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Can a cement injection outperform a brace for spine fractures?

NCT ID NCT01643395

Disease control Sponsor: University Hospital, Clermont-Ferrand 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether injecting bone cement into a recently fractured vertebra (vertebroplasty) reduces disability better than wearing a brace. Adults aged 18–70 with a traumatic spinal fracture (within 15 days) are randomly assigned to one of the two treatments. The study measures disability, quality of life, and spinal alignment to see which approach offers better recovery.

What this could mean

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

Active substance
vertebroplasty (injection of bone cement into the fractured vertebra)
What this could lead to
If vertebroplasty proves more effective than a brace, it could offer a faster, more reliable recovery for people with recent spinal fractures.
What could go wrong
The trial is relatively small, and vertebroplasty carries risks such as cement leakage or infection. It may not prove superior to conservative care.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

99 people

The number who actually took part.

Start date

Sep 2010

Finished

Apr 2013

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 to 70 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: * 18 - 70 year old * volunteers * Vertebral compression fractures Magerl type A * Acute Trauma (less than 15 days) * Between T5 and L5 * Patient able to undergo both vertebroplasty and conservative treatment * Consent form obtained Exclusion Criteria: * Neural arch fracture * C1 to T4 fracture * Neurologic symptoms caused by the fracture * Encephalic trauma with Glasgow Coma Scale less than 15 * Ongoing cancer * Routine painkillers intake * Local or systemic infection * Coagulation's disorder * Pregnancy * Involvement in an another clinical trial

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Conditions

The condition(s) this trial relates to.

Fractures, Compression injury spinal fracture spinal injury

As listed by the trial registrant

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

Spinal trauma Vertebral compression fracture

Contacts and locations

Locations

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003, France

More trials for these conditions

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