European Spine Journal

, Volume 20, Issue 9, pp 1486–1495 | Cite as

A novel synthetic material for spinal fusion: a prospective clinical trial of porous bioactive titanium metal for lumbar interbody fusion

  • Shunsuke Fujibayashi
  • Mitsuru Takemoto
  • Masashi Neo
  • Tomiharu Matsushita
  • Tadashi Kokubo
  • Kenji Doi
  • Tatsuya Ito
  • Akira Shimizu
  • Takashi Nakamura
Original Article

Abstract

The objective of this study was to establish the efficacy and safety of porous bioactive titanium metal for use in a spinal fusion device, based on a prospective human clinical trial. A high-strength spinal interbody fusion device was manufactured from porous titanium metal. A bioactive surface was produced by simple chemical and thermal treatment. Five patients with unstable lumbar spine disease were treated surgically using this device in a clinical trial approved by our Ethics Review Committee and the University Hospital Medical Information Network. Clinical and radiological results were reported at the minimum follow-up period of 1 year. The optimal mechanical strength and interconnected structure of the porous titanium metal were adjusted for the device. The whole surface of porous titanium metal was treated uniformly and its bioactive ability was confirmed before clinical use. Successful bony union was achieved in all cases within 6 months without the need for autologous iliac crest bone grafting. Two specific findings including an anchoring effect and gap filling were evident radiologically. All clinical parameters improved significantly after the operation and no adverse effects were encountered during the follow-up period. Although a larger and longer-term follow-up clinical study is mandatory to reach any firm conclusions, the study results show that this porous bioactive titanium metal is promising material for a spinal fusion device.

Keywords

Porous titanium metal Spinal fusion Biomaterial Clinical trial 

References

  1. 1.
    Banwart JC, Asher MA, Hassanein RS (1995) Iliac crest bone graft harvest donor site morbidity. A statistical evaluation. Spine 20:1055–1060PubMedCrossRefGoogle Scholar
  2. 2.
    Bloebaum RD, Beeks D, Dorr LD, Savory CG, DuPont J, Hofmann AA (1994) Complications with hydroxyapatite particulate separation in total hip arthroplasty. Clin Orthop 298:19–26PubMedGoogle Scholar
  3. 3.
    Boden SD, Zdeblick TA, Sandu HS, Heim SE (2000) The use of rhBMP-2 in interbody fusion cages: definitive evidence of osteoinduction in humans: a preliminary report. Spine 25:376–381PubMedCrossRefGoogle Scholar
  4. 4.
    Brantigan JW, Cunningham BW, Warden K, McAfee PC, Steffee AD (1993) Compression strength of donor bone for posterior lumbar interbody fusion. Spine 18:1213–1221PubMedCrossRefGoogle Scholar
  5. 5.
    De Groot K, Geesink R, Klein CP, Serekian P (1987) Plasma sprayed coatings of hydroxyapatite. J Biomed Mater Res 21:1375–1381PubMedCrossRefGoogle Scholar
  6. 6.
    Desogus N, Ennas F, Leuze R et al (2005) Posterior lumbar interbody fusion with PEEK cages: personal experience with 20 patients. J Neurosurg Sci 49:137–141PubMedGoogle Scholar
  7. 7.
    Ducheyne P, Qiu Q (1999) Bioactive ceramics: the effect of surface reactivity on bone formation and bone cell function. Biomaterials 20:2287–2303PubMedCrossRefGoogle Scholar
  8. 8.
    Fujibayashi S, Shikata J, Tanaka C, Matsushita M, Nakamura T (2001) Lumbar posterolateral fusion with biphasic calcium phosphate ceramic. J Spinal Disord 14:214–221PubMedCrossRefGoogle Scholar
  9. 9.
    Fujibayashi S, Nakamura T, Nishiguchi S, Tamura J, Uchida M, Kim HM et al (2001) Bioactive titanium: effect of sodium removal on the bone-bonding ability of bioactive titanium prepared by alkali and heat treatment. J Biomed Mater Res 56:562–570PubMedCrossRefGoogle Scholar
  10. 10.
    Fujibayashi S, Neo M, Kim HM, Kokubo T, Nakamura T (2004) Osteoinduction of porous bioactive titanium metal. Biomaterials 25:443–450PubMedCrossRefGoogle Scholar
  11. 11.
    Fujibayashi S, Neo M, Takemoto M, Ota M, Nakamura T (2010) Paraspinal-approach transforaminal lumbar interbody fusion for the treatment of lumbar foraminal stenosis. J Neurosurg Spine 13:500–508PubMedCrossRefGoogle Scholar
  12. 12.
    Hench LL (1998) Bioactive materials: the potential for tissue regeneration. J Biomed Mater Res 41:511–518PubMedCrossRefGoogle Scholar
  13. 13.
    Jost B, Cripton PA, Lund T, Oxland TR, Lippuner K, Jaeger P et al (1998) Compressive strength of interbody cages in lumbar spine: the effect of cage shape, posterior instrumentation and bone density. Eur Spine J 7:132–141PubMedCrossRefGoogle Scholar
  14. 14.
    Kawanabe K, Ise K, Goto K, Akiyama H, Nakamura T, Kaneuji A et al (2009) A new cementless total hip arthroplasty with bioactive titanium porous-coating by alkaline and heat treatment: average 4.8-year results. J Biomed Mater Res Part B: Appl Biomater 90B:476–481CrossRefGoogle Scholar
  15. 15.
    Kim HM, Kokubo T, Fujibayashi S, Nishiguchi S, Nakamura T (2000) Bioactive macroporous titanium surface layer on titanium substrate. J Biomed Mater Res 52:553–557PubMedCrossRefGoogle Scholar
  16. 16.
    Kokubo T (1991) Bioactive glass ceramics: properties and applications. Biomaterials 12:155–163PubMedCrossRefGoogle Scholar
  17. 17.
    Kokubo T, Kushitani H, Sakka S, Kitsugi T, Yamamuro T (1990) Solutions able to reproduce in vivo surface-structure changes in bioactive glass-ceramic A-W. J Biomed Mater Res 24:721–734PubMedCrossRefGoogle Scholar
  18. 18.
    Kokubo T, Miyaji F, Kim HM, Nakamura T (1996) Spontaneous formation of bonelike apatite layer on chemically treated titanium metals. J Am Ceram Soc 79:1127–1129CrossRefGoogle Scholar
  19. 19.
    McClellan JW, Mulconrey DS, Forbes RJ, Fullmer N (2006) Vertebral bone resorption after transforaminal lumbar interbody fusion with bone morphogenetic protein (rhBMP-2). J Spinal Disord Tech 19:483–486PubMedCrossRefGoogle Scholar
  20. 20.
    Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR (1988) Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging. Radiology 166:193–199PubMedGoogle Scholar
  21. 21.
    Morscher EW, Hefti A, Aebi U (1998) Severe osteolysis after third body wear due to hydroxyapatite particles from acetabular cup coating. J Bone Joint Surg Br 80:267–272PubMedCrossRefGoogle Scholar
  22. 22.
    Nachemson AL (1981) Disc pressure measurements. Spine 6:93–97PubMedCrossRefGoogle Scholar
  23. 23.
    Otsuki B, Takemoto M, Fujibayashi S, Neo M, Kokubo T, Nakamura T (2006) Pore throat size and connectivity determine bone and tissue ingrowth into porous implants: three-dimensional micro-CT based structural analyses of porous bioactive titanium implants. Biomaterials 27:5892–5900PubMedCrossRefGoogle Scholar
  24. 24.
    Takemoto M, Fujibayashi S, Neo M, Suzuki J, Kokubo T, Nakamura T (2005) Mechanical properties and osteoconductivity of porous bioactive titanium. Biomaterials 26:6014–6023PubMedCrossRefGoogle Scholar
  25. 25.
    Takemoto M, Fujibayashi S, Neo M, Suzuki J, Matsushita T, Kokubo T, Nakamura T (2006) Osteoinductive porous titanium implants: effect of sodium removal by dilute HCl treatment. Biomaterials 27:2682–2691PubMedCrossRefGoogle Scholar
  26. 26.
    Takemoto M, Fujibayashi S, Neo M, So K, Akiyama N, Matsushita T et al (2007) A porous bioactive titanium implant for spinal interbody fusion: an experimental study using a canine model. J Neurosurg Spine 7:435–443PubMedCrossRefGoogle Scholar
  27. 27.
    Toth JM, Boden SD, Burkus JK MD, Badura JM, Peckham SM, McKay WF (2009) Short-term osteoclastic activity induced by locally high concentrations of recombinant human bone morphogenetic protein-2 in a cancellous bone environment. Spine 34:539–550PubMedCrossRefGoogle Scholar
  28. 28.
    Tullberg T, Brandt B, Rydberg J, Fritzell P (1996) Fusion rate after posterior lumbar interbody fusion with carbon fiber implant: 1-year follow-up of 51 patients. Eur Spine J 5:178–182PubMedCrossRefGoogle Scholar
  29. 29.
    Tullberg T (1998) Failure of a carbon fiber implant: a case report. Spine 23:1804–1806PubMedCrossRefGoogle Scholar
  30. 30.
    Vaccaro AR, Lawrence JP, Patel T, Katz LD, Anderson DG, Fischgrund JS et al (2008) The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis. Spine 33:2850–2862PubMedCrossRefGoogle Scholar
  31. 31.
    Vaidya R, Sethi A, Bartol S, Jacobson M, Coe C, Craig JG (2008) Complications in the use of rhBMP-2 in PEEK cages for interbody spinal fusions. J Spinal Disord Tech 21:557–562PubMedCrossRefGoogle Scholar
  32. 32.
    Wen CE, Mabuchi M, Yamada Y, Shimojima K, Chino Y, Asahina T (2001) Processing of biocompatible porous Ti and Mg. Scripta Mater 45:1147–1153CrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Shunsuke Fujibayashi
    • 1
  • Mitsuru Takemoto
    • 1
  • Masashi Neo
    • 1
  • Tomiharu Matsushita
    • 2
  • Tadashi Kokubo
    • 2
  • Kenji Doi
    • 3
  • Tatsuya Ito
    • 4
  • Akira Shimizu
    • 4
  • Takashi Nakamura
    • 1
  1. 1.Department of Orthopedic Surgery, Graduate School of MedicineKyoto UniversityKyotoJapan
  2. 2.Department of Biomedical Sciences, College of Life and Health SciencesChubu UniversityKasugaiJapan
  3. 3.Osaka Yakin Kogyou Co.,LtdMikiJapan
  4. 4.Department of Experimental Therapeutics, Translational Research CenterKyoto University HospitalKyotoJapan

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