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Medtronic releases 2-year study comparing balloon kyphoplasty with nonsurgical spinal fracture care
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Medtronic Inc., announced in a press release that 2-year data from the largest multicenter randomized controlled study of Kyphon Balloon Kyphoplasty for spine fractures indicated that balloon kyphoplasty relieved back pain, increased patient satisfaction and improved mobility and quality of life more than nonsurgical care in the treatment of painful spinal fractures.
The FREE (Fracture Reduction Evaluation) study of 300 patients at 21 centers in eight countries was published online on in The Journal of Bone and Mineral Research. The 2-year data follows the 1-year results published by The Lancet in February 2009, Medtronic noted.
According to the press release, patients in the study were randomized to either the balloon kyphoplasty group (n=149) or a nonsurgical control group (n=151). At 24 months, data were available for 232 patients (120 kyphoplasty and 112 non-surgical patients). The primary endpoint of the study was the change in quality of life at 1 month as measured by improvement in the Physical Component Summary of the SF-36 survey.
The key findings of the study were as follows: that kyphoplasty decreased pain; had a higher patient satisfaction; offered better quality of life; improved mobility; and demonstrated safety.
The study was sponsored by the Kyphon Products Division at Medtronic, Inc. and supports the benefits specifically of Kyphon Balloon Kyphoplasty compared with nonsurgical care. Devices to perform Kyphon Balloon Kyphoplasty are sold by Medtronic.