Retrospective chart review of patients treated with prodisc® C Vivo at 2 contiguous levels.

Prospective follow-up of patients treated with prodisc® C Vivo at 2 contiguous levels.

The prodisc® C Vivo device is a non-keeled cervical disc replacement prosthesis. The device is modular intervertebral disc prostheses designed to replace a diseased and/or a degenerated disc of the cervical spine in SCDD patients, thereby restoring disc height, biomechanical stability and allowing the potential for motion at the affected vertebral segment.

The primary objective of the study is to evaluate the post-operative performance of the prodisc® C Vivo after implantation by the occurrence of secondary surgical interventions in patients treated with prodisc® C Vivo at 2 levels. The State of the Art (SOTA) will be used as the comparison data collected in this study.

Nominal variables will be presented as count (percent). For numerical variables, the results will be presented as minimum, 25th percentile, mean, standard deviation, median, 75th percentile and maximum. Frequency tables for system organ class and preferred terms will be compiled based on participants experiencing an ADE (Adverse Device Event), and on the number of ADEs (from initial surgery to present, including intraoperative and post-operative complications). These percentage variables will include multiple data collection factors, such as the number and proportions of patients with no secondary surgical interventions (SSIs) (revision, removal, re-operation, supplemental fixation) at the index level(s) from initial surgery to present, Patient Reported Outcome (PRO) assessments, and self-assessment of Health Surveys (SF 12).