Professor Rachelle Buchbinder, a rheumatologist and clinical epidemiologist, writes:
In recent years, hundreds of Australians have undergone a controversial procedure for spinal fractures associated with osteoporosis.
The procedure, called vertebroplasty, involves placing a needle into the vertebra and injecting it with bone cement, to ‘fix’ the fracture, possibly by stopping the fragments of bone from moving and causing pain.
In 2009, I was co-author of one of two placebo-controlled trials, published in the New England Journal of Medicine, which reported that vertebroplasty was ineffective for osteoporotic spinal fractures (see here and here).
These findings were met with disbelief among those who perform the procedure, and some proponents suggested that vertebroplasty might still be useful for people with certain characteristics like more severe pain or more recent onset of symptoms.
To test this theory, the authors of the two trials combined the raw data for each person enrolled in their respective studies and then reanalysed the data as if patients were in a single large study (an ‘individual patient data meta-analysis’).
This allows testing of whether treatment effects vary among different groups of people.
Consistent with the original results, our findings in this study, published recently in the BMJ, did not support the hypothesis that selected subgroups would benefit from vertebroplasty.
In particular, they failed to show an advantage of vertebroplasty over placebo for participants with recent onset fracture or severe pain.
Vertebroplasty is still a subsidised treatment in Australia although this funding is under review.
At the present time, the best available evidence does not support a role for vertebroplasty in the treatment of osteoporotic vertebral fractures, even in selected subgroups of people with more severe pain or more acute symptoms.
• Rachelle Buchbinder is Director of the Monash Department of Clinical Epidemiology at Cabrini Hospital.
• Declaration from Croakey: Vertebroplasty featured as a case study in a 2008 book that I co-authored with Ray Moynihan, Ten Questions You Must Ask Your Doctor. At that time, we noted that the procedure was being recommended to patients although it was “essentially unproven” as no randomised controlled trials had been completed. The question now is: will the evidence change practice and policy?