Lumbar Spinal StenosisNCT04594980

Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

A study testing lumbar fusion in people with Lumbar Spinal Stenosis and Intervertebral Disc Degeneration, run by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the effectiveness of minimally invasive decompression and fusion over the traditional open decompression and fusion in patients with single-level lumbar stenosis caused by degenerative spondylolisthesis. Postoperative follow-up will continue for 12 months. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Lumbar Spinal Stenosis, Intervertebral Disc Degeneration
What is being tested?: lumbar fusion
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteRussia
Study dates: 20 Jan 2022to 1 Mar 2026
Phase: Interventional
Are there results?: None posted in the registry

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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 40-75 years;
Neurogenic claudication or bilateral radiculopathy caused by single level combination of degenerative stenosis and spondylolisthesis confirmed by MRI at one level L3-L4 or L4-L5 or L5-S1;
Symptoms persisting for at least three months prior to surgery;
Given written Informed Consent Form;
Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;
Oswestry Disability Index score of at least 40/100 at baseline;

Who cannot join

Bilateral foraminal stenosis requiring surgical decompression on both sides;
Degenerative spondylolisthesis Type 2B, 3 subtypes by Gille;
More than one symptomatic level requiring multi-level surgical decompression and/or fusion;
Any condition that cannot be treated with mini-invasive unilateral decompression and fusion;
Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
Spondylolisthesis grade II or higher of any etiology;

Show all 11Show fewer

Prior lumbar spinal fusion at any level;
Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduct of the study;
History or presence of any other major neurological disease or condition that may interfere with the study assessments;
Severe arterial insufficiency of the legs or other peripheral vascular disease;
Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).

Trial locations and contacts

1 site in 1 country.

Russia1 site

Priorov National Medical Research Center of Traumatology and Orthopedics
Moscow, 127299

Other trials in Russia

About this study

Official title: An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Decompression and Fusion and Traditional Open

Conditions: Lumbar Spinal Stenosis, Intervertebral Disc Degeneration
Being tested: lumbar fusion
Medical subject headings: Spinal Stenosis, Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lumbar fusionProcedure or surgery
Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique.

Study groups in NCT04594980
Study group	Role	What they receive
Minimally invasive TLIF	Other	Patients will undergo a single level decompression and fusion using a minimally invasive technique. Followed posterior screw fixation is mandatory. Receives: Procedure: lumbar fusion
Open TLIF	Other	Patients will undergo a single level decompression and fusion using an open traditional technique. Followed posterior screw fixation is mandatory. Receives: Procedure: lumbar fusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in Oswestry Disability Index (ODI)
To observe the change of ODI 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

Secondary outcomes (16)

Change from baseline in Oswestry Disability Index (ODI)
To observe the change of ODI 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: Through 2 years
Change from baseline in Numeric Pain Rating Score (NPRS)
To observe the change of NPRS as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain)
Measured: Through 2 years
Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D).
To observe the change of EQ-5D as compared to baseline through follow-up terms. It assesses 5 components related to aspects of life: mobility, self-care, activity in daily life, pain, anxiety or depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Through 2 years
Change from baseline in Douleur Neuropathique 4 (DN4)
To observe the change of DN4 as compared to baseline through follow-up terms. The scale result ranges 0-10 points. The sum > 4 points indicates the neuropathic component of pain
Measured: Through 2 years
Change from baseline in The Health Transition Item from SF-36 (HTI Item)
To observe the change of HTI Item through follow-up terms. Patient's answers range from ''Much Better,'' ''Somewhat Better,'' ''About the Same,'' ''Somewhat Worse,'' to ''Much Worse.''
Measured: Through 2 years
Change from baseline in Clinical Global Impression Of Change (CGIC) scale
To observe the change of CGIC through follow-up terms. The answers range from "-2 Significantly worse compared to Baseline" to "+2 Significantly improved compared to Baseline". 7-points scale indicates the patient's condition assessed by physician.
Measured: Through 2 years
Cost-effectiveness
Total cost of surgical procedure (implanted system, the salary for surgery team) and the cost of patient's staying at the clinic before discharge.
Measured: 14th day of hospital stay
Fusion rate success
Interbody fusion rate on CT based on Tan grades
Measured: 12 months and 24 months post op
Surgery duration
Surgery duration, min
Measured: Day of surgery
Reoperations rate
Incidence of reoperations
Measured: Through 2 years
Pelvic Incidence
To observe the sagittal balance parameter - Pelvic Incidence - by sagittal scans of spine by X-Ray, in degrees
Measured: Through 2 years
Change from baseline in Pelvic Tilt
To observe the sagittal balance parameter - Pelvic Tilt - by sagittal scans of spine by X-Ray compared to baseline, in degrees
Measured: Through 2 years
Change from baseline in Global Lordosis Angle
To observe the sagittal balance parameter - Global Lordosis Angle - by sagittal scans of spine by X-Ray compared to baseline, in degrees
Measured: Through 2 years
Change from baseline in Segmental Lordosis
To observe the sagittal balance parameter - Segmental Lordosis (the angle of treated level) - by sagittal scans of spine by X-Ray compared to baseline, in degrees
Measured: Through 2 years
Change from baseline in Sagittal Vertical Axis
To observe the sagittal balance parameter - Sagittal Vertical Axis - by sagittal scans of spine by X-Ray compared to baseline, in mm
Measured: Through 2 years
Adverse Events
Document Adverse Events (incl. adverse events related to device) occurrence throughout the study
Measured: Through 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 20221 Mar 2026

First posted20 Oct 2020
Study start20 Jan 2022
Primary completion27 Feb 2024
Study completion1 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04594980
Sponsor's protocol ID: NS02-01
Status last verified: Mar 2026
First submitted: 10 Oct 2020
Last updated: 3 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data are available upon reasonable request. Please contact the corresponding author for detail.

Publications

Krutko A, Kuzmin N, Baykov E, Leonova O. MIS-TLIF Versus Open TLIF in Combined Lumbar Stenosis and Low-Grade Spondylolisthesis : Of Discharge Timing and Treatment Pricing. Spine (Phila Pa 1976). 2026 Sep 15;51(18):1326-1332. doi: 10.1097/BRS.0000000000005669. Epub 2026 Feb 23.
PubMed 41740626
Leonova ON, Cherepanov EA, Krutko AV. MIS-TLIF versus O-TLIF for single-level degenerative stenosis: study protocol for randomised controlled trial. BMJ Open. 2021 Mar 5;11(3):e041134. doi: 10.1136/bmjopen-2020-041134.
PubMed 33674366

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis

All Lumbar Spinal Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Decompression and Fusion and Traditional Open
ClinicalTrials.gov ID: NCT04594980
Acronym / sponsor ID: NS02-01
Conditions: Lumbar Spinal Stenosis, Intervertebral Disc Degeneration
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: N.N. Priorov National Medical Research Center of Traumatology and OrthopedicsUniversity, hospital or other
Study start: 20 Jan 2022 (actual)
Primary completion: 27 Feb 2024 (actual)
Study completion: 1 Mar 2026 (actual)
First posted: 20 Oct 2020 (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.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Minimally invasive TLIF	Other	Procedure: lumbar fusionPatients will undergo a single level decompression and fusion using a minimally invasive technique. Followed posterior screw fixation is mandatory.
Open TLIF	Other	Procedure: lumbar fusionPatients will undergo a single level decompression and fusion using an open traditional technique. Followed posterior screw fixation is mandatory.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age 40-75 years;
Neurogenic claudication or bilateral radiculopathy caused by single level combination of degenerative stenosis and spondylolisthesis confirmed by MRI at one level L3-L4 or L4-L5 or L5-S1;
Symptoms persisting for at least three months prior to surgery;
Given written Informed Consent Form;
Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;

Key exclusion criteria (11 listed)

Bilateral foraminal stenosis requiring surgical decompression on both sides;
Degenerative spondylolisthesis Type 2B, 3 subtypes by Gille;
More than one symptomatic level requiring multi-level surgical decompression and/or fusion;
Any condition that cannot be treated with mini-invasive unilateral decompression and fusion;
Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;

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
lumbar fusionTransforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique.	Procedure or surgery	Minimally invasive TLIF, Open TLIF

Primary outcome

Change from baseline in Oswestry Disability Index (ODI)
Time frame: 3 months
To observe the change of ODI 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

16 secondary outcomes

Change from baseline in Oswestry Disability Index (ODI)
Time frame: Through 2 years
Change from baseline in Numeric Pain Rating Score (NPRS)
Time frame: Through 2 years
Change from baseline in EuroQol Five-Dimensional descriptive system questionnaire (EQ-5D).
Time frame: Through 2 years
Change from baseline in Douleur Neuropathique 4 (DN4)
Time frame: Through 2 years
Change from baseline in The Health Transition Item from SF-36 (HTI Item)
Time frame: Through 2 years
Change from baseline in Clinical Global Impression Of Change (CGIC) scale
Time frame: Through 2 years
Cost-effectiveness
Time frame: 14th day of hospital stay
Fusion rate success
Time frame: 12 months and 24 months post op
Surgery duration
Time frame: Day of surgery
Reoperations rate
Time frame: Through 2 years
Pelvic Incidence
Time frame: Through 2 years
Change from baseline in Pelvic Tilt
Time frame: Through 2 years
Change from baseline in Global Lordosis Angle
Time frame: Through 2 years
Change from baseline in Segmental Lordosis
Time frame: Through 2 years
Change from baseline in Sagittal Vertical Axis
Time frame: Through 2 years
Adverse Events
Time frame: Through 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
Derived from this study: PubMed 41740626Krutko A, Kuzmin N, Baykov E, Leonova O. MIS-TLIF Versus Open TLIF in Combined Lumbar Stenosis and Low-Grade Spondylolisthesis : Of Discharge Timing and Treatment Pricing. Spine (Phila Pa 1976). 2026 Sep 15;51(18):1326-1332. doi: 10.1097/BRS.0000000000005669. Epub 2026 Feb 23.
Derived from this study: PubMed 33674366Leonova ON, Cherepanov EA, Krutko AV. MIS-TLIF versus O-TLIF for single-level degenerative stenosis: study protocol for randomised controlled trial. BMJ Open. 2021 Mar 5;11(3):e041134. doi: 10.1136/bmjopen-2020-041134.
Individual participant dataSharing planned: Yes. Data are available upon reasonable request. Please contact the corresponding author for detail.

Related trials for Lumbar Spinal Stenosis

Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 11 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: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Oswestry Disability Index (ODI) (time frame: 3 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 NCT04594980, which also lists 2 linked publications.

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 3 Mar 2026.