Percutaneous Vertebroplasty Versus Conservative Treatment of Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

September 16, 2005

Last Updated Date

March 26, 2008

Start Date ^ICMJE

March 2004

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Level of pain [ Time Frame: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months. ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Level of pain before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.

Change History

Complete list of historical versions of study NCT00203554 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Needs for analgetics, number of days at hospital, level of ADL

Descriptive Information

Brief Title ^ICMJE

Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

Official Title ^ICMJE

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

Brief Summary

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

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pain
Osteoporosis
Fracture

Intervention ^ICMJE

Genetic: Poly methylmetacrylate, PMMA

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00203554

Responsible Party

Leif Sorensen, Cons. Neuroradiologist, Aarhus University Hospital

Study ID Numbers ^ICMJE

20020306

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Leif Sorensen, Consultant

Unaffiliated

Information Provided By

University of Aarhus

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP