Openly accessible

Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640]

Buchbinder, Rachelle, Osborne, Richard, Ebeling, Peter, Wark, John, Mitchell, Peter, Wriedt, Chris, Wengier, Lainie, Connell, David, Graves, Stephen, Staples, Margaret and Murphy, Bridie 2008, Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640], BMC musculoskeletal disorders, vol. 9, no. 156, pp. 1-9.

Attached Files
Name Description MIMEType Size Downloads
osborne-efficacyandsafety-2008.pdf Published version application/pdf 258.22KB 116

Title Efficacy and safety of vertebroplasty for treatment of painful osteoporotic vertebral fractures: a randomised controlled trial [ACTRN012605000079640]
Author(s) Buchbinder, Rachelle
Osborne, Richard
Ebeling, Peter
Wark, John
Mitchell, Peter
Wriedt, Chris
Wengier, Lainie
Connell, David
Graves, Stephen
Staples, Margaret
Murphy, Bridie
Journal name BMC musculoskeletal disorders
Volume number 9
Issue number 156
Start page 1
End page 9
Total pages 9
Publisher BioMed Central Ltd.
Place of publication London, England
Publication date 2008-11-25
ISSN 1471-2474
Summary Background: Vertebroplasty is a promising but as yet unproven treatment for painful osteoporotic vertebral fractures. It involves radiographic-guided injection of various types of bone cement directly into the vertebral fracture site. Uncontrolled studies and two controlled quasi-experimental before-after studies comparing volunteers who were offered treatment to those who refused it, have suggested an early benefit including rapid pain relief and improved function. Conversely, several uncontrolled studies and one of the controlled before-after studies have also suggested that vertebroplasty may increase the risk of subsequent vertebral fractures, particularly in vertebrae adjacent to treated levels or if cement leakage into the adjacent disc has occurred. As yet, there are no completed randomised controlled trials of vertebroplasty for osteoporotic vertebral fractures. The aims of this participant and outcome assessor-blinded randomised placebo-controlled trial are to i) determine the short-term efficacy and safety (3 months) of vertebroplasty for alleviating pain and improving function for painful osteoporotic vertebral fractures; and ii) determine its medium to longer-term efficacy and safety, particularly the risk of further fracture over 2 years.

Design: A double-blind randomised controlled trial of 200 participants with one or two recent painful osteoporotic vertebral fractures. Participants will be stratified by duration of symptoms (< and ≥ 6 weeks), gender and treating radiologist and randomly allocated to either the treatment or placebo. Outcomes will be assessed at baseline, 1 week, 1, 3, 6, 12 and 24 months. Outcome measures include overall, night and rest pain on 10 cm visual analogue scales, quality of life measured by the Assessment of Quality of Life, Osteoporosis Quality of Life and EQ-5D questionnaires; participant perceived recovery on a 7-point ordinal scale ranging from 'a great deal worse' to 'a great deal better'; disability measured by the Roland-Morris Disability Questionnaire; timed 'Up and Go' test; and adverse effects. The presence of new fractures will be assessed by radiographs of the thoracic and lumbar spine performed at 12 and 24 months.

Discussion:
The results of this trial will be of major international importance and findings will be immediately translatable into clinical practice.

Trial registration:
Australian Clinical Trial Register # [ACTRN012605000079640]
Notes This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Language eng
Field of Research 110399 Clinical Sciences not elsewhere classified
HERDC Research category C1.1 Refereed article in a scholarly journal
HERDC collection year 2008
Copyright notice ©2008, Buchbinder et al
Persistent URL http://hdl.handle.net/10536/DRO/DU:30019460

Document type: Journal Article
Collections: School of Health and Social Development
Open Access Collection
Connect to link resolver
 
Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved.

Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.

Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 26 times in TR Web of Science
Scopus Citation Count Cited 30 times in Scopus
Google Scholar Search Google Scholar
Access Statistics: 400 Abstract Views, 116 File Downloads  -  Detailed Statistics
Created: Tue, 15 Sep 2009, 11:38:55 EST by Lorraine Driscoll

Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.