Abstract

Purpose: Balloon kyphoplasty (BKP) is a minimally invasive treatment for acute vertebral compression fractures (VCF) aiming vertebral deformity correction and fracture stabilisation. We performed the first multicenter randomized trial. Material and Methods: Patients with 1-3 non-traumatic VCF (< 3 months old) were randomly assigned to receive BKP (N=149) or nonsurgical care (NSC) (N=151). Quality of life, back pain and function, days of disability and bed rest were assessed at baseline, 1, 3, 6 and 12 months. Results: The difference between groups in change-from-baseline in the physical component summary of the SF-36, improved 3.5 points (95%CI: 1.6 to 5.4; p=0.0004) more in the BKP group when averaged across 12 months of follow-up. Compared with the NSC group, those assigned to BKP also had greater improvement in quality of life (EuroQol-5D), back function (Roland-Morris), had also significant less back pain and reported fewer days of limited activity in the previous 2 weeks due to back pain No difference was seen in radiographically detected subsequent VCF between groups (p=0.5). Conclusion and Significance: Compared to NSC, BKP improved quality of life, back pain and disability that last at least one year after the procedure. No difference is seen between groups in radiographically subsequent VCF's.