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dc.contributor.authorFujibayashi, Shunsukeja
dc.contributor.authorTakemoto, Mitsuruja
dc.contributor.authorNeo, Masashija
dc.contributor.authorMatsushita, Tomiharuja
dc.contributor.authorKokubo, Tadashija
dc.contributor.authorDoi, Kenjija
dc.contributor.authorIto, Tatsuyaja
dc.contributor.authorShimizu, Akiraja
dc.contributor.authorNakamura, Takashija
dc.contributor.alternative藤林, 俊介ja
dc.date.accessioned2012-02-06T07:55:24Z-
dc.date.available2012-02-06T07:55:24Z-
dc.date.issued2011-09ja
dc.identifier.issn0940-6719ja
dc.identifier.urihttp://hdl.handle.net/2433/152450-
dc.description.abstractThe 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.ja
dc.format.mimetypeapplication/pdfja
dc.language.isoengja
dc.publisherSpringer-Verlagja
dc.rightsThe final publication is available at www.springerlink.comja
dc.rightsこの論文は出版社版でありません。引用の際には出版社版をご確認ご利用ください。This is not the published version. Please cite only the published version.ja
dc.subjectPorous titanium metalja
dc.subjectSpinal fusionja
dc.subjectBiomaterialja
dc.subjectClinical trialja
dc.subject.meshAdultja
dc.subject.meshFemaleja
dc.subject.meshHumansja
dc.subject.meshLumbar Vertebrae/surgeryja
dc.subject.meshMaleja
dc.subject.meshMiddle Agedja
dc.subject.meshPain Measurementja
dc.subject.meshPatient Satisfactionja
dc.subject.meshProspective Studiesja
dc.subject.meshSpinal Fusion/instrumentationja
dc.subject.meshSpinal Fusion/methodsja
dc.subject.meshSpondylolisthesis/surgeryja
dc.subject.meshTitaniumja
dc.subject.meshTreatment Outcomeja
dc.titleA novel synthetic material for spinal fusion: a prospective clinical trial of porous bioactive titanium metal for lumbar interbody fusionja
dc.type.niitypeJournal Articleja
dc.identifier.ncidAA10852035ja
dc.identifier.jtitleEuropean spine journalja
dc.identifier.volume20ja
dc.identifier.issue9ja
dc.identifier.spage1486ja
dc.identifier.epage1495ja
dc.relation.doi10.1007/s00586-011-1728-3ja
dc.textversionauthorja
dc.identifier.pmid21369760ja
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