Texas Spine Care Center in San Antonio has enrolled its 10th patient in a trial comparing the safety and effectiveness of Centinel Spine's disc replacement products to a similar FDA-approved product.
The multicenter, prospective, randomized controlled trial compares Centinel's Prodisc C SK and Prodisc C Vivo to Zimmer Biomet's Mobi-C cervical disc in the treatment of two-level symptomatic cervical disc disease, Texas Spine Care and Centinel said in a May 24 news release. The Prodisc models being tested are built on the Prodisc technology platform, the world's most widely used total disc replacement system.
Prodisc technology has been used in over 125,000 device implants worldwide in the last 30 years, and the trial is testing the devices to earn FDA approval for multilevel use in the U.S.
The trial's patients will be evaluated before surgery and two weeks, six weeks, three months, six months, one year and two years after surgery. After the two-year evaluation, the patients will potentially be asked to return for annual evaluations for seven years.
The goal is to enroll approximately 20 patients at Texas Spine Care Center out of 390 study participants overall.
More information about the trial can be found here.