title: Cost-effectiveness of balloon kyphoplasty versus standard medical treatment in patients with osteoporotic vertebral compression fracture: a Swedish multicenter randomized controlled trial with 2-year follow-up.
abstract: METHODS
  A multicenter, randomized, controlled, cost-effectiveness analysis.
  
  
  OBJECTIVE
  To assess the cost-effectiveness of balloon kyphoplasty (BKP) compared with standard medical treatment (control) in patients with acute/subacute (<3 months) vertebral compression fracture (VCF) due to osteoporosis.
  
  
  BACKGROUND
  Patients with a VCF due to osteoporosis are common and will increase in number in an aging population, putting a substantial strain on health care. Selected patients may benefit from stabilizing the fracture with cement through BKP, a minimally invasive procedure. BKP has been reported to give good short-time clinical results, and economic modeling has suggested that the procedure could be cost-effective after 2 years compared with standard treatment.
  
  
  METHODS
  Hospitalized patients with back pain due to VCF were randomized to BKP or to control using a computer-generated random list. All costs associated with VCF and cost-effectiveness were reported primarily from the perspective of society. We used EQ-5D to assess quality of life (QoL). The accumulated quality-adjusted life years (QALYs) gained and costs/QALY gained were assessed using intention to treat.
  
  
  RESULTS
  Between February 2003 and December 2005, a total of 63 out of 67 Swedish patients were analyzed: BKP (n = 32) and control (n = 31). Societal cost per patient for BKP was SEK 160,017 (SD = 151,083) = €16,668 (SD = 15,735), and for control SEK 84,816 (SD = 40,954) = €8835 (SD = 4266), a significant difference of 75,198 (95% confidence intervals [CI] = 16,037-120,104) = €7833 (95% CI = 1671-12,511). The accumulated difference in QALYs was 0.085 (95% CI = -0.132 to 0.306) in favor of BKP. Cost/QALY gained using BKP was SEK 884,682 = €92,154 and US $134,043.
  
  
  CONCLUSIONS
  In this randomized controlled trial, it was not possible to demonstrate that BKP was cost-effective compared with standard medical treatment in patients treated for an acute/subacute vertebral fracture due to osteoporosis. However, sensitivity analysis indicated a certain degree of uncertainty, which needs to be considered.
authors.affiliation: Department of Orthopaedic Surgery, Falun Hospital, Falun, Sweden. peter.fritzell@ltdalarna.se
authors.forename: Peter
authors.initials: P
authors.lastname: Fritzell
authors.forename: Acke
authors.initials: A
authors.lastname: Ohlin
authors.forename: Fredrik
authors.initials: F
authors.lastname: Borgström
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003362:Cost-Benefit Analysis; D005260:Female; D005500:Follow-Up Studies; D050815:Fractures, Compression / Q000601:surgery*; D006801:Humans; D058498:Kyphoplasty / Q000191:economics* / Q000379:methods; D008297:Male; D008875:Middle Aged; D058866:Osteoporotic Fractures / Q000601:surgery*; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D016103:Spinal Fractures / Q000601:surgery*; D011795:Surveys and Questionnaires; D013548:Sweden; D016896:Treatment Outcome