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Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc-L Total Disc Replacement Compared with Circumferential Arthrodesis for the Treatment of Two-Level Lumbar Degenerative Disc Disease by Rick Delamarter, Jack E. Zigler, Richard A. Balderston, Frank P. Cammisa, Jeffrey A. Goldstein, and Jeffrey M. Spivak J Bone Joint Surg Am Volume 93(8):705-715 April 20, 2011 ©2011 by The Journal of Bone and Joint Surgery, Inc.

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Page 1: Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc-L Total Disc Replacement Compared

Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of

the ProDisc-L Total Disc Replacement Compared with Circumferential Arthrodesis for the Treatment of Two-Level

Lumbar Degenerative Disc Disease

by Rick Delamarter, Jack E. Zigler, Richard A. Balderston, Frank P. Cammisa, Jeffrey A. Goldstein, and Jeffrey M. Spivak

J Bone Joint Surg AmVolume 93(8):705-715

April 20, 2011

©2011 by The Journal of Bone and Joint Surgery, Inc.

Page 2: Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc-L Total Disc Replacement Compared

Flow diagram of the study design.

Rick Delamarter et al. J Bone Joint Surg Am 2011;93:705-715

©2011 by The Journal of Bone and Joint Surgery, Inc.

Page 3: Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc-L Total Disc Replacement Compared

Lateral radiographs of the lumbar spine of a thirty-eight-year-old man, made twenty-four months after treatment with the ProDisc-L total disc replacement at L3-L4 and L4-L5.

Rick Delamarter et al. J Bone Joint Surg Am 2011;93:705-715

©2011 by The Journal of Bone and Joint Surgery, Inc.

Page 4: Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc-L Total Disc Replacement Compared

Line graph showing the percentage of patients using narcotics for each surgical treatment over time.

Rick Delamarter et al. J Bone Joint Surg Am 2011;93:705-715

©2011 by The Journal of Bone and Joint Surgery, Inc.