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Is fusion necessary? new trial tests if simpler back surgery works just as well

NCT ID NCT05273879

Knowledge-focused Sponsor: Sklifosovsky Institute of Emergency Care Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two surgical approaches for single-level lumbar spinal stenosis: decompression alone versus decompression with spinal fusion. Researchers will track 86 patients aged 45-75 over two years to see if the simpler procedure works just as well. The goal is to determine whether fusion is truly needed, which could reduce surgical risks and costs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could show that decompression alone is just as effective as decompression plus fusion, potentially sparing patients from unnecessary surgery.
What could go wrong
This is a relatively small trial (86 participants) and results may not apply to all patients. The non-inferiority design means it can only show that one approach is not worse than the other, not that it is better.

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

About 86 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

45 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: * 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. Exclusion Criteria: * 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; * 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.

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Conditions

The condition(s) this trial relates to.

Constriction, Pathologic lumbar spinal stenosis spinal stenosis

As listed by the trial registrant

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

Lumbar spinal stenosis Spinal fusion Spinal stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pirogov National Medical and Surgical Center

    RECRUITING

    Moscow, Moscow, 105203, Russia

  • Sklifosovsky Research Institute for Emergency Medicine

    RECRUITING

    Moscow, Moscow, 107045, Russia

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