Nordsten-DS (5-year follow-up)
Trial question
Is decompression surgery noninferior to decompression with additional instrumented fusion in patients with degenerative lumbar spondylolisthesis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
69.0% female
31.0% male
N = 262
262 patients (180 female, 82 male).
Inclusion criteria: patients aged 18-80 years with symptomatic lumbar spinal stenosis and a spondylolisthesis ≥ 3 mm at the stenotic level.
Key exclusion criteria: age > 80 years; ASA Classification > 3; cauda equina syndrome; slip ≥ 3 mm in more than 1 level; isthmic defect in pars interarticularis; fracture or former fusion of the thoracolumbar region; previous surgery in the level of spondylolisthesis.
Interventions
N=133 decompression alone (surgery with decompression preserving the posterior midline).
N=129 decompression and instrumented fusion (posterior decompression followed by implantation of pedicle screws with rods and bone grafting across the level of spondylolisthesis and optional use of an intervertebral fusion device).
Primary outcome
≥ 30% reduction in Oswestry disability index at 5 years
63%
63%
63.0 %
47.3 %
31.5 %
15.8 %
0.0 %
Decompression
alone
Decompression and instrumented
fusion
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in ≥ 30% reduction in Oswestry disability index at 5 years (63% vs. 63%; AD 0.4%, 95% CI -11.2 to 11.9).
Secondary outcomes
No significant difference in mean reduction in Oswestry disability index at 5 years (-17.8 points vs. -17.8 points; MD -0.02, 95% CI -3.85 to 3.8).
No significant difference in reduction in mean Zurich Claudication Questionnaire symptom severity (-1.06 points vs. -0.99 points; MD -0.07, 95% CI -0.26 to 0.13).
No significant difference in mean reduction in NRS leg pain (-3.52 points vs. -2.93 points; MD -0.59, 95% CI -1.36 to 0.18).
Safety outcomes
No significant difference in adverse events and subsequent lumbar surgery.
Conclusion
In patients aged 18-80 years with symptomatic lumbar spinal stenosis and a spondylolisthesis ≥ 3 mm at the stenotic level, decompression alone was noninferior to decompression and instrumented fusion with respect to ≥ 30% reduction in Oswestry disability index at 5 years.
Reference
Eric Loratang Kgomotso, Christian Hellum, Morten Wang Fagerland et al. Decompression alone or with fusion for degenerative lumbar spondylolisthesis (Nordsten-DS): five year follow-up of a randomised, multicentre, non-inferiority trial. BMJ. 2024 Aug 7:386:e079771.
Open reference URL