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Less invasive back surgery may be as effective as major revision for spinal stenosis

NCT ID NCT07661199

Disease control Sponsor: Charite University, Berlin, Germany 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This trial compares two surgical approaches for people who develop spinal stenosis near a previous lumbar fusion. One group receives a smaller surgery (microdecompression alone), while the other gets the standard larger surgery (decompression plus extending the fusion). The study measures disability, pain, complications, and reoperation rates over two years to see if the less invasive option works just as well.

What this could mean

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

Active substance
Microsurgical decompression with or without fusion extension
What this could lead to
If microdecompression alone works as well as the more invasive surgery, patients could avoid a larger operation with fewer risks and faster recovery.
What could go wrong
This is a single trial, and results may not apply to all patients. The less invasive surgery might lead to more reoperations or worse long-term outcomes.

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 338 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2031

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: * Age ≥18 years. * Oswestry Disability Index (ODI) between 30% and 80% at screening. * Symptomatic adjacent segment stenosis following degenerative lumbar fusion surgery. * Persistent symptoms despite at least 6 weeks of appropriate conservative treatment. * Radiological evidence of adjacent segment spinal stenosis on magnetic resonance imaging (MRI). * Ability to understand the study procedures and complete patient-reported outcome questionnaires. * Ability to provide written informed consent. Exclusion Criteria: * Adjacent segment kyphosis or scoliosis greater than 10 degrees. * Screw loosening or pseudarthrosis of the previous fusion construct. * Known current pregnancy or breastfeeding. * Acute traumatic spinal injury or fracture. * Active inflammatory disease of the spine. * Active neoplastic disease of the spine. * Contraindication to spinal surgery. * Inability to provide informed consent or complete study questionnaires. * Symptoms attributable to spinal stenosis are not the predominant clinical complaint * Foraminal stenosis grade ≥2 according to the Lee classification. * Dynamic spondylolisthesis ≥3 mm on flexion-extension radiographs. * Persons involuntarily detained by judicial or administrative order.

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Conditions

The condition(s) this trial relates to.

lumbar spinal stenosis spinal stenosis

As listed by the trial registrant

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

Adjacent segment disease Lumbar 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

    1 site. 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

  • Charité - Universitätsmedizin Berlin

    Berlin, State of Berlin, 10117, Germany

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