Balloon Kyphoplasty: Frequently Asked Questions

How common are vertebral compression fractures?

In the United States, approximately 150,000 patients are hospitalized every year with compression fractures (average hospital stay 8 days), resulting in costs in excess of $1.6 billion. According to the National Osteoporosis Foundation, the annual direct expenditure (hospitals and nursing homes) for osteoporotic and related fractures has been estimated at $17 billion (2001). This figure translates to $47 million each day, and the cost is rising.

Vertebral Compression Fracture (VCF)

How long does the procedure take? What kind of anesthesia is used?

Balloon kyphoplasty typically takes one hour per fracture treated and may require an overnight hospital stay. The procedure can be done using either local or general anesthesia; the surgeon will determine the most appropriate method, based on the patient's overall condition.

What are the potential benefits of the procedure?

Balloon kyphoplasty has been shown to restore vertebral body height and correct spinal deformity with a low complication rate. Studies also report:

• Significant reduction in back pain
• Significant improvement in quality of life
• Significant reduction in number of days per month that a patient remains in bed; most patients had a 100% reduction in days in bed, one month post-surgery
• Significant improvement in mobility
• Improved ability to perform activities of daily living, such as walking, hobbies and work
• Significant reduction in number of days where pain interfered with daily activities

Are there risks associated with balloon kyphoplasty?

Any type of surgery involves risk. Although the complication rate for balloon kyphoplasty is low, serious adverse events can occur, including:

• myocardial infarction (heart attack)
• cerebrovascular accident (stroke)
• pulmonary embolism (cement leakage that migrates to the lungs)
• cardiac arrest (heart stops beating)

Other risks (relevant to the anatomy being treated with bone cement) include deep or superficial wound infection, and leakage of cement into the muscle and tissue surrounding the spinal cord. Patients are encouraged to discuss these, and other risks, with their physician.

Is balloon kyphoplasty covered by insurance?

In most cases, Medicare provides coverage for balloon kyphoplasty. Other insurance plans may also cover the procedure.

Does a physician need special training to do the procedure?

Yes. A physician needs advanced training to perform the procedure. Worldwide, over 12,800 orthopaedic surgeons, neurosurgeons and interventional radiologists who specialize in treating the spine have already been trained. Physicians who manage osteoporosis (general practitioners, rheumatologists, internists, etc.) can refer patients to a trained spine specialist for treatment. As of January 31, 2008, over 393,000 patients and 460,000 fractures worldwide were treated with balloon kyphoplasty (since 2000 when the product was commercialized).