VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures (VOLCANO)
|ClinicalTrials.gov Identifier: NCT01643395|
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : February 17, 2014
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 or disease||Intervention/treatment||Phase|
|Vertebral Compression Fracture Spinal Trauma||Other: vertebroplasty Other: conservative therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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.
- Disability scale [ Time Frame: at 1 month ]
- Spine radiological measurements [ Time Frame: at 1, 3 and 6 months ]
- Disability and qol [ Time Frame: at 3 and 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643395
|CHU de Clermont-Ferrand|
|Clermont-Ferrand, France, 63003|
|Principal Investigator:||Emmanuel CHABERT||University Hospital, Clermont-Ferrand|