Percutaneous Vertebroplasty Versus Conservative Treatment of Pain - Tabular View

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

This study has been completed.

Study NCT00203554. Last updated on March 26, 2008. Information provided by University of Aarhus

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

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 ]

Condition ^†

Pain
Osteoporosis
Fracture

Intervention ^†

Genetic: Poly methylmetacrylate, PMMA

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

March 2004

Completion Date

January 2008

Eligibility Criteria ^†

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 ^††

Location Countries ^†

Denmark

Administrative Information Fields

NCT ID ^†

NCT00203554

Organization ID

20020306

Secondary IDs ^††

Study Sponsor ^†

University of Aarhus

Collaborators ^††

Investigators ^†

Principal Investigator:

Leif Sorensen, Consultant

Unaffiliated

Information Provided By

University of Aarhus

Verification Date

March 2008

First Received Date ^†

September 16, 2005

Last Updated Date

March 26, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.