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A 24-month evaluation of a percutaneous osseointegrated limb-skin interface in an ovine amputation model

  • Clinical Applications of Biomaterials
  • Original Research
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Abstract

Percutaneous osseointegrated (OI) prostheses directly connect an artificial limb to the residual appendicular skeleton via a permanently implanted endoprosthesis with a bridging connector that protrudes through the skin. The resulting stoma produces unique medical and biological challenges. Previously, a study using a large animal amputation model indicated that infection could be largely prevented, for at least a 12-month period, but the terminal epithelium continued to downgrow. The current study was undertaken to test the longer-term efficacy of this implant construct to maintain a stable skin-implant interface for 24 months. Using the previously successful amputation and implantation surgical procedure, a total of eight sheep were fitted with a percutaneous OI prosthesis. Two animals were removed from the study due to early complications. Of the remaining six sheep, one (16.7%) became infected at 15-months post-implantation and five remained infection-free for the intended 24 months. The histological data of the remaining animals further confirmed the grossly observable epithelial downgrowth. Albeit a receding interface, it was clear that all animals that survived to the end of the study had residual fibrous soft-tissue ingrowth into, and debris within, the exposed titanium porous-coated surface. Overall, the data demonstrated that the porous coated subdermal barrier offered initial protection against infection. However, the fibrous skin attachment was continuously lysed over time by the down-growing epithelium.

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References

  1. Branemark P-I, Chien S. The osseointegration book: from calvarium to calcaneus. Berlin, London: Quintessenz; 2005.

    Google Scholar 

  2. Pendegrass CJ, Goodship AE, Blunn GW. Development of a soft tissue seal around bone-anchored transcutaneous amputation prostheses. Biomaterials. 2006;27:4183–91.

    Article  Google Scholar 

  3. Kang NV, Pendegrass C, Marks L, Blunn G. Osseocutaneous integration of an intraosseous transcutaneous amputation prosthesis implant used for reconstruction of a transhumeral amputee: case report. J Hand Surg. 2010;35:1130–4.

    Article  Google Scholar 

  4. Juhnke DL, Beck JP, Jeyapalina S, Aschoff HH. Fifteen years of experience with Integral-Leg-Prosthesis: cohort study of artificial limb attachment system. J Rehabil Res Dev. 2015;52:407–20.

    Article  Google Scholar 

  5. Kang NV, Morritt D, Pendegrass C, Blunn G. Use of ITAP implants for prosthetic reconstruction of extra-oral craniofacial defects. J Plast Reconstr Aesthet Surg. 2013;66:497–505.

    Article  Google Scholar 

  6. Jeyapalina S, Beck JP, Bachus KN, Bloebaum RD. Cortical bone response to the presence of load-bearing percutaneous osseointegrated prostheses. Anat Rec. 2012;295:1437–45.

    Article  Google Scholar 

  7. Aschoff HH, Kennon RE, Keggi JM, Rubin LE. Transcutaneous, distal femoral, intramedullary attachment for above-the-knee prostheses: an endo-exo device. J Bone Joint Surg Am. 2010;92:180–6.

    Article  Google Scholar 

  8. Aschoff HH. The endo-exo-femoral prosthesis. Traumatol Orthop Surg Russia. 2011;1:101–5.

    Google Scholar 

  9. Al Muderis M, Khemka A, Lord SJ, Van de Meent H, Frolke JP. Safety of osseointegrated implants for transfemoral amputees: a two-center prospective cohort study. J Bone Joint Surg Am. 2016;98:900–9.

    Article  Google Scholar 

  10. Hagberg K, Branemark R. One hundred patients treated with osseointegrated transfemoral amputation prostheses—rehabilitation perspective. J Rehabil Res Dev. 2009;46:331–44.

    Article  Google Scholar 

  11. Hagberg K, Branemark R, Gunterberg B, Rydevik B. Osseointegrated trans-femoral amputation prostheses: prospective results of general and condition-specific quality of life in 18 patients at 2-year follow-up. Prosthet Orthot Int. 2008;32:29–41.

    Article  Google Scholar 

  12. Rydevik B, Shubayev VI, Myers RR. Osseoperception. In: Brånemark P-I, Chien S, Gröndahl H-G, Robinson K, editors. The osseointegration book from calvarium to calcaneus. Berlin: Quintessenz; 2005. p. 149–56.

    Google Scholar 

  13. Jacobs R, Van Steenberghe D. From osseoperception to implant-mediated sensory-motor interactions and related clinical implications. J Oral Rehabil. 2006;33:282–92.

    Article  Google Scholar 

  14. Hagberg K, Haggstrom E, Jonsson S, Rydevik B, Branemark R. Osseoperception and osseointegrated prosthetic limbs. Psychoprosthetics. London: Springer; 2008. p. 131–40.

    Chapter  Google Scholar 

  15. Klineberg I. Introduction: from osseointegration to osseoperception. The functional translation. Clin Exp Pharmacol Physiol. 2005;32:97–9.

    Article  Google Scholar 

  16. Branemark R, Berlin O, Hagberg K, Bergh P, Gunterberg B, Rydevik B. A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: a prospective study of 51 patients. Bone Joint J. 2014;96B:106–13.

    Article  Google Scholar 

  17. Tillander J, Hagberg K, Hagberg L, Branemark R. Osseointegrated titanium implants for limb prostheses attachments: infectious complications. Clin Orthop Relat Res. 2010;468:2781–8.

    Article  Google Scholar 

  18. Tsikandylakis G, Berlin O, Branemark R. Implant survival, adverse events, and bone remodeling of osseointegrated percutaneous implants for transhumeral amputees. Clin Orthop Relat Res. 2014;472:2947–56.

    Article  Google Scholar 

  19. Jeyapalina S, Beck JP, Bachus KN, Williams DL, Bloebaum RD. Efficacy of a porous-structured titanium subdermal barrier for preventing infection in percutaneous osseointegrated prostheses. J Orthop Res. 2012;30:1304–11.

    Article  Google Scholar 

  20. Holt BM, Bachus KN, Beck JP, Bloebaum RD, Jeyapalina S. Immediate post-implantation skin immobilization decreases skin regression around percutaneous osseointegrated prosthetic implant systems. J Biomed Mater Res A. 2013;101:2075–82.

    Article  Google Scholar 

  21. Holt BM, Betz DH, Ford TA, Beck JP, Bloebaum RD, Jeyapalina S. Pig dorsum model for examining impaired wound healing at the skin-implant interface of percutaneous devices. J Mater Sci Mater Med. 2013;24:2181–93.

    Article  Google Scholar 

  22. Isackson D, McGill LD, Bachus KN. Percutaneous implants with porous titanium dermal barriers: an in vivo evaluation of infection risk. Med Eng Phys. 2011;33:418–26.

    Article  Google Scholar 

  23. Mitchell SJ, Jeyapalina S, Nichols FR, Agarwal J, Bachus KN. Negative pressure wound therapy limits downgrowth in percutaneous devices. Wound Repair Regen. 2016;24:35–44.

    Article  Google Scholar 

  24. von Recum AF. Applications and failure modes of percutaneous devices: a review. J Biomed Mater Res. 1984;18:323–36.

    Article  Google Scholar 

  25. Shelton TJ, Beck JP, Bloebaum RD, Bachus KN. Percutaneous osseointegrated prostheses for amputees: limb compensation in a 12-month ovine model. J Biomech. 2011;44:2601–6.

    Article  Google Scholar 

  26. Emmanual J, Hornbeck C, Bloebaum RD. A polymethyl methacrylate method for large specimens of mineralized bone with implants. Stain Technol. 1987;62:401–10.

    Article  Google Scholar 

  27. Freedberg IM, Tomic-Canic M, Komine M, Blumenberg M. Keratins and the keratinocyte activation cycle. J Invest Dermatol. 2001;116:633–40.

    Article  Google Scholar 

  28. Tomic-Canic M, Komine M, Freedberg IM, Blumenberg M. Epidermal signal transduction and transcription factor activation in activated keratinocytes. J Dermatol Sci. 1998;17:167–81.

    Article  Google Scholar 

  29. Gerritsen M, Lutterman JA, Jansen JA. Wound healing around bone-anchored percutaneous devices in experimental diabetes mellitus. J Biomed Mater Res. 2000;53:702–9.

    Article  Google Scholar 

  30. Gerritsen M, Lutterman JA, Jansen JA. The influence of impaired wound healing on the tissue reaction to percutaneous devices using titanium fiber mesh anchorage. J Biomed Mater Res. 2000;52:135–41.

    Article  Google Scholar 

  31. Jansen JA, Paquay YG, van der Waerden JP. Tissue reaction to soft-tissue anchored percutaneous implants in rabbits. J Biomed Mater Res. 1994;28:1047–54.

    Article  Google Scholar 

  32. Jansen JA, van der Waerden JP, de Groot K. Epithelial reaction to percutaneous implant materials: in vitro and in vivo experiments. J Invest Surg. 1989;2:29–49.

    Article  Google Scholar 

  33. Chehroudi B, Brunette DM. Subcutaneous microfabricated surfaces inhibit epithelial recession and promote long-term survival of percutaneous implants. Biomaterials. 2002;23:229–37.

    Article  Google Scholar 

  34. Pendegrass CJ, Goodship AE, Price JS, Blunn GW. Nature’s answer to breaching the skin barrier: an innovative development for amputees. J Anat. 2006;209:59–67.

    Article  Google Scholar 

  35. Sullivan J, Uden M, Robinson KP, Sooriakumaran S. Rehabilitation of the trans-femoral amputee with an osseointegrated prosthesis: the United Kingdom experience. Prosthet Orthot Int. 2003;27:114–20.

    Article  Google Scholar 

  36. Jansen JA, van der Waerden JP, van der Lubbe HB, de Groot K. Tissue response to percutaneous implants in rabbits. J Biomed Mater Res. 1990;24:295–307.

    Article  Google Scholar 

  37. Hugate R, Clarke R, Hoeman T, Friedman A. Transcutaneous implants in a porcine model: the use of highly porous tantalum. Int J Adv Mater Res. 2015;1:32–40.

    Google Scholar 

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Acknowledgements

This research is supported by the Department of Defense (W81XWH-11-1-0435) grant, the Office of Rehabilitation R&D Service, DVA SLC HCS, the Albert & Margaret Hofmann Chair, and the Department of Orthopaedics, University of Utah School of Medicine, Salt Lake City. Authors would like to express their sincere gratitude to the DJO Global for supplying the implants, and IMDS Inc. for animal study support. Authors also would like to thank Roy D. Bloebaum, Ph.D., and his team at the Bone and Joint Research Laboratory, SLC VA Medical Center for embedding the post-mortem samples and for acquiring the SEM data. While the US Army Medical Research Acquisition Activity (Fort Detrick, MD, USA) awarded and administering acquisition office for this study, the content of this research does not necessarily reflect the position or the policy of the Government, and no official endorsement should be inferred.

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Authors and Affiliations

  1. Orthopaedic Research Laboratories, University of Utah Orthopaedic Center and Department of Veterans Affairs Medical Center, Salt Lake City, UT, 84108, USA

    Sujee Jeyapalina, James Peter Beck & Kent N. Bachus

  2. Department of Surgery, Division of Plastic Surgery, University of Utah, Salt Lake City, UT, 84112, USA

    Sujee Jeyapalina & Jayant Agarwal

  3. Department of Bioengineering, University of Utah, Salt Lake City, UT, 84112, USA

    Kent N. Bachus

Authors
  1. Sujee Jeyapalina
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  2. James Peter Beck
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  4. Kent N. Bachus
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Correspondence to Kent N. Bachus.

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Jeyapalina, S., Beck, J., Agarwal, J. et al. A 24-month evaluation of a percutaneous osseointegrated limb-skin interface in an ovine amputation model. J Mater Sci: Mater Med 28, 179 (2017). https://doi.org/10.1007/s10856-017-5980-x

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  • DOI: https://doi.org/10.1007/s10856-017-5980-x

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