Abstract No. 11: Percutaneous vertebroplasty versus conservative therapy in patients with an acute osteoporotic vertebral compression fracture. Vertos II: A randomized controlled trial

Article Outline

• Purpose
• Materials and Methods
• Results
• Conclusion
• Copyright

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Purpose 

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.

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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.

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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.

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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.