Journal article
Two-year results of a randomized placebo-controlled trial of vertebroplasty for acute osteoporotic vertebral fractures
F Kroon, M Staples, PR Ebeling, JD Wark, RH Osborne, PJ Mitchell, CHR Wriedt, R Buchbinder
Journal of Bone and Mineral Research | Published : 2014
DOI: 10.1002/jbmr.2157
Abstract
We previously reported the results of a randomized controlled trial that found no benefit of vertebroplasty over a sham procedure for acute osteoporotic vertebral fractures up to 6 months. We report here the 12-month and 24-month clinical outcomes of this trial. Eligible participants (n= 78) were randomly assigned to receive either vertebroplasty (n= 38) or a sham procedure (n= 40). Randomization was stratified by treatment center, sex, and symptom duration (<6 weeks or ≥6 weeks). Participants, investigators (except the treating radiologists), and outcome assessors were blinded to group assignments. Enrolment occurred between April 2004 and October 2008 with follow-up completed October 2010...
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Awarded by National Health and Medical Research Council of Australia
Funding Acknowledgements
This work was supported by grants from the National Health and Medical Research Council of Australia (284354), Arthritis Australia, the Cabrini Education and Research Institute, and Cook Australia. None of the funders had any role in the design of the trial, the collection or analysis of the data, the preparation of the manuscript, or the decision to submit the manuscript for publication. We thank Dr. David Connell, Ms. Lainie Wengier, Dr. James Burnes, Dr. Michelle Leech, Dr. Winston Chong, Dr. Stuart Lyon, and members of the radiology departments of Cabrini Hospital, Royal Melbourne Hospital, Monash Medical Centre, and the Alfred Hospital for their participation in the trial.