CONDITIONS TREATED: Cervical Disc Disease
This investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD). Subjects will be randomized in a 2:1 ratio to the one-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the one-level Mobi-C® Cervical Disc (control group). Subjects enrolled in the study will be evaluated pre-operatively, at the time of surgery, discharge, and at 6 weeks, 3, 6, 12, and 24 months and then annually until 7 years post-surgery.
Status: Actively Enrolling New Study Participants
Site Principal Investigator: Ali Araghi, DO
Clinical Study Partner: The CORE Institute
OFFICIAL TITLE: A Multicenter, Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of the BAGUERA C Cervical Disc Prosthesis to the Mobi-C® Cervical Disc for the Treatment of Patients With Symptomatic Cervical Disc Disease at a Single Level
INTERVENTION / TREATMENT
Device: BAGUERA®C Cervical Disc Prosthesis
Device: Mobi-C® Cervical Disc
Link to Clinicaltrials.gov listing: https://clinicaltrials.gov/study/NCT04520776
