Long-term Study Comparing Reoperation Rates After Micro-decompression Alone Versus Decompression with Fusion in Adults with Lumbar Spinal Stenosis and Degenerative Spondylolisthesis

What this Trial Is About

This research focuses on patients with degenerative lumbar spinal stenosis and degenerative spondylolisthesis, conditions causing severe, persistent pain and disability due to narrowing of the spinal canal. The study investigates the long-term need for reoperations comparing two surgical approaches micro-decompression alone versus decompression combined with instrumented fusion. This is a long-term follow-up observational study aiming to clarify concerns about whether additional fusion surgery reduces the risk of further operations and to address the ongoing debate in spine surgery practices. Participants underwent surgery between September 2007 and December 2015, either with a midline-preserving micro-decompression alone or with decompression followed by an instrumented fusion, sometimes including a cage. The study uses data from the Norwegian registry for spine surgery NORspine and the Norwegian Patient Registry to track reoperations up to 16 years after the initial surgery. Researchers will compare the frequency and timing of reoperations, complications, and risk factors between the two surgical methods. During the study, patient data collected at baseline, 3 months, 1 year, and long-term follow-up 7 to 15 years will be analyzed. Researchers will review health records to validate reoperation details and classify complications. The primary outcome is the rate of reoperations occurring more than 90 days after the initial surgery, assessed up to August 31, 2023. Secondary outcomes include early reoperation rates, hazard ratios, survival functions, and complications. Statistical analyses will help determine whether micro-decompression alone is not inferior to decompression with fusion regarding reoperation risk over 10 years.

Long-term Reoperations After Lumbar Spinal Stenosis Surgery