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New minimally invasive technique may spare spinal fracture patients from major surgery

NCT ID NCT07645092

Disease control Sponsor: University Hospital, Grenoble 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a less invasive surgical approach for severe thoracolumbar burst fractures, a type of spinal injury. The procedure combines vertebral augmentation (using a device to restore bone height) with percutaneous fixation (screws placed through small incisions). The goal is to see if this technique can avoid the need for a more invasive surgery called corpectomy, which removes part of the vertebra. The study includes 30 adults with a specific fracture severity score, and will track whether patients need additional surgery and how well the spine heals.

What this could mean

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

Active substance
vertebral expansion device and percutaneous fixation
What this could lead to
If successful, this could offer a less invasive surgical option for severe spinal fractures, reducing recovery time and avoiding more complex surgery.
What could go wrong
This is a small, early-stage study with only 30 participants. The technique may not work for all fracture types, and there is a risk of implant failure or need for additional 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.

Participants

About 30 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 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.

Who is studied

In this study, all adult patients treated for thoracic and lumbar spine fractures with a Load Sharing Classification (LSC) score ≥ 7, who underwent posterior fixation (+1/-1 levels) combined with anterior vertebral augmentation, will be eligible for inclusion. Epidemiological data, preoperative management, AO Spine classification \[1\], operative data, and radiological findings are collected and analyzed. Data collection is performed using patients' medical records and during a follow-up telephone visit.

Ages

18 to 100 years

Sex

Anyone

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: * Adult patient at the time of the fracture. * Patient who underwent posterior fixation (+1/-1 levels) combined with anterior vertebral augmentation: Fracture with a Load Sharing Classification (LSC) score ≥ 7 Single vertebral level involved Percutaneous surgery * Preoperative CT scans (thoracic and lumbar spine) * Postoperative CT scans (thoracic and lumbar spine) Exclusion Criteria: * Persons deprived of liberty by judicial or administrative decision, or persons under legal protection measures. * Non-inclusion criteria include: Performance of a laminectomy Pathological fractures Fractures classified as type C or B2 according to the AO Spine classification Presence of severe scoliosis Neurological deficit More than one vertebral fracture

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Conditions

The condition(s) this trial relates to.

spinal fracture

As listed by the trial registrant

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

Thoracolumbar burst fractures

How to take part

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

  1. 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 ↗

  2. 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.