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Less invasive back surgery may offer faster relief for spinal stenosis patients

NCT ID NCT04594980

Symptom relief Sponsor: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two surgical approaches for people with a single level of lumbar spinal stenosis (a narrowed spine canal causing leg pain and trouble walking). 96 adults aged 40-75 were randomly assigned to receive either minimally invasive decompression and fusion or traditional open surgery. The goal was to see which method better improves disability and pain over 12 months after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

96 people

The number who actually took part.

Started

Jan 2022

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 40-75 years; 2. 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; 3. Symptoms persisting for at least three months prior to surgery; 4. Given written Informed Consent Form; 5. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements; 6. Oswestry Disability Index score of at least 40/100 at baseline; Exclusion Criteria: 1. Bilateral foraminal stenosis requiring surgical decompression on both sides; 2. Degenerative spondylolisthesis Type 2B, 3 subtypes by Gille; 3. More than one symptomatic level requiring multi-level surgical decompression and/or fusion; 4. Any condition that cannot be treated with mini-invasive unilateral decompression and fusion; 5. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol; 6. Spondylolisthesis grade II or higher of any etiology; 7. Prior lumbar spinal fusion at any level; 8. Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduct of the study; 9. History or presence of any other major neurological disease or condition that may interfere with the study assessments; 10. Severe arterial insufficiency of the legs or other peripheral vascular disease; 11. Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar spinal stenosis spinal stenosis spondylolisthesis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intervertebral disc degeneration Lumbar spinal stenosis

Contacts and locations

Locations

  • Priorov National Medical Research Center of Traumatology and Orthopedics

    Moscow, 127299, Russia

More trials for these conditions

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