UN PERSPECTIVA PARA INTEGRAR EVIDENCIA DEL MUNDO REAL EN EL DISEÑO DE ESTUDIOS DE EXCEPCIÓN DE DISPOSITIVOS INVESTIGACIONALES PARA LA REEMPLAZO TOTAL DEarticulación lumbar.
PMID: 41839575 ·
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Resumen
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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