VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01643395

Acronym

VOLCANO

Enrollment

Registered

2012-07-18

Start date

2010-09-30

Completion date

2013-04-30

Last updated

2014-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertebral Compression Fracture, Spinal Trauma

Keywords

Trauma, vertebral, compression fracture, spinal, acute, vertebroplasty, conservative treatment

Brief 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).

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

Interventions

OTHERvertebroplasty

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

OTHERconservative therapy

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Disability scale	at 1 month

Secondary

Measure	Time frame
Spine radiological measurements	at 1, 3 and 6 months
Disability and qol	at 3 and 6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026