A randomized trial of vertebroplasty for osteoporotic spinal fractures.

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.)

• Authors: David F Kallmes, Bryan A Comstock, Patrick J Heagerty, Judith A Turner, David J Wilson, Terry H Diamond, Richard Edwards, Leigh A Gray, Lydia Stout, Sara Owen, William Hollingworth, Basavaraj Ghdoke, Deborah J Annesley-Williams, Stuart H Ralston, Jeffrey G Jarvik
• Journal: The New England journal of medicine (N Engl J Med) Vol. 361 Issue 6 Pg. 569-79 (Aug 06 2009) ISSN: 1533-4406 [Electronic] United States
• PMID: 19657122 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: 2009 Massachusetts Medical Society

Chemical References

• Bone Cements
• Polymethacrylic Acids
• polymethacrylic acid

Topics

• Aged
• Back Pain (etiology, therapy)
• Bone Cements
• Cross-Over Studies
• Disability Evaluation
• Double-Blind Method
• Female
• Fractures, Compression (complications, therapy)
• Humans
• Injections, Spinal
• Male
• Osteoporosis (complications)
• Outcome Assessment, Health Care
• Pain Measurement
• Placebo Effect
• Polymethacrylic Acids
• Spinal Fractures (etiology, therapy)
• Treatment Failure
• Vertebroplasty (adverse effects, methods)