Centinel Spine Clinical Study for Total Disc Replacement for 2-Level Symptomatic Cervical Disc Disease
By Admin | May 22, 2022
SAN ANTONIO, May 24, 2022 - Texas Spine Care Center announced today their 10th patient enrolled 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. The prodisc C Vivo 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 multilevel use.
We are excited at Texas Spine Care Center to provide cutting edge technologies to our patients. These investigational implants allow for greater flexibility in the operating room to select the disc replacement that best fits an individual patient's anatomy.
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...(More)
For more info please read, Centinel Spine Clinical Study for Total Disc Replacement for 2-Level Symptomatic Cervical Disc Disease, by PR Newswire