Vertebral augmentation
Clinical evidence
For vertebral augmentation procedures
- Vertebral height restoration study
- Mortality risk studies
- BKP data summary
- VCF care pathway study
- FREE study
Vertebral height restoration study
Achieving sustainable height restoration in vertebral compression fracture procedures
A cadaveric study1 evaluated three different bi-lateral procedures with respect to height restoration and sustainability post-operatively:
- Balloon kyphoplasty (BKP)
- BKP using Kyphon Assist™ directional cannula (BKP with KA)
- Titanium implantable vertebral augmentation device (TIVAD)
At least
94%
height restoration attained
with all treatments1
BKP using Kyphon Assist™ directional cannula best sustained vertebral height after highest loading1
Challenging results of the 2019 SAKOS study,2 the height-restoration study found that while all three treatments restored height nearly equally, BKP with the Kyphon Assist™ system best sustained height after highest loading† compared to BKP alone or TIVAD.1
Mortality risk studies
Mortality risk evidence following vertebral compression fractures
Taken together, a collection of six studies4–9 provide evidence that balloon kyphoplasty patients tend to have improved survivorship, i.e., lower mortality risk, than those undergoing other vertebral augmentation or nonoperative treatments.
These large (greater than 1000 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
Balloon kyphoplasty (BKP) clinincal data summary
Treating vertebral compression fractures (VCF) with BKP since 1999
Our priority has always been to raise awareness of available treatments for VCF and to refine our innovative technology in partnership with physicians.
VCFs are associated with a downward spiral of complications, including pain, difficulties with activities of daily living, and higher mortality rates.14–16 Clinical evidence over decades and thousands of patients has shown that balloon kyphoplasty (BKP) offers important clinical benefits, including pain relief, reduced opioid use, and improved quality of life.13,17–21
57%
of patients decreased or discontinued opioid use within seven months after BKP.13
Explore six study summaries‡
Testing the efficacy of the Medtronic Kyphon™ balloon platform
- Trends in opioid use following balloon kyphoplasty or vertebroplasty for the treatment of vertebral compression fractures
- Prospective and multicenter evaluation of outcomes for quality of life and activities of daily living for balloon kyphoplasty in the treatment of vertebral compression fractures: the EVOLVE trial
- A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis
- Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial
- Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial
- A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters
VCF care pathway study
Managing VCFs with an evidence-based approach
Using the RAND™/UCLA Appropriateness Method (RAM), a multispecialty expert panel reviewed 576 clinical scenarios to establish a comprehensive clinical care pathway for VCF management. The resulting pathway may be helpful in reducing undesirable practice variations and improve quality of care.12
The VCF clinical care pathway includes guidance on:
- Key VCF signs and symptoms
- Diagnostic evaluation of VCF patients
- Appropriateness criteria for vertebral augmentation (VA) or nonsurgical management (NSM)
- Contraindications for VA patient follow-up
RAM provides a highly structured approach to produce patient-specific recommendations by combining best available scientific evidence with the collective judgment of a panel of experts.
The final document included results of the 83-study literature review (systematic reviews, randomized controlled trials, and observational studies), each including at least 200 patients.12
Fracture Reduction Evaluation (FREE) study
Comparison of balloon kyphoplasty versus non-surgical management
In the largest randomized controlled trial comparing balloon kyphoplasty (BKP) to non-surgical management (NSM) in patients with osteoporosis, balloon kyphoplasty was shown to be more effective than non-surgical management for the treatment of acute vertebral compression fractures (VCFs) at 12 months (Wardlaw) and 24 months (Boonen).10,11
3 times greater
pain reduction
in BKP patients at one week compared to non-surgical management10
4 times greater
improvement
in quality of life at 1 month compared to NSM patients10
5 fewer
days
of restricted activity at1 month compared to baseline10