Percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures: an open prospective study.

OBJECTIVE: To assess the efficacy and safety of percutaneous vertebroplasty in osteoporotic vertebral compression fractures responsible for severe and persistent pain. METHODS: Sixteen patients were included in this open prospective study. Inclusion criteria were: one or 2 vertebral fractures responsible for severe pain, i.e., higher than 50 mm on a visual analog scale (VAS: 0-100 mm), scores 3, 4 or 5 according to the McGill-Melzack scoring system, and evolving for more than 3 months. Assessment criteria were the changes over time (Days 3, 30, 90, 180) in VAS and McGill-Melzack scoring system. The changes over time in a generic health status instrument score [the Nottingham Health Profile (NHP)] were also assessed. Statistical comparisons were performed using the Wilcoxon T test. RESULTS: There were 9 women and 7 men: postmenopausal osteoporosis (n = 7), corticosteroid induced osteoporosis (n = 2), and male osteoporosis (n = 7). Vertebroplasty was performed in 20 vertebrae. A statistically significant decrease of both VAS (-53%, p < 0.0005) and McGill-Melzack scoring system (p < 0.005) was observed at Day 3. The results were also significant at Days 30, 90, and 180 for both scales (p < 0.005 and p < 0.01, respectively). A significant decrease over time for 5/6 dimensions of the NHP score was also noted: pain (p < 0.01), physical mobility (p < 0.05), emotional reactions (p < 0.05), social isolation (p < 0.05), and energy (p < 0.05). We observed no adverse event, and no vertebral fracture has occurred after 6 months of followup. CONCLUSION: Percutaneous vertebroplasty is a useful and safe procedure for treating persistent painful osteoporotic fractures. Controlled studies with longterm followup are required.