title: Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study.
abstract: 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.
  
  
  OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Orthopaedic Department, University of Sassari, Sassari, Italy.
authors.forename: Paolo Tranquilli
authors.initials: PT
authors.lastname: Leali
authors.affiliation: Orthopaedic Department, Paediatric Hospital Nice CHU-Lenval, France.
authors.forename: Federico
authors.initials: F
authors.lastname: Solla
authors.affiliation: Spinal Unit, Cantonal Hospital Fribourg, Switzerland.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Maestretti
authors.affiliation: Orthopaedic Department, Santorso Hospital AUSSL 4, Schio, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Balsano
authors.affiliation: Orthopaedic Department, University of Sassari, Sassari, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Doria
keywords: conservative care; multicenter prospective randomized study; osteoporotic vertebral compression fractures (VCFs); percutaneous vertebroplasty (PV)