Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

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

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2008-01-31

Brief Summary

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The purpose of this study is to compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.

Detailed Description

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In vertebroplasty a bone cement is injected in one or more fractured vertebra. The indication is pain that needs high doses of analgesics.

The cement is a well known product called poly methyl metacrylate (PMMA) normally used fixate joint prosthesis.

Vertebroplasty is done in local anaesthesia. The treatment was introduced in 1984 in France and today thousands of patients have been treated worldwide, but so far no randomized controlled trials have been published.

Conditions

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Pain Osteoporosis Fracture

Keywords

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osteoporosis vertebra fracture pain percutaneous vertebroplasty polymethylmetacrylate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Poly methylmetacrylate, PMMA

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* new pain in spine (within 6 months)
* x-ray verified low energy spinal fracture(s)

Exclusion Criteria

* less than 20% or more than 90% reduction of the vertebral height
* lack of pain at fracture level
* no need for continuous analgesic treatment
* patient no able to communicate
* general anaesthesia contraindicated
* MRI not possible
* coagulopathy (not adjustable)
* spondylitis
* discitis
* spinal metastasis

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Aarhus University Hospital

Principal Investigators

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Leif Sorensen, Consultant

Role: PRINCIPAL_INVESTIGATOR

Locations

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Dep of Neuroradiology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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20020306

Identifier Type: -

Identifier Source: org_study_id