Blinded A randomized Blinded placebo August RCT trial of controlled trial of 2009 vertebroplasty vertebroplasty for painful for painful osteoporotic vertebral vertebral fractures up to 12 fractures. months old in (Buchbinder et outpatients only. al NEJM, 2009) NRS Pain entry score requirement not defined. Blinded A Randomized Blinded placebo August RCT Trial of controlled of 2009 Vertebroplasty vertebroplasty for for painful Osteoporotic vertebral Spinal fractures up to 12 Fractures. months old. (Kallmes et al, Outpatients only. NEJM<2009) NRS Pain entry score ≥3/10. Open Vertebroplasty Open label RCT label versus comparing RCT conservative vertebroplasty to 2010 treatment in conservative acute therapy for osteoporotic fracture less than vertebral 6 weeks compression duration. fractures Outpatients only. (Vertos II): an NRS Pain entry open-label score ≥5/10. randomised trial. (Klazen et al, Lancet 2010) 5 Other MSAC 27.1 trials not Nov studies assessment considered 2011 have relevant to been conclusions in MSAC 27.1 in assessment MSAC 27.1
Blinded RCT A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. (Buchbinder et al NEJM, 2009) Blinded placebo controlled trial of vertebroplasty for painful vertebral fractures up to 12 months old in outpatients only. NRS Pain entry score requirement not defined. August 2009 Blinded RCT A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures. (Kallmes et al, NEJM<2009) Blinded placebo controlled of vertebroplasty for painful vertebral fractures up to 12 months old. Outpatients only. NRS Pain entry score ≥3/10. August 2009 Open label RCT Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. (Klazen et al, Lancet 2010) Open label RCT comparing vertebroplasty to conservative therapy for fracture less than 6 weeks duration. Outpatients only. NRS Pain entry score ≥5/10. 2010 Other studies have been in MSAC 27.1 MSAC 27.1 assessment trials not considered relevant to conclusions in MSAC 27.1 assessment Nov 2011 5
Application-Form-Vertebroplasty%20MSAC_redactions.docx