Bad Wildungen

Researchers are evaluating the long-term safety and performance of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device designed to treat low-back pain caused by degenerative lesions of grades II, III, and IV according to the Pfirrmann MRI classification. This post-market surveillance study involves a device that has already received CE certification and is commercially available in Europe. The study is sponsored by BACKBONE, the device's designer and manufacturer, aiming to document clinical outcomes after lumbar dynamic stabilization surgery using the LISA implant. The LISA device includes three parts: a PEEK interspinous spacer placed between two adjacent spinous processes, a polyester band wrapped around the spinous processes and through the spacer, and a titanium blocker that locks the band inside the spacer. The study focuses on patients undergoing surgery with this device to treat lumbar degenerative disease. No additional treatment groups or comparators are described. Participants will be assessed over a two-year period following surgery, with primary outcomes including the implant survival rate defined by successful implantation without the need for reoperation, revision, or removal, as well as changes in the Oswestry Disability Index (ODI) from before surgery to 1-year and 2-year follow-ups. Researchers will monitor safety and performance through these clinical evaluations to ensure the device's long-term effectiveness and safety.