VERTOS V: A randomised sham-controlled trial on vertebroplasty for painful chronic osteoporotic vertebral fractures

Purpose: VERTOS V is a sham-controlled randomised trial on vertebroplasty comparing clinical outcomes in patients with sustained pain for 3 or more months after osteoporotic vertebral compression fracture (VCF). Material and Methods: In March 2013, VERTOS V commenced at 4 centres in The Netherlands. Inclusion criteria are VCF at T5 or lower with focal tenderness at the fracture level, as assessed by an internist on physical examination, visual analogue scale (VAS) score ≥5 for 3 months or more, decreased bone density, defined as T score, less than -1 and age ≥50 years. Sixty patients were included, 30 in each arm. Crossovers are not allowed. Follow-up is at regular intervals during a 6-month period with VAS scores for pain as the primary endpoint. Secondary endpoints are back pain-related disability and quality of life measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis and physical function measured with the Roland Morris Disability questionnaire. Results: Clinically significant pain relief is defined as a decrease in VAS score from baseline of 3 points or more. No results are present yet because the study commenced in March 2013. The trial and the baseline results of patients enrolled in the study between March 2013 and August 2013 will be presented. Conclusion: Vertos V is a methodologically sound multicentre randomised sham controlled trial on vertebroplasty in patients with pain for 3 months or more after vertebral compression fractures.