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Study Challenges Effectiveness of Common Spine Procedure

December 11th, 2009

Research supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) raises questions about a routine surgical treatment for vertebral (spine) fractures. The study, the first of its type, appeared in a recent issue of the New England Journal of Medicine.

Vertebral fractures from osteoporosis affect approximately 700,000 individuals in the United States, yet only one third of these people receive treatment. These fractures can cause severe back pain and loss of function. Due to the lack of effective repair options for vertebral fractures, a procedure known as vertebroplasty has become increasingly common in the past six years. Vertebroplasty involves injecting an orthopaedic cement mixture into the affected vertebra (spine bone) for the purpose of stabilizing the fracture.

David Kallmes, M.D., and other researchers from the Investigational Vertebroplasty Safety and Efficacy Trial (INVEST) sought to evaluate the effectiveness of vertebroplasty in treating osteoporosis-related spine fractures. The investigators, from eight medical centers in the United States, United Kingdom and Australia, enrolled 131 patients who were randomly assigned to receive a vertebroplasty or a simulated (placebo) procedure in which no cement mixture was injected.

Within three days of the intervention and one month later, both groups of patients showed similar improvements in pain relief and function. Kallmes and his team do not refute that vertebroplasty is more effective than regular, non-operative medical management. Instead, they suggest that something other than the cement injections - such as local anesthesia, sedation, or patient expectation - is helping these patients. The investigators plan to follow study participants for a full year to determine whether the long-term outcome is similar in the two groups.

SOURCE: National Institute of Arthritis and Muscuiloskeletal and Skin Diseases

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