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

February 22, 2017 updated by: JORDI BLASCO ANDALUZ, Hospital Clinic of Barcelona

Analysis of the Impact in the Quality of Life of Patients With Pain Secondary to Osteoporotic Vertebral Fractures Receiving Conservative Treatment Versus Percutaneous Vertebroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

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

  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Hospital Clinic of Barcelona

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Medical Treatment
Other: Medical treatment
standard antalgic medical treatment
Active Comparator: vertebroplasty
Procedure: percutaneous injection of cement into the vertebral body
percutaneous injection of cement into the vertebral body

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Impact into quality of life with the Qualeffo-41 test
Time Frame: Baseline, 2 weeks, 2 months, 6 months and 1 year
Baseline, 2 weeks, 2 months, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Analyze pain alleviation with the Analog Visual Scale
Time Frame: Baseline, 2 weeks, 2 months, 6 months and 1 year
Baseline, 2 weeks, 2 months, 6 months and 1 year

Collaborators and Investigators

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

Sponsor

Hospital Clinic of Barcelona

Collaborators

Sociedad Española de Radiologia Medica

Investigators

  • Principal Investigator: Jordi Blasco, MD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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, 2006

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCPB-VP

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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