Abstract No. 11: Percutaneous vertebroplasty versus conservative therapy in patients with an acute osteoporotic vertebral compression fracture. Vertos II: A randomized controlled trial
Primary outcome was pain relief at 1 month and 1 year as measured with the Visual Analog Score (VAS). Secondary outcomes were cost-effectiveness at 1 year and the occurence of secondary fractures.
Materials and Methods
VERTOS II is a prospective multicenter randomized controlled trial comparing percutaneous vertebroplasty (PV) with conservative therapy in 202 patients with an acute vertebral compression fracture (VCF). Inclusion criteria were: (1)VCF on X-ray of the spine (minimal 15% loss of height), (2)level of VCF Th5 or lower, (3)back pain ≤ 6 weeks, (4)bone edema on MRI of the fractured vertebral body, (5)focal tenderness on VCF level and (6)decreased bone density with T-scores ≤ -1. Radiological imaging results and standard questionnaires addressing clinical symptoms, pain medication and visual analogue scale (VAS) were compared to baseline and between groups. Cost-effectiveness of both therapies were obtained and compared. Follow-up was at regular intervals over 1 year period. Secondary fractures, necessary additional therapies and complications of both treatments were recorded. Analyses were by intention to treat.
Results
PV offered better pain relief at 1 day (VAS 3.7 vs 6.7; P<0.001), 1 week (VAS 3.5 vs 5.6; P<0.001), 1 month (VAS 2.5 vs. 4.9; P<0.001), 3 months (VAS 2.5 vs. 3.9; P=0.025), 6 months (VAS 2.3 vs. 3.9; P=0.014), and 1 year (VAS 2.2 vs. 3.8; P=0.014). During the first month after PV pain medication was significantly reduced compared with conservative therapy but this difference was no longer significant at longer follow-up intervals. PV generated additional €2,450 direct medical costs per patient at 1 year follow-up. The adjusted incremental cost-effectiveness ratio amounted to €22,685 per quality-of-life-year gained, indicating that PV may be considered cost-effective. During the first year after PV, 120 pain-free-days were gained. The incidence of new fractures was similar in both groups during 1 year follow-up (P=0.28) There were no serious complications or adverse events.
Conclusion
PV for acute, osteoporotic VCFs is effective and safe. Pain relief after PV is immediate, sustained during one year and significantly better than with conservative therapy at acceptable costs.
1Radiology, St. Elisabeth Ziekenhuis, Tilburg, Netherlands
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