The effectiveness and safety of vertebroplasty for osteoporotic vertebral compression fractures. A double blind, prospective, randomized, controlled study.

BACKGROUND Vertebral compression fractures (VCFs) constitute a major health care problem in western countries. Several treatments modalities are available to relieve pain and allow increased activities. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body) is a relatively new procedure to manage patients with these fractures. The aim of this study is to evaluate the efficacy and safety of percutaneous vertebroplasty compared with standard conservative care. METHODS/DESIGNS In this double blind, prospective, randomized, controlled study the short- (3 months), medium- (6 months) and long-term (24 months) efficacy and safety of vertebroplasty to alleviate pain and improve function for painful osteoporotic vertebral fractures will be compared to standard conservative therapy. Conservative care will consist of 3 weeks of bed rest, wearing a rigid hyperextension corset, followed by 2-3 months in a Cheneau brace. In each of the two groups, patients will also receive treatment for osteoporosis according to their metabolic profile. Two hundred patients with painful osteoporotic vertebral compression fractures will be recruited over a 3 year period according to inclusion and exclusion criteria. We will randomly assign participants to receive either vertebroplasty or conservative care. Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life questionnaires at baseline and at post-randomization time points (1, 3, 6, 12 and 24 months). Each patient will be evaluated for pre-operative MRI, and pre- and post-operative radiographs; all scans will be evaluated independently by 2 orthopaedic surgeons. Laboratory tests to assess their metabolic bone profile will be also performed. Our primary outcome will be change from baseline to 1, 3, 6, 12 and 24 months in the VAS score between the 2 groups. DISCUSSION To date, vertebroplasty has been not been compared with standard conservative care for the management of patients with painful osteoporotic vertebral fractures in a randomised controlled trial. Therefore, the results of this study will allow to draw firm conclusions on this controversial topic.