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Balloon Kyphoplasty for the Treatment of Acute Vertebral Compression Fractures: 2-Year Results From a Randomized Trial

Boonen, Steven; Van Meirhaeghe, Jan; Bastian, Leonard; Cummings, Steven R.; Ranstam, Jonas LU ; Tillman, John B.; Eastell, Richard; Talmadge, Karen and Wardlaw, Douglas (2011) In Journal of Bone and Mineral Research 26(7). p.1627-1637
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 nonsurgical 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 nonsurgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in Short-Form 36 (SF-36) Physical Component Summary (PCS) scores when averaged across the 24-month follow-up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI)... (More)
Vertebral fractures are often painful and lead to reduced quality of life and disability. We compared the efficacy and safety of balloon kyphoplasty to nonsurgical 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 nonsurgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in Short-Form 36 (SF-36) Physical Component Summary (PCS) scores when averaged across the 24-month follow-up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI) 1.47-5.01, p = .0004]; the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13-5.64, p = .003) but not at 12 months (1.70 points, 95% CI -0.59 to 3.98, p = .15) or 24 months (1.68 points, 95% CI -0.63 to 3.99, p = .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<.0001); the difference between groups remained statistically significant at 24 months (-0.80 points, 95% CI -1.39 to -0.20, p = .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 (similar to 18%) within the second year. Compared with nonsurgical management, kyphoplasty rapidly reduces pain and improves function, disability, and quality of life without increasing the risk of additional vertebral fractures. The differences from nonsurgical 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. (C) 2011 American Society for Bone and Mineral Research. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
BALLOON KYPHOPLASTY, VERTEBRAL FRACTURE, OSTEOPOROSIS
in
Journal of Bone and Mineral Research
volume
26
issue
7
pages
1627 - 1637
publisher
AMBMR
external identifiers
  • wos:000292061400026
  • scopus:79959512563
ISSN
1523-4681
DOI
10.1002/jbmr.364
language
English
LU publication?
yes
id
1510d015-b39b-4fed-8abe-332c6f7a2d5a (old id 2042264)
date added to LUP
2011-08-02 08:59:07
date last changed
2017-10-01 03:31:05
@article{1510d015-b39b-4fed-8abe-332c6f7a2d5a,
  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 nonsurgical 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 nonsurgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in Short-Form 36 (SF-36) Physical Component Summary (PCS) scores when averaged across the 24-month follow-up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI) 1.47-5.01, p = .0004]; the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13-5.64, p = .003) but not at 12 months (1.70 points, 95% CI -0.59 to 3.98, p = .15) or 24 months (1.68 points, 95% CI -0.63 to 3.99, p = .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&lt;.0001); the difference between groups remained statistically significant at 24 months (-0.80 points, 95% CI -1.39 to -0.20, p = .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 (similar to 18%) within the second year. Compared with nonsurgical management, kyphoplasty rapidly reduces pain and improves function, disability, and quality of life without increasing the risk of additional vertebral fractures. The differences from nonsurgical 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. (C) 2011 American Society for Bone and Mineral Research.},
  author       = {Boonen, Steven and Van Meirhaeghe, Jan and Bastian, Leonard and Cummings, Steven R. and Ranstam, Jonas and Tillman, John B. and Eastell, Richard and Talmadge, Karen and Wardlaw, Douglas},
  issn         = {1523-4681},
  keyword      = {BALLOON KYPHOPLASTY,VERTEBRAL FRACTURE,OSTEOPOROSIS},
  language     = {eng},
  number       = {7},
  pages        = {1627--1637},
  publisher    = {AMBMR},
  series       = {Journal of Bone and Mineral Research},
  title        = {Balloon Kyphoplasty for the Treatment of Acute Vertebral Compression Fractures: 2-Year Results From a Randomized Trial},
  url          = {http://dx.doi.org/10.1002/jbmr.364},
  volume       = {26},
  year         = {2011},
}