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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
165
All 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.
Pirogov National Medical Surgical Center
Moscow, Russia
RECRUITINGBurdenko Neurosurgery Institute
Moscow, Russia
RECRUITINGPriorov National Medical Research Center of Traumatology and Orthopedics
Moscow, Russia
RECRUITINGChange from baseline in lumbar balance parameters
To observe the change from baseline in sagittal vertical axis by full body X-Ray, in mm
Time frame: 3 months postoperatively
Change from baseline in lumbar balance parameters
To observe the change from baseline in sagittal vertical axis by full body X-Ray, in mm
Time frame: 12 months postoperatively
Change from baseline in lumbar balance parameters
To observe the change from baseline in full balance integrated index by full body X-Ray
Time frame: 3 months and 12 months postoperatively
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
Time frame: 3 months and 12 months postoperatively
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
Time frame: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
To observe the change from baseline in segmental lordosis at operated level by full body X-Ray, in degrees
Time frame: 3 months and 12 months postoperatively
Change in the cross-sectional area of the dural sac, mm2
To observe the change in the cross-sectional area of the dural sac at operated lumbar level by MRI
Time frame: 3 months after surgery
Change from baseline in Oswestry Disability Index
To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms (min - 0 - the best result, patient is active; max - 50 - the worst result, patient is not physically active
Time frame: 3 months and 12 months postoperatively
Change from baseline in Numeric Pain Rating Scale
To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain)
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in Neuropathic Pain 4 Questions
To observe the change of Neuropathic Pain 4 Questions as compared to baseline through follow-up terms. If the total score is more than 4, the pain is neuropathic.
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in The Health Transition Item from SF-36
To observe the The Health Transition Item as compared to baseline through follow-up terms (Patient's answers range from 2 - ''Much Better,'' 1 -''Somewhat Better,'' 0 - ''About the Same,'' -1 - ''Somewhat Worse,'' to -2 - ''Much Worse.'')
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in posture alignment
To observe the patient's self-assessment of posture changes as compared to baseline (Patient asked: "How has your posture changed since the surgery?" 1 - better, 0 - unchanged (don't know), -1 - worse
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Adverse Events
Document Adverse Events (incl. adverse events related to device) occurrence throughout the study
Time frame: during study, an average of 12 months
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