Balloon Kyphoplasty

For Vertebral Compression Fractures

OVERVIEW

Balloon kyphoplasty is a minimally invasive procedure designed to repair vertebral compression fractures (VCFs) by reducing and stabilizing the fractures. It treats pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions.

How It Works

The goal of balloon kyphoplasty is to relieve pain, restore lost vertebral body height, and stabilize the fracture. The procedure involves the insertion of two inflatable bone tamps (balloons), or IBTs, into the vertebrae. The IBTs are inflated under volumetric control, reducing the fracture and pushing the endplates apart, thereby partially restoring vertebral height and correcting angular deformity.1 The newly formed cavity is filled with bone cement after IBT removal.

Kyphon Balloon Kyphoplasty Procedure Animation

Balloon Kyphoplasty Procedure

Through a pair of small incisions, each approximately 1 cm in length, the specialty physician uses a needle and cannula to create a small pathway into each side of a fractured vertebral body. A small balloon is guided through each cannula into the vertebra. Each balloon is carefully inflated in an attempt to raise the collapsed vertebra and return it to its normal position. Inflation of the balloon creates a void (cavity) in the vertebral body.

Once the vertebra is in the correct position, the balloons are deflated and removed. The resultant cavities are filled with bone cement forming an “internal cast” to support the surrounding bone and prevent further collapse.

The balloon kyphoplasty procedure typically takes about one hour per fracture and may be performed in an outpatient setting. The procedure can be done using either local or general anesthesia; the specialty physician will determine the most appropriate method, based on the patient’s overall condition.

Balloon Kyphoplasty Outcomes

Clinical evidence supports the ability of Kyphon Balloon Kyphoplasty to partially restore normal spine anatomy and improve quality of life in patients with vertebral compression fractures.2-4

Short-Term Benefits (<1 Year) Long-Term Benefits (>1 Year)

Vertebral Height Restoration2-5

Vertebral Height Restoration2-5

Reduction in Back Pain2-7

Sustained Reduction of Back Pain2-5

Quality of Life Improvement2-8

Sustained Quality of Life2-5

Improvement in Mobility2-8

Maintenance of Improvement in Mobility2-5

Low Complication Rate2-7

The complication rate with Kyphon Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and though rare, some of which may be fatal. View indications, safety, and warnings for complete information.

Fracture Reduction Evaluation (FREE) Study

A Medtronic-sponsored, randomized controlled trial comparing Kyphon Balloon Kyphoplasty to non-surgical treatment* found that people with spinal fractures treated with Kyphon Balloon Kyphoplasty:

  • Experienced 3 times greater pain reduction than people treated with non-surgical management one week after the procedure8
  • Experienced 4 times greater quality of life than people treated with non-surgical management8
  • Enjoyed 5 more days of unrestricted activity per month than people treated with non-surgical management8

View 12-month and 24-month outcomes


*Non-surgical management included analgesics, bed rest, bracing, physiotherapy, rehabilitation programs, walking aids, calcium and vitamin D supplements, and antiresorptive or anabolic agents.

Understanding Mortality Risks for Patients with VCF

Majority of studies 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-up12

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.9-13

View evidence

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.14

Vertebral fractures are the most common osteoporotic fractures, yet approximately two-thirds are undiagnosed and untreated.15

  • Patients have as much as a 5-fold increased risk of another fracture within 1 year of initial fracture.15
  • Incidence of vertebral compression fracture increases progressively with age throughout later life.15

Comparison of BKP 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:11

  • Significantly shorter length of stay11
  • Greater likelihood of routine discharges to home11
  • Significantly lower readmission rate11

1

Wardlaw D, Van Meirhaeghe J, Ranstam J, et al. Balloon kyphoplasty in patients with osteoporotic vertebral compression fractures. Expert Rev Med Devices. 2012 Jul;9(4):423-36.

2

Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. 2011;26(7):1627-1637.

3

Van Meirhaeghe J, Bastian L, Boonen S, et al. A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine. 2013;38(12):971-983.

4

Dohm M, Black C, Dacre A, et al. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures (VCFs) due to osteoporosis. AJNR 2014. http://www.ajnr.org/content/35/12/2227.full.pdf+html.

5

Medtronic data on file. Tillman J, Shabe P, Rose M, et al. Fracture reduction evaluation study 24-month final clinical study report, August 27, 2010. Medtronic Spinal and Biologics Europe BVBA.

6

Berenson J, Pflugmacher R, Jarzem P, et al. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol. 2011;12(3):225-235.

7

Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009;373(9668):1016-24.

8

Tillman J, Shabe P, Rose M, Elson P, Wülfert E, Ashraf T. Fracture Reduction Evaluation Study 24-month final clinical study report, August 27, 2010. Medtronic Spinal and Biologics Europe BVBA. fractures (VCFs) due to osteoporosis. Am J Neuroradiol. 2014;35(12):2227-2236.

9

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.

10

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.

11

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.

12

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.

13

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.

15

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.