VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures (VOLCANO)

University Hospital, Clermont-Ferrand

Status and phase: Completed; Phase 3

Conditions: Spinal Trauma; Vertebral Compression Fracture

Treatments: Other: vertebroplasty; Other: conservative therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01643395

CHU-0122

Details and patient eligibility

About

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).

Full 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

Enrollment: 99 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

vertebroplasty

Experimental group

Treatment:

Other: vertebroplasty

conservative therapy (brace)

Other group

Treatment:

Other: conservative therapy