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Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis
Sponsor: Sklifosovsky Institute of Emergency Care
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.
Official title: 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
Key Details
Gender
All
Age Range
45 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2022-04-01
Completion Date
2026-12-30
Last Updated
2025-12-18
Healthy Volunteers
No
Interventions
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.
Locations (2)
Pirogov National Medical and Surgical Center
Moscow, Moscow, Russia
Sklifosovsky Research Institute for Emergency Medicine
Moscow, Moscow, Russia