Clinical outcomes after acute osteoporotic vertebral fractures: a 2-year non-randomised trial comparing percutaneous vertebroplasty with conservative therapy

Objective: To assess the safety and efficacy of percutaneous vertebroplasty for the treatment of acute osteoporotic vertebral fractures. Design: A prospective, non-randomised, "intention-to-treat" 2-year study. Patients and setting: 126 consecutive patients (39 men and 87 women, aged 51-95 years) with acute osteoporotic vertebral fractures presenting to St George Hospital from November 2000 to December 2002. They comprised 88 patients treated by percutaneous vertebroplasty and 38 by conservative therapy. Main outcome measures: Primary outcomes - changes in patients' pain score and level of function recorded at 24 hours, 6 weeks, 6-12 months and 24 months after therapy. Secondary outcomes - occurrence of new clinical or radiological vertebral fractures and survival at 2 years. Results: Three minor complications (fractured pedicle and psoas muscle haemorrhage) occurred in the vertebroplasty group during the first year of the study. Outcomes in vertebroplasty-treated patients (60% reduction in visual analogue pain scores from 20 to 8-1 P < 0.001), a rapid return to normal function (29% improvement in physical functioning from 14 to 18; P < 0.001) and lower rates of hospitalisation (43% reduction in the mean number of hospital bed-days occupied) were better than those treated conservatively (P < 0.001 for the comparison of all variables at 24 hours). Lower pain scores persisted in the vertebroplasty-treated group at 6 weeks (P < 0.001), but no differences between the two groups were evident at 12 and 24 months. In the vertebroplasty-treated group compared with the control group, the rates of new vertebral fractures (clinically and by radiographic assessment) (hazard ratio, 1.13; 95% CI, 0.52-2.46; P = 0.76) and death (hazard ratio, 1.07; 95% CI, 0.42-2.76; P= 0.89) showed no significant difference. Conclusion: The analgesic benefit of percutaneous vertebroplasty and the low complication rates suggest that it is a useful therapy for acute painful osteoporotic vertebral fractures.