Clinical evidence

Mortality risk studies

Mortality risk evidence following vertebral compression fractures

Taken together, a collection of six studies^3–8 provide evidence that balloon kyphoplasty patients tend to have improved survivorship, i.e., lower mortality risk, than those undergoing vertebroplasty or nonoperative treatments.

These large (greater than 1,000 subjects), peer-reviewed clinical studies with follow-up of at least 12 months evaluated mortality rates following vertebral compression fracture (VCF) in patients treated with balloon kyphoplasty, compared with other operative or nonoperative treatments.^§

• Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty “sham“ trials?
• Morbidity and mortality after vertebral fractures: comparison of vertebral augmentation and nonoperative management in the Medicare population
  
• Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data
  
• Mortality following the diagnosis of a vertebral compression fracture in the Medicare population
  
• Major medical outcomes with spinal augmentation versus conservative therapy 
  
• Mortality risk for operated and nonoperated vertebral fracture patients in the Medicare population

Study limitations

All studies presented:

• Used retrospective database analyses and are prone to selection bias
• May have explanatory variables that are not captured in the database, which may explain mortality effects
• Have study designs that cannot demonstrate causality of treatment received with mortality outcomes
• Indicate, to some extent, that BKP (and vertebroplasty) subjects have better “baseline” health, which may at least partially explain the mortality benefit