VOLCANO: VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

• Sponsor: University Hospital, Clermont-Ferrand (Other)
• Overall Status: Completed
• CT.gov ID: NCT01643395
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Vertebral Compression Fracture; Spinal Trauma	Other: vertebroplasty; Other: conservative therapy	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vertebroplasty	Other: vertebroplasty; Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse
Other: conservative therapy (brace)	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.

Outcome Measures

Primary Outcome Measures

1. Disability scale [at 1 month]

Secondary Outcome Measures

1. Spine radiological measurements [at 1, 3 and 6 months]

2. Disability and qol [at 3 and 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Clermont-Ferrand	Clermont-Ferrand		France	63003

Sponsors and Collaborators

• University Hospital, Clermont-Ferrand

Investigators

• Principal Investigator: Emmanuel CHABERT, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT01643395
• Other Study ID Numbers: CHU-0122
• First Posted: Jul 18, 2012
• Last Update Posted: Feb 17, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by University Hospital, Clermont-Ferrand: Trauma; vertebral; compression fracture; spinal; acute; vertebroplasty; conservative treatment
• Additional relevant MeSH terms: Fractures, Bone; Spinal Fractures; Fractures, Compression

Study Results

No Results Posted as of Feb 17, 2014