SHAM-CONTROLLED TRIAL OF PERCUTANEOUS VERTEBROPLASTY

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DESCRIPTION (provided by applicant): The objective of this research protocol is to improve the quality of life for patients suffering from painful, osteoporotic vertebral compression fractures. This objective will be met by examining the clinical efficacy of percutaneous vertebroplasty for treatment of painful, osteoporotic vertebral compression fractures. Spontaneous, atraumatic compression fractures occur in more than 700,000 patients per year. Pain associated with these fractures may be excruciating, but treatment options, before the advent of percutaneous vertebroplasty, were limited. Analgesic medications, bedrest, and bracing have heretofore represented the mainstay of treatment, but each of these therapies has substantial limitations. Because of the dearth of viable treatment options for osteoporotic vertebral compression fractures, the practice of percutaneous vertebroplasty, which involves injection of polymethylmethacrylate (PMMA), or medical cement, into the fractured vertebra, has disseminated rapidly. However, evidence for the efficacy of percutaneous vertebroplasty currently is limited to uncontrolled, non-blinded, small case series. Even though high rates of success are reported, with up to 90% of patients achieving substantial pain relief, these case series have not accounted for numerous important potential biases. These biases include the natural tendency for compression fractures to heal spontaneously, regression toward the mean (wherein patients seek medical attention when pain is maximum), and the placebo effect. Also, previous studies have not used validated health outcomes scales specific for vertebroplasty, and no attempt has been made to determine the cost effectiveness of the procedure. We will perform a sham-controlled, prospective trial of percutaneous vertebroplasty in order to exclude confounding variables, such as the placebo effect, as the explanation for the apparent efficacy of vertebroplasty. Furthermore, we will validate a new, vertebroplasty-specific health outcomes instrument. Last, we will determine the cost-effectiveness of percutaneous vertebroplasty. Successful implementation of the trial will provide compelling evidence regarding the true efficacy of percutaneous vertebroplasty, to allow rationale decision-making in caring for patients suffering from painful, osteoporotic compression fractures.