Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

March 26, 2008 updated by: University of Aarhus

Percutaneous Vertebroplasty Versus Conservative Treatment of Pain: A Prospective, Randomized Controlled Study of Osteoporotic Fractures in the Spine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, DK 8000
        • Dep of Neuroradiology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of pain
Time Frame: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.
before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Needs for analgetics, number of days at hospital, level of ADL
Time Frame: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.
before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Leif Sorensen, Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 27, 2008

Last Update Submitted That Met QC Criteria

March 26, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20020306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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