Vertebroplasty is a useful technique to manage patients with osteoporotic vertebral fractures who are suffering uncontrolled pain. Vertebroplasty is most effective when performed within the first 3-4 weeks of fracture while the fracture is still pliable. Early fracture pain that is not controlled with medical therapy is likely generated by motion within the fracture caused by different body positions. The vertebral body enlarges in the supine position and is squashed by gravity in the upright position. This "dynamic mobility" of the fracture occurs in old patients (mean age 80) with severe osteoporosis. Medical treatment in this severely affected patient group consists of increasing opioid medication, toxic for elderly patients, and hospitalisation. The VAPOUR trial is a blinded randomised trial of vertebroplasty for patients with severe pain, not controlled by medical therapy, caused by a fracture which is less than 6 weeks duration at the time of vertebroplasty. Patient were randomised at time of procedure to receive either a vertebroplasty or placebo procedure. The placebo was designed to simulate the patient experience of vertebroplasty. 120 patients were enrolled in 4 centres in Sydney. 95 of the 120 patients had fractures less than or equal to 3-weeks duration – early vertebroplasty intervention to control acute severe pain.
The VAPOUR trial showed vertebroplasty more effective than placebo in reducing pain and disability and resulted in 36% preservation of vertebral body height compared to placebo on spinal radiographs at 6-months.
Three other blinded trials of vertebroplasty have shown no more benefit from vertebroplasty than placebo. These trials were exclusively outpatient trials (compared to 57% inpatients in the VAPOUR trial), enrolled patients with older fractures and less severe symptoms, and used different vertebroplasty technique to the VAPOUR trial. The differences between these blinded trials and the status of the evidence will be presented.