LUMBAR STENOSISNCT07139938
Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression
A study testing Isolated lumbar decomression in people with LUMBAR STENOSIS and Sagittal Imbalance, run by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics at 3 sites in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LUMBAR STENOSIS, Sagittal Imbalance, Degeneration Lumbar Spine
- What is being tested?
- Isolated lumbar decomression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 3 sitesRussia
- Study dates
- 6 Oct 2025to 6 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 5. Given written Informed Consent;
- 6. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
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- Non-Inclusion Criteria:
- 1. Prior any lumbar surgery;
- 2. Scoliosis of any non-degenerative etiology (due to vertebral fractures, idiopathic, etc.);
- 3. Degenerative scoliosis > 20 degrees;
- 4. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
- 5. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;
Who cannot join
- 1. Performed intraoperative discotomy;
- 2. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia3 sites, 3 recruiting
- Recruiting
Pirogov National Medical Surgical Center
Moscow, 105203
- Recruiting
Burdenko Neurosurgery Institute
Moscow, 125047
- Recruiting
Priorov National Medical Research Center of Traumatology and Orthopedics
Moscow, 127299
Aleksandr Krutko, MD, PhD, +7 495 744 40 11, ortho-ped@mail.ru
About this study
Official title: Multicenter Study of Spontaneous Correction of Sagittal Imbalance After Isolated Decompression Surgery Without Corrective Fusion Procedure for Lumbar Spinal Stenosis
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.
- Being tested
- Isolated lumbar decomression
- Keywords
- lumbar stenosis, sagittal imbalance, lumbar decompression
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated lumbar decomressionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Other | Isolated lumbar decompression Receives: Procedure: Isolated lumbar decomression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in lumbar balance parameters
To observe the change from baseline in sagittal vertical axis by full body X-Ray, in mm
Measured: 3 months postoperatively
Secondary outcomes (12)
Change from baseline in lumbar balance parameters
To observe the change from baseline in sagittal vertical axis by full body X-Ray, in mm
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.'')
Measured: 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
Measured: 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
Measured: during study, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start6 Oct 2025
- Primary completion6 Oct 2026 (estimated)
- Study completion6 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LUMBAR STENOSISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
- Sponsor type
- University, hospital or other
- Collaborators
- Burdenko Neurosurgery Institute, Pirogov National Medical Surgical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139938
- Sponsor's protocol ID
- NS12-05
- Status last verified
- Jul 2026
- First submitted
- 15 Aug 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Spontaneous Correction of Sagittal Imbalance After Isolated Decompression Surgery Without Corrective Fusion Procedure for Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT07139938
- Acronym / sponsor ID
- NS12-05
- Keywords
- lumbar stenosis, sagittal imbalance, lumbar decompression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- N.N. Priorov National Medical Research Center of Traumatology and OrthopedicsUniversity, hospital or other
- Collaborators
- Burdenko Neurosurgery Institute, Pirogov National Medical Surgical Center
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 6 Oct 2026 (estimated)
- Study completion
- 6 Oct 2027 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Other | Procedure: Isolated lumbar decomressionIsolated lumbar decompression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
- 5. Given written Informed Consent;
Key exclusion criteria (2 listed)
- 1. Performed intraoperative discotomy;
- 2. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isolated lumbar decomressionAll 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. | Procedure or surgery | Cohort |
Primary outcome
Change from baseline in lumbar balance parameters
Time frame: 3 months postoperatively
To observe the change from baseline in sagittal vertical axis by full body X-Ray, in mm
12 secondary outcomes
Change from baseline in lumbar balance parameters
Time frame: 12 months postoperatively
Change from baseline in lumbar balance parameters
Time frame: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
Time frame: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
Time frame: 3 months and 12 months postoperatively
Change from baseline in lumbar balance parameters
Time frame: 3 months and 12 months postoperatively
Change in the cross-sectional area of the dural sac, mm2
Time frame: 3 months after surgery
Change from baseline in Oswestry Disability Index
Time frame: 3 months and 12 months postoperatively
Change from baseline in Numeric Pain Rating Scale
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in Neuropathic Pain 4 Questions
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
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in posture alignment
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Adverse Events
Time frame: during study, an average of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolated lumbar decomression in people with LUMBAR STENOSIS and Sagittal Imbalance, run by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksandr Krutko, MD, PhD (+7 495 744 40 11, ortho-ped@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in lumbar balance parameters (time frame: 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.