An interventional study of Isolated lumbar decomression in LUMBAR STENOSIS, Sagittal Imbalance and Degeneration Lumbar Spine, sponsored by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics. Recruiting at 3 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics · Not applicable, Interventional, and Treatment
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.
456 studies on the registry are indexed under Constriction, Pathologic; 109 are open to participants now.
This study's planned enrollment of 165 is above the median of 72 across 295 interventional studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →N.N. Priorov National Medical Research Center of Traumatology and Orthopedics is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non-Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Isolated lumbar decompression
Procedure: Isolated lumbar decomression
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.
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: 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
Started Oct 2025 (actual). Primary completion is estimated for Oct 2026, 12 months after the start.
Of 90 non-industry interventional studies with no phase under Constriction, Pathologic, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 49. This study's planned 12 months is below that.
Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 18 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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N.N. Priorov National Medical Research Center of Traumatology and Orthopedics