Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials?

Osteoporos Int. 2018 Feb;29(2):375-383. doi: 10.1007/s00198-017-4281-z. Epub 2017 Oct 24.


The 5-year period following 2009 saw a steep reduction in vertebral augmentation volume and was associated with elevated mortality risk in vertebral compression fracture (VCF) patients. The risk of mortality following a VCF diagnosis was 85.1% at 10 years and was found to be lower for balloon kyphoplasty (BKP) and vertebroplasty (VP) patients.

Introduction: BKP and VP are associated with lower mortality risks than non-surgical management (NSM) of VCF. VP versus sham trials published in 2009 sparked controversy over its effectiveness, leading to diminished referral volumes. We hypothesized that lower BKP/VP utilization would lead to a greater mortality risk for VCF patients.

Methods: BKP/VP utilization was evaluated for VCF patients in the 100% US Medicare data set (2005-2014). Survival and morbidity were analyzed by the Kaplan-Meier method and compared between NSM, BKP, and VP using Cox regression with adjustment by propensity score and various factors.

Results: The cohort included 261,756 BKP (12.6%) and 117,232 VP (5.6%) patients, comprising 20% of the VCF patient population in 2005, peaking at 24% in 2007-2008, and declining to 14% in 2014. The propensity-adjusted mortality risk for VCF patients was 4% (95% CI, 3-4%; p < 0.001) greater in 2010-2014 versus 2005-2009. The 10-year risk of mortality for the overall cohort was 85.1%. BKP and VP cohorts had a 19% (95% CI, 19-19%; p < 0.001) and 7% (95% CI, 7-8%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the NSM cohort, respectively. The BKP cohort had a 13% (95% CI, 12-13%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the VP cohort.

Conclusions: Changes in treatment patterns following the 2009 VP publications led to fewer augmentation procedures. In turn, the 5-year period following 2009 was associated with elevated mortality risk in VCF patients. This provides insight into the implications of treatment pattern changes and associated mortality risks.

Keywords: Balloon kyphoplasty; Mortality; Vertebral augmentation; Vertebral compression fracture; Vertebroplasty.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Attitude of Health Personnel
  • Comorbidity
  • Female
  • Fractures, Compression / mortality*
  • Fractures, Compression / surgery
  • Humans
  • Kaplan-Meier Estimate
  • Kyphoplasty / statistics & numerical data
  • Length of Stay / statistics & numerical data
  • Male
  • Medicare / statistics & numerical data
  • Mortality / trends
  • Osteoporotic Fractures / mortality*
  • Osteoporotic Fractures / surgery
  • Randomized Controlled Trials as Topic / standards
  • Research Design / standards
  • Risk Assessment / methods
  • Spinal Fractures / mortality*
  • Spinal Fractures / surgery
  • United States / epidemiology
  • Vertebroplasty / statistics & numerical data*