Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis: Open-label Multicenter Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the long-term clinical outcomes of two surgical approaches for patients with single-level lumbar spinal stenosis: spinal decompression alone versus spinal decompression combined with fusion. This trial aims to provide clear evidence on whether spinal fusion is necessary following decompression surgery. The study will also compare the economic impact of these treatments over a two-year period after surgery. Participants will be randomly assigned to one of two groups: minimally invasive decompression without fusion or minimally invasive decompression followed by transforaminal interbody fusion with cage placement and pedicle screw fixation. In the decompression group, important spinal structures like the spinous process and ligaments are preserved. Follow-up assessments will occur at 3, 6, 12, and 24 months post-surgery. During the study, participants will undergo evaluations including the Oswestry Disability Index to measure disability, as well as quality of life and pain assessments using SF-36, EQ-5D-5L, and various psychological scales. Researchers will also monitor spinal alignment, fusion quality, treatment costs, and hospital stay duration. The total study period lasts 24 months, during which participants will attend scheduled follow-up visits for comprehensive monitoring and data collection.

Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis