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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 London Spine Lumbar Stenosis

The article discusses a clinical trial aimed at comparing the long-term clinical results of two surgical methods for single-level lumbar spinal stenosis. The study focuses on the non-inferiority of decompression compared to the standard fusion procedure. Participants meeting the inclusion criteria will be randomly divided into two groups, with one group undergoing decompression and the other undergoing decompression and fusion. The primary endpoint is the evaluation of Oswestry Disability Index dynamics after 24 months compared to the baseline level. Secondary outcomes include various scales and parameters related to surgical management. The authors believe that this study will contribute to improving the evidence for different surgical techniques for lumbar spine stenosis surgery

Summarised by Mr Mo Akmal – Lead Spinal Surgeon
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Published article

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.

Spine Lumbar Spinal Stenosis Expert. Best Spinal Surgeon UK
Abstract 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,

Abstract

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.

Keywords: Decompression; Laminotomy; Lumbar spinal stenosis; Randomized controlled trial; Spinal Fusion.

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Read the original publication:

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

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Abstract 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

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