Long-Term Study of the LISA Implant for Treating Low-Back Pain Due to Degenerative Lumbar Disease Using Lumbar Dynamic Stabilization Surgery

What this Trial Is About

Researchers are evaluating the Lumbar Implant for Stiffness Augmentation LISA, a medical device designed to treat low-back pain caused by degenerative lesions classified as grades II, III, and IV by Pfirrmann MRI. This post-market surveillance study aims to assess the long-term safety and performance of the LISA implant, which has already received CE certification and is used commercially in Europe. The study is sponsored by BACKBONE, the devices developer and manufacturer. The LISA implant consists of 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 observes patients who undergo lumbar dynamic stabilization surgery using the LISA implant. It documents surgical details such as surgery duration, blood loss, and hospitalization time. Follow-ups occur at multiple points up to 72 months after surgery to monitor implant survival, complications, and patient outcomes. Participants will be assessed before surgery and at various intervals after surgery, including 3, 6, 12, 24, 48, and 72 months. Evaluations include clinical questionnaires like the Oswestry Disability Index and Visual Analogue Scale for back and leg pain, radiological assessments of the spine, and monitoring for device-related complications or reoperations. Researchers will track patient satisfaction and surgeon assessments while collecting data on recovery times and the implants long-term performance. The study continues until December 2028 to gather comprehensive safety and effectiveness information.

LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant