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Review
. 2005 Jul;36(3):301-13.
doi: 10.1016/j.ocl.2005.03.004.

Clinical results of ProDisc-II lumbar total disc replacement: report from the United States clinical trial

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Review

Clinical results of ProDisc-II lumbar total disc replacement: report from the United States clinical trial

Rick B Delamarter et al. Orthop Clin North Am. 2005 Jul.

Abstract

The much-awaited clinical use of lumbar artificial discs has begun in the United States. The United States Investigational Device Exemption (US IDE) clinical trial of the ProDisc-II prosthetic disc (Synthes, Paoli, PA) was recently completed, with all indications that it meets or surpasses the test of equivalence against fusion controls. This is a review of the clinical performance of the ProDisc-II artificial disc and includes an interim report from the US IDE trial at one site.

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