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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
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.)
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.
Source Information
From the Monash Department of Clinical Epidemiology, Cabrini Hospital, and the Department of Epidemiology and Preventive Medicine, Monash University, Malvern, VIC (R.B., M.P.S., B.M.); Public Health Innovation, Deakin University, Melbourne, VIC (R.H.O.); the Department of Medicine (Royal Melbourne Hospital/Western Hospital), University of Melbourne Western Hospital, Footscray, VIC (P.R.E.); the Department of Medicine (Royal Melbourne Hospital/Western Hospital) and the Department of Radiology, University of Melbourne, Royal Melbourne Hospital, Parkville, VIC (J.D.W., P.M.); Cabrini Medical Imaging, Cabrini Health, Malvern, VIC (C.W.); and the Australian Orthopaedic Association, National Joint Replacement Register, Data Management & Analysis Centre, University of Adelaide, Adelaide, SA (S.G.) — all in Australia.
Address reprint requests to Dr. Buchbinder at the Department of Clinical Epidemiology, Suite 41 Cabrini Medical Centre, 183 Wattletree Rd., Malvern, VIC 3144, Australia, or at rachelle.buchbinder{at}med.monash.edu.au.
Related Letters:
Trials of Vertebroplasty for Vertebral Fractures
Clark W., Lyon S., Burnes J., Baerlocher M. O., Munk P. L., Liu D. M., Lotz J. C., Grey A., Bolland M., Buchbinder R., Osborne R., Staples M., Kallmes D. F., Heagerty P. J., Jarvik J. G., Weinstein J. N.
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N Engl J Med 2009;
361:2097-2100, Nov 19, 2009.
Correspondence
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