Safety of balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures in Europe: a meta-analysis of randomized controlled trials.
OBJECTIVE
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.
Health-Care Technology Assessment Agency, Carlos III Institute of Health, Av. Monforte de Lemos 5, 28029, Madrid, Spain, cbouza@isciii.es.
Carmen
C
Bouza
Teresa
T
López-Cuadrado
Nuria
N
Almendro
José María
JM
Amate
D001843:Bone Cements / Q000009:adverse effects; D002484:Cementation / Q000009:adverse effects; D005060:Europe; D005119:Extravasation of Diagnostic and Therapeutic Materials / Q000209:etiology; D050815:Fractures, Compression / Q000601:surgery*; D006801:Humans; D058498:Kyphoplasty / Q000009:adverse effects* / Q000379:methods; D058866:Osteoporotic Fractures / Q000601:surgery*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012008:Recurrence; D016103:Spinal Fractures / Q000601:surgery*
D001843:Bone Cements