Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis
NCT ID: NCT05273879
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
86 participants
INTERVENTIONAL
2022-04-01
2026-12-30
Brief Summary
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This trial should provide the first level of evidence for the need for spinal fusion in patients with single-level lumbar stenosis, subject to the high homogeneous comparison groups. Additional results will allow comparing the economic aspects of different surgical treatments for 2 years after surgery.
Detailed Description
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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 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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decompression group
minimally invasive decompression without fusion
decompression
laminotomy of the corresponding adjacent vertebrae, partial flavectomy and medial facetectomy are planned to be performed unilaterally. Depending on the surgeon's personal preferences, the following two options are available: 1) equivalent decompression procedure contralaterally and 2) crossover contralateral decompression. Irrespective of the selected option, the spinous process, the interspinous and supraspinous ligaments, part of the facet joints, and the corresponding part of the vertebral arch must be preserved intact in all participants.
fusion group
minimally invasive decompression with trans-foraminal interbody fusion
fusion
First, decompression is performed according to one of the above methods. Next, trans-foraminal interbody fusion with a cage (TLIF) and fixation with pedicle screws are performed.
Interventions
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decompression
laminotomy of the corresponding adjacent vertebrae, partial flavectomy and medial facetectomy are planned to be performed unilaterally. Depending on the surgeon's personal preferences, the following two options are available: 1) equivalent decompression procedure contralaterally and 2) crossover contralateral decompression. Irrespective of the selected option, the spinous process, the interspinous and supraspinous ligaments, part of the facet joints, and the corresponding part of the vertebral arch must be preserved intact in all participants.
fusion
First, decompression is performed according to one of the above methods. Next, trans-foraminal interbody fusion with a cage (TLIF) and fixation with pedicle screws are performed.
Eligibility Criteria
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Inclusion Criteria
* stenosis C or D according to Shizas et al. according to MRI at the level of L2-L3, L3-L4, L4-L5 or L5-S1;
* clinical manifestations of lumbar stenosis (neurogenic claudication syndrome and/or radiculopathy);
* lack of effect from conservative therapy within 3 months;
* Informed consent to take part in the study.
Exclusion Criteria
* spinal instability according to functional radiography;
* sagittal imbalance (type 4 according to C. Barrey);
* bone density of the vertebrae at the level of the operation is less than 100 HU;
* clinically significant spinal stenosis at 2 or more levels;
* previously performed surgeries on the spine;
* risk of anesthesia 4 or 5 according to ASA;
* inability to take part in control examinations within 2 years after the operation;
* participation in other clinical trials related to surgical or conservative treatment of diseases of the spine.
45 Years
75 Years
ALL
No
Sponsors
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Pirogov National Medical Surgical Center
OTHER_GOV
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
OTHER
Sklifosovsky Institute of Emergency Care
OTHER_GOV
Responsible Party
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Ivan Lvov, MD, PhD
Senior fellow
Principal Investigators
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Andrey Grin, MD, PhD
Role: STUDY_CHAIR
Sklifosovsky Research Institute for Emergency Medicine
Locations
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Pirogov National Medical and Surgical Center
Moscow, Moscow, Russia
Sklifosovsky Research Institute for Emergency Medicine
Moscow, Moscow, Russia
Countries
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Central Contacts
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Facility Contacts
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Valeriy Lebedev, MD, PhD
Role: primary
Ivan Lvov, MD, PhD
Role: primary
Anton Kordonskiy, MD, PhD
Role: backup
References
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Grin A, Lvov I, Talypov A, Smirnov V, Kordonskiy A, Lebedev V, Zuev A, Senko I, Pogonchenkova I, Krylov V. 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. Trials. 2023 Jul 10;24(1):451. doi: 10.1186/s13063-023-07486-8.
Other Identifiers
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03\2022
Identifier Type: -
Identifier Source: org_study_id