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Safety of balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures in Europe: a meta-analysis of randomized controlled trials

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Abstract

Purpose

The study aims to evaluate the safety of balloon kyphoplasty in the treatment of painful osteoporotic vertebral compression fractures in Europe.

Methods

Systematic review of the literature, until September 2013, and meta-analysis of randomized controlled trials performed in Europe assessing the safety of balloon kyphoplasty in patients with symptomatic osteoporotic vertebral fractures. Outcomes sought include cement leaks, serious clinical complications and new vertebral fractures.

Results

Six randomized controlled trials fulfilled the inclusion criteria. These studies included data on 525 treated levels in 424 patients. Cement leakages were detected in 18.3 % (95 % CI 11.6, 23.0) of fractures intervened. In about 0.5 % (95 % CI 0.1, 1.1) of fractures leakages proved to be symptomatic. Serious clinical complications were recorded in 11.5 % (95 % CI 1.1, 21.7) of patients treated with balloon kyphoplasty with several of these cases requiring intensive treatment or postoperative surgery. New vertebral fractures were detected in 20.7 % (95 % CI 0.4, 40.9) of patients treated but rates showed an upward pattern when the follow-up period increased. In 54 % of such cases, the fractures were located in regions adjacent to the treated level.

Conclusions

The safety profile and associated complications of balloon kyphoplasty shown in this analysis, based on the evidence provided by existing randomized controlled trials, can be of help to the practicing clinician who must contrast them with the potential benefits of the technique. These data represent an important step towards a balanced evaluation of the intervention though, a better reporting and more reliable data on long-term assessment of potential sequelae are needed.

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Acknowledgments

We thank Raimundo Alcázar for his help with literature searches and Zuleika Saz-Parkinson for her help in the English manuscript revision.

Conflict of interest

No corporate/industry funds were received in support of this work. None of the authors have a financial interest in any of the devices discussed in this report.

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Authors and Affiliations

  1. Health-Care Technology Assessment Agency, Carlos III Institute of Health, Av. Monforte de Lemos 5, 28029, Madrid, Spain

    Carmen Bouza, Nuria Almendro & José María Amate

  2. National Centre for Epidemiology, Carlos III Health Institute, Madrid, Spain

    Teresa López-Cuadrado

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  1. Carmen Bouza
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  2. Teresa López-Cuadrado
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  3. Nuria Almendro
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  4. José María Amate
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Correspondence to Carmen Bouza.

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Bouza, C., López-Cuadrado, T., Almendro, N. et al. Safety of balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures in Europe: a meta-analysis of randomized controlled trials. Eur Spine J 24, 715–723 (2015). https://doi.org/10.1007/s00586-014-3581-7

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  • DOI: https://doi.org/10.1007/s00586-014-3581-7

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