Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-27 @ 10:34 PM
Study NCT ID:
NCT01643395
Status:
COMPLETED
Last Update Posted:
2014-02-17
First Post:
2012-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VOLCANO
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).
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: