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.
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the Department of Health and Human Services' National Institutes of Health (NIH), is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. For more information about NIAMS, call the information clearinghouse at 301-495-4484 or 877-22-NIAMS (free call) or visit the NIAMS Web site at http://www.niams.nih.gov. For more information about osteoporosis, call the NIH Osteoporosis and Related Bone Diseases ~ National Resource Center at 202-223-0344 or 800-624-2663 (free call) or visit http://www.bones.nih.gov.
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Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, Edwards R, Gray LA, Stout L, Owen S, Hollingworth W, Ghdoke B, Annesley-Williams DJ, Ralston SH, Jarvik JG. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009 Aug 6;361:569-79.