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Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial

BACKGROUND: The necessity of spinal segment fusion after decompression is one of the most controversial and unresolved issues in single-level lumbar spinal stenosis surgery. To date, only one trial carried out 15 years ago focused on this problem. The key purpose of the current trial is to compare t...

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Autores principales: Grin, Andrey, Lvov, Ivan, Talypov, Aleksandr, Smirnov, Vladimir, Kordonskiy, Anton, Lebedev, Valeriy, Zuev, Andrey, Senko, Ilya, Pogonchenkova, Iren, Krylov, Vladimir
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10332049/
https://www.ncbi.nlm.nih.gov/pubmed/37430281
http://dx.doi.org/10.1186/s13063-023-07486-8
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author Grin, Andrey
Lvov, Ivan
Talypov, Aleksandr
Smirnov, Vladimir
Kordonskiy, Anton
Lebedev, Valeriy
Zuev, Andrey
Senko, Ilya
Pogonchenkova, Iren
Krylov, Vladimir
author_facet Grin, Andrey
Lvov, Ivan
Talypov, Aleksandr
Smirnov, Vladimir
Kordonskiy, Anton
Lebedev, Valeriy
Zuev, Andrey
Senko, Ilya
Pogonchenkova, Iren
Krylov, Vladimir
author_sort Grin, Andrey
collection PubMed
description BACKGROUND: The necessity of spinal segment fusion after decompression is one of the most controversial and unresolved issues in single-level lumbar spinal stenosis surgery. To date, only one trial carried out 15 years ago focused on this problem. The key purpose of the current trial is to compare the long-term clinical results of the two surgical methods (decompression vs. decompression and fusion) in patients with single-level lumbar stenosis. METHODS: This study is focused on the non-inferior clinical results of decompression compared with the standard fusion procedure. In the decompression group, the spinous process, the interspinous and supraspinous ligaments, part of the facet joints, and corresponding parts of the vertebral arch are to be preserved intact. In the fusion group, decompression is to be supplemented with transforaminal interbody fusion. Participants meeting the inclusion criteria will be randomly divided into two equal groups (1:1), depending on the surgical method. The final analysis will include 86 patients (43 per group). The primary endpoint is Oswestry Disability Index dynamics at the end of the 24-month follow-up compared to the baseline level. Secondary outcomes included those estimated using the SF-36 scale, EQ-5D-5L, and psychological scales. Additional parameters will include sagittal balance of the spine, fusion results, total cost of surgery, and hospital stay followed by two-year treatment. Follow-up examinations will be performed at 3, 6, 12, and 24 months DISCUSSION: Authors suggest that this study will improve the evidence for application of various surgical techniques for lumbar spine stenosis surgery and verify the existing protocol for surgical management. TRIAL REGISTRATION: ClinicalTrials.gov NCT05273879. Registered on March 10, 2022. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07486-8.
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spelling pubmed-103320492023-07-11 Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial Grin, Andrey Lvov, Ivan Talypov, Aleksandr Smirnov, Vladimir Kordonskiy, Anton Lebedev, Valeriy Zuev, Andrey Senko, Ilya Pogonchenkova, Iren Krylov, Vladimir Trials Study Protocol BACKGROUND: The necessity of spinal segment fusion after decompression is one of the most controversial and unresolved issues in single-level lumbar spinal stenosis surgery. To date, only one trial carried out 15 years ago focused on this problem. The key purpose of the current trial is to compare the long-term clinical results of the two surgical methods (decompression vs. decompression and fusion) in patients with single-level lumbar stenosis. METHODS: This study is focused on the non-inferior clinical results of decompression compared with the standard fusion procedure. In the decompression group, the spinous process, the interspinous and supraspinous ligaments, part of the facet joints, and corresponding parts of the vertebral arch are to be preserved intact. In the fusion group, decompression is to be supplemented with transforaminal interbody fusion. Participants meeting the inclusion criteria will be randomly divided into two equal groups (1:1), depending on the surgical method. The final analysis will include 86 patients (43 per group). The primary endpoint is Oswestry Disability Index dynamics at the end of the 24-month follow-up compared to the baseline level. Secondary outcomes included those estimated using the SF-36 scale, EQ-5D-5L, and psychological scales. Additional parameters will include sagittal balance of the spine, fusion results, total cost of surgery, and hospital stay followed by two-year treatment. Follow-up examinations will be performed at 3, 6, 12, and 24 months DISCUSSION: Authors suggest that this study will improve the evidence for application of various surgical techniques for lumbar spine stenosis surgery and verify the existing protocol for surgical management. TRIAL REGISTRATION: ClinicalTrials.gov NCT05273879. Registered on March 10, 2022. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07486-8. BioMed Central 2023-07-10 /pmc/articles/PMC10332049/ /pubmed/37430281 http://dx.doi.org/10.1186/s13063-023-07486-8 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Grin, Andrey
Lvov, Ivan
Talypov, Aleksandr
Smirnov, Vladimir
Kordonskiy, Anton
Lebedev, Valeriy
Zuev, Andrey
Senko, Ilya
Pogonchenkova, Iren
Krylov, Vladimir
Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial
title Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial
title_full Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial
title_fullStr Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial
title_full_unstemmed Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial
title_short Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial
title_sort necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10332049/
https://www.ncbi.nlm.nih.gov/pubmed/37430281
http://dx.doi.org/10.1186/s13063-023-07486-8
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