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A preclinical large animal study on a novel intervertebral fusion cage covered with high porosity titanium sheets with a triple pore structure used for spinal fusion

European Spine Journal volume 24, pages 2530–2537 (2015)Cite this article

Abstract

Purpose

To evaluate the osteoconductivity and the bonding strength of the newly developed interbody cage covered with the porous titanium sheet (porous Ti cage) to vertebral bodies in a sheep model.

Methods

Twelve sheep underwent anterior lumbar interbody fusion at L2–3 and L4–5 using either the new porous Ti cages (Group-P) or conventional Ti cages with autogenous iliac bone (Group-C). The animals were euthanized at 2 or 4 months postoperatively and subjected to radiological, biomechanical, and histological examinations.

Results

Computed tomography analyses showed that the ratio of bone contact area in Group-P was significantly increased at 4 months compared with that at 2 months (p = 0.01). Although the ratio of bone contact area in Group-C was significantly higher than Group-P at 2 months (p < 0.001), there was no statistically significant difference between the two groups at 4 months. Biomechanical test showed that there was no significant difference in bonding strength between the two groups at either 2 or 4 months. Histological analyses revealed that the bone apposition ratio increased significantly with time in Group-P (p < 0.001). Although Group-C showed significantly higher bone apposition ratio than Group-P at 2 months (p = 0.001), there was no statistical difference between the two groups at 4 months.

Conclusions

There was bone ingrowth into the porous Ti sheet, and bonding capacity of the porous Ti cage to the host bone increased with time. However, the speed of union to the bone with a porous Ti cage was marginally lower than a conventional cage along with an autogenous bone graft. Although it needs further experiment with a larger sample size, the results of the current study suggested that this material could achieve interbody fusion without the need for bone grafts.

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Acknowledgments

We thank Toshio Matsumoto, B.S. and Takehiko Nakajima, B.S., HOYA Pentax Co., for their technical support and providing Ti porous materials and downsized intervertebral spacers for the animals. Furthermore, we thank Ken Nagahama, M.D., Ph.D. for his support in performing the surgery and to Fumio Sasazawa, M.D., Ph.D for capturing CT images. This study was supported by HOYA Pentax Co., Start-up Grant of Northern Advancement Center for Science & Technology, and Strategic Promotion of Innovative Research and Development, Japan Science and Technology Agency.

Conflict of interest

Manabu Ito has received research grants from HOYA-Pentax, Co., Robert-Reid, Inc and Century-Medical, Co., and is a board member of AOSpine Knowledge Forum. Toru Yamamoto has received endowments from Mizuho Ikakogyo, Co., Ltd. The other authors declare that they have no conflict of interest.

Author information

Affiliations

  1. Department of Orthopedic Surgery, Graduate School of Medicine, Hokkaido University, North-15, West-7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan

    Katsuhisa Yamada & Norimasa Iwasaki

  2. Department of Spine and Spinal Cord Disorders, National Hospital Organization, Hokkaido Medical Center, Sapporo, Japan

    Manabu Ito

  3. Industrial Research Institute, Industrial Technology Research Development, Hokkaido Research Organization, Sapporo, Japan

    Toshiyuki Akazawa

  4. Department of Oral and Maxillofacial Surgery, School of Dentistry, Health Sciences University of Hokkaido, Tobetsu-cho, Japan

    Masaru Murata

  5. Division of Biomedical Engineering and Science, Faculty of Health Sciences, Hokkaido University, Sapporo, Japan

    Toru Yamamoto

Authors
  1. Katsuhisa Yamada
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  2. Manabu Ito
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  3. Toshiyuki Akazawa
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  4. Masaru Murata
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  5. Toru Yamamoto
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  6. Norimasa Iwasaki
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Corresponding author

Correspondence to Katsuhisa Yamada.

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Yamada, K., Ito, M., Akazawa, T. et al. A preclinical large animal study on a novel intervertebral fusion cage covered with high porosity titanium sheets with a triple pore structure used for spinal fusion. Eur Spine J 24, 2530–2537 (2015). https://doi.org/10.1007/s00586-015-4047-2

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  • DOI: https://doi.org/10.1007/s00586-015-4047-2

Keywords

  • Biomaterial
  • Intervertebral cage
  • Porous titanium
  • Bone ingrowth
  • Interbody fusion