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Findings from a pilot randomized trial of spinal decompression alone or spinal decompression plus instrumented fusion – Lumbar Fusion

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The article discusses the SpInOuT feasibility study, which aimed to determine if a randomized controlled trial (RCT) could be conducted to assess the effectiveness of instrumented fusion in addition to decompression surgery for symptomatic spinal stenosis. A pilot randomized trial was conducted across five NHS hospitals, with patients randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. However, due to a low number of patients recruited and randomized, completion rates, quality of life, imaging, and health economic outcomes could not be assessed as intended. The study highlights the need for a definitive RCT that stratifies patients based on factors such as dynamic spondylolisthesis and pelvic incidence-lumbar lordosis (PI-LL) mismatch in order to inform surgical decision-making

Summarised by Mr Mo Akmal – Lead Spinal Surgeon
The London Spine Unit : best rated spine centre in UK

Published article

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.

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Bone Jt Open. 2023 Aug 8;4(8):573-579. doi: 10.1302/2633-1462.48.BJO-2023-0049.ABSTRACTAIMS: 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,

Bone Jt Open. 2023 Aug 8;4(8):573-579. doi: 10.1302/2633-1462.48.BJO-2023-0049.

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.

PMID:37549931 | DOI:10.1302/2633-1462.48.BJO-2023-0049

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Findings from a pilot randomized trial of spinal decompression alone or spinal decompression plus instrumented fusion

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Bone Jt Open. 2023 Aug 8;4(8):573-579. doi: 10.1302/2633-1462.48.BJO-2023-0049.ABSTRACTAIMS: 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

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