Percutaneous vertebroplasty provides no demonstrable clinical benefit over placebo or sham procedures in patients with vertebral fractures, according to an international Task Force auspiced by the American Society for Bone and Mineral Research (ASBMR).
The findings are of particular interest in Australia given that the Medical Services Advisory Committee (MSAC) have been reconsidering re-listing the controversial procedure which was removed from the MBS in 2011.
MSAC was due to consider the issue in November last year but the outcome has not yet been made public.
The ASBMR Task Force found the evidence from placebo-controlled trials did not support any clinically meaningful improvement in pain, disability or quality of life.
Lead author Professor Peter Ebeling, of Monash University, Victoria, told the limbic there was a marginal but not clinically significant improvement in pain at four weeks post-procedure based on data from five studies.
The Task Force took into consideration the 2016 Lancet paper (VAPOUR) which had showed there was an improvement in pain at two months in patients with severe pain at baseline and a procedure within six weeks of the fracture.
“We thought that was interesting and we looked at that paper very carefully and then we combined it with the data from the four other studies.”
“Based on the evidence from the five studies, it’s pretty clear there is a very marginal benefit on pain at four weeks but it is not sustained,” said Professor Ebeling, past-President of the Australian and NZ Bone and Mineral Society.
“I think the MSAC was re-convened on the basis of that one positive study out of five; the other four being negative.”
He said the procedure may in fact be useful in some patients but there was not enough information for selecting the patients who might benefit the most.
“We don’t want it to be the routine standard of care. Patients should be advised about the current evidence regarding the procedure.”
He added it was critical that patients with an initial vertebral fracture were prescribed anti-osteoporosis medications to help prevent any further fractures.
An editorial in the Journal of Bone and Mineral Research said the lack of clear benefits of vertebroplasty or kyphoplasty was compounded by concerns that by altering the biomechanics of an osteoporotic spine, the procedures may increase the risk of fractures in adjacent vertebrae.
However the Task Force was unable to find clear evidence for either an increase or a decrease in fractures after these procedures, the editorial said.
“Bracing and exercise, which are relatively safe and inexpensive, may provide some limited benefit.”
The Task Force also recommended that no further trials of vertebroplasty be performed ‘unless they are adequately powered to alter the conclusions of the current body of evidence’.