Abstract
Purpose
To compare the efficacy and safety of balloon kyphoplasty (BKP) to non-surgical management (NSM) over 24 months in patients with acute painful fractures by clinical outcomes and vertebral body kyphosis correction and surgical parameters.
Material and Methods
Three hundred Adult patients with one to three VCF's were randomised within 3 months of the acute fracture; 149 to Balloon Kyphoplasty and 151 to Non-surgical management. Subjective QOL assessments and objective functional (Timed up and go [TUG]) and vertebral body kyphotic angulation (KA), were assessed over 24 months; we also report surgical parameters and adverse events temporally related to surgery (within 30-days).
Results
Kyphoplasty was associated with greater improvements in SF-36 PCS scores when averaged across the 24-month follow-up period, compared with NSM (overall treatment effect 3.24points, 95% CI, 1.47–5.01; p=0.0004)., and TUG (overall treatment effect −3.00 seconds, 95% CI, −1.0 to −5.1; p<0.0043). At 24 months, the change from baseline in KA was statistically significantly improved in the kyphoplasty group (average 3.1°of correction for BKP versus 0.8°for NSM, p=0.003). On average IBT inflation volumes were consistent with cement volumes at 2.4 cc per side. The most common adverse events within 30-days were back pain, new vertebral fracture, nausea/vomiting and UTI. BKP is calculated to be cost-effective in the UK setting.
Conclusions
Compared with NSM, BKP improves patient function and QOL when averaged over 24-months and results in better improvement of index vertebral body kyphotic angulation.
Author potential conflicts of interest; JVM, LB; SB, DW and JR are consultants for Medtronic Spine LLC for the FREE study; JBT is currently employed by Medtronic, Inc.
