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New cement promises stronger healing for spine fractures

NCT ID NCT00931333

Disease control Sponsor: University Hospital, Bordeaux 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested a special cement that mimics natural bone to repair broken vertebrae in adults aged 18 to 65. The cement is designed to be absorbed by the body and replaced with new bone over time. Only 4 people took part before the study was stopped early. The goal was to see if the cement could safely restore vertebra height and reduce pain.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

4 people

The number who actually took part.

Start date

Jul 2009

Finished

Feb 2011

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 65 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: * Patients aged between 18 and 65 years old, BMI \< 30 * Stable and important fracture of the vertebral body between T9 and L5 * Diagnostic maximum 3 weeks after the trauma causing the fracture * Type A1 to A3 (MAGERL scale) assessed by CT scan * Lumbar local traumatic angle \> 10°, and thoracic \> 15° * Given informed consent * Patient with French health system Exclusion Criteria: * For women: no efficient contraception (intra uterine device, or contraceptive pill) * Pregnant or feeding women * Fractures due to metastasis or multiple myeloma * Symptomatic compression of the spinal cord * Multi site vertebroplasty * Scoliosis with a Cobb angle \> 20° * Surgery zone local infection * All surgical contraindications * Immune system abnormalities, immune deficiency or suppression, HIV or BHV or CHV (positive serology) * Severe hyperparathyroidism: calcium \> 2,45 mmol/l and \[PTH\] ≥ 50pg / ml * Uncontrolled diabetes (untreated or non stabilized by treatment) * Long corticoid treatment (more than 6 months and stopped since less than 3 months) * Chemotherapy * All contra indication to MCPC: osteomyelitis, bone degenerative disease or necrosis of surgery site. * Known allergy to indigotine

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Conditions

The condition(s) this trial relates to.

spinal fracture spinal injury

As listed by the trial registrant

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

Vertebra trauma

Contacts and locations

Locations

  • Service d'orthopédie-traumatolologie (C), Hôpital Pellegrin

    Bordeaux, 33076, France

More trials for these conditions

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