Lumbar Spinal StenosisNCT05273879
Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis
A study testing decompression and fusion in people with Lumbar Spinal Stenosis and Spinal Stenosis, run by Sklifosovsky Institute of Emergency Care at 2 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Lumbar Spinal Stenosis, Spinal Stenosis, Spinal Fusion
- What is being tested?
- decompression and fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Apr 2022to 30 Dec 2026
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites, 2 recruiting
- Recruiting
Pirogov National Medical and Surgical Center
Moscow, Moscow, 105203
Valeriy Lebedev, MD, PhD, +79264922952, horizont_vbl@mail.ru
Dmitriy Epifanov
- Recruiting
Sklifosovsky Research Institute for Emergency Medicine
Moscow, Moscow, 107045
Ivan Lvov, MD, PhD, +79265760074, dr.speleolog@gmail.com
Anton Kordonskiy, MD, PhD, +79265724547, akord.neuro@mail.ru
About this study
Official title: 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
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.
Read the detailed description
The necessity of spinal segment fusion after decompression is one of the most controversial and unresolved issues in single-level lumbar spinal stenosis surgery. To date, only one trial carried out 15 years ago focused on this problem. The key purpose of the current trial is to compare the long-term clinical results of the two surgical methods (decompression vs. decompression and fusion) in patients with single-level lumbar stenosis.
This study is focused on the non-inferior clinical results of decompression compared with the standard fusion procedure. In the decompression group, the spinous process, the interspinous and supraspinous ligaments, part of the facet joints, and corresponding parts of the vertebral arch are to be preserved intact. In the fusion group, decompression is to be supplemented with transforaminal interbody fusion. Participants meeting the inclusion criteria will be randomly divided into two equal groups (1:1), depending on the surgical method. The final analysis will include 86 patients (43 per group). The primary endpoint is Oswestry Disability Index dynamics at the end of the 24-month follow-up compared to the baseline level. Secondary outcomes included those estimated using the SF-36 scale, EQ-5D-5L, and psychological scales. Additional parameters will include sagittal balance of the spine, fusion results, total cost of surgery, and hospital stay followed by two-year treatment. Follow-up examinations will be performed at 3, 6, 12, and 24 months Authors suggest that this study will improve the evidence for application of various surgical techniques for lumbar spine stenosis surgery and verify the existing protocol for surgical management.
- Conditions
- Lumbar Spinal Stenosis, Spinal Stenosis, Spinal Fusion
- Being tested
- decompression, fusion
- Keywords
- lumbar spine, lumbar fusion, laminotomy, decompression without fusion, lumbar stenosis
- Medical subject headings
- Spinal Stenosis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decompressionProcedure or surgery
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.
fusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| decompression group | Other | minimally invasive decompression without fusion Receives: Procedure: decompression |
| fusion group | Other | minimally invasive decompression with trans-foraminal interbody fusion Receives: Procedure: fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
The questionnaire includes 10 sections containing 6 statements each. Depending on the answer, a score is assigned (from 0 to 5). The maximum number of points is 50. After that, the points are converted into percentages (from 0 to 100%).
Measured: 24 months
Secondary outcomes (12)
SF-36 v.1 scale (standard form)
The questionnaire contains 36 questions, grouped into 8 scales that assess physical functioning, role-playing, bodily pain, general health, vitality, social functioning, emotional state, and mental health. For each of them, the maximum score is 100 points.
Measured: 24 months
EQ-5D-5L
The questionnaire contains 5 sections (mobility, self-care, usual activities, pain, anxiety) of three statements and the EQ-VAS visual analog pain scale. The results can be converted into a single numerical value (index) adjusted for the patient's region of residence
Measured: 24 months
Won-Korff Chronic Pain Syndrome Assessment Scale
allows evaluating the severity of pain and its impact on life in points. Grade 0 corresponds to the absence of pain, and grade IV to the maximum limitation of life because of severe pain.
Measured: 24 months
Pain Catastrophizing Scale
makes it possible to assess completely the psychological aspects of pain perception, in particular the exaggerated negative perception of painful stimuli. The questionnaire contains 13 questions, each of which is evaluated in points (0 points, no symptom, 4, the patient experiences these feelings all the time).
Measured: 24 months
Chronic Pain Coping Inventory
allow one of eight scales to classify a patient's preferred strategy for coping with chronic pain.
Measured: 24 months
scale of the American Society of Anesthesiologists ASA
This classification distinguishes 5 classes of physical status depending on the presence of concomitant diseases (Class I, healthy patient, Class V, dying).
Measured: baseline
The cost of the treatment
The cost of hospitalization of the patient, including the performance of surgical intervention, as well as the period of the patient's incapacity for work because of spinal disease, will also be calculated. Also, within 2 years after the intervention, the cost of subsequent treatment in rehabilitation centers and other hospitals for complications of the operation or other manifestations of degenerative-dystrophic changes in the lumbar spine will be considered.
Measured: 24 months
quality of fusion
according to CT data, the quality of fusion using the Tan criteria will be graded into one of four grades of fusion-grade I (complete fusion) to grade IV (bipolar pseudarthrosis)
Measured: 24 months
pelvic tilt (PT)
a parameter defined as the angle created by a line running from the sacral endplate midpoint to the center of the bifemoral heads and the vertical axis. Will be evaluated on X-ray.
Measured: 24 months
pelvic incidence (PI)
the angle between the line perpendicular to the sacral endplate at its midpoint and a line connecting this point to the axis of the femoral head. Will be evaluated on X-ray.
Measured: 24 months
sacral slope (SS)
the angle between the tangent line to the superior endplate of S1 and the horizontal plane. Will be evaluated on X-ray.
Measured: 24 months
al axis displacement (SVA)
a horizontal distance between a plumb line dropped from the center of the C7 body and the posterior-superior corner of the S1 body. Will be evaluated on X-ray.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Apr 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sklifosovsky Institute of Emergency Care
- Sponsor type
- Other government
- Collaborators
- Pirogov National Medical Surgical Center, Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
- Responsible party
- Principal investigator, Ivan Lvov, MD, PhD, Sklifosovsky Institute of Emergency Care
- Investigators
- Andrey Grin, MD, PhD, Study chair, Sklifosovsky Research Institute for Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273879
- Sponsor's protocol ID
- 03\2022
- Status last verified
- Dec 2025
- First submitted
- 19 Feb 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request in Sklifosovsky Research Institute for Emergency Medicine
Publications
Grin A, Lvov I, Talypov A, Smirnov V, Kordonskiy A, Lebedev V, Zuev A, Senko I, Pogonchenkova I, Krylov V. Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial. Trials. 2023 Jul 10;24(1):451. doi: 10.1186/s13063-023-07486-8.
PubMed 37430281
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05273879
- Acronym / sponsor ID
- 03\2022
- Conditions
- Lumbar Spinal Stenosis, Spinal Stenosis, Spinal Fusion
- Keywords
- lumbar spine, lumbar fusion, laminotomy, decompression without fusion, lumbar stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Sklifosovsky Institute of Emergency CareOther government
- Collaborators
- Pirogov National Medical Surgical Center, Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Mar 2022 (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.
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.
Detailed description
The necessity of spinal segment fusion after decompression is one of the most controversial and unresolved issues in single-level lumbar spinal stenosis surgery. To date, only one trial carried out 15 years ago focused on this problem. The key purpose of the current trial is to compare the long-term clinical results of the two surgical methods (decompression vs. decompression and fusion) in patients with single-level lumbar stenosis.
This study is focused on the non-inferior clinical results of decompression compared with the standard fusion procedure. In the decompression group, the spinous process, the interspinous and supraspinous ligaments, part of the facet joints, and corresponding parts of the vertebral arch are to be preserved intact. In the fusion group, decompression is to be supplemented with transforaminal interbody fusion. Participants meeting the inclusion criteria will be randomly divided into two equal groups (1:1), depending on the surgical method. The final analysis will include 86 patients (43 per group). The primary endpoint is Oswestry Disability Index dynamics at the end of the 24-month follow-up compared to the baseline level. Secondary outcomes included those estimated using the SF-36 scale, EQ-5D-5L, and psychological scales. Additional parameters will include sagittal balance of the spine, fusion results, total cost of surgery, and hospital stay followed by two-year treatment. Follow-up examinations will be performed at 3, 6, 12, and 24 months Authors suggest that this study will improve the evidence for application of various surgical techniques for lumbar spine stenosis surgery and verify the existing protocol for surgical management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| decompression group | Other | Procedure: decompressionminimally invasive decompression without fusion |
| fusion group | Other | Procedure: fusionminimally invasive decompression with trans-foraminal interbody fusion |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| decompressionlaminotomy 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. | Procedure or surgery | decompression group |
| fusionFirst, 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. | Procedure or surgery | fusion group |
Primary outcome
Oswestry Disability Index
Time frame: 24 months
The questionnaire includes 10 sections containing 6 statements each. Depending on the answer, a score is assigned (from 0 to 5). The maximum number of points is 50. After that, the points are converted into percentages (from 0 to 100%).
12 secondary outcomes
SF-36 v.1 scale (standard form)
Time frame: 24 months
EQ-5D-5L
Time frame: 24 months
Won-Korff Chronic Pain Syndrome Assessment Scale
Time frame: 24 months
Pain Catastrophizing Scale
Time frame: 24 months
Chronic Pain Coping Inventory
Time frame: 24 months
scale of the American Society of Anesthesiologists ASA
Time frame: baseline
The cost of the treatment
Time frame: 24 months
quality of fusion
Time frame: 24 months
pelvic tilt (PT)
Time frame: 24 months
pelvic incidence (PI)
Time frame: 24 months
sacral slope (SS)
Time frame: 24 months
al axis displacement (SVA)
Time frame: 24 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 18 Dec 2025.
- Derived from this study: PubMed 37430281Grin A, Lvov I, Talypov A, Smirnov V, Kordonskiy A, Lebedev V, Zuev A, Senko I, Pogonchenkova I, Krylov V. Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial. Trials. 2023 Jul 10;24(1):451. doi: 10.1186/s13063-023-07486-8.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request in Sklifosovsky Research Institute for Emergency Medicine
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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.
Andrey Grin, MD, PhD study chair
Sklifosovsky Research Institute for Emergency Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decompression and fusion in people with Lumbar Spinal Stenosis and Spinal Stenosis, run by Sklifosovsky Institute of Emergency Care at 2 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 5 inclusion and 9 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Ivan Lvov, MD, PhD (+79265760074, dr.speleolog@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05273879, which also lists 1 linked publication.
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 18 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.