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A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures

Open access
Kallmes, David F., Comstock, Bryan A., Heagerty, Patrick J., Turner, Judith A., Wilson, David J., Diamond, Terry H., Edwards, Richard, Gray, Leigh A., Stout, Lydia, Owen, Sara, Hollingworth, William, Ghdoke, Basavaraj, Annesley-Williams, Deborah J., Ralston, Stuart H., Jarvik, Jeffrey G.·2009·New England Journal of Medicine

Abstract

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.)

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Metadata

Authors
Kallmes, D. F., Comstock, B. A., Heagerty, P. J., Turner, J. A., Wilson, D. J., Diamond, T. H., Edwards, R., Gray, L. A., Stout, L., Owen, S., Hollingworth, W., Ghdoke, B., Annesley-Williams, D. J., Ralston, S. H., & Jarvik, J. G.
Venue
New England Journal of Medicine
Published
2009-08-06
Volume
361
Issue
6
Pages
569-579
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2059724197
Cited by
1,439
References
9
FWCI
137.47
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures. https://app.cochat.ai/papers/10.1056/nejmoa0900563
The paper
Kallmes, D. F., Comstock, B. A., Heagerty, P. J., Turner, J. A., Wilson, D. J., Diamond, T. H., Edwards, R., Gray, L. A., Stout, L., Owen, S., Hollingworth, W., Ghdoke, B., Annesley-Williams, D. J., Ralston, S. H., & Jarvik, J. G. (2009). A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures. New England Journal of Medicine. https://doi.org/10.1056/nejmoa0900563

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.