Openly accessible

A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures

Buchbinder, Rachelle, Osborne, Richard H., Ebeling, Peter R., Wark, John D., Mitchell, Peter, Wriedt, Chris, Graves, Stephen, Staples, Margaret P. and Murphy, Bridie 2009, A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures, New England journal of medicine, vol. 361, no. 6, pp. 557-568.

Attached Files
Name Description MIMEType Size Downloads
osborne-randomizedtrial-2009.pdf Published version application/pdf 355.74KB 581

Title A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures
Author(s) Buchbinder, Rachelle
Osborne, Richard H.
Ebeling, Peter R.
Wark, John D.
Mitchell, Peter
Wriedt, Chris
Graves, Stephen
Staples, Margaret P.
Murphy, Bridie
Journal name New England journal of medicine
Volume number 361
Issue number 6
Start page 557
End page 568
Total pages 12
Publisher Massachusetts Medical Society
Place of publication Boston, Mass.
Publication date 2009-08-06
ISSN 0028-4793
1533-4406
Summary Background Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures, but there is limited evidence to support its use.

Methods We performed a multicenter, randomized, double-blind, placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months' duration and unhealed, as confirmed by magnetic resonance imaging, were randomly assigned to undergo vertebroplasty or a sham procedure. Participants were stratified according to treatment center, sex, and duration of symptoms (<6 weeks or 6 weeks). Outcomes were assessed at 1 week and at 1, 3, and 6 months. The primary outcome was overall pain (on a scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months.

Results A total of 78 participants were enrolled, and 71 (35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group) completed the 6-month follow-up (91%). Vertebroplasty did not result in a significant advantage in any measured outcome at any time point. There were significant reductions in overall pain in both study groups at each follow-up assessment. At 3 months, the mean (±SD) reductions in the score for pain in the vertebroplasty and control groups were 2.6±2.9 and 1.9±3.3, respectively (adjusted between-group difference, 0.6; 95% confidence interval, –0.7 to 1.8). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven incident vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6-month follow-up period.

Conclusions
We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment. (Australian New Zealand Clinical Trials Registry number, ACTRN012605000079640.)
Notes Reproduced with the kind permission of the copyright owner.
Language eng
Field of Research 111717 Primary Health Care
Socio Economic Objective 920204 Evaluation of Health Outcomes
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2009, Massachusetts Medical Society
Persistent URL http://hdl.handle.net/10536/DRO/DU:30019842

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 392 times in TR Web of Science
Scopus Citation Count Cited 502 times in Scopus
Google Scholar Search Google Scholar
Access Statistics: 529 Abstract Views, 581 File Downloads  -  Detailed Statistics
Created: Wed, 23 Sep 2009, 13:55:53 EST by Deborah Wittahatchy

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.