National FDA Study Compares Devices for Treatment of Two-Level Symptomatic Cervical Disc Disease
I am excited to announce that The Anand Spine Group is participating in an Investigational Device Exemption (IDE) study – monitored by the Food and Drug Administration (FDA) and sponsored by West Chester, PA-based, Centinel Spine, LLC – evaluating two different cervical total disc replacement (TDR) devices.
We are one of many investigators throughout the U.S. taking part in the study comparing the prodisc C Vivo and prodisc C SK devices with an FDA-approved TDR device in order to validate their safety and effectiveness for the treatment of two-level symptomatic cervical disc disease (SCDD). The prodisc C Vivo product has been used since 2009, and is the most frequently implanted TDR product outside of the United States. The prodisc C SK implant is a variation of the prodisc C Nova device, an implant successfully used outside of the United States since 2010.
This an important study because it enables surgeons to select the most efficacious TDR implant that best matches the patient’s anatomy. As a result, we can potentially optimize clinical outcomes and preserve spinal motion with arthroplasty. We hope that this study will provide us the scientific data needed to support the continued use of these TDR devices that aim to correct patients’ underlying spinal conditions while helping to restore their range of motion.
Study participants must be between the ages of 18 and 69 who are experiencing intractable radiculopathy of the neck (arm pain and/or neurological deficit) with or without neck pain. These symptoms could be signs of SCDD or other potential spinal conditions.
Patients can learn more about the cervical total disc replacement study by calling our office at (310) 423-9779.
