Paolo Tranquilli Leali1, Federico Solla2, Gianluca Maestretti3, Massimo Balsano4, Carlo Doria1. 1. Orthopaedic Department, University of Sassari, Sassari, Italy. 2. Orthopaedic Department, Paediatric Hospital Nice CHU-Lenval, France. 3. Spinal Unit, Cantonal Hospital Fribourg, Switzerland. 4. Orthopaedic Department, Santorso Hospital AUSSL 4, Schio, Italy.
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. PURPOSE: The aim of this paper was to analyse a multicenter international experience of 200 compression fractures treated withpercutaneous 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 painfor 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 withPV 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.
RCT Entities:
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.
Authors: Rachelle Buchbinder; Richard H Osborne; Peter R Ebeling; John D Wark; Peter Mitchell; Chris Wriedt; Stephen Graves; Margaret P Staples; Bridie Murphy Journal: N Engl J Med Date: 2009-08-06 Impact factor: 91.245