Percutaneous Vertebroplasty Versus Conservative Treatment of Pain - Full Text View

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

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	Genetic: Poly methylmetacrylate, PMMA

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

Resource links provided by NLM:

MedlinePlus related topics: Fractures Osteoporosis

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

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 Measures:

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 ]

Enrollment:	27
Study Start Date:	March 2004
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203554

Locations

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

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:

Leif Sorensen, Consultant

Unaffiliated

More Information

No publications provided

Responsible Party:	Aarhus University Hospital ( Leif Sorensen, Cons. Neuroradiologist )
Study ID Numbers:	20020306
Study First Received:	September 16, 2005
Last Updated:	March 26, 2008
ClinicalTrials.gov Identifier:	NCT00203554 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

osteoporosis
vertebra
fracture
pain

percutaneous
vertebroplasty
polymethylmetacrylate

Study placed in the following topic categories:

Polymethyl Methacrylate
Vasodilator Agents
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

Osteoporosis
Bone Diseases, Metabolic
Pain
Cardiovascular Agents
Bone Diseases

Additional relevant MeSH terms:

Vasodilator Agents
Physiological Effects of Drugs
Fractures, Bone
Wounds and Injuries
Antimutagenic Agents
Osteoporosis
Disorders of Environmental Origin
Bone Diseases, Metabolic

Cardiovascular Agents
Protective Agents
Bone Diseases
Pharmacologic Actions
Polymethyl Methacrylate
Musculoskeletal Diseases
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2009