VAPOUR Study Supports Safety and Efficacy of Vertebroplasty for Acute Painful Osteoporotic Fractures

August 22, 2016—The Society of NeuroInterventional Surgery (SNIS) announced the publication of a study demonstrating that vertebroplasty is safe and effective for reducing acute pain and disability in patients who have experienced spinal fractures of < 6 weeks' duration. Findings from VAPOUR, which is a multicenter, randomized, double-blind, placebo-controlled trial, were published by William Clark, MD, et al in The Lancet.

According to SNIS, the VAPOUR study included 120 patients in Australia. Sixty-one patients were randomly assigned to vertebroplasty and 59 to a placebo procedure. Only patients with severe pain ≥ 7 on a Numeric Rating Scale of 10 were enrolled. In the vertebroplasty procedure, a special cement is injected in the fractured vertebra to stabilize the fracture and relieve patients of pressure.

After 14 days of treatment, 23% of patients in the vertebroplasty group reported a Numeric Rating Scale pain score < 4. Whereas 53% of patients in the placebo group still had moderate or severe pain 6 months after the procedure, patients in the vertebroplasty group reported lower pain at all time intervals after the procedure.

The investigators concluded that vertebroplasty could help these patients manage their pain, which could lead to reduced hospital stays and, in turn, overall health care savings. In addition, the study also found the procedure does not contribute to future fractures as previously thought.

A companion expert commentary addressing the study is also available in The Lancet. The commentary, “Resurrection of Evidence for Vertebroplasty?” was authored by Joshua A. Hirsch, MD, and Ronil V. Chandra, MD.

Dr. Hirsch, who is Past President of SNIS, commented, “These findings are important because, for the first time, vertebroplasty has been demonstrated to reduce pain more effectively than a sham intervention. Moreover, the trial suggests that conservative therapy including narcotics, bedrest, and back braces, are themselves not risk-free. Indeed, in prior open label trials such as VERTOS 2, vertebroplasty has performed dramatically better than conservative therapy.” Dr. Hirsch is Director of Interventional and Endovascular Neuroradiology as well as Vice Chair of Interventional Radiology at the Massachusetts General Hospital/Harvard Medical School in Boston, Massachusetts.