Comparison of Vertebropexy Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial

What this Trial Is About

The trial investigates the treatment of degenerative lumbar spinal disease, focusing on the need for additional fusion surgery compared to the risk of revision surgery. It evaluates a new ligamentous fixation technique called vertebropexy, which aims to stabilize the spine without immobilizing segments, potentially reducing complications common with traditional spinal fusion. This randomized controlled trial seeks to produce convincing long-term results to support vertebropexy as an alternative to established surgeries like decompression and fusion. Participants receive one of several surgical procedures. These include microsurgical lumbar laminotomy with partial facet joint removal while preserving midline structures, decompression combined with vertebropexy using ligament allografts or sutures, and decompression with instrumented fusion using pedicle screws and fusion devices. The choice of procedure depends on the patient's condition. The trial compares vertebropexy with conventional decompression or fusion surgery. During the study, participants are monitored for two years after surgery. Researchers assess disability using the Oswestry Disability Index, pain levels, symptom function, satisfaction, quality of life, revision surgeries, complications, surgery duration, blood loss, hospital stay length, and use of analgesia and physical therapy. These evaluations help determine the effectiveness and risks of vertebropexy versus standard treatments, with a total follow-up extending up to two years post-operation.

Vertebropexy - Randomized-controlled Trial