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Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc

Richard T. Holt, Mohammed E. Majd, Jorge Isaza, Scott L. Blumenthal, Paul C. McAfee, Richard D. Guyer, Fred Harden Geisler, Rolando García, John J. Regan

Open publisher page 17 citations

Abstract

Background Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charite artificial disc represents the first level I data comparison of TDR to fusion.

About this research paper

What this paper is about

Background Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charite artificial disc represents the first level I data comparison of TDR to fusion.

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OpenAlex reports 17 citations for this work. Citation counts describe recorded attention and do not establish research quality.

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Available abstract

Background Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charite artificial disc represents the first level I data comparison of TDR to fusion.

Key concepts: Investigational device exemption, Food and drug administration, Medicine, Lumbar, Surgery, Pharmacology

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Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc — Research Paper | ScholarLens