Cervical total disc replacement (cTDR) in properly indicated patients with single-level cervical disc pathology has been demonstrated to achieve satisfactory neural decompression and clinical outcomes equivalent to or better than anterior cervical discectomy and fusion (ACDF) in 7 different prospective, randomized, controlled US FDA trials.

This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. Clinical outcomes at up to 60 months were evaluated, including validated outcome measures, incidence of reoperation, and adverse events. The complete study data and methodology were critically reviewed by 3 independent surgeon authors without affiliation with the IDE study or financial or institutional bias toward the study sponsor.

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