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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

2007; Elsevier BV; Volume: 1; Issue: 1 Linguagem: Inglês

10.1016/s1935-9810(07)70043-9

1935-9810

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

Anesthesia and Pain Management

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.