RecruitingNot ApplicableNCT05273879

Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis

Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis: Study Protocol for an Open-label Multicenter Non-inferiority Randomized Controlled Clinical Trial


Sponsor

Sklifosovsky Institute of Emergency Care

Enrollment

86 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Long-term clinical results of two methods of surgical treatment (spinal decompression with or without fusion) in patients with single-level lumbar stenosis will be compared. A clear framework for surgical treatment methods and standardized postoperative rehabilitation treatment will be set to obtain the maximum homogeneity of the patient groups. 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.


Eligibility

Min Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether spinal decompression surgery (laminectomy) alone is as effective as decompression plus spinal fusion for treating lumbar spinal stenosis at a single level. The goal is to find out if adding fusion — a more complex and costly procedure — is always necessary. You may be eligible if: - You are between 45 and 75 years old - You have severe single-level lumbar stenosis confirmed by MRI (at L2-L3, L3-L4, L4-L5, or L5-S1) - You have symptoms such as leg pain with walking (claudication) or nerve pain (radiculopathy) - Conservative treatment has not helped after 3 months - You are willing to attend follow-up appointments for 2 years You may NOT be eligible if: - You have spondylolisthesis (vertebral slippage) greater than 3 mm - You have spinal instability - You have severe spinal stenosis at 2 or more levels - You have had previous spinal surgery - You have low bone density (below 100 HU) - You have severe sagittal imbalance (spinal curvature) - Your anesthesia risk is rated ASA 4 or 5 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREdecompression

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.

PROCEDUREfusion

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.


Locations(2)

Pirogov National Medical and Surgical Center

Moscow, Moscow, Russia

Sklifosovsky Research Institute for Emergency Medicine

Moscow, Moscow, Russia

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NCT05273879


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