Safety and Efficacy of Vertebroplasty in the Treatment of Osteoporotic Vertebral Compression Fractures: A Prospective Multicenter International Randomized Controlled Study

Clin Cases Miner Bone Metab. Sep-Dec 2016;13(3):234-236. doi: 10.11138/ccmbm/2016.13.3.234. Epub 2017 Feb 10.


Background: Vertebral compression fractures (VCFs) treated non-operatively can diminish function and quality of life, and lead to chronic health effects. The short-term safety and effectiveness of vertebroplasty for symptomatic VCFs are well-documented, but long-term follow-up is needed.

Purpose: The aim of this paper was to analyse a multicenter international experience of 200 compression fractures treated with percutaneous vertebroplasty (VP) and compare the results of this procedure with the result of 200 patients treated conservatively. To estimate cost-effectiveness of VP compared to conservative care in terms of: pain reduction, quality of life, complications, secondary fractures and mortality.

Materials and methods: 400 patients have been enrolled in a prospective randomized controlled study with painful VCFs with bone edema on MR imaging, local back pain for 6 weeks or less, osteoporosis and aged 55 years or older; after obtaining informed consent patients are included and randomized for VP or conservative care. Before treatment and at follow-up with regular intervals during 1-year period were administered to patients standard questionnaires addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score for pain, Oswestry Disability Index (ODI) score to evaluate functional activity.

Results: 200 patients treated with PV compared with 200 patients treated conservatively had significantly better VAS and used less analgesics 1 day after treatment. Twenty-four hours after VP, there was a reduction in pain scores and an improvement in physical functions, whereas remain unchanged in the patients treated conservatively.

Conclusions: Pain relief and improvement of mobility and function after PV is immediate and significantly better in the short term compared with non-surgical care treatment.

Keywords: conservative care; multicenter prospective randomized study; osteoporotic vertebral compression fractures (VCFs); percutaneous vertebroplasty (PV).