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A randomized trial of vertebroplasty for osteoporotic spinal fractures.

Pubmed ID: 
19657122
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 (43% vs. 12%, P<0.001). 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.)

Date published: 
Thu, 08/06/2009
Journal: 
The New England journal of medicine
Journal: 
The New England journal of medicine
Author: 
Kallmes DF
Comstock BA
Heagerty PJ
Turner JA
Wilson DJ
Diamond TH
Edwards R
Gray LA
Stout L
Owen S
Hollingworth W
Ghdoke B
Annesley-Williams DJ
Ralston SH
Jarvik JG
MESH Headers: 
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
Source: 
N Engl J Med. 2009 Aug 6;361(6):569-79.
CAP: 
Vertebroplasty no better than simulated procedure for pain and disability due to osteoprotic spinal fractures.
Stellar: 
Not Stellar