A randomized trial of vertebroplasty for osteoporotic spinal fractures
PainSci notes on Kallmes 2009:
One of two very similar trials in 2009 that showed no benefit to vertebroplasty. See Buchbinder for more commentary.
original abstract †Abstracts here may not perfectly match originals, for a variety of technical and practical reasons. Some abstacts are truncated for my purposes here, if they are particularly long-winded and unhelpful. I occasionally add clarifying notes. And I make some minor corrections.
BACKGROUND: Vertebroplasty is commonly used to treat painful, osteoporotic vertebral compression fractures.
METHODS: In this multicenter trial, we randomly assigned 131 patients who had one to three painful osteoporotic vertebral compression fractures to undergo either vertebroplasty or a simulated procedure without cement (control group). The primary outcomes were scores on the modified Roland-Morris Disability Questionnaire (RDQ) (on a scale of 0 to 23, with higher scores indicating greater disability) and patients' ratings of average pain intensity during the preceding 24 hours at 1 month (on a scale of 0 to 10, with higher scores indicating more severe pain). Patients were allowed to cross over to the other study group after 1 month.
RESULTS: All patients underwent the assigned intervention (68 vertebroplasties and 63 simulated procedures). The baseline characteristics were similar in the two groups. At 1 month, there was no significant difference between the vertebroplasty group and the control group in either the RDQ score (difference, 0.7; 95% confidence interval [CI], -1.3 to 2.8; P=0.49) or the pain rating (difference, 0.7; 95% CI, -0.3 to 1.7; P=0.19). Both groups had immediate improvement in disability and pain scores after the intervention. Although the two groups did not differ significantly on any secondary outcome measure at 1 month, there was a trend toward a higher rate of clinically meaningful improvement in pain (a 30% decrease from baseline) in the vertebroplasty group (64% vs. 48%, P=0.06). At 3 months, there was a higher crossover rate in the control group than in the vertebroplasty group (51% vs. 13%, P<0.001) [corrected]. There was one serious adverse event in each group.
CONCLUSIONS: Improvements in pain and pain-related disability associated with osteoporotic compression fractures in patients treated with vertebroplasty were similar to the improvements in a control group. (ClinicalTrials.gov number, NCT00068822.)
related content
- “A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures,” Rachelle Buchbinder, Richard H. Osborne, Peter R. Ebeling, John D. Wark, Peter Mitchell, Chris Wriedt, Stephen Graves, Margaret P. Staples, and Bridie Murphy, New England Journal of Medicine, 2009.
- “Percutaneous vertebroplasty for osteoporotic vertebral compression fracture,” Rachelle Buchbinder, Kamran Golmohammadi, Renea V Johnston, Richard J Owen, Joanne Homik, Allyson Jones, Sukhvinder S Dhillon, David F Kallmes, and Robert G W Lambert, Cochrane Database of Systematic Reviews, 2015.
- “Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for the treatment of osteoporotic vertebral fractures: a systematic review and cost-effectiveness analysis,” Matt Stevenson, Tim Gomersall, Myfanwy Lloyd Jones, Andrew Rawdin, Monica Hernández, Sofia Dias, David Wilson, and Angie Rees, Health Technol Assess, 2014.
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