05/13/2022
Centinel Spine Clinical Study for Total Disc Replacement for 2-Level Symptomatic Cervical Disc Disease
Buffalo, NY 5/13/2022 – Axis Neurosurgery & Spine announced today their involvement as investigators 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 540 published papers across a global clinical usage period of 30+ years. The prodisc technology has been validated with over 225,000 device implantations and a reported reoperation rate of less than 1%. The prodisc C Vivo system has been used outside the US for over 10 years, and the prodisc C SK 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 2-level use.
Enrolled patients will be evaluated before surgery, as well as after surgery (at 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 for up to 7 years. Approximately 20 patients will be included in the study at Axis Neurosurgery & Spine, 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, contact Axis Neurosurgery & Spine at 716-634-3500
For additional information on the clinical trial, including inclusion/exclusion criteria, please visit https://clinicaltrials.gov/ct2/show/NCT04012996 or visit https://www.axisneurosurgery.com/
Ryan DenHaese, M.S. M.D., FAANS
Board Certified Neurosurgeon
About Centinel Spine, LLC
Centinel Spine®, LLC is a leading global medical device company addressing cervical and lumbar spinal disease through anterior surgical access. The company offers a continuum of trusted, brand-name, motion-preserving and fusion solutions backed by over 30 years of clinical success—providing the most robust and clinically-proven technology platforms in the world for total disc replacement (prodisc®) and Integrated Interbody™ fusion (STALIF®).
Centinel Spine continues to advance its pioneering culture and corporate mission to become a catalyst of change in the spine industry and alter the way spine surgery is perceived. Centinel Spine remains the only company with comprehensive motion-preserving and fusion solutions for both cervical and lumbar anterior column reconstruction.
