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

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.