The Anand Spine Group is proud to announce that it is an investigator in the Centinel Spine, LLC, Multicenter, 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).
The prodisc® products being used in the trial are built on the prodisc® technology platform, the most widely used Total Disc Replacement system in the world. No other disc replacement system has been studied more, with over 13,000 patients reported on in more than 540 articles over a global clinical usage period of over 30 years. The prodisc technology has been validated with over 125,000 device implantations and a reported reoperation rate of less than 1%. The prodisc C Vivo has been used outside the US for over 10 years, and the prodisc CSK device is an evolution of the original prodisc C with a smaller keel design.
The Mobi-C (Zimmer Biomet) is FDA approved for 1- and 2-level use. The prodisc® systems are being investigated for approval by the FDA for multilevel use.
Enrolled patients will be evaluated before surgery as well as after surgery (2 and 6 weeks, 3-, 6-, 12- and 24 months) with each visit taking approximately 1-2 hours. After the 2-year visit, patients may be asked to return annually for follow-up visits up to 7 years. Approximately 20 patients will be included in the study at The Anand Spine Group with a minimum of 390 in the study overall. Patients with appropriate indications should review their condition with their doctor to determine if involvement in the clinical trial is appropriate. To discuss your eligibility, please contact us at 310-423-9779.
For additional information on the clinical trial, including inclusion/exclusion criteria, please visit Clinical Research Trials, Los Angeles, CA (infospine.net) and 2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C – Full Text View – ClinicalTrials.gov.