Investigators of this study found clinical outcomes at 2-year and 5-year follow-up were not better in patients with lumbar spinal stenosis who underwent decompression surgery with fusion compared with the outcomes for patients who underwent decompression alone.
Researchers performed a multicenter, clinical superiority trial for 247 patients with lumbar spinal stenosis either with or without degenerative spondylolisthesis. Investigators randomly assigned 123 patients to undergo decompression surgery with fusion and 124 patients underwent decompression surgery alone. The randomization was stratified with regard to the presence of preoperative degenerative spondylolisthesis.
Investigators used patient-reported outcomes from the National Swedish Register for Spine Surgery and the Zurich Claudication Questionnaire, a 6-minute walk test and a health economic evaluation to assess patients’ outcomes. The Oswestry Disability Index (ODI) 2 years postoperatively was the primary study outcome.
Results showed no significant differences between groups with regard to mean ODI score at 2 years postoperatively or outcomes for the 6-minute walk test. Investigators noted patients with or without spondylolisthesis had similar outcomes after 2 years.
Researchers found no significant differences in clinical outcomes between the treatment groups for patients with 5-year follow-up visits. The mean length of hospitalization for patients who underwent fusion and decompression vs. decompression surgery alone was 7.4 days and 4.1 days, respectively. Patients who underwent fusion and decompression had longer operating times, a greater amount of bleeding and higher surgical costs than patients who underwent decompression alone. Additional lumbar spine surgery was needed at a mean follow-up of 6.5 years in 22% of patients who underwent fusion and decompression and in 21% of patients who underwent decompression alone. ‒ by Monica Jaramillo
Disclosures: The study was supported by Avtal om Läkarutbildning och Forskning (Agreement concerning Cooperation on Medical Education and Research) between Uppsala University and Uppsala County Council and by the Stockholm Spine Center. Johnson & Johnson also provided financial support for the health economic analysis.