Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study

Launched by AZIENDA USL DI BOLOGNA · Mar 21, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two types of surgery for people with lumbar degenerative disease, specifically focusing on conditions like lumbar spinal stenosis. The trial aims to determine which surgical approach—decompression alone or decompression with fusion—works better and to identify factors that might predict the success of the surgery. Researchers want to help patients with ongoing pain and limited mobility who haven't found relief from other treatments.

To participate in this study, you need to be between 65 and 74 years old and have specific types of lumbar stenosis. This includes narrowing of the spinal canal due to age-related changes in the spine, which is causing you ongoing symptoms for at least 12 weeks. You should not have any significant spinal instability or prior spinal surgeries. If you join the trial, you will receive one of the surgical treatments and be monitored to see how well it helps your symptoms. Your participation could contribute to understanding the best surgical options for people with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • degenerative lumbar stenosis caused by bone hypertrophy, osteoarthritis of facet joints, ligamentous hypertrophy, disc protrusion
• • midsagittal spinal canal diameter of 12 mm or less
• • no radiological signs of instability, i.e. pathological motion on preoperative dynamic lumbar X-ray
• • ongoing symptoms for a minimum of 12 weeks with no improvement to conservative treatment
• • eligibility for decompression alone (MiD) or decompression and fusion (MiD+F)
• Exclusion Criteria:
• • congenital, traumatic, infectious and neoplastic lumbar stenosis,
• • spondylolisthesis (on static X-ray), lumbar scoliosis (Cobb\>10°),
• • previous lumbar surgery, other types of operations (endoscopic decompression, anterior interbody fusions, interspinous devices etc.).
• • patients with spine deformity requiring long fusion (i.e. \>=3 levels)