Berlin, and R. Branemark, Implant Survival, Adverse Events, and Bone Remodeling of Osseointegrated Percutaneous Implants for Transhumeral Amputees. Clin 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. 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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 Percutaneous Osseointegrated Prostheses. Clin Orthop Relat Res, 2013: p. 1-9. 25. 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. 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 Are bone-anchored prostheses about to revolutionise the world of prosthetics? 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. Dumas, Dynamic input to determine hip joint moments, power and work on the prosthetic limb of transfemoral amputees: ground reaction vs knee reaction. Prosthet Orthot Int, 2011. 35(2): p. 140-9. 36. Frossard, L., N. Stevenson, J. Sullivan, M. Uden, and M. Pearcy, Categorization of Activities of Daily Living of Lower Limb Amputees During Short-Term Use of a Portable Kinetic Recording System: A Preliminary Study. JPO Journal of Prosthetics and Orthotics, 2011. 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. Viceconti, Risk of failure during gait for direct skeletal attachment of a femoral prosthesis: a finite element study. Med Eng Phys, 2009. 31(5): p. 595-600. 40. 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. 1Laurent 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? eP rin t V er sio n 2Context Socket Attachment Socket Socket Context Attachment FixationSocket Fixation eP rin t V er sio n 3ITAP Commercial fixations Integral 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/eP rin t V er sio n 4ILP/OPL ITAP Commercial fixations Osseointegrated Prosthesis for Rehabilitation of Amputees Integrum AB Sweden OPRA 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 eP rin t V er sio n 5ILP/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 eP rin t V er sio n 6OPRA 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 eP rin t V er sio n 7OPRA 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 eP rin t V er sio n 8OPRA 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 80 500 180 * Estimation Most published and acknowledged eP rin t V er sio n 9Hagberg, 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 eP rin t V er sio n 10 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 eP rin t V er sio n 11 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 eP rin t V er sio n 12 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 eP rin t V er sio n 13 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 eP rin t V er sio n 14 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 Benefits Health-related quality of life: SF 36 eP rin t V er sio n 15 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 eP rin t V er sio n 16 Benefits Benefits Sitting 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 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/ eP r n t V er sio n 17 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 eP rin t V er sio n 18 Benefits Benefits Hip range of movement http://osseointeg.ning.com/pro file/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 eP rin t V er sio n 19 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 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% eP rin t V er sio n 20 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 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% 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 infections Inclusion 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% eP rin t V er sio n 21 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 infections Inclusion 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 eP rin t V er sio n 22 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 eP rin t V er sio n 23 Risks vs Benefits Benefits Risks Future developments eP rin t V er sio n 24 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 eP rin t V er sio n 25 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 rin V er sio n 26 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.htmleP rin t V er sio n 27 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 eP rin t V er sio n 28 Australia : leader worldwide Clinical know-how • 3rd largest population worldwide • largest population outside Europe • Fastest growing population worldwide OPRA 500 cases 15 years ≈ 33 cases/year ILP/OPL 80 cases 2 years ≈ 40 cases/year Population Population Australia : leader worldwide Clinical know-how Several world firsts • Broadest range of case-mix Case-mix eP rin t V er sio n 29 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 eP rin t V er sio n 30 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 QLD NT Demand eP rin t V er sio n 31 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 rin t V er sio n 32 Soon, it might! Eligibility criteria Change Inclusion • 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 components o All patients = K4 regardless of functional outcomes • Manufacturing of purposely designed components (e.g., knee) o Larger ROM o Safer (e.g., fall) o Capitalising more on osseoperception o Better monitoring of ADL and usage Developt eP rin t V er sio n 33 Inclusion Developt Soon, it might! • Before surgery o Referral of patients o Participate to screening • After surgery o 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 eP rin t V er ion 34 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 LinkedIn www.ca.linkedin.com/pub/laurent-frossard/5/4b4/b59/ Google+ www.plus.google.com/#113083134851353167716/about Facebook www.facebook.com/YourResearchProjecteP rin t V er i n