ClinicalTrials.gg
CompletedNCT01643395VOLCANOUpdated Aug 5, 2026

VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

A Phase 3 interventional study of vertebroplasty and conservative therapy in Vertebral Compression Fracture and Spinal Trauma, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Primary conditionFractures, CompressionRegistry: Wounds and InjuriesReclassifiedWhy we changed it
Registry
Wounds and Injuries — the first condition term the registry derived for this study.
ClinicalTrials.gg
Fractures, Compression
Why
  1. The study's listed conditions name Fractures, Compression, a narrower term within Wounds and Injuries.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University Hospital, Clermont-Ferrand · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

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

02

Conditions studied

  • Vertebral Compression Fracture
  • Spinal Trauma

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Keywords

  • Trauma
  • vertebral
  • compression fracture
  • spinal
  • acute
  • vertebroplasty
  • conservative treatment
03

In context

Fractures, Compression Reclassified

50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.

This study's enrollment of 99 is above the median of 73 across 32 interventional studies indexed under Fractures, Compression.

Browse Fractures, Compression studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Compared within Fractures, Compression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Wounds and Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
99 participants (actual)

Study arms

  • Experimental
    vertebroplasty

    Other: vertebroplasty

  • Other
    conservative therapy (brace)

    Other: conservative therapy

Interventions

  • Othervertebroplasty

    Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse

  • Otherconservative therapy

    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.

06

What researchers measure

Primary outcomes

  1. Disability scale

    Time frame: at 1 month

Secondary outcomes

  1. Spine radiological measurements

    Time frame: at 1, 3 and 6 months

  2. Disability and qol

    Time frame: at 3 and 6 months

07

Study locations

1 site
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01643395
Responsible party
Sponsor
First posted
Jul 18, 2012
Start date
Sep 2010
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Aug 5, 2026

Study contacts

Emmanuel CHABERT
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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