A Multi-Center Prospective Randomized Controlled Trial Comparing the Safety and Effectiveness of prodisc C SK and prodisc C Vivo to Mobi-C Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)

Brief description of study

The purpose of this research study is to see if the prodisc C SK and prodisc C Vivo (cervical disc replacement devices) are safe and effective in the treatment of symptomatic cervical disc disease when compared against a similar total disc replacement device currently approved by the Food and Drug Administration (FDA). For this study, the “similar device” that currently has FDA approval and is on the market is the Mobi-C cervical disc replacement device (the “control” implant). Symptomatic cervical disc disease results when discs in the cervical spine breaks down after continued wear and tear. This wear and tear takes place because the discs that separate the vertebrae of the spine do not have the same blood supply as other parts of the body, so it is harder for them to get nutrients and they can become dehydrated. Consequently, when the discs become damaged they cannot heal and the damage gets worse with time. The study implants (prodisc C SK and prodisc C Vivo) are investigational implants, meaning the (FDA) has not approved them for commercial use, only for participants in this study.


Clinical Study Identifier: s18-00779
ClinicalTrials.gov Identifier: NCT04012996
Principal Investigator: Aaron James Buckland.


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