A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemptions Study of Lumbar Total Disc Replacement With the CHARITÉ™ Artificial Disc Versus Lumbar Fusion

L. Blumenthal, Scott; C. McAfee, Paul; D. Guyer, Richard; H. Geisler, Fred; T. Holt, Richard; García, Rolando; J. Regan, John; D. Ohnmeiss, Donna

doi:10.1097/01.brs.0000170587.32676.0e

Public

A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemptions Study of Lumbar Total Disc Replacement With the CHARITÉ™ Artificial Disc Versus Lumbar Fusion

Published in Spine • Jul 1, 2005

Authors:

Scott L. Blumenthal

Paul C. McAfee

Richard D. Guyer

Abstract

STUDY DESIGN: A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. OBJECTIVES: The purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement, using the CHARITE artificial disc (DePuy S...

Subject

Medicine

Oswestry Disability Index

Investigational device exemption

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