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Review Article

Technical Overview of Osseointegrated Transfemoral Prostheses: Orthopedic Surgery and Implant Design Centered

[+] Author and Article Information
Andrii Maryniak

Center for Medical Education,
Poznan University of Medical Sciences,
Poznan 61-701, Poland
e-mail: andre.maryniak@mail.utoronto.ca

Brock Laschowski

Institute of Biomaterials and
Biomedical Engineering,
University of Toronto,
Toronto, ON M5S 3G9, Canada
e-mail: brock.laschowski@mail.utoronto.ca

Jan Andrysek

Bloorview Research Institute,
Holland Bloorview Kids Rehabilitation Hospital,
Toronto, ON M4G 1R8, Canada
e-mail: jandrysek@hollandbloorview.ca

1Corresponding author.

Manuscript received November 12, 2017; final manuscript received January 16, 2018; published online February 27, 2018. Assoc. Editor: Peter McNair.

ASME J of Medical Diagnostics 1(2), 020801 (Feb 27, 2018) (7 pages) Paper No: JESMDT-17-2051; doi: 10.1115/1.4039105 History: Received November 12, 2017; Revised January 16, 2018

Bone-anchored prostheses represent a promising solution to numerous medical complications associated with conventional socket-suspended prostheses. The following technical overview was constructed for engineers and orthopedic surgeons interested in osseointegrated implants for transfemoral prosthesis-residuum interfacing. Existing osseointegrated implants comprise different biomaterial compositions (i.e., titanium alloy versus cobalt-chromium-molybdenum alloy) and mechanical designs (i.e., screw-fixated versus press-fixated devices). Perioperative systems of osseointegration surgery include preoperative assessments (i.e., alongside inclusion and exclusion criteria), intraoperative procedures, and postoperative rehabilitation (i.e., static loading and dynamic gait rehabilitation). The intraoperative procedures involve transecting and reorganizing the residual musculature, embedding the implant into the femoral intramedullary cavity, and coupling the osseointegrated implant to an external prosthesis. Postoperative clinical evaluations have demonstrated significant biomechanical, psychological, and physiological improvements in patients using bone-anchored prostheses compared to conventional socket-suspended prostheses. Nevertheless, bacterial infections surrounding the skin-implant bio-interface, often resulting from Staphylococcus aureus or other coagulase-negative staphylococci, remain a relatively frequent medical complication, which can culminate in periprosthetic osteomyelitis and/or implant extraction. The technical overview concludes with discussing the recent Food and Drug Administration humanitarian use device designations, financial analyses between bone-anchored prostheses and socket-suspended prostheses, and applications of vibrotactile osseoperception for augmenting walking and balance feedback control.

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References

Pitkin, M. , 2009, “ On the Way to Total Integration of Prosthetic Pylon With Residuum,” J. Rehabil. Res. Develop., 46, pp. 345–360. [CrossRef]
Leijendekkers, R. A. , Van Hinte, G. , Frolke, J. P. , Van De Meent, H. , Nijhuis-Van Der Sanden, M. W. G. , and Staal, J. B. , 2017, “ Comparison of Bone-Anchored Prostheses and Socket Prostheses for Patients With a Lower Extremity Amputation: A Systematic Review,” Disability Rehabil., 39(11), pp. 1045–1058. [CrossRef]
Leijendekkers, R. A. , Van Hinte, G. , Nijhuis-Van Der Sanden, M. W. G. , and Staal, J. B. , 2017, “ Gait Rehabilitation for a Patient With an Osseointegrated Prosthesis Following Transfemoral Amputation,” Physiother. Theory Pract., 33(2), pp. 147–161. [CrossRef] [PubMed]
Leijendekkers, R. A. , Staal, J. B. , Van Hinte, G. , Frolke, J. P. , Van De Meent, H. , Atsma, F. , Nijhuis-Van Der Sanden, M. W. G. , and Hoogeboom, T. J. , 2016, “ Long-Term Outcomes Following Lower Extremity Press-Fit Bone-Anchored Prosthesis Surgery: A 5-Year Longitudinal Study Protocol,” BMC Musculoskeletal Disord., 17(1), p. 484.
Pantall, A. , Durham, S. , and Ewins, D. , 2011, “ Surface Electromyographic Activity of Five Residual Limb Muscles Recorded During Isometric Contraction in Transfemoral Amputees With Osseointegrated Prostheses,” Clin. Biomech., 26(7), pp. 760–765. [CrossRef]
Tillander, J. , Hagberg, K. , Hagberg, L. , and Branemark, R. , 2010, “ Osseointegrated Titanium Implants for Limb Prostheses Attachments: Infectious Complications,” Clin. Orthop. Relat. Res., 468(10), pp. 2781–2788. [CrossRef] [PubMed]
Branemark, R. , Berlin, O. , Hagberg, K. , Bergh, P. , Gunterberg, B. , and Rydevik, B. , 2014, “ A Novel Osseointegrated Percutaneous Prosthetic System for the Treatment of Patients With Transfemoral Amputation: A Prospective Study of 51 Patients,” Bone Jt. J., 96-B(1), pp. 106–113. [CrossRef]
Hagberg, K. , Haggstrom, E. , Uden, M. , and Branemark, R. , 2005, “ Socket Versus Bone-Anchored Trans-Femoral Prostheses: Hip Range of Motion and Sitting Comfort,” Prosthetics Orthotics Int., 29(2), pp. 153–163. [CrossRef]
Hagberg, K. , and Branemark, R. , 2009, “ One Hundred Patients Treated With Osseointegrated Transfemoral Amputation Prostheses—Rehabilitation Perspective,” J. Rehabil. Res. Develop., 46, pp. 331–344. [CrossRef]
Lee, W. C. C. , Frossard, L. A. , Hagberg, K. , Haggstrom, E. , Gow, D. L. , Gray, S. , and Branemark, R. , 2008, “ Magnitude and Variability of Loading on the Osseointegrated Implant of Transfemoral Amputees During Walking,” Med. Eng. Phys., 30(7), pp. 825–833. [CrossRef] [PubMed]
Sullivan, J. , Uden, M. , Robinson, K. P. , and Sooriakumaran, S. , 2003, “ Rehabilitation of the Trans-Femoral Amputee With an Osseointegrated Prosthesis: The United Kingdom Experience,” Prosthetics Orthotics Int., 27(2), pp. 114–120. [CrossRef]
Tranberg, R. , Zugner, R. , and Karrholm, J. , 2011, “ Improvements in Hip- and Pelvic Motion for Patients With Osseointegrated Trans-Femoral Prostheses,” Gait Posture, 33(2), pp. 165–168. [CrossRef] [PubMed]
Van De Meent, H. , Hopman, M. T. , and Frolke, J. P. , 2013, “ Walking Ability and Quality of Life in Subjects With Transfemoral Amputation: A Comparison of Osseointegration With Socket Prostheses,” Arch. Phys. Med. Rehabil., 94(11), pp. 2174–2178. [CrossRef] [PubMed]
Li, Y. , and Branemark, R. , 2017, “ Osseointegrated Prostheses for Rehabilitation Following Amputation: The Pioneering Swedish Model,” Unfallchirurg, 120(4), pp. 285–292. [CrossRef] [PubMed]
Lee, W. C. C. , Frossard, L. A. , Hagberg, K. , Haggstrom, E. , Branemark, R. , Evans, J. H. , and Pearcy, M. J. , 2007, “ Kinetics of Transfemoral Amputees With Osseointegrated Fixation Performing Common Activities of Daily Living,” Clin. Biomech., 22(6), pp. 665–673. [CrossRef]
Haggstrom, E. , Hansson, E. , and Hagberg, K. , 2012, “ Comparison of Prosthetic Costs and Service Between Osseointegrated and Conventional Suspended Transfemoral Prostheses,” Prosthetics Orthotics Int., 37(2), pp. 152–160. [CrossRef]
Van Eck, C. F. , and McGough, R. L. , 2015, “ Clinical Outcome of Osseointegrated Prostheses for Lower Extremity Amputations: A Systematic Review of the Literature,” Curr. Orthop. Pract., 26(4), pp. 349–357. [CrossRef]
Branemark, R. , Branemark, P. I. , Rydevik, B. , and Myers, R. R. , 2001, “ Osseointegration in Skeletal Reconstruction and Rehabilitation: A Review,” J. Rehabil. Res. Develop., 38(2), pp. 175–181.
Nebergall, A. , Bragdon, C. , Antonellis, A. , Karrholm, J. , Branemark, R. , Berlin, O. , and Malchau, H. , 2012, “ Stable Fixation of an Osseointegrated Implant System for Above-the-Knee Amputees: Titel RSA and Radiographic Evaluation of Migration and Bone Remodeling in 55 Cases,” Acta Orthop., 83(2), pp. 121–128. [CrossRef] [PubMed]
Eriksson, E. , and Branemark, P. I. , 1994, “ Osseointegration From the Perspective of the Plastic Surgeon,” Plast. Reconstr. Surg., 93(3), pp. 626–637. [CrossRef] [PubMed]
Aschoff, H. H. , Kennon, R. E. , Keggi, J. M. , and Rubin, L. E. , 2010, “ Transcutaneous, Distal Femoral, Intramedullary Attachment for Above-the-Knee Prostheses: An Endo-Exo Device,” J. Bone Jt. Surg., 92(Suppl. 2), pp. 180–186. [CrossRef]
Hagberg, K. , Branemark, R. , Gunterberg, B. , and Rydevik, B. , 2008, “ Osseointegrated Trans-Femoral Amputation Prostheses: Prospective Results of General and Condition-Specific Quality of Life in 18 Patients at 2-Year Follow-Up,” Prosthetics Orthotics Int., 32(1), pp. 29–41. [CrossRef]
Hagberg, K. , Hansson, E. , and Branemark, R. , 2014, “ Outcome of Percutaneous Osseointegrated Prostheses for Patients With Unilateral Transfemoral Amputation at Two-Year Follow-Up,” Arch. Phys. Med. Rehabil., 95(11), pp. 2120–2127. [CrossRef] [PubMed]
Tomaszewski, P. K. , Verdonschot, N. , Bulstra, S. K. , and Verkerke, G. J. , 2010, “ A Comparative Finite-Element Analysis of Bone Failure and Load Transfer of Osseointegrated Prostheses Fixations,” Ann. Biomed. Eng., 38(7), pp. 2418–2427. [CrossRef] [PubMed]
Frossard, L. , Hagberg, K. , Haggstrom, E. , Gow, D. L. , Branemark, R. , and Pearcy, M. , 2010, “ Functional Outcome of Transfemoral Amputees Fitted With an Osseointegrated Fixation: Temporal Gait Characteristics,” J. Prosthetics Orthotics, 22(1), pp. 11–20. [CrossRef]
Atallah, R. , Li, J. J. , Lu, W. , Leijendekkers, R. , Frölke, J. P. , and Al Muderis, M. , 2017, “ Osseointegrated Transtibial Implants in Patients With Peripheral Vascular Disease: A Multicenter Case Series of 5 Patients With 1-Year Follow-Up,” J. Bone Jt. Surg., 99(18), pp. 1516–1523. [CrossRef]
Schwarze, M. , Hurschler, C. , Seehaus, F. , Correa, T. , and Welke, B. , 2014, “ Influence of Transfemoral Amputation Length on Resulting Loads at the Osseointegrated Prosthesis Fixation During Walking and Falling,” Clin. Biomech., 29(3), pp. 272–276. [CrossRef]
Albrektsson, T. , Branemark, P. I. , Hansson, H. A. , and Lindstrom, J. , 1981, “ Osseointegrated Titanium Implants: Requirements for Ensuring a Long-Lasting, Direct Bone-to-Implant Anchorage in Man,” Acta Orthop. Scand., 52(2), pp. 155–170. [CrossRef] [PubMed]
Pitkin, M. , 2013, “ Design Features of Implants for Direct Skeletal Attachment of Limb Prostheses,” J. Biomed. Mater. Res., Part A, 101(11), pp. 3339–3348.
Lee, W. C. C. , Doocey, J. M. , Branemark, R. , Adam, C. J. , Evans, J. H. , Pearcy, M. J. , and Frossard, L. A. , 2008, “ FE Stress Analysis of the Interface Between the Bone and an Osseointegrated Implant for Amputees—Implications to Refine the Rehabilitation Program,” Clin. Biomech., 23(10), pp. 1243–1250. [CrossRef]
Tomaszewski, P. K. , Verdonschot, N. , Bulstra, S. K. , Rietman, J. S. , and Verkerke, G. J. , 2012, “ Simulated Bone Remodeling Around Two Types of Osseointegrated Implants for Direct Fixation of Upper-Leg Prostheses,” J. Mech. Behav. Biomed. Mater., 15, pp. 167–175. [CrossRef] [PubMed]
Thompson, M. L. , Backman, D. , Branemark, R. , and Mechefske, C. K. , 2011, “ Evaluating the Bending Response of Two Osseointegrated Transfemoral Implant Systems Using 3D Digital Image Correlation,” ASME J. Biomech. Eng., 133(5), p. 051006.
Frolke, J. P. M. , Leijendekkers, R. A. , and Van De Meent, H. , 2017, “ Osseointegrated Prosthesis for Patients With an Amputation: Multidisciplinary Team Approach in The Netherlands,” Unfallchirurg, 120, pp. 293–299. [CrossRef] [PubMed]
Xu, W. , and Robinson, K. , 2008, “ X-Ray Image Review of the Bone Remodeling Around an Osseointegrated Trans-Femoral Implant and a Finite Element Simulation Case Study,” Ann. Biomed. Eng., 36(3), pp. 435–443. [CrossRef] [PubMed]
Zhang, M. , Don, X. , and Fa, Y. , 2006, “ Stress Analysis of Osseointegrated Transfemoral Prosthesis: A Finite Element Model,” Annual International Conference of the Engineering in Medicine and Biology Society (EMBS), Shanghai, China, Jan. 17–18, pp. 4060–4063.
Frossard, L. A. , Stevenson, N. , Smeathers, J. , Haggstrom, E. , Hagberg, K. , Sullivan, J. , Ewins, D. , Gow, D. L. , Gray, S. , and Branemark, R. , 2008, “ Monitoring of the Load Regime Applied on the Osseointegrated Fixation of a Trans-Femoral Amputee: A Tool for Evidence-Based Practice,” Prosthetics Orthotics Int., 32(1), pp. 68–78. [CrossRef]
Al Muderis, M. , Khemka, A. , Lord, S. J. , Van De Meent, H. , and Frolke, J. P. , 2016, “ Safety of Osseointegrated Implants for Transfemoral Amputees: A Two-Center Prospective Cohort Study,” J. Bone Jt. Surg., 98(11), pp. 900–909. [CrossRef]
Helgason, B. , Palssona, H. , Runarssona, T. P. , Frossard, L. A. , and Viceconti, M. , 2009, “ Risk of Failure During Gait for Direct Skeletal Attachment of a Femoral Prosthesis: A Finite Element Study,” Med. Eng. Phys., 31(5), pp. 595–600. [CrossRef] [PubMed]
Khemka, A. , FarajAllah, C. I. , Lord, S. J. , Bosley, B. , and Al Muderis, M. , 2016, “ Osseointegrated Total Hip Replacement Connected to a Lower Limb Prosthesis: A Proof-of-Concept Study With Three Cases,” J. Orthop. Surg. Res., 11, p. 13.
Al Muderis, M. , Tetsworth, K. , Khemka, A. , Wilmot, S. , Bosley, B. , Lord, S. J. , and Glatt, V. , 2016, “ The Osseointegration Group of Australia Accelerated Protocol (OGAAP-1) for Two-Stage Osseointegrated Reconstruction of Amputated Limbs,” Bone Jt. J., 98-B(7), pp. 952–960. [CrossRef]
Welke, B. , Schwarze, M. , Hurschler, C. , Calliess, T. , and Seehaus, F. , 2013, “ Multi-Body Simulation of Various Falling Scenarios for Determining Resulting Loads at the Prosthesis Interface of Transfemoral Amputees With Osseointegrated Fixation,” J. Orthop. Res., 31(7), pp. 1123–1129. [CrossRef] [PubMed]
Haket, L. M. , Frolke, J. P. M. , Verdonschot, N. , Tomaszewski, P. K. , and Van De Meent, H. , 2017, “ Periprosthetic Cortical Bone Remodeling in Patients With an Osseointegrated Leg Prosthesis,” J. Orthop. Res., 35(6), pp. 1237–1241. [CrossRef] [PubMed]
Khemka, A. , Frossard, L. A. , Lord, S. J. , Bosley, B. , and Al Muderis, M. , 2015, “ Osseointegrated Total Knee Replacement Connected to a Lower Limb Prosthesis: 4 Cases,” Acta Orthop., 86(6), pp. 740–744. [CrossRef] [PubMed]
Pantall, A. , and Ewins, D. , 2013, “ Muscle Activity During Stance Phase of Walking: Comparison of Males With Transfemoral Amputation With Osseointegrated Fixations to Nondisabled Male Volunteers,” J. Rehabil. Res. Develop., 50(4), pp. 499–514. [CrossRef]
Hebert, J. S. , Rehani, M. , and Stiegelmar, R. , 2017, “ Osseointegration for Lower-Limb Amputation: A Systematic Review of Clinical Outcomes,” J. Bone Jt. Surg., 5(10), p. e10.
Al Muderis, M. , Lu, W. , Tetsworth, K. , Bosley, B. , and Li, J. J. , 2017, “ Single-Stage Osseointegrated Reconstruction and Rehabilitation of Lower Limb Amputees: The Osseointegration Group of Australia Accelerated Protocol-2 (OGAAP-2) for a Prospective Cohort Study,” BMJ Open, 7(3), p. e013508.
Al Muderis, M. , Lu, W. , and Li, J. J. , 2017, “ Osseointegrated Prosthetic Limb for the Treatment of Lower Limb Amputations: Experience and Outcomes,” Unfallchirurg, 120(4), pp. 306–311. [CrossRef] [PubMed]
Guirao, L. , Samitier, C. B. , Costea, M. , Camos, J. M. , Majo, M. , and Pleguezuelos, E. , 2017, “ Improvement in Walking Abilities in Transfemoral Amputees With a Distal Weight Bearing Implant,” Prosthetics Orthotics Int., 41(1), pp. 26–32. [CrossRef]
Schalk, S. A. , Jonkergouw, N. , Van Der Meer, F. , Swaan, W. M. , Aschoff, H. H. , and Van Der Wurff, P. , 2015, “ The Evaluation of Daily Life Activities After Application of an Osseointegrated Prosthesis Fixation in a Bilateral Transfemoral Amputee: A Case Study,” Medicine, 94(36), p. e1416.
Frossard, L. , Gow, D. L. , Hagberg, K. , Cairns, N. , Contoyannis, B. , Gray, S. , Branemark, R. , and Pearcy, M. , 2010, “ Apparatus for Monitoring Load Bearing Rehabilitation Exercises of a Transfemoral Amputee Fitted With an Osseointegrated Fixation: A Proof-of-Concept Study,” Gait Posture, 31(2), pp. 223–228. [CrossRef] [PubMed]
Vertriest, S. , Coorevits, P. , Hagberg, K. , Branemark, R. , Haggstrom, E. , Vanderstraeten, G. , and Frossard, L. , 2015, “ Static Load Bearing Exercises of Individuals With Transfemoral Amputation Fitted With an Osseointegrated Implant: Reliability of Kinetic Data,” IEEE Trans. Neural Syst. Rehabil. Eng., 23(3), p. 423–430.
Cairns, N. J. , Adam, C. J. , Pearcy, M. J. , and Smeathers, J. , 2011, “ Evaluation of Modal Analysis Techniques Using Physical Models to Detect Osseointegration of Implants in Transfemoral Amputees,” Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), Boston, MA, Aug. 30–Sept. 3, pp. 1600–1603.
Lundberg, M. , Hagberg, K. , and Bullington, J. , 2011, “ My Prosthesis as a Part of Me: A Qualitative Analysis of Living With an Osseointegrated Prosthetic Limb,” Prosthetics Orthotics Int., 35(2), pp. 207–214. [CrossRef]
Tillander, J. , Hagberg, K. , Berlin, O. , Hagberg, L. , and Branemark, R. , 2017, “ Osteomyelitis Risk in Patients With Transfemoral Amputations Treated With Osseointegration Prostheses,” Clin. Orthop. Relat. Res., 475(12), pp. 3100–3108.
Lenneras, M. , Tsikandylakis, G. , Trobos, M. , Omar, O. , Vazirisani, F. , Palmquist, A. , Berlin, O. , Branemark, R. , and Thomsen, P. , 2017, “ The Clinical, Radiological, Microbiological, and Molecular Profile of the Skin-Penetration Site of Transfemoral Amputees Treated With Bone-Anchored Prostheses,” J. Biomed. Mater. Res., Part A, 105, pp. 578–589. [CrossRef]
Frossard, L. , Berg, D. , Merlo, G. , Quincey, T. , and Burkett, B. , 2017, “ Cost Comparison of Socket-Suspended and Bone-Anchored Transfemoral Prostheses,” J. Prosthetics Orthotics, 29(4), pp. 150–160. [CrossRef]
Frossard, L. A. , Merlo, G. , Burkett, B. , Quincey, T. , and Berg, D. , 2017, “ Cost-Effectiveness of Bone-Anchored Prostheses Using Osseointegrated Fixation: Myth or Reality?,” Prosthetics Orthotics Int., epub.
Haggstrom, E. , Hagberg, K. , Rydevik, B. , and Branemark, R. , 2013, “ Vibrotactile Evaluation: Osseointegrated Versus Socket-Suspended Transfemoral Prostheses,” J. Rehabil. Res. Develop., 50, pp. 1423–1434. [CrossRef]
Dumas, R. , Branemark, R. , and Frossard, L. , 2017, “ Gait Analysis of Transfemoral Amputees: Errors in Inverse Dynamics Are Substantial and Depend on Prosthetic Design,” IEEE Trans. Neural Syst. Rehabil. Eng., 25(6), pp. 679–685. [CrossRef] [PubMed]
Frossard, L. , Hagberg, K. , Haggstrom, E. , and Branemark, R. , 2009, “ Load-Relief of Walking Aids on Osseointegrated Fixation: Instrument for Evidence-Based Practice,” IEEE Trans. Neural Syst. Rehabil. Eng., 17(1), pp. 9–14. [CrossRef] [PubMed]
Frossard, L. , Tranberg, R. , Haggstrom, E. , Pearcy, M. , and Branemark, R. , 2010, “ Load on Osseointegrated Fixation of a Transfemoral Amputee During a Fall: Loading, Descent, Impact and Recovery Analysis,” Prosthetics Orthotics Int., 34(1), pp. 85–97. [CrossRef]
Vertriest, S. , Coorevits, P. , Hagberg, K. , Branemark, R. , Haggstrom, E. E. , Vanderstraeten, G. , and Frossard, L. A. , 2016, “ Static Load Bearing Exercises of Individuals With Transfemoral Amputation Fitted With an Osseointegrated Implant: Loading Compliance,” Prosthetics Orthotics Int., 41(4), pp. 393–401.

Figures

Grahic Jump Location
Fig. 1

Example of a press-fixated osseointegrated transfemoral implant. Photograph courtesy of Dr. Lluis Guirao Cano, MD., Ph.D. (Hospital de Mataró, Consorci Sanitari del Maresme, Spain).

Grahic Jump Location
Fig. 2

Schematic of the OPRA osseointegration implant system. Photograph courtesy of Jonas Bergman (CEO of Integrum, Sweden).

Grahic Jump Location
Fig. 3

Surgically embedding an osseointegrated implant into the patient's femoral intramedullary cavity. Photograph courtesy of Dr. Lluis Guirao Cano, MD., Ph.D. (Hospital de Mataró, Consorci Sanitari del Maresme, Spain).

Grahic Jump Location
Fig. 4

Transfemoral amputee patient with the OPRA osseointegration implant system standing beside Dr. Rickard Branemark. Photograph courtesy of Jonas Bergman (CEO of Integrum, Sweden).

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