Neurosurgery
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The US Food and Drug Administration allows a previously unapproved device to be used clinically to collect safety and effectiveness data under their Investigational Device Exemption (IDE) category. The process usually falls under 3 different trial categories: noninferiority, equivalency, and superiority. To confidently inform our patients, understanding the basic concepts of these trials is paramount. The purpose of this manuscript was to provide a comprehensive review of these topics using recently published IDE trials and economic analyses of cervical total disc replacement as illustrative examples. ⋯ While large Food and Drug Administration IDE studies are often besieged by complex statistical considerations and calculations, it is fundamentally important that clinicians understand at least the terminology and basic concepts on a practical level.
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The relationship between calcification in primary plaque and restenosis after carotid endarterectomy (CEA) has been seldom investigated. ⋯ Carotid plaque calcification may be inversely associated with recurrent stenosis 1 year after CEA or later. Preoperative CT assessment for less calcification will benefit restenosis patients by early prediction and close follow-up.