Research in context
Evidence before this study
A systematic literature review by the Australian Medicare Services Advisory Committee in 2011 focused on three good quality randomised trials of vertebroplasty. Two masked trials (Kallmes and colleagues, Buchbinder and colleagues) enrolled patients with fractures up to 12 months' duration and found vertebroplasty no more effective than placebo in pain reduction. Subgroup meta-analysis of these masked trials (by Staples and colleagues) identified 57 patients with fractures of less than 6 weeks' duration, and found vertebroplasty no more effective than placebo in this acute fracture subgroup. Conversely, an open-label randomised trial (Klazen and colleagues) of patients with fractures of less than 6 weeks' duration showed that vertebroplasty was more effective than conservative care in reducing pain. The review concluded that the two masked trials were of superior methodological quality and provided evidence of lack of efficacy for vertebroplasty. However, the small representation of patients with uncontrolled pain and acute fractures of less than 6 weeks' duration in the masked trials caused uncertainty for the role of vertebroplasty in this subgroup. The review recommended a high quality placebo-controlled trial to specifically assess this patient group. This is such a trial.
Added value of this study
This randomised, parallel group, placebo-controlled trial, was designed to answer the question as to whether vertebroplasty compared with placebo improved pain measures, primarily, and disability measures, secondarily, in patients with fractures of less than 6 weeks' duration. There were 120 patients, twice the number of the subgroup meta-analysis of previous masked trials, thereby increasing the statistical power. Our findings show that vertebroplasty improved both pain and disability measures.
Implications of all the available evidence
Until now, there has been no evidence that vertebroplasty was more effective than placebo in the treatment of acute, painful, osteoporotic vertebral fractures, most notably for those in the thoracolumbar region. No masked studies have exclusively examined acute fractures of less than 6 weeks' duration but only in a subgroup analysis with small patient numbers. Our study will allow those people with acute painful fractures to have an additional modality of pain management that is known to be effective.