Efficacy and safety of percutaneous sacroplasty for painful osteoporotic sacral insufficiency fractures: a prospective, multicenter trial.

STUDY DESIGN A prospective observational cohort study of consecutive osteoporotic patients with sacral insufficiency fractures (SIFs). OBJECTIVE Assess the safety and efficacy of sacroplasty in treating osteoporotic SIFs. SUMMARY OF BACKGROUND DATA SIFs can cause low back pain in osteoporotic patients. Symptomatic improvement may require up to 12 months. Treatment includes limited weight-bearing and bed rest, oral analgesics, and sacral corsets. Significant mortality and morbidity are associated with pelvic insufficiency fractures. Percutaneous sacroplasty is an alternative treatment for SIF patients, and initial reports have documented its safe and effective performance. Yet, follow-up intervals have been short, and study cohorts small precluding definitive assessment of sacroplasty's safety and efficacy. METHODS Baseline Visual Analogue Scale (VAS), analgesic usage, and duration of symptoms were recorded. Subsequent VAS ratings were assessed at 30 minutes and at 2, 4, 12, 24, and 52 weeks postprocedure. Analgesic usage and patient satisfaction were assessed at final follow-up. Each procedure was performed under intravenous conscious sedation using fluoroscopy. Two bone trochars were inserted between the sacral foramen and sacroiliac joint through which 2 to 3 mL of polymethylmethacrylate was injected. RESULTS Thirty-seven patients, 27 females, were treated. Mean age was 76.6 years, and mean symptom duration was 34.4 days. All patients were available at each follow-up interval except 1 patient who died due to unrelated pulmonary disease before the 4-week follow-up. The mean VAS score at baseline was 7.7 and 3.2 within 30 minutes, and 2.1 at 2, 1.7 at 4, 1.3 at 12, 1.0 at 24, and 0.7 at 52 weeks postprocedure. Improvement at each interval and overall was statistically significant using the Wilcoxon Rank Sum Test. One case of transient S1 radiculitis was encountered. CONCLUSIONS Sacroplasty appears to be a safe and effective treatment for painful SIF. The rate of improvement is rapid and sustained through 1 year.