Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

This study has been completed.

Sponsored by: University of Aarhus
Information provided by: University of Aarhus
ClinicalTrials.gov Identifier: NCT00203554

clinical trials Purpose

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.
Condition Intervention
Pain
Osteoporosis
Fracture
  Device: Poly methylmetacrylate, PMMA

MedlinePlus related topics:  Osteoporosis;   Pain

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by University of Aarhus:
Primary Outcome Measures: 
  • Level of pain before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.

Secondary Outcome Measures: 
  • Needs for analgetics, number of days at hospital, level of ADL

Total Enrollment:  50

Study start: March 2004;  Expected completion: September 2005

In vertebroplasty a bone cement is injected i one or more fractured vertebra. The indication is pain that needs high dosis of analgetics.

The cement is a well known product called poly metyl 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 randomizeed controlled trials have been published.

clinical trials Eligibility

Genders Eligible for Study:  Both
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 analgetic treatment
  • patient no able to communicate
  • general anaesthesia contraindicated
  • MRI not possible
  • coagulopathy (not adjustable)
  • spondylitis
  • discitis
  • spinal metastasis

clinical trials Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00203554

Leif Sorensen, Consultant      +45 8949 3355    lsore@as.aaa.dk

Denmark
      Dep of Neuroradiology, Aarhus University Hospital, Aarhus,  DK 8000,  Denmark; Recruiting
Carsten Gyldensted, Professor  +45 8949 3351    cgyld@as.aaa.dk 
Leif Sorensen, Consultant,  Principal Investigator

Study chairs or principal investigators

Leif Sorensen, Consultant,  Principal Investigator,  Unaffiliated   

clinical trials More Information

Study ID Numbers:  20020306
Last Updated:  November 2, 2006
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00203554
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
ClinicalTrials.gov processed this record on June 12, 2007
Last Updated: 07/07/2008
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