Comparing Vertebropexy Ligament Technique with Standard Decompression and Fusion Surgery for Degenerative Lumbar Spine Conditions in Adults

What this Trial Is About

The trial explores treatment options for degenerative lumbar spinal disease, focusing on comparing the need for additional fusion surgery against the risk of revision surgery. It evaluates the ligamentous fixation technique called vertebropexy, a newer approach aiming to stabilize the spine by reinforcing spinal segments with ligaments rather than rigid fixation. This randomized controlled trial seeks to determine whether vertebropexy offers long-term benefits compared to standard decompression or fusion surgeries. Participants will undergo one of several surgical procedures standard microsurgical lumbar laminotomy decompression preserving midline structures, decompression combined with vertebropexy using ligamentous allografts and suture materials, or decompression with posterolateral instrumented fusion involving pedicle screws, rods, and bone grafts. Vertebropexy procedures involve targeted ligament reinforcement to stabilize the spine without immobilization. The trial includes groups randomized to these different surgical approaches to assess outcomes. Participants will be followed for two years after surgery, with evaluations including disability assessments using the Oswestry Disability Index, pain scales, symptom and satisfaction measures, quality of life surveys, and tracking of revision surgeries and complications. Perioperative factors such as surgery duration, hospital stay length, and blood loss are also recorded. Use of analgesics and physical therapy will be monitored. The study aims to provide detailed information on the efficacy and risks associated with vertebropexy and standard surgical treatments for lumbar spinal disease, with overall participation lasting up to two years postoperatively.

Vertebropexy - Randomized-controlled Trial