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Austevoll 2021 — NORDSTEN-DS at two years

One-paragraph summary

NORDSTEN-DS randomized patients with symptomatic stenosis and single-level degenerative spondylolisthesis ≥3 mm to decompression alone or decompression plus instrumented fusion. ODI improved by 20.6 and 21.3 points, respectively (difference 0.7; 95% CI −2.8 to 4.3). A ≥30% ODI reduction occurred in 71.4% versus 72.9% in modified intention-to-treat analysis (difference −1.4 percentage points; 95% CI −12.2 to 9.4), meeting the −15-point noninferiority margin (Austevoll 2021, PMID 34347953).

Key findings

  • Decompression alone met the prespecified two-year noninferiority criterion.
  • Per-protocol responders were 75.5% in each group.
  • Reoperation occurred in 12.5% with decompression alone and 9.1% with fusion.
  • The mean ODI difference was close to zero with a confidence interval excluding a large average fusion advantage.

Limitations

  • Open-label surgery makes expectation and co-intervention effects possible.
  • The noninferiority margin is a clinical judgment and must be shown with the result.
  • Findings apply to the trial's selected single-level degenerative spondylolisthesis population.

Why it matters

It supplied a large pragmatic noninferiority test of the exact question raised by the Swedish trial and was later sustained at five years.

Cited by wiki pages

  • Overview
  • Decompression versus fusion
  • Clinical trials landscape