VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures (VOLCANO)
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).
|Vertebral Compression Fracture Spinal Trauma||Other: vertebroplasty Other: conservative therapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures|
- 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 ]
|Study Start Date:||September 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643395
|CHU de Clermont-Ferrand|
|Clermont-Ferrand, France, 63003|
|Principal Investigator:||Emmanuel CHABERT||University Hospital, Clermont-Ferrand|