From Journal Watch > Journal Watch (General)

Vertebroplasty: New Trial, Conflicting Results

Allan S. Brett, MD

Authors and Disclosures

Abstract and Introduction

Abstract

This time, vertebroplasty led to less pain immediately and at 1 year.

Introduction

In two randomized trials published last year, vertebroplasty was no better than a sham procedure for pain relief in patients with vertebral fractures (JW Gen Med Sep 1 2009, p. 133, and N Engl J Med 2009; 361:569). Critics of those trials claimed, among other things, that the procedure was done too late in the clinical course to be effective. In this new study from the Netherlands and Belgium, 202 patients with vertebral fractures were randomized to either vertebroplasty or conservative management within 6 weeks after pain onset.

At baseline, mean pain scores on a 10-point visual analog scale were about 7.7 in both groups. At 1 month, scores dropped by 5.2 points in the vertebroplasty group and by 2.7 points in the control group — a significant difference. At 1 year, mean scores remained significantly lower in the vertebroplasty group than in the control group (by 1.6 points). Several secondary endpoints also favored vertebroplasty.

Comment

These results contradict those of last year's sham-controlled trials. Because patients in this study were not blinded to treatment assignment, the results could partly reflect placebo effects and a tendency for patients who receive interventions to inflate the benefits of those interventions. Alternatively, the different outcomes could reflect different timing of vertebroplasty (after average pain duration of 4 weeks in this trial, compared with 9 and 18 weeks in the two sham-controlled trials). Although this study strengthens the case somewhat for performing vertebroplasty soon after vertebral fractures occur, most patients improve spontaneously