Vertebroplasty

For Vertebral Compression Fractures

Vertebroplasty is a minimally invasive procedure for stabilizing vertebral compression fractures (VCFs). It treats painful pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesion.

How It Works

The goal of vertebroplasty is to relieve pain and stabilize the fracture. A Kyphon V Premium Vertebroplasty procedure uses a small-gauge osteo introducer to percutaneously access the vertebral body and inject highly viscous bone cement into the trabeculae to stabilize the fracture.

Kyphon Kurve Lab Demonstration

View a demonstration of the surgical technique used with the Kyphon Kurve™ bone filler device used to precisely target cement flow. Note: There is no audio.
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Prevalence of VCFs

Osteoporosis, a condition characterized by low bone mass and deterioration in the micro architecture of bone tissue, causes more than 700,000 spinal fractures each year in the U.S.6

Vertebral fractures are the most common osteoporotic fractures, yet approximately two-thirds are undiagnosed and untreated.7

  • Patients have as much as a 5-fold increased risk of another fracture within 1 year of initial fracture.7
  • Incidence of vertebral compression fracture increases progressively with age throughout later life.7

Understanding Mortality Risks for Patients with VCF

Majority of studies1-5 show that kyphoplasty/vertebroplasty patients have lower mortality risk (up to 43% lower) than patients treated with non-surgical management at up to 5 years follow-up4

Several recent large clinical studies followed for at least 12 months after vertebral compression fracture (VCF) have concluded that mortality rates following VCFs are significantly higher for patients treated conservatively versus VP or BKP, while other studies have concluded no difference.1-5

View evidence

Comparison of Vertebroplasty to Non-surgical Management

A recent retrospective analysis of 68,752 hospitalized Medicare patients reported that, compared to non-surgical management (NSM, n= 38,249), balloon kyphoplasty (BKP, n=22,817) and vertebroplasty (VP, n=7,686) had:3

  • Significantly shorter length of stay3
  • Greater likelihood of routine discharges to home3
  • Significantly lower readmission rate3

Based on analysis of 68,752 hospitalized Medicare patients.

For patients treated with VP, length of stay is at 5.73 days, discharges to home is at 39%, and readmission rate is at 52.4% (vs. 7.38 days, 24%, and 62% for NSM respectively).

All studies presented:

  • are retrospective database analyses and are prone to selection bias;
  • have 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 VP) subjects have better “baseline” health, which may at least partially explain the mortality benefit.

Risks of Vertebroplasty

There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and though rare, some of which may be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events and methods of use, please refer to the devices’ Instructions for Use included with the product or view indications, safety, and warnings.

1

Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and mortality after vertebral fractures: comparison of vertebral augmentation and nonoperative management in the Medicare population. Spine. 2015;40(15):1228-1241.

2

Edidin AA, Ong KL, Lau E, Kurtz SM. Mortality risk for operated and nonoperated vertebral fracture patients in the Medicare population.J Bone Miner Res. 2011;26(7):1617-1626.

3

Chen AT, Cohen DB, Skolasky RL. Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity after vertebral compression fracture in the Medicare population. J Bone Joint Surg Am. 2013;95(19):1729-36.

4

Lange A, Kasperk C, Alvares L, Sauermann S, Braun S. Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data. Spine. 2014;39(4):318-26.

5

McCullough BJ, Comstock BA, Deyo RA, Kreuter W, Jarvik JG. Major medical outcomes with spinal augmentation vs conservative therapy. JAMA Intern Med. 2013;173(16):1514-21.

6

IOF. https://www.iofbonehealth.org/breaking-spine-report-2010. Accessed July 25, 2016.

7

Brunton S, Carmichael B, Gold D et al. Vertebral compression fractures in primary care: recommendations from a consensus panel. J Fam Pract. 2005;54(9):781-788.