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New surgical approach aims to fix failed back fusions by restoring natural spinal curve

NCT ID NCT07050290

Disease control 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests a surgical technique to restore the natural curve (lordosis) of the lower spine in people who have had a previous spinal fusion that failed or caused ongoing pain. The procedure is done through the same incision used in the prior surgery. Researchers will measure changes in spinal alignment, pain levels, and disability in 20 adults with failed back surgery syndrome or degenerative spine conditions.

What this could mean

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

Active substance
surgical procedure to restore segmental lordosis via posterior approach
What this could lead to
If successful, this technique could offer a safer, more effective way to correct spinal alignment after a failed fusion, potentially reducing pain and disability.
What could go wrong
This is a small, early-stage study with only 20 participants, so results may not apply broadly. Surgery carries risks like infection, nerve damage, or incomplete symptom relief.

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 20 people

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

Started

Jun 2025

Expected to finish

Jul 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\. Over 18 years' old; * 2\. Lumbar back pain with / without radicular leg pain (with / without neurological deficit) with / without neurogenic claudication, symptoms persisting for at least 3 months prior to surgery; * 3\. 1) Failed back lumbar fusion surgery at the same level or on an adjacent segment or 2) Symptomatic discopathy with loss of segmental lordosis at one of the levels L3-L4, L4-L5 or L5-S1, confirmed by MRI и Rg, with/without degenerative stenosis/spondylolisthesis * 4\. Need for a planned surgical procedure with a major extent of segmental lordosis restoration (more than 10°); * 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 Exclusion Criteria: * 1\. Interbody implants previously placed via non-posterior approach at the level of surgery (which cannot be removed through the posterior approach); * 2\. Complete interbody fusion after previous surgery at the level of surgery; * 3\. HU values of lumbar body vertebrae less than 120 HU; * 4\. Any contraindication or inability to undergo baseline and/or follow up MRI, CT or X-ray as required per protocol; * 5\. Back or non-radicular pain of unknown etiology; * 6\. History or presence of any other major neurological disease or condition that may interfere with the study assessments; * 7\. 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.

Failed Back Surgery Syndrome lumbar disk degenerative disorder lumbar disk disease spondylolisthesis

As listed by the trial registrant

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

Degeneration lumbar spine Degenerative spondylolisthesis Failed back surgery syndrome Sagittal imbalance

Contacts and locations

Locations

  • Priorov National Medical Research Center of Traumatology and Orthopedics

    Moscow, 127299, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.