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A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures.

Pubmed ID: 
19657121
Abstract: 

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 > 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.)

Date published: 
Thu, 08/06/2009
Journal: 
The New England journal of medicine
Journal: 
The New England journal of medicine
Author: 
Buchbinder R
Osborne RH
Ebeling PR
Wark JD
Mitchell P
Wriedt C
Graves S
Staples MP
Murphy B
MESH Headers: 
Activities of Daily Living
Aged
Back Pain/etiology/therapy
Bone Cements
Double-Blind Method
Female
Humans
Injections, Spinal
Male
Osteoporosis/*complications
Pain Measurement
Placebo Effect
Polymethacrylic Acids
Quality of Life
Spinal Fractures/etiology/*therapy
Treatment Failure
*Vertebroplasty/methods
Source: 
N Engl J Med. 2009 Aug 6;361(6):557-68.
Stellar: 
Not Stellar