Advanced

Pain, Quality of Life, and Safety Outcomes of Kyphoplasty for Vertebral Compression Fractures : Report of a Task Force of the American Society for Bone and Mineral Research

Rodriguez, Alexander J.; Fink, Howard A.; Mirigian, Lynn; Guañabens, Nuria; Eastell, Richard; Akesson, Kristina LU ; Bauer, Douglas C. and Ebeling, Peter R. (2017) In Journal of Bone and Mineral Research 32(9). p.1935-1944
Abstract

The relative efficacy and harms of balloon kyphoplasty (BK) for treating vertebral compression fractures (VCF) are uncertain. We searched multiple electronic databases to March 2016 for randomized and quasi-randomized controlled trials comparing BK with control treatment (nonsurgical management [NSM], percutaneous vertebroplasty [PV], KIVA VCF treatment system [Benvenue Medical, Inc., Santa Clara, CA, USA], vertebral body stenting, or other) in adults with VCF. Outcomes included back pain, back disability, quality of life, new VCF, and adverse events (AEs). One reviewer extracted data, a second checked accuracy, and two rated risk of bias (ROB). Mean differences and 95% confidence intervals (CIs) were calculated using inverse-variance... (More)

The relative efficacy and harms of balloon kyphoplasty (BK) for treating vertebral compression fractures (VCF) are uncertain. We searched multiple electronic databases to March 2016 for randomized and quasi-randomized controlled trials comparing BK with control treatment (nonsurgical management [NSM], percutaneous vertebroplasty [PV], KIVA VCF treatment system [Benvenue Medical, Inc., Santa Clara, CA, USA], vertebral body stenting, or other) in adults with VCF. Outcomes included back pain, back disability, quality of life, new VCF, and adverse events (AEs). One reviewer extracted data, a second checked accuracy, and two rated risk of bias (ROB). Mean differences and 95% confidence intervals (CIs) were calculated using inverse-variance models. Risk ratios of new VCF and AE were calculated using Mantel-Haenszel models. Ten unique trials enrolled 1837 participants (age range, 61 to 76 years; 74% female), all rated as having high or uncertain ROB. Versus NSM, BK was associated with greater reductions in pain, back-related disability, and better quality of life (k = 1 trial) that appeared to lessen over time, but were less than minimally clinically important differences. Risk of new VCF at 3 and 12 months was not significantly different (k = 2 trials). Risk of any AE was increased at 1 month (RR = 1.73; 95% CI, 1.36 to 2.21). There were no significant differences between BK and PV in back pain, back disability, quality of life, risk of new VCF, or any AE (k = 1 to 3 trials). Limitations included lack of a BK versus sham comparison, availability of only one RCT of BK versus NSM, and lack of study blinding. Individuals with painful VCF experienced symptomatic improvement compared with baseline with all interventions. The clinical importance of the greater improvements with BK versus NSM is unclear, may be due to placebo effect, and may not counterbalance short-term AE risks. Outcomes appeared similar between BK and other surgical interventions. Well-conducted randomized trials comparing BK with sham would help resolve remaining uncertainty about the relative benefits and harms of BK.

(Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
AGING, KYPHOPLASTY, OSTEOPOROSIS, PAIN, QUALITY OF LIFE, VERTEBRAL COMPRESSION FRACTURE
in
Journal of Bone and Mineral Research
volume
32
issue
9
pages
10 pages
publisher
AMBMR
external identifiers
  • scopus:85021309338
ISSN
0884-0431
DOI
10.1002/jbmr.3170
language
English
LU publication?
yes
id
521ebc5d-6708-48d4-a3e7-f1cf3ee86fbe
date added to LUP
2018-01-25 08:18:36
date last changed
2018-05-29 09:56:24
@article{521ebc5d-6708-48d4-a3e7-f1cf3ee86fbe,
  abstract     = {<p>The relative efficacy and harms of balloon kyphoplasty (BK) for treating vertebral compression fractures (VCF) are uncertain. We searched multiple electronic databases to March 2016 for randomized and quasi-randomized controlled trials comparing BK with control treatment (nonsurgical management [NSM], percutaneous vertebroplasty [PV], KIVA VCF treatment system [Benvenue Medical, Inc., Santa Clara, CA, USA], vertebral body stenting, or other) in adults with VCF. Outcomes included back pain, back disability, quality of life, new VCF, and adverse events (AEs). One reviewer extracted data, a second checked accuracy, and two rated risk of bias (ROB). Mean differences and 95% confidence intervals (CIs) were calculated using inverse-variance models. Risk ratios of new VCF and AE were calculated using Mantel-Haenszel models. Ten unique trials enrolled 1837 participants (age range, 61 to 76 years; 74% female), all rated as having high or uncertain ROB. Versus NSM, BK was associated with greater reductions in pain, back-related disability, and better quality of life (k = 1 trial) that appeared to lessen over time, but were less than minimally clinically important differences. Risk of new VCF at 3 and 12 months was not significantly different (k = 2 trials). Risk of any AE was increased at 1 month (RR = 1.73; 95% CI, 1.36 to 2.21). There were no significant differences between BK and PV in back pain, back disability, quality of life, risk of new VCF, or any AE (k = 1 to 3 trials). Limitations included lack of a BK versus sham comparison, availability of only one RCT of BK versus NSM, and lack of study blinding. Individuals with painful VCF experienced symptomatic improvement compared with baseline with all interventions. The clinical importance of the greater improvements with BK versus NSM is unclear, may be due to placebo effect, and may not counterbalance short-term AE risks. Outcomes appeared similar between BK and other surgical interventions. Well-conducted randomized trials comparing BK with sham would help resolve remaining uncertainty about the relative benefits and harms of BK.</p>},
  author       = {Rodriguez, Alexander J. and Fink, Howard A. and Mirigian, Lynn and Guañabens, Nuria and Eastell, Richard and Akesson, Kristina and Bauer, Douglas C. and Ebeling, Peter R.},
  issn         = {0884-0431},
  keyword      = {AGING,KYPHOPLASTY,OSTEOPOROSIS,PAIN,QUALITY OF LIFE,VERTEBRAL COMPRESSION FRACTURE},
  language     = {eng},
  month        = {09},
  number       = {9},
  pages        = {1935--1944},
  publisher    = {AMBMR},
  series       = {Journal of Bone and Mineral Research},
  title        = {Pain, Quality of Life, and Safety Outcomes of Kyphoplasty for Vertebral Compression Fractures : Report of a Task Force of the American Society for Bone and Mineral Research},
  url          = {http://dx.doi.org/10.1002/jbmr.3170},
  volume       = {32},
  year         = {2017},
}