Alert Indications, Safety, and Warnings

VERTEBROPLASTY PROCEDURE OVERVIEW

Vertebroplasty treats painful pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions. The goal of vertebroplasty is to relieve pain and stabilize vertebral compression fractures (VCFs). The 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.

PREVALANCE OF VERTEBRAL COMPRESSION FRACTURES

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 United States.1

Vertebral fractures are the most common osteoporotic fractures, yet approximately two-thirds are undiagnosed and untreated.2

  • Patients have as much as a 5-fold increased risk of another fracture within 1 year of initial fracture.2
  • Incidence of vertebral compression fracture increases progressively with age throughout later life.2

VERTEBROPLASTY CLINICAL EVIDENCE

For more than 20 years, Medtronic has been committed to gathering clinical data on vertebroplasty and balloon kyphoplasty. Patients are central to our mission, and that’s why we support VCF research through randomized controlled trials and observational studies as well as big-data healthcare claims analysis.

EXPLORE CLINICAL DATA

MORTALITY RISKS OF VERTEBRAL COMPRESSION FRACTURES

The majority of studies1,3-7 have shown that vertebroplasty and kyphoplasty patients have lower mortality risk (up to 43% lower) than patients treated with non-surgical management at up to 5 years follow-up.6

Several large retrospective analyses of medical claims data after vertebral compression fracture (VCF) have concluded that mortality rates following VCFs are significantly higher for patients treated conservatively versus vertebroplasty or balloon kyphoplasty, while other studies have concluded no difference.1,3-7


COMPARING VERTEBROPLASTY AND BALLOON KYPHOPLASTY 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) had:

  • Significantly shorter length of stay5
  • Greater likelihood of routine discharges to home5
  • Significantly lower readmission rate5
Vertebroplasty (VP, n=7,686) was also included in the analysis and showed favorable trends vs. NSM with respect to length of stay, likelihood of routine discharge to home, and readmission rate; however, an assessment of the statistical significance of these trends were not reported.5

Length of Stay Discharges to Home Readmission Rate

Balloon
Kyphoplasty

3.74 days

60% of patients

35% of patients

Vertebroplasty

5.73 days

39% of patients

52% of patients

Non-Surgical
Management

7.38 days

24% of patients

62% of patients

P Value

p<0.001

p<0.001

p<0.001

This retrospective study does not show outcome measures such as pain scores and quality of life assessments; use of diagnosis and procedure codes does not permit characterization of the fractures or procedures; total charges were underestimated since physician payments are not part of the database; selection bias and insufficient data limit ability to present general view of data groups and demographics.

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 balloon kyphoplasty (and vertebroplasty) subjects have better “baseline” health, which may at least partially explain the mortality benefit.

KYPHON™ V PREMIUM VERTEBROPLASTY

Kyphon™ V Premium vertebroplasty is a minimally invasive treatment for vertebral compression factures. Learn more about the system. 

FIND PRODUCT DETAILS

VERTEBROPLASTY REIMBURSEMENT 

Find reimbursement support for Medtronic vertebroplasty. 

FIND RESOURCES 
1

IOF. https://www.osteoporosis.foundation/educational-hub/files/breaking-spine. Accessed May 3, 2021.

2

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.

3

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.

4

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.

5

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.

6

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.

7

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.