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Title: A novel synthetic material for spinal fusion: a prospective clinical trial of porous bioactive titanium metal for lumbar interbody fusion
Authors: Fujibayashi, Shunsuke  kyouindb  KAKEN_id
Takemoto, Mitsuru
Neo, Masashi
Matsushita, Tomiharu
Kokubo, Tadashi
Doi, Kenji
Ito, Tatsuya  kyouindb  KAKEN_id
Shimizu, Akira  kyouindb  KAKEN_id
Nakamura, Takashi
Author's alias: 藤林, 俊介
Keywords: Porous titanium metal
Spinal fusion
Clinical trial
Issue Date: Sep-2011
Publisher: Springer-Verlag
Journal title: European spine journal
Volume: 20
Issue: 9
Start page: 1486
End page: 1495
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.
Rights: The final publication is available at
This is not the published version. Please cite only the published version.
DOI(Published Version): 10.1007/s00586-011-1728-3
PubMed ID: 21369760
Appears in Collections:Journal Articles

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