evelopment of innovative evaluation method based on the minimum guarantee strength of combination medical device
| Project/Area Number |
17K13041
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Multi-year Fund |
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| Research Field |
Medical engineering assessment
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| Research Institution | University of Tsukuba |
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Principal Investigator |
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| Research Collaborator |
Ito Atsuo
Mutsuzaki Hirotaka
Hashimoto Koichi
Fujii Kengo
Yanagisawa Yohei
Matsumoto Yukei
Nagashima Katsuya
Sogo Yu
Kobayashi Fumiko
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| Project Period (FY) |
2017-04-01 – 2019-03-31
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| Project Status |
Completed (Fiscal Year 2018)
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| Budget Amount *help |
¥3,900,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥900,000)
Fiscal Year 2018: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2017: ¥3,120,000 (Direct Cost: ¥2,400,000、Indirect Cost: ¥720,000)
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| Keywords | コンビネーション医療機器 / ワイブル解析 / FGF-2 / ハイドロキシアパタイト / トモシンセシス / 医療・福祉 / トランスレーショナルリサーチ / Weibull解析 / 椎弓根スクリュー |
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| Outline of Final Research Achievements |
Towards practical use of fibroblast growth factor-2 slow release hydroxyapatite-coated pedicle screw for cervical spine, we tried to develop a new evaluation method incorporating Weibull analysis in order to demonstrate ‘reduction of occurrence of implant loosening’.
At first, our mechanical test by animal study showed the effectiveness of Ap-FGF coating. Second, our retrospective investigation of clinical cases has collected information on adverse events with conventional cervical pedicel screw. We could not get the construction of a radiological evaluation using Weibull analysis. Although retrospective investigation of clinical cases has collected information on adverse events with conventional products, it has been difficult to measure quantitatively with the continuous variable of the parameter on loosening. As a proposal of the solution, we did a preliminary evaluation of the tomosynthesis images.
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| Academic Significance and Societal Importance of the Research Achievements |
開発品の開発コンセプトである「骨固定不良（インプラント弛み）の発生低減」を示す場合、平均発生率を比較するt検定等の従来型統計手法は、膨大なN数を要し、このような低確率事象への適用には不向きであり、臨床試験で検証するには大規模臨床試験を要する。不具合の平均発生率ではなく、測定強度値の分布から低強度の不良品の発生確率を求めるWeibull統計法を用いることで、比較的少ないN数で最低保証強度や強度信頼性を検証できるのではないかと着想した。つまり、X線やCT画像等を用いた放射線学的解析にWeibull解析を取り入れた評価法を開発することで、低確率事象の解析法構築の先駆けとなり得ると考えた。
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Report
(3 results)
Research Products
(6 results)
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[Journal Article] Implant failure of pedicle screws in long-segment posterior cervical fusion is likely to occur at C7 and is avoidable by concomitant C6 or T1 buttress pedicle screws.2019
Author(s)
Nagashima K, Koda M, Abe T, Kumagai H, Miura K, Fujii K, Noguchi H, Funayama T, Miyamoto T, Mannoji C, Furuya T, Yamazaki M.
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Journal Title
Journal of Clinical Neuroscience
Volume: 63
Pages: 106-109
DOI
Related Report
Peer Reviewed
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