A randomized trial of vertebroplasty for osteoporotic spinal fractures.
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.)
Kallmes
David F
DF
Department of Radiology, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, USA. kallmes.david@mayo.edu
Comstock
Bryan A
BA
Heagerty
Patrick J
PJ
Turner
Judith A
JA
Wilson
David J
DJ
Diamond
Terry H
TH
Edwards
Richard
R
Gray
Leigh A
LA
Stout
Lydia
L
Owen
Sara
S
Hollingworth
William
W
Ghdoke
Basavaraj
B
Annesley-Williams
Deborah J
DJ
Ralston
Stuart H
SH
Jarvik
Jeffrey G
JG
D000368:Aged; D001416:Back Pain / Q000209:etiology / Q000628:therapy; D001843:Bone Cements; D018592:Cross-Over Studies; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D050815:Fractures, Compression / Q000150:complications / Q000628:therapy*; D006801:Humans; D007278:Injections, Spinal; D008297:Male; D010024:Osteoporosis / Q000150:complications*; D017063:Outcome Assessment, Health Care; D010147:Pain Measurement; D015990:Placebo Effect; D011109:Polymethacrylic Acids; D016103:Spinal Fractures / Q000209:etiology / Q000628:therapy*; D017211:Treatment Failure; D054854:Vertebroplasty / Q000009:adverse effects / Q000379:methods
D001843:Bone Cements; D011109:Polymethacrylic Acids; C030613:polymethacrylic acid