VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures (VOLCANO)

February 14, 2014 updated by: University Hospital, Clermont-Ferrand

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vertebroplasty
Other: vertebroplasty
Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse
Other: conservative therapy (brace)
Other: conservative 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disability scale
Time Frame: at 1 month
at 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Spine radiological measurements
Time Frame: at 1, 3 and 6 months
at 1, 3 and 6 months
Disability and qol
Time Frame: at 3 and 6 months
at 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Emmanuel CHABERT, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

July 17, 2012

First Posted (Estimate)

July 18, 2012

Study Record Updates

Last Update Posted (Estimate)

February 17, 2014

Last Update Submitted That Met QC Criteria

February 14, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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