Prospective Multicenter Balloon Kyphoplasty Study

Immediate, marked and sustained results were seen in all pain, functional and mental health outcomes. SF-36 scores showed clinically significant and lasting improvement in quality of life for this highly-impaired patient group. Patients were able to quickly resume normal activities such as standing, lifting 10 pounds, and bending after having kyphoplasty and were able to maintain these activities out to two years. Additionally, patients reported immediate and sustained pain relief, along with a statistically significant decrease in number of days in bed due to back pain.

The study also measured restoration of vertebral body height as reported by an independent radiologist. Of the 52 patient radiographs evaluated, 82% showed at least 10% vertebral body height restoration. The average midline vertebral body height restored was 32%.

Cement extravasation rate was low and limited to the immediate area of the vertebra(e) treated; all occurrences of extravasation were asymptomatic. There were no device or procedure-related complications during the 2-year follow-up and patients reported being very satisfied with the procedure.

This powerful study adds to the growing clinical support demonstrating that balloon kyphoplasty provides rapid and long-lasting clinical and functional improvement, including restoration of anatomic alignment.

Source: Garfin SR, Buckley RA, Ledlie JT. Balloon Kyphoplasty for Symptomatic Vertebral Body Compression Fractures Results in Rapid, Significant, and Sustained Improvements in Back Pain, Function, and Quality of Life for Elderly Patients. Spine. 2006 Sept 1;31:2213-2220.

*Dr. Garfin and Dr. Ledlie are paid Kyphon consultants.

Kyphon Inc.'s Fracture:Line, Volume 3, Number 2 - Fall 2006

As with any surgery, there are potential risks. Although balloon kyphoplasty is designed to minimize these risks as much as possible, there is a chance that complications could occur. 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), paralysis or muscle weakness, death. Patients should consult with their doctor for a full discussion of risks.