VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures
VOLCANO
1 other identifier
interventional
99
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 13, 2012
CompletedFirst Posted
Study publicly available on registry
July 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFebruary 17, 2014
February 1, 2014
2.6 years
July 13, 2012
February 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disability scale
at 1 month
Secondary Outcomes (2)
Spine radiological measurements
at 1, 3 and 6 months
Disability and qol
at 3 and 6 months
Study Arms (2)
vertebroplasty
EXPERIMENTALconservative therapy (brace)
OTHERInterventions
Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003, France
Related Publications (1)
Chabert E, Hugonnet E, Kastler A, Sakka L, Rabbo FA, Zerroug A, Coudeyre E, Pereira B, Coll G. Vertebroplasty versus bracing in acute vertebral compression fractures: A prospective randomized trial. Ann Phys Rehabil Med. 2023 Sep;66(6):101746. doi: 10.1016/j.rehab.2023.101746. Epub 2023 Apr 6.
PMID: 37030247DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuel CHABERT
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2012
First Posted
July 18, 2012
Study Start
September 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
February 17, 2014
Record last verified: 2014-02