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The effectiveness of decompression alone compared with additional fusion for lumbar spinal stenosis with degenerative spondylolisthesis: a pragmatic comparative non-inferiority observational study from the Norwegian Registry for Spine Surgery

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Abstract

Purpose

To evaluate the effect of adding fusion to decompression in patients operated for lumbar spinal stenosis with a concomitant lumbar degenerative spondylolisthesis.

Methods

After propensity score matching, 260 patients operated with decompression and fusion and 260 patients operated with decompression alone were compared. Primary outcome measures were leg and back pain [Numeric Rating Scale (NRS), 0–10] and Oswestry Disability Index (ODI, 0–100) at 12 months.

Results

At 12-month follow-up, the fusion group rated their pain significantly lower than the decompression alone group [leg pain 3.0 and 3.6, respectively, mean difference −0.6, 95 % confidence interval (CI) −1.2 to −0.05, p = 0.03 and back pain 3.3 and 3.9, respectively, mean difference −0.6, 95 % CI −1.1 to −0.1, p = 0.02]. ODI was not significantly different between the groups (21.0 versus 23.3, mean difference −2.3, 95 % CI −5.8 to 1.1, p = 0.18). Seventy-four percent of the fusion group and 63 % of the decompression alone group achieved a clinically important improvement in back pain (difference in proportion of responders = 11 %, 95 % CI 2–20 %, p = 0.01), corresponding to a number needed to treat of 9 patients (95 % CI 5–50). There was no significant difference in responder rate for leg pain (74 and 67 %, respectively, difference 7 %, 95 % CI −1 to 16 %, p = 0.09) or for ODI (67 and 59 %, respectively, difference 8 %, 95 % CI 0–18 %, p = 0.06). The duration of surgery and hospital stay was longer for the fusion group (mean difference 68 min, 95 % CI 58–78, p < 0.01 and mean difference 4.2 days, 95 % CI 3.5–4.8, p < 0.01).

Conclusion

In the present non-inferiority study, we cannot conclude that decompression alone is as good as decompression with additional fusion. However, the small differences in the groups’ effect sizes suggest that a considerable number of patients can be treated with decompression alone. A challenge in future studies will be to find the best treatment option for each patient.

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Correspondence to Ivar M. Austevoll.

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Funding

Helse Bergen HF, Haukeland University Hospital, Bergen, Norway.

Conflict of interest

The authors declare that they have no conflict of interest.

Appendix

Appendix

See Tables 6, 7 and 8.

Table 6 Baseline characteristic for patients excluded due to matching. Proportions are given unless stated otherwise
Table 7 Proportion of fusion performed in each hospital
Table 8 Group statistics for decompression alone versus decompression and additional instrumented fusion. Proportions are given unless stated otherwise

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Austevoll, I.M., Gjestad, R., Brox, J.I. et al. The effectiveness of decompression alone compared with additional fusion for lumbar spinal stenosis with degenerative spondylolisthesis: a pragmatic comparative non-inferiority observational study from the Norwegian Registry for Spine Surgery. Eur Spine J 26, 404–413 (2017). https://doi.org/10.1007/s00586-016-4683-1

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