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OpenTrials
Completed

NCT Number: NCT01643395

VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

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).

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Key information

Conditions

Vertebral Compression Fracture Fractures, Bone Fractures, Compression Spinal Trauma Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vertebroplasty

Other

Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse

conservative therapy

Other

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.

Primary outcomes

  1. Disability scale

    Time frame: at 1 month

Secondary outcomes

  1. Spine radiological measurements

    Time frame: at 1, 3 and 6 months

  2. Disability and qol

    Time frame: at 3 and 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: VOLCANO

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2012
Registry last updated
Feb 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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