A procedure performed regularly on thousands of people with painful spinal fractures may not in fact work, according to the preliminary results of scientific studies conducted in Australia and the United States.
Released at a medical conference this week, the early results of an Australian randomised trial showed that patients undergoing the real procedure — called Vertebroplasty — did no better than people given a sham procedure: levels of pain and functioning were similar in the two groups.
The results of another study, led by the high-profile Mayo clinic in the United States, were discussed at a recent conference in Australia. That trial is understood to have come up with similar findings, raising serious concerns that this commonly used procedure may not work.
Vertebroplasty involves a surgeon injecting cement into spinal vertebrae in order to “fix” the fracture and stop fragments of bone moving.
But like a lot of surgical procedures, this one has come onto the market and is becoming popular before it has been rigorously tested because, unlike drugs, there are no laws requiring such rigorous evaluation.
Despite a lack of good quality evidence to support its use, the procedure has been given an interim Medicare item number, which brings legitimacy and reimbursement to surgeons who perform it.
In Australia, more than 2000 of these spinal procedures have been performed and there are estimates more than 25,000 a year are being done in the United States.
Vertebroplasty is one of the examples Melissa Sweet and I used to illustrate why we all need to be much more skeptical in our dealings with the medical profession, in our book, Ten Questions You Must Ask Your Doctor, published recently in Australia and North America.
As we revealed in the book, the unproven procedure also carries the potential risk of increasing the chances of future fracture and if its benefits are dubious, its potential harms become even more serious.
Surgeons who promote the operation argue any future fractures can simply be fixed in the same way — by an injection of cement — and they have already raised questions about the preliminary findings of the new Australian study.
Approached by Crikey, the study authors refused to comment on their preliminary results, as they are currently being reviewed for publication in a medical journal.
It may however be time to also start reviewing Medicare funding for this procedure, and more broadly for health authorities to ensure surgical procedures are proven to be safe and effective, before they are widely used.