About this trial
Sagittal spinal imbalance may be caused by orthopedic problems, compression of the neural structures of the spinal canal, and pain syndrome (functional imbalance). Sagittal imbalance in combination with appropriate clinical symptoms may require surgical correction of the spine with fixation. However, in some cases, patients experience spontaneous correction of sagittal balance after isolated decompression without any correction or fusion. Therefore, it is necessary to clarify whether isolated decompression may cause spontaneous correction of sagittal imbalance in patients with degenerative lumbar stenosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age 45 and over;
2. Radicular leg pain and/or neurogenic claudication with/without back pain, caused by single- or multi-level degenerative lumbar stenosis with/without spodylolisthesis, confirmed by MRI;
3. Planned isolated decompression of the spinal canal without implantation of any devices;
4. Symptoms persisting for at least 3 months prior to surgery;
Disqualifiers
1. Performed intraoperative discotomy;
2. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)
Trial design
Single group
Treatments tested in this trial
Isolated lumbar decomression
Procedure/SurgeryAll patients will undergo microsurgical decompression of stenosed neural structures of the lumbar canal at all clinically significant levels with saving the posterior spinal column (type of decompression may be as unilateral, bilateral, or bilateral from a unilateral approach (over-the-top)), including endoscopic decompression. Degenerative lumbar stenosis may be caused by thickened yellow and posterior longitudinal ligaments, facet joints hypertrophy, vertebral body osteophytes posteriorly, synovial (facet joints cysts) and disc cysts.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in lumbar balance parameters
To observe the change from baseline in sagittal vertical axis by full body X-Ray, in mm
Secondary outcomes
Change from baseline in lumbar balance parameters
To observe the change from baseline in sagittal vertical axis by full body X-Ray, in mm
Change from baseline in lumbar balance parameters
To observe the change from baseline in full balance integrated index by full body X-Ray
Change from baseline in lumbar balance parameters
To observe the change from baseline in lumbar lordosis (L1-S1) by full body X-Ray, in degrees
Change from baseline in lumbar balance parameters
To observe the change from baseline in low lumbar lordosis (L4-S1) by full body X-Ray, in degrees
Sponsors and contacts
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N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Lead sponsor
Burdenko Neurosurgery Institute
Collaborator
Pirogov National Medical Surgical Center
Collaborator