NCT01643395
Completed
Phase 3
VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures
University Hospital, Clermont-Ferrand1 site in 1 country99 target enrollmentSeptember 2010
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Vertebral Compression Fracture
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Disability scale
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Disability scale
Time Frame: at 1 month
Secondary Outcomes
- Spine radiological measurements(at 1, 3 and 6 months)
- Disability and qol(at 3 and 6 months)
Study Sites (1)
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