Title: Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial
Authors: Boonen, Steven ×
Van Meirhaeghe, Jan
Bastian, Leonard
Cummings, Steven R
Ranstam, Jonas
Tillman, John B
Eastell, Richard
Talmadge, Karen
Wardlaw, Douglas #
Issue Date: Jul-2011
Publisher: Blackwell Science, Inc.
Series Title: Journal of Bone and Mineral Research vol:26 issue:7 pages:1627-1637
Article number: 10.1002/jbmr.364
Abstract: Vertebral fractures are often painful and lead to reduced quality of life and disability. We compared the efficacy and safety of balloon kyphoplasty to non-surgical therapy over 24 months in patients with acute painful fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n = 149) or non-surgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in SF-36 PCS scores when averaged across the 24-month follow-up period, compared with non-surgical therapy (overall treatment effect 3.24 points, 95% confidence interval [CI] 1.47-5.01; p = 0.0004); the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13-5.64; p = 0.003) but not at 12 (1.70 points, 95% CI -0.59 to 3.98; p = 0.15) or 24 months (1.68 points, 95% CI -0.63 to 3.99; p = 0.15). Greater improvement in back pain was observed over 24 months for kyphoplasty (overall treatment effect -1.49 points, 95% CI -1.88 to -1.10; p < 0.0001); the difference between groups remained statistically significant at 24 months (-0.80 points, 95% CI -1.39 to -0.20; p = 0.009). There were two device-related serious adverse events in the second year that occurred at index vertebrae (a spondylitis and an anterior cement migration). There was no statistically significant difference between groups in the number of patients (47.5% for kyphoplasty, 44.1% for control) with new radiographic vertebral fractures; fewer fractures occurred (∼18%) within the second year. Compared with non-surgical management, kyphoplasty rapidly reduces pain and improves function, disability, and QOL without increasing the risk of additional vertebral fractures. The differences from non-surgical management are statistically significant when averaged across 24 months. Most outcomes are not statistically different at 24 months, but the reduction in back pain remains statistically significant at all time points. © 2011 American Society for Bone and Mineral Research.
ISSN: 0884-0431
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Gerontology and Geriatrics
× corresponding author
# (joint) last author

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