A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement.

Abstract

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