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

This study is currently recruiting participants.
Verified July 2012 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01643395
First received: July 13, 2012
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Disability scale [ Time Frame: at 1 month ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 140
Study Start Date: September 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643395

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN     04 73 75 11 95     placarin@chu-clermontferrand.fr    
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Emmanuel CHABERT University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01643395     History of Changes
Other Study ID Numbers: CHU-0122
Study First Received: July 13, 2012
Last Updated: July 17, 2012
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013