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Back surgery without fusion: does the spine Self-Correct?

NCT ID NCT07139938

Knowledge-focused 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study looks at whether people with a curved spine (sagittal imbalance) from lumbar spinal stenosis can have their spine naturally straighten after a simple decompression surgery, without needing a more complex fusion procedure. Researchers will measure spine alignment changes in 165 adults aged 45 and older over time. The goal is to understand if less invasive surgery alone can restore balance.

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 165 people

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

Started

Oct 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

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

18 years and older

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 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. 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; Exclusion Criteria: * 1\. Performed intraoperative discotomy; * 2\. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)

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Conditions

The condition(s) this trial relates to.

Constriction, Pathologic lumbar disk degenerative disorder lumbar disk disease lumbar spinal stenosis

As listed by the trial registrant

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

Degeneration lumbar spine Lumbar decompression Lumbar stenosis Sagittal imbalance

How to take part

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

  1. The places running it

    3 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

  • Burdenko Neurosurgery Institute

    RECRUITING

    Moscow, 125047, Russia

  • Pirogov National Medical Surgical Center

    RECRUITING

    Moscow, 105203, Russia

  • Priorov National Medical Research Center of Traumatology and Orthopedics

    RECRUITING

    Moscow, 127299, Russia

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