Percutaneous vertebroplasty has been performed for more than ten years to treat painful osteoporotic vertebral compression fractures. Clinical results have been encouraging, but little is known about the efficacy and safety of this minimally invasive procedure. We therefore performed a systematic review to assess the efficacy and safety of percutaneous vertebroplasty in osteoporotic vertebral compression fractures. A search was conducted using Medline, Embase and The Cochrane Controlled Trials Register. The search yielded fifteen studies, eleven prospective, three retrospective and one controlled trial. Totally 1,136 interventions were performed on 793 patients. Mean pain scores, measured using a 0 to 10 VAS score, improved significantly from 7.8 to 3.1 (-60.3%) immediately after percutaneous vertebroplasty. The short-term complication rate varied between 0.4 and 75.6%. Leakage of cement outside the vertebral body was markedly common, ranging from 3.3 to 75.6%. Although the majority was asymptomatic, a few devastating clinical adverse effects were reported (mean 2.4%). Although percutaneous vertebroplasty is a widely accepted treatment for osteoporotic vertebral fractures, we revealed only a single controlled trial. We conclude that there are insufficient data available to reliably assess efficacy of percutaneous vertebroplasty. The procedure has a low rate of clinical complications, but potential complications can be devastating. In the future, assessing the efficacy of percutaneous vertebroplasty requires controlled trials with long-term follow-up.