Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single level degenerative cervical radiculopathy: Two- year results of an FDA investigational device exemption study
Various designs of total disc replacement (TDR) devices have been compared to ACDF with favorable outcomes in FDA-approved investigational device exemption (IDE) trials. The design of M6-C with a compressible viscoelastic nuclear core and an annular structure is substantially different than prior designs and has previously demonstrated favorable kinematics and clinical outcomes in small case series.
Source: The Spine Journal - Category: Orthopaedics Authors: Frank M. Phillips, Domagoj Coric, Rick Sasso, Todd Lanman, William Lavelle, Scott Blumenthal, Carl Lauryssen, Richard Guyer, Todd Albert, Jack Zigler, Frank Cammisa, Robert Alden Milam Tags: Clinical Study Source Type: research