Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful 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

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2011-06-01

Brief Summary

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The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.

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Detailed Description

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Osteoporotic vertebral fractures are associated with pain and severe disability in a high percentage of patients. Vertebroplasty has become the treatment of choice to alleviate pain in those patients who have not responded to medical treatment.Although several case series and non-randomized studies have shown the effectiveness of vertebroplasty in alleviating pain secondary to osteoporotic vertebral fractures, the long-term effect of this treatment has not been compared to standard medical treatment in a randomized study.

In our study we have analyzed the long-term effect of vertebroplasty in terms of quality of life in patients with painful osteoporotic vertebral fractures, randomizing them into two arms: percutaneous vertebroplasty or conventional medical treatment.

Conditions

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Spinal Fracture Osteoporosis Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vertebroplasty

Group Type ACTIVE_COMPARATOR

percutaneous injection of cement into the vertebral body

Intervention Type PROCEDURE

percutaneous injection of cement into the vertebral body

Medical Treatment

Group Type ACTIVE_COMPARATOR

Medical treatment

Intervention Type OTHER

standard antalgic medical treatment

Interventions

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percutaneous injection of cement into the vertebral body

Intervention Type PROCEDURE

Medical treatment

standard antalgic medical treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5
* Fragility; i.e. fracture not in relation with significant trauma
* Recent fracture, pain beginning not earlier than 1 year before inclusion

Exclusion Criteria

* No vertebral edema on STIR MR images
* Uncorrectable bleeding diatheses
* Active infection
* Substantial retropulsion of bony fragments
* Non-osteoporotic fracture
* Concomitant neoplasm

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No