VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

Study Overview
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Brief Summary
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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
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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

Official Title
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VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

Conditions
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Vertebral Compression Fracture, Spinal Trauma

Intervention / Treatment
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* Other: vertebroplasty
* Other: conservative therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vertebroplasty<br> | Other: vertebroplasty<br>* Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse<br>|
| Other: conservative therapy (brace)<br> | Other: conservative therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability scale |  | at 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spine radiological measurements |  | at 1, 3 and 6 months | 
| Disability and qol |  | at 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma, vertebral, compression fracture, spinal, acute, vertebroplasty, conservative treatment