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

Primary Purpose

Vertebral Compression Fracture, Spinal Trauma

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
vertebroplasty
conservative therapy
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertebral Compression Fracture focused on measuring Trauma, vertebral, compression fracture, spinal, acute, vertebroplasty, conservative treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

vertebroplasty

conservative therapy (brace)

Arm Description

Outcomes

Primary Outcome Measures

Disability scale

Secondary Outcome Measures

Spine radiological measurements
Disability and qol

Full Information

First Posted
July 13, 2012
Last Updated
February 14, 2014
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT01643395
Brief Title
VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures
Acronym
VOLCANO
Official Title
VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Compression Fracture, Spinal Trauma
Keywords
Trauma, vertebral, compression fracture, spinal, acute, vertebroplasty, conservative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vertebroplasty
Arm Type
Experimental
Arm Title
conservative therapy (brace)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
vertebroplasty
Intervention Description
Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse
Intervention Type
Other
Intervention Name(s)
conservative therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Disability scale
Time Frame
at 1 month
Secondary Outcome Measure Information:
Title
Spine radiological measurements
Time Frame
at 1, 3 and 6 months
Title
Disability and qol
Time Frame
at 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel CHABERT
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

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VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

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