Vertebral Compression FracturePhase 3VOLCANONCT01643395
VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures
A Phase 3 study testing vertebroplasty and conservative therapy in people with Vertebral Compression Fracture and Spinal Trauma, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The purpose of this protocol is to prove the efficacy of vertebroplasty in patients suffering from acute non osteoporotic vertebral compression fracture. Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vertebral Compression Fracture, Spinal Trauma
- What is being tested?
- vertebroplasty and conservative therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Local or systemic infection
- Coagulation's disorder
- Pregnancy
- Involvement in an another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this protocol is to prove the efficacy of vertebroplasty in patients suffering from acute non osteoporotic vertebral compression fracture.
Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse.
Our study will compare vertebroplasty versus conservative therapy (brace).
Read the detailed description
The study is a prospective, randomized trial comparing conservative treatment (brace) and vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression fracture (VCF) type A according Magerl classification
- Conditions
- Vertebral Compression Fracture, Spinal Trauma
- Being tested
- vertebroplasty, conservative therapy
- Keywords
- Trauma, vertebral, compression fracture, spinal, acute, vertebroplasty, conservative treatment
- Medical subject headings
- Wounds and Injuries, Fractures, Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vertebroplastyOther
Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse
conservative therapyOther
The study is a prospective, randomized trial comparing conservative treatment (brace) and vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression fracture (VCF) type A according Magerl classification.
| Study group | Role | What they receive |
|---|---|---|
| vertebroplasty | Experimental | Not described Receives: Other: vertebroplasty |
| conservative therapy (brace) | Other | Not described Receives: Other: conservative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability scale
Measured: at 1 month
Secondary outcomes (2)
Spine radiological measurements
Measured: at 1, 3 and 6 months
Disability and qol
Measured: at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startSep 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vertebral Compression FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel CHABERT, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643395
- Sponsor's protocol ID
- CHU-0122
- Acronym
- VOLCANO
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2012
- Last updated
- 5 Aug 2026
- Results posted
- No
Publications
Chabert E, Hugonnet E, Kastler A, Sakka L, Rabbo FA, Zerroug A, Coudeyre E, Pereira B, Coll G. Vertebroplasty versus bracing in acute vertebral compression fractures: A prospective randomized trial. Ann Phys Rehabil Med. 2023 Sep;66(6):101746. doi: 10.1016/j.rehab.2023.101746. Epub 2023 Apr 6.
PubMed 37030247
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures
- ClinicalTrials.gov ID
- NCT01643395
- Acronym / sponsor ID
- VOLCANO / CHU-0122
- Conditions
- Vertebral Compression Fracture, Spinal Trauma
- Keywords
- Trauma, vertebral, compression fracture, spinal, acute, vertebroplasty, conservative treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to prove the efficacy of vertebroplasty in patients suffering from acute non osteoporotic vertebral compression fracture.
Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse.
Our study will compare vertebroplasty versus conservative therapy (brace).
Detailed description
The study is a prospective, randomized trial comparing conservative treatment (brace) and vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression fracture (VCF) type A according Magerl classification
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vertebroplasty | Experimental | Other: vertebroplasty |
| conservative therapy (brace) | Other | Other: conservative therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 - 70 year old
- volunteers
- Vertebral compression fractures Magerl type A
- Acute Trauma (less than 15 days)
- Between T5 and L5
Key exclusion criteria (10 listed)
- Neural arch fracture
- C1 to T4 fracture
- Neurologic symptoms caused by the fracture
- Encephalic trauma with Glasgow Coma Scale less than 15
- Ongoing cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vertebroplastyVertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse | Other | vertebroplasty |
| conservative therapyThe study is a prospective, randomized trial comparing conservative treatment (brace) and vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression fracture (VCF) type A according Magerl classification. | Other | conservative therapy (brace) |
Primary outcome
Disability scale
Time frame: at 1 month
2 secondary outcomes
Spine radiological measurements
Time frame: at 1, 3 and 6 months
Disability and qol
Time frame: at 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 37030247Chabert E, Hugonnet E, Kastler A, Sakka L, Rabbo FA, Zerroug A, Coudeyre E, Pereira B, Coll G. Vertebroplasty versus bracing in acute vertebral compression fractures: A prospective randomized trial. Ann Phys Rehabil Med. 2023 Sep;66(6):101746. doi: 10.1016/j.rehab.2023.101746. Epub 2023 Apr 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel CHABERT principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vertebroplasty and conservative therapy in people with Vertebral Compression Fracture and Spinal Trauma, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability scale (time frame: at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01643395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.