VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

Vertebral Compression Fracture Clinical Trial

— VOLCANO  

Official title:

VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643395
• Other study ID #: CHU-0122
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2012
• Last updated: February 14, 2014
• Start date: September 2010
• Est. completion date: April 2013

Study information

• Verified date: February 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Compression
• Spinal Fractures
• Spinal Trauma
• Vertebral Compression Fracture

Intervention

Other:
• vertebroplasty
Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse
• 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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability scale		at 1 month	Yes
Secondary	Spine radiological measurements		at 1, 3 and 6 months	Yes
Secondary	Disability and qol		at 3 and 6 months	Yes