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.)

Figure 1

Enrollment, Randomization, and Follow-up of the Study Participants.

Figure 2

Treatment Comparisons on Secondary Outcome Measures (Intent-to-Treat Analyses) at One Month. † For continuous outcome measures, treatments were compared from ANCOVA models that adjusted for randomized treatment assignment, the baseline value of the outcome measure, and recruitment site. Treatment effects are coded such that negative treatment effects favor the control procedure and positive treatment effects favor vertebroplasty. Treatment comparisons and confidence intervals for one-month opioid use are reported as an odds ratio from a logistic regression model, adjusting for baseline opioid use and recruitment site. Odds ratios less than 1.0 favor vertebroplasty and greater than 1.0 favor the control procedure.

Figure 3

Mean (95% confidence intervals) Roland-Morris Disability Questionnaire (RDQ) and pain numerical rating scores (average pain intensity, prior 24 hours) by treatment adherence over time. Treatment “crossover” was defined as having had the non-randomized procedure prior to the three-month study assessment.