Findings from a pilot randomized trial of spinal decompression alone or spinal decompression plus instrumented fusion: the Spinal Fusion Indications and Outcomes Randomised Trial (SpInOuT-F) feasibility study: the Spinal Fusion Indications and Outcomes Randomised Trial (SpInOuT-F) feasibility study

Nicolas J. A. Beresford-Cleary, Alan Silman, Chrishan Thakar, Adrian Gardner, Ian Harding, Cushla Cooper, Jonathan Cook, Dominique A. Rothenfluh

Research output: Contribution to journalArticlepeer-review

Abstract

Aims:
Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted.

Methods:
As part of the SpInOuT-F study, a pilot randomized trial was carried out across five NHS hospitals. Patients were randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. Patient-reported outcome measures were collected at baseline and three months. The intended sample size was 60 patients.

Results:
Of the 90 patients screened, 77 passed the initial screening criteria. A total of 27 patients had a PI-LL mismatch and 23 had a dynamic spondylolisthesis. Following secondary inclusion and exclusion criteria, 31 patients were eligible for the study. Six patients were randomized and one underwent surgery during the study period. Given the low number of patients recruited and randomized, it was not possible to assess completion rates, quality of life, imaging, or health economic outcomes as intended.

Conclusion:
This study provides a unique insight into the prevalence of dynamic spondylolisthesis and PI-LL mismatch in patients with symptomatic spinal stenosis, and demonstrates that there is a need for a definitive RCT which stratifies for these groups in order to inform surgical decision-making. Nonetheless a definitive study would need further refinement in design and implementation in order to be feasible.
Original languageEnglish
Pages (from-to)573-579
JournalBone & joint open
Early online date8 Aug 2023
DOIs
Publication statusPublished - Aug 2023

Bibliographical note

Copyright © 2023 Author(s) et al. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (CC BY-NC- ND 4.0)
licence, which permits the copying and redistribution of the work only, and provided
the original author and source are credited. See https://creativecommons.org/licenses/
by-nc-nd/4.0/

Data Access Statement

All data generated or analyzed during this study are included in the published article
and/or in the supplementary material.

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