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The Efficacy and Safety of Vertebral Augmentation : A Second ASBMR Task Force Report

Ebeling, Peter R.; Akesson, Kristina LU ; Bauer, Douglas C.; Buchbinder, Rachelle; Eastell, Richard; Fink, Howard A.; Giangregorio, Lora; Guanabens, Nuria; Kado, Deborah and Kallmes, David, et al. (2019) In Journal of Bone and Mineral Research 34(1). p.3-21
Abstract

Vertebral augmentation is among the current standards of care to reduce pain in patients with vertebral fractures (VF), yet a lack of consensus regarding efficacy and safety of percutaneous vertebroplasty and kyphoplasty raises questions on what basis clinicians should choose one therapy over another. Given the lack of consensus in the field, the American Society for Bone and Mineral Research (ASBMR) leadership charged this Task Force to address key questions on the efficacy and safety of vertebral augmentation and other nonpharmacological approaches for the treatment of pain after VF. This report details the findings and recommendations of this Task Force. For patients with acutely painful VF, percutaneous vertebroplasty provides no... (More)

Vertebral augmentation is among the current standards of care to reduce pain in patients with vertebral fractures (VF), yet a lack of consensus regarding efficacy and safety of percutaneous vertebroplasty and kyphoplasty raises questions on what basis clinicians should choose one therapy over another. Given the lack of consensus in the field, the American Society for Bone and Mineral Research (ASBMR) leadership charged this Task Force to address key questions on the efficacy and safety of vertebral augmentation and other nonpharmacological approaches for the treatment of pain after VF. This report details the findings and recommendations of this Task Force. For patients with acutely painful VF, percutaneous vertebroplasty provides no demonstrable clinically significant benefit over placebo. Results did not differ according to duration of pain. There is also insufficient evidence to support kyphoplasty over nonsurgical management, percutaneous vertebroplasty, vertebral body stenting, or KIVA®. There is limited evidence to determine the risk of incident VF or serious adverse effects (AE) related to either percutaneous vertebroplasty or kyphoplasty. No recommendation can be made about harms, but they cannot be excluded. For patients with painful VF, it is unclear whether spinal bracing improves physical function, disability, or quality of life. Exercise may improve mobility and may reduce pain and fear of falling but does not reduce falls or fractures in individuals with VF. General and intervention-specific research recommendations stress the need to reduce study bias and address methodological flaws in study design and data collection. This includes the need for larger sample sizes, inclusion of a placebo control, more data on serious AE, and more research on nonpharmacologic interventions. Routine use of vertebral augmentation is not supported by current evidence. When it is offered, patients should be fully informed about the evidence. Anti-osteoporotic medications reduce the risk of subsequent vertebral fractures by 40–70%.

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published
subject
keywords
KYPHOPLASTY, OSTEOPOROSIS, VERTEBRAL AUGMENTATION, VERTEBRAL FRACTURE, VERTEBROPLASTY
in
Journal of Bone and Mineral Research
volume
34
issue
1
pages
19 pages
publisher
AMBMR
external identifiers
  • scopus:85060528352
ISSN
0884-0431
DOI
10.1002/jbmr.3653
language
English
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yes
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21ee3499-cb03-429a-b210-36e4999c7ce9
date added to LUP
2019-02-07 08:39:48
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2019-03-19 04:05:07
@article{21ee3499-cb03-429a-b210-36e4999c7ce9,
  abstract     = {<p>Vertebral augmentation is among the current standards of care to reduce pain in patients with vertebral fractures (VF), yet a lack of consensus regarding efficacy and safety of percutaneous vertebroplasty and kyphoplasty raises questions on what basis clinicians should choose one therapy over another. Given the lack of consensus in the field, the American Society for Bone and Mineral Research (ASBMR) leadership charged this Task Force to address key questions on the efficacy and safety of vertebral augmentation and other nonpharmacological approaches for the treatment of pain after VF. This report details the findings and recommendations of this Task Force. For patients with acutely painful VF, percutaneous vertebroplasty provides no demonstrable clinically significant benefit over placebo. Results did not differ according to duration of pain. There is also insufficient evidence to support kyphoplasty over nonsurgical management, percutaneous vertebroplasty, vertebral body stenting, or KIVA®. There is limited evidence to determine the risk of incident VF or serious adverse effects (AE) related to either percutaneous vertebroplasty or kyphoplasty. No recommendation can be made about harms, but they cannot be excluded. For patients with painful VF, it is unclear whether spinal bracing improves physical function, disability, or quality of life. Exercise may improve mobility and may reduce pain and fear of falling but does not reduce falls or fractures in individuals with VF. General and intervention-specific research recommendations stress the need to reduce study bias and address methodological flaws in study design and data collection. This includes the need for larger sample sizes, inclusion of a placebo control, more data on serious AE, and more research on nonpharmacologic interventions. Routine use of vertebral augmentation is not supported by current evidence. When it is offered, patients should be fully informed about the evidence. Anti-osteoporotic medications reduce the risk of subsequent vertebral fractures by 40–70%.</p>},
  author       = {Ebeling, Peter R. and Akesson, Kristina and Bauer, Douglas C. and Buchbinder, Rachelle and Eastell, Richard and Fink, Howard A. and Giangregorio, Lora and Guanabens, Nuria and Kado, Deborah and Kallmes, David and Katzman, Wendy and Rodriguez, Alexander and Wermers, Robert and Wilson, H. Alexander and Bouxsein, Mary L.},
  issn         = {0884-0431},
  keyword      = {KYPHOPLASTY,OSTEOPOROSIS,VERTEBRAL AUGMENTATION,VERTEBRAL FRACTURE,VERTEBROPLASTY},
  language     = {eng},
  number       = {1},
  pages        = {3--21},
  publisher    = {AMBMR},
  series       = {Journal of Bone and Mineral Research},
  title        = {The Efficacy and Safety of Vertebral Augmentation : A Second ASBMR Task Force Report},
  url          = {http://dx.doi.org/10.1002/jbmr.3653},
  volume       = {34},
  year         = {2019},
}