Impact of negative clinical trial results for vertebroplasty on vertebral augmentation procedure rates

Fabrice Smieliauskas*, Sandi Lam, David H. Howard

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

18 Scopus citations


Background Vertebroplasty and kyphoplasty are procedures for treating vertebral compression fractures (VCFs). In August 2009, 2 randomized trials in the New England Journal of Medicine found that vertebroplasty did not reduce pain or disability relative to a sham procedure among patients with osteoporotic VCFs. Study Design We evaluated quarterly trends in per capita rates of vertebroplasties and kyphoplasties using the Florida hospital inpatient discharge and ambulatory surgery center databases from 2005 to 2012, supplemented with physician specialty and population data. We reported trends by procedure type, patient diagnosis, and physician specialty. We modeled the procedures as interrupted time series with a break when the clinical trials were published, and estimated changes in procedure rates and health expenditures resulting from the trials. Results The trials led to a 51.5% decline in the per capita vertebroplasty rate and a 40.0% decline in the kyphoplasty rate (both results p < 0.010) compared with what procedure rates would have been without the trials. Vertebroplasty rates for interventional radiologists displayed no significant change; rates for surgeons and other specialists declined by 73.1% (p < 0.010). Overall, these changes imply nationwide health expenditure savings of just over $1 billion per year. Conclusions Publication of negative clinical trial results led to moderate reductions in vertebroplasties and kyphoplasties for osteoporotic VCFs. However, vertebroplasty and kyphoplasty continue to be widely used to treat patients with osteoarthritis. Substantial differences in response across physicians suggest an important role for specialty society clinical guidelines in modulating how clinical evidence is incorporated into routine practice.

Original languageEnglish (US)
Pages (from-to)525-533.e1
JournalJournal of the American College of Surgeons
Issue number3
StatePublished - Sep 2014


  • AAOS
  • Abbreviations and Acronyms
  • American Academy of Orthopaedic Surgeons
  • CPT
  • Current Procedural Terminology
  • ICD-9
  • International Classification of Diseases, Ninth Revision
  • VAP
  • VCF
  • vertebral augmentation procedure
  • vertebral compression fracture

ASJC Scopus subject areas

  • Medicine(all)


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