NCT01643395

VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Vertebral Compression Fracture
• Spinal Trauma

Interventions

Type	Name	Description
OTHER	vertebroplasty	Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse
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.

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-07-18
• Last updated: 2014-02-17

Locations

1 site across 1 country: France