VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-04-30

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).

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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

Conditions

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Vertebral Compression Fracture Spinal Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vertebroplasty

Group Type EXPERIMENTAL

vertebroplasty

Intervention Type OTHER

Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse

conservative therapy (brace)

Group Type OTHER

conservative therapy

Intervention Type OTHER

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.

Interventions

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vertebroplasty

Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse

Intervention Type 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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No