Vertebral augmentation
Clinical evidence
For vertebral augmentation procedures
A cadaveric study1 evaluated three different bi-lateral procedures with respect to height restoration and sustainability post-operatively:
94%
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
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.§
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
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
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:
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
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
† 5000 cycles at 1250N simulating lifting 5–10kg weight from the ground.
‡ Studies were sponsored by Medtronic.
§ Five studies indicated improved mortality with BKP and 1 study indicated no difference between BKP/VP and NSM.