STUDY DESIGN: Multicenter randomized controlled trial. OBJECTIVE: To compare the efficacy and safety of balloon kyphoplasty (BKP) to non-surgical management (NSM) over 24 months in patients with painful vertebral compression fractures (VCF). SUMMARY OF BACKGROUND DATA: Recently, several large randomized controlled trials have been conducted and reported how vertebral augmentation compares with NSM for patients with acute VCFs. Few of these trials report on the surgical aspects and radiographic vertebral deformity results. METHODS: Adults with 1 to 3 VCF were randomized within 3 months of pain to undergo bilateral BKP (n = 149) or NSM (n = 151). Surgical parameters, subjective quality of life (QOL) assessments and objective functional (timed up and go (TUG)) and radiographic assessments were collected. RESULTS: Compared with NSM, the BKP group had greater improvements in SF-36 physical component summary (PCS) scores at one month (5.4 points, 95%CI 3.4 to 7.3; p < 0.0001) and when averaged across the 24-months (overall treatment effect 2.7 points, 95% CI 1.3 to 4.1; p < 0.0001). The kyphoplasty group also had greater functionality by assessing TUG (overall treatment effect -2.5 seconds, 95% CI -0.8 to -4.2; p = 0.0036). At 24 months, the change in index fracture kyphotic angulation was statistically significantly improved in the kyphoplasty group (average 3.1 degrees of correction for kyphoplasty compared to 0.8 degrees in the control, p = 0.003). Number of baseline prevalent fractures (p = 0.003) and treatment assignment (p = 0.004) are the most predictive variables for PCS improvement; however in BKP patients there may also be a link with kyphotic angulation. In BKP, the highest quart for kyphotic angulation correction had higher PCS improvement (13.4 points) compared to the quart having lowest correction of angulation (7.40 points, p = 0.0146 for difference). The most common adverse events (AEs) temporally related to surgery (ie, within 30-days) were back pain (20 BKP, 11 NSM) new VCF (11 BKP, 7 NSM), nausea/vomiting (12 BKP, 4 NSM) and urinary tract infection (10 BKP, 3 NSM). Several other AEs were possibly related to patient positioning in the operating room. CONCLUSION: Compared with NSM, BKP improves patient QOL and pain averaged over 24-months and results in better improvement of index vertebral body kyphotic angulation. Peri-operative complications may be reduced with more care in patient positioning.
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