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
Sklifosovsky Institute of Emergency Care
86 participants
Apr 1, 2022
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
Inclusion Criteria5
- age of patients from 45 to 75 years;
- 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 Criteria9
- spondylolisthesis more than 3 mm;
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05273879