Letters
Musculoskeletal diseases
Volume 192 - Issue 3

Vertebroplasty appears no better than placebo for painful osteoporotic spinal fractures, and has potential to cause harm

Authors:  Rachelle Buchbinder, Richard H Osborne and David Kallmes

Med J Aust 2010; 192 (3): 174-175. || doi: 10.5694/j.1326-5377.2010.tb03467.x
Published online: 1 February 2010
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In reply: The letters by Graziotti and Pile raise spurious issues that in no way threaten the key message of our trials. Participation rates in both trials were better than other controlled trials of vertebroplasty or kyphoplasty.1,2 Eligible patients who declined enrolment in the Investigational Vertebroplasty Efficacy and Safety Trial (INVEST) had similar levels of pain and disability to those who participated.3 Both trials adhered to stringent eligibility criteria, ensuring that only patients with pain due to acute or subacute fractures were included. All operators were trained and experienced, and the low incidence of serious adverse effects in both trials is consistent with the literature. There is no evidence that the outcome of vertebroplasty is influenced by cement distribution or volume.4 Local anaesthetic infiltration of the periosteum of the pedicles, as occurred in one trial,3 is unlikely to have a sustained effect.

As Pile points out, most osteoporotic vertebral fractures heal quickly; this implies that most people would be unlikely to benefit from early invasive intervention. Consistent with this, public funding for vertebroplasty in Australia only has interim approval for patients whose pain is not controlled by conservative medical therapy. While duration of medical therapy is not specified, historically, this has ranged from at least 4 to 6 weeks. Thus, both trials included patients similar to those who would qualify for government-subsidised funding of the procedure in Australia.

While Pile acknowledges that vertebroplasty appears to be of no value in patients with persisting symptoms (the group most likely to derive benefit), he seems to suggest that it may have a role in early treatment (within days to a month). As well as being at odds with his earlier statement, this is not supported by the available data. Many participants in both trials had short symptom duration (Australian trial, 32% < 6 weeks; INVEST, 20% < 6 weeks and 41% ≤ 13 weeks), and neither trial found evidence that symptom duration was a treatment effect modifier. The trial by Rousing et al reported comparable outcomes from vertebroplasty and conservative treatment in patients with acute symptoms (40 patients, < 2 weeks; 10 patients, 2–8 weeks).5 While no data were presented, the immediate (12–24 hours) benefit from vertebroplasty reported in this open study, like clinical experience, could be attributable to many factors including local anaesthesia, regression to the mean, and expectation bias.

The onus remains on proponents of vertebroplasty to prove that any benefits of vertebroplasty outweigh the potential risks.

Authors

  • Rachelle Buchbinder1,2
  • Richard H Osborne3
  • David Kallmes4
  • 1. Monash Department of Clinical Epidemiology at Cabrini Hospital, Cabrini Hospital and Monash University, Melbourne, VIC.
  • 2. Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC.
  • 3. Public Health Innovation, Faculty of Health, Medicine, Nursing and Behavioural Sciences, Deakin University, Melbourne, VIC.
  • 4. Mayo Clinic, Rochester, Minn, USA.

Correspondence: rachelle.buchbinder@med.monash.edu.au

References

View this article on Wiley Online Library