The Journal of Bone and Joint Surgery (American). 2009;91:2748.
doi:10.2106/JBJS.9111.ebo579
© 2009 The Journal of Bone and Joint Surgery, Inc.
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Evidence-Based Orthopaedics

The ProDisc-C Total Disc Replacement System Was Effective for Symptomatic Cervical Disc Disease

Murrey D, Janssen M, Delamarter R, Goldstein J, Zigler J, Tay B, Darden B. Results of the Prospective, Randomized, Controlled Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc-C Total Disc Replacement Versus Anterior Discectomy and Fusion for the Treatment of 1-Level Symptomatic Cervical Disc Disease. Spine J. 2009 Apr;9:275-86.[CrossRef][Medline]

The first 150 words of the full text of this article appear below.


   Introduction
 
Question: In patients with symptomatic cervical disc disease, what is the safety and efficacy of the ProDisc-C total disc replacement system (Synthes, West Chester, PA) compared with anterior cervical discectomy and fusion?

Design: Randomized (allocation concealed), blinded (patients), controlled, noninferiority trial with 24-month follow-up (U.S. Food and Drug Administration [FDA] investigational device exemption study).

Setting: 13 investigational sites in the United States.

Patients: 209 patients between 18 and 60 years of age (mean age, 43 y; 55% women) with symptomatic cervical disc disease causing intractable, debilitating radiculopathy from 1 vertebral segment between C3 and C7. Patients were also unresponsive to nonoperative treatment for ≥6 weeks and had a neck disability index (NDI) score of ≥30%. Exclusion criteria included ≥1 vertebral level requiring treatment, marked cervical instability on resting lateral or flexion-extension radiographs, allergies to materials used in the procedures, previous surgery at the level to be treated, infection, . . . [Full Text of this Article]

Henry H. Bohlman, MD

Case Western Reserve University, Cleveland, Ohio


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