Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc®-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease

E. Zigler, Jack; B. Delamarter, Rick; M. Spivak, Jeffrey; Linovitz, Raymond; O. Danielson, Guy; Haider, Thomas; P. Cammisa, Frank; Zuchermann, Jim; Balderston, Richard; H. Kitchel, Scott; T. Foley, Kevin; G. Watkins, Robert; S. Bradford, David; J. Yue, James; A. Yuan, Hansen; N. Herkowitz, Harry; Geiger, Doug; A. Bendo, John; Peppers, Timothy; L. Sachs, Barton; P. Girardi, Federico; A. Kropf, Michael; Goldstein, Jeff

doi:10.1097/brs.0b013e318054e377

Public

Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc®-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease

Published in Spine • May 1, 2007

Authors:

Jack E. Zigler

Rick B. Delamarter

Jeffrey M. Spivak

Abstract

STUDY DESIGN: A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. OBJECTIVE: To evaluate the safety and effectiveness of the ProDisc-L (Synthes Spine, West Chester, PA) lumbar total disc replacement compared to circumferenti...

Subject

Investigational device exemption

Medicine

Oswestry Disability Index

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