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腰椎全関節置換のための研究装置特例研究設計にリアルワールド証拠を統合するための視点

PMID: 41839575 · 2026-05-04

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学術誌International journal of spine surgery

年2026-05-04

PMID41839575

抄録

Investigational device exemption (IDE) studies for spine technologies have evolved significantly since the early 2000s, when traditional randomized controlled trials (RCTs) established a specific regulatory framework for lumbar total disc replacement. Modern clinical trial designs are pragmatic and can address escalating costs (lumbar fusion costs increased 177% between 2004 and 2015), patient enrollment challenges, and evolving regulatory acceptance of alternative evidence standards. Following

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