Decompression alone or with fusion for degenerative lumbar spondylolisthesis (Nordsten-DS): five year follow-up of a randomised, multicentre, non-inferiority trial
Authors: Kgomotso Eric Loratang , Hellum Christian , Fagerland Morten Wang , Solberg Tore , Brox Jens Ivar , Storheim Kjersti , Hermansen Erland , Franssen Eric , Weber Clemens , Brisby Helena , Algaard Knut Robert Hector , Furunes Håvard , Banitalebi Hasan , Ljøstad Inger , Indrekvam Kari , Austevoll Ivar Magne 
Published: August 2024

Abstract

Objective
To assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis.

Design
Five year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS).

Setting
16 public orthopaedic and neurosurgical clinics in Norway.

Participants
Patients aged 18-80 years with symptomatic lumbar spinal stenosis and a spondylolisthesis of 3 mm or more at the stenotic level.

Interventions
Decompression surgery alone and decompression with additional instrumented fusion (1:1).

Main outcome measures
The primary outcome was a 30% or more reduction in Oswestry disability index from baseline to five year follow-up. The predefined non-inferiority margin was a −15 percentage point difference in the proportion of patients who met the primary outcome. Secondary outcomes included the mean change in Oswestry disability index, Zurich claudication questionnaire, numeric rating scale for leg and back pain, and EuroQol Group 5-Dimension (EQ-5D-3L) questionnaire.

Results
From 12 February 2014 to 18 December 2017, 267 participants were randomly assigned to decompression alone (n=134) and decompression with instrumented fusion (n=133). Of these, 230 (88%) responded to the five year questionnaire: 121 in the decompression group and 109 in the fusion group. Mean age at baseline was 66.2 years (SD 7.6), and 69% were women. In the modified intention-to-treat analysis with multiple imputation of missing data, 84 (63%) of 133 people in the decompression alone group and 81 (63%) of 129 people in the fusion group had a at least a 30% reduction in Oswestry disability index, a difference of 0.4 percentage points. (95% confidence interval (CI) −11.2 to 11.9). The respective results of the per protocol analysis were 65 (65%) of 100 in the decompression alone group and 59 (66%) of 89 in the fusion group, a difference of −1.3 percentage points (95% CI −14.5 to 12.2). Both 95% CIs were higher than the predefined non-inferiority margin of −15%. The mean change in Oswestry disability index from baseline to five years was −17.8 in both groups (mean difference 0.02 (95% CI −3.8 to 3.9)). Results of the other secondary outcomes were in the same direction as the primary outcome. From two to five year follow-up, a new lumbar operation occurred in six (5%) of 123 people in the decompression group and 11 (10%) of 113 people in the fusion group, with a total from baseline to five years of 21 (16%) of 129 people and 23 (18%) of 125, respectively.

Conclusions
In participants with degenerative spondylolisthesis, decompression alone was non-inferior to decompression with instrumented fusion five years after primary surgery. Proportions of subsequent surgeries at the index level or an adjacent lumbar level were no different between the groups.

Trial registration

ClinicalTrials.gov
NCT02051374