We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643395
First Posted: July 18, 2012
Last Update Posted: February 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose

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).


Condition Intervention Phase
Vertebral Compression Fracture Spinal Trauma Other: vertebroplasty Other: conservative therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Disability scale [ Time Frame: at 1 month ]

Secondary Outcome Measures:
  • Spine radiological measurements [ Time Frame: at 1, 3 and 6 months ]
  • Disability and qol [ Time Frame: at 3 and 6 months ]

Enrollment: 99
Study Start Date: September 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vertebroplasty Other: vertebroplasty
Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse
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.

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643395


Locations
France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Emmanuel CHABERT University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01643395     History of Changes
Other Study ID Numbers: CHU-0122
First Submitted: July 13, 2012
First Posted: July 18, 2012
Last Update Posted: February 17, 2014
Last Verified: February 2014

Keywords provided by University Hospital, Clermont-Ferrand:
Trauma
vertebral
compression fracture
spinal
acute
vertebroplasty
conservative treatment

Additional relevant MeSH terms:
Fractures, Bone
Spinal Fractures
Fractures, Compression
Wounds and Injuries
Spinal Injuries
Back Injuries