Abstract

Percutaneous vertebroplasty (PV) is an alternative option to treat pain after an osteoporotic vertebral compression fracture (OVCF). Controversy exists as to whether PV increases the risk for new OVCFs or prevents further vertebral height loss in treated levels. We assessed both during one year follow-up in patients with acute OVCF randomised to PV or a sham procedure. VERTOS IV is a prospective multicentre randomised controlled trial (RCT) comparing PV with sham therapy in 180 patients. New OVCFs and further vertebral height loss were assessed at 3, 6 and 12 months. After a median follow-up of 12 months (interquartile range (IQR)= 12-12) 31 new fractures were reported in 15 patients from the PV group and 28 new fractures in 19 patients from the sham group. The difference in incidence was not significant (F(1,522)=0.277, p=0.60). There was no higher fracture risk for adjacent versus distant vertebrae. After sham procedure, further height loss of treated vertebrae occurred more frequently (7 patients in the PV group and 36 in the sham group- (F(1,1222)=12, p < .001) and was more severe (p < .001) than after PV. PV does not increase the risk of OVCFs in the first year after cementation when compared to a sham procedure. The risk of further vertebral height loss is significantly higher after sham intervention, i.e., cementation protects against progressive vertebral body collapse.

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