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Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial

Wardlaw, Douglas; Cummings, Steven R.; Van Meirhaeghe, Jan; Bastian, Leonard; Tillman, John B.; Ranstam, Jonas LU ; Eastell, Richard; Shabe, Peter; Talmadge, Karen and Boonen, Steven (2009) In The Lancet 373(9668). p.1016-1024
Abstract
Background Balloon kyphoplasty is a minimally invasive procedure for the treatment of painful vertebral fractures, which is intended to reduce pain and improve quality of life. We assessed the efficacy and safety of the procedure. Methods Adults with one to three acute vertebral fractures were eligible for enrolment in this randomised controlled trial at 21 sites in eight countries. We randomly assigned 300 patients by a computer-generated sequence to receive kyphoplasty treatment (n=149) or non-surgical care (n=151). The primary outcome was the difference in change from baseline to 1 month in the short-form (SF)-36 physical component summary (PCS) score (scale 0-100) between the kyphoplasty and control groups. Quality of life and other... (More)
Background Balloon kyphoplasty is a minimally invasive procedure for the treatment of painful vertebral fractures, which is intended to reduce pain and improve quality of life. We assessed the efficacy and safety of the procedure. Methods Adults with one to three acute vertebral fractures were eligible for enrolment in this randomised controlled trial at 21 sites in eight countries. We randomly assigned 300 patients by a computer-generated sequence to receive kyphoplasty treatment (n=149) or non-surgical care (n=151). The primary outcome was the difference in change from baseline to 1 month in the short-form (SF)-36 physical component summary (PCS) score (scale 0-100) between the kyphoplasty and control groups. Quality of life and other efficacy measurements and safety were assessed up to 12 months. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00211211. Findings 138 participants in the kyphoplasty group and 128 controls completed follow-up at 1 month. By use of repeated measures mixed effects modelling, all 300 randomised participants were included in the analysis. Mean SF-36 PCS score improved by 7.2 points (95% CI 5.7-8.8), from 26.0 at baseline to 33.4 at 1 month, in the kyphoplasty group, and by 2.0 points (0.4-3.6), from 25.5 to 27.4, in the non-surgical group (difference between groups 5.2 points, 2.9-7.4; p<0.0001). The frequency of adverse events did not differ between groups. There were two serious adverse events related to kyphoplasty (haematoma and urinary tract infection); other serious adverse events (such as myocardial infarction and pulmonary embolism) did not occur perioperatively and were not related to procedure. Interpretation Our findings suggest that balloon Icyphoplasty is an effective and safe procedure for patients with acute vertebral fractures and will help to inform decisions regarding its use as an early treatment option. Funding Medtronic Spine LLC. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
The Lancet
volume
373
issue
9668
pages
1016 - 1024
publisher
Elsevier Limited
external identifiers
  • wos:000264398200029
  • scopus:62349121784
ISSN
1474-547X
DOI
10.1016/S0140-6736(09)60010-6
language
English
LU publication?
yes
id
584f92ee-bf76-4f85-b643-800a9fc78baf (old id 1404634)
date added to LUP
2009-06-15 09:45:20
date last changed
2017-12-10 03:45:12
@article{584f92ee-bf76-4f85-b643-800a9fc78baf,
  abstract     = {Background Balloon kyphoplasty is a minimally invasive procedure for the treatment of painful vertebral fractures, which is intended to reduce pain and improve quality of life. We assessed the efficacy and safety of the procedure. Methods Adults with one to three acute vertebral fractures were eligible for enrolment in this randomised controlled trial at 21 sites in eight countries. We randomly assigned 300 patients by a computer-generated sequence to receive kyphoplasty treatment (n=149) or non-surgical care (n=151). The primary outcome was the difference in change from baseline to 1 month in the short-form (SF)-36 physical component summary (PCS) score (scale 0-100) between the kyphoplasty and control groups. Quality of life and other efficacy measurements and safety were assessed up to 12 months. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00211211. Findings 138 participants in the kyphoplasty group and 128 controls completed follow-up at 1 month. By use of repeated measures mixed effects modelling, all 300 randomised participants were included in the analysis. Mean SF-36 PCS score improved by 7.2 points (95% CI 5.7-8.8), from 26.0 at baseline to 33.4 at 1 month, in the kyphoplasty group, and by 2.0 points (0.4-3.6), from 25.5 to 27.4, in the non-surgical group (difference between groups 5.2 points, 2.9-7.4; p&lt;0.0001). The frequency of adverse events did not differ between groups. There were two serious adverse events related to kyphoplasty (haematoma and urinary tract infection); other serious adverse events (such as myocardial infarction and pulmonary embolism) did not occur perioperatively and were not related to procedure. Interpretation Our findings suggest that balloon Icyphoplasty is an effective and safe procedure for patients with acute vertebral fractures and will help to inform decisions regarding its use as an early treatment option. Funding Medtronic Spine LLC.},
  author       = {Wardlaw, Douglas and Cummings, Steven R. and Van Meirhaeghe, Jan and Bastian, Leonard and Tillman, John B. and Ranstam, Jonas and Eastell, Richard and Shabe, Peter and Talmadge, Karen and Boonen, Steven},
  issn         = {1474-547X},
  language     = {eng},
  number       = {9668},
  pages        = {1016--1024},
  publisher    = {Elsevier Limited},
  series       = {The Lancet},
  title        = {Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial},
  url          = {http://dx.doi.org/10.1016/S0140-6736(09)60010-6},
  volume       = {373},
  year         = {2009},
}