Efficacy and safety of vertebroplasty for treatment of painful osteoporotic spinal fractures: a randomised double-blind placebo-controlled trial

The procedure used will be standardised across all sites (currently includes four hospitals in Melbourne, Cabrini, Alfred and Royal Melbourne Hospitals and Monash Medical Centre). Participants are randomly allocated to receive either a Vertebroplasty or Placebo Procedure. All participants will receive sedation/analgesia (midazolam and fentanyl), which will be administered by the radiologist performing the procedure. Participants undergoing vertebroplasty will have the left pedicle of the fracture vertebra infiltrated by a needle, which will be gently tapped into place using a hammer. The progress of the needle will be monitored so the correct position is determined. The bone cement (poly-methyl methacrylate) will be injected under Xray guidance, with the working time for the injection being approximately 2 minutes. A unilateral approach will be used unless there is inadequate instillation of cement, in which case a bipedicular approach will be used. Extreme care is taken to ensure that no leakage of cement occurs either into a vein or outside the bone. The injection will be stopped when significant resistance is met, when the cement reaches the posterior quarter of the vertebral body or when there is escape into extraosseous structures or veins. Only patients in the active group will receive antibiotics (Keflin) against infection. Both procedures take approximately 30-60 minutes.