Pain Reduction by Percutaneous Vertebroplasty for Vertebral Compression Fractures with and without Intravertebral Clefts

Background: Vertebroplasty has become a common treatment for relieving pain in osteoporotic vertebral fractures. However, there is contradictory evidence regarding its efficacy. The aim of this study was to determine the degree of pain relief offered by percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures (OVCFs) in patients with or without an intravertebral cleft. Material and Methods: In this multicenter, randomized, placebo-controlled trial all patients who had one or multiple painful, unhealed compression fractures were randomly assigned to undergo vertebroplasty or a sham procedure. The patients in the vertebroplasty group were divided into two subgroups: A - with intravertebral cleft, and B - without intravertebral cleft. They were followed up for the mean pain reduction assessed by visual analogue scale (VAS), and changes in the quality of life using the osteoporosis and Roland-Morris disability questionnaire scores (RDQ) at 1, 6, and 12 months, and two years after the procedure. Results: A total of 1,311 patients were studied (vertebroplasty 661, sham 650). The data showed that those with intravertebral clefts had significantly less severe back pain (p = 0.01) and functional disability (p=0.03) at month 12 compared to those without intravertebral cleft. However, the study groups did not differ significantly with respect to the pain score or the RDQ score at other measurement points (p>0.05). There was a trend in the RDQ score toward less pain in patients with filled clefts compared with patients without clefts after one and two years after surgery, this difference did not approach statistical significance. Conclusion: We found no significant benefit of percutaneous vertebroplasty (PVP) over a sham procedure in patients with vertebral compression fractures with or without vertebral clefts 6 months after surgery. One and two years after surgery, there was a trend toward less pain.