Study to Evaluate the Safety and Effectiveness of DISC Care Device in Preventing Lumbar Disc Herniation Recurrence After Surgery

What this Trial Is About

This clinical investigation aims to evaluate DISC Care, a device designed to prevent lumbar disc herniation from recurring in patients who have undergone lumbar disc hernia surgery. The study focuses on assessing whether the DISC Care implant can reduce the chance of herniation recurrence and whether it is a safe device to use. Participants will be adults between 18 and 75 years old with confirmed posterolateral disc hernias and specific clinical features. Participants will receive the DISC Care implant during surgery to prevent further disc herniation. After implantation, they will be followed for two years with a total of seven visits scheduled to monitor their progress. The study includes regular assessments at 6 weeks, 6 months, 12 months, and 24 months to evaluate safety, device performance, pain levels, disability, neurological status, disc condition, and costs related to the condition and treatment. During the study, participants will undergo clinical evaluations, imaging scans such as CT or MRI, and questionnaires to assess pain and quality of life. Researchers will monitor for any adverse events or complications and measure if the disc height is maintained and if there is any recurrence of herniation. Participants will be regularly checked for leg and back pain changes, neurological health, and disability related to their back condition. The study involves detailed follow-up and safety monitoring over the full two-year period after implantation.

Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence