VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

Phase 3

Completed

• Conditions: Spinal Trauma; Vertebral Compression Fracture
• Interventions: Other: vertebroplasty; Other: conservative therapy

• Registration Number: NCT01643395
• Lead Sponsor: University Hospital, Clermont-Ferrand

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).

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-18
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-14
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
vertebroplasty	vertebroplasty	-
conservative therapy (brace)	conservative therapy	-

Primary Outcome Measures

Name	Time	Method
Disability scale	at 1 month

Secondary Outcome Measures

Name	Time	Method
Spine radiological measurements	at 1, 3 and 6 months
Disability and qol	at 3 and 6 months

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France