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BACKGROUND AND OBJECTIVEPercutaneous vertebroplasty is widely used to treat osteoporotic vertebral compression fractures. Prior research has produced conflicting data concerning the utility of vertebr
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BACKGROUND AND OBJECTIVEPercutaneous vertebroplasty is widely used to treat osteoporotic vertebral compression fractures. Prior research has produced conflicting data concerning the utility of vertebroplasty for reducing pain, disability, and improving quality of life. This study was designed to help clarify the efficacy of this procedure.
METHODSThis randomized, double-blind trial included patients at least 50 years of age with one to three osteoporotic compression fractures. The subjects were randomized to receive polymethylmethacrylate cement injections or to undergo a sham procedure with periosteal needle placement, but no cement injection. The primary outcome measure was a ten-point visual analogue scale (VAS) for pain. Secondary outcome measures included the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and the Roland-Morris Disability Questionnaire (RMDQ). Assessments were made at one day, one week, and one, three, six and 12 months after the procedure.
RESULTSBoth the vertebroplasty (n=90) and sham (n=86) groups showed a significant reduction in VAS scores at all times, with no significant difference between the groups at any follow-up. Statistically significant pain reduction began one day post-procedure in both groups. Similar patterns were found for QUALEFFO and RMDQ scores. A post hoc analysis did reveal more patients in the sham group with VAS scores of above five after 12 months.
CONCLUSIONThis study of patients with painful osteoporotic vertebral fractures found no significant difference in pain reduction between groups treated with vertebroplasty and those treated with a sham procedure.
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