In the largest multicenter randomised controlled study of surgical intervention versus non-surgical care for acute vertebral compression fractures, patients undergoing balloon kyphoplasty showed superior improvement in quality of life, back function and back pain compared to those who had non-surgical care alone one month after surgery. The benefits of balloon kyphoplasty were sustained on average throughout 12 months.
The study of 300 patients at 21 centres in eight countries was published in the online edition of The Lancet on February 24 and provides clinical evidence of improved outcomes with balloon kyphoplasty when treating patients with acute fractures.
Study results of additional outcome measures show that balloon kyphoplasty patients experienced faster and significantly greater improvements in quality of life, back pain and back function for at least one year when compared to patients receiving non-surgical treatments. Balloon kyphoplasty patients also reported fewer days of limited activity and less use of analgesics or walking aids than those solely receiving non-surgical management. The frequency of adverse events did not differ between the groups. Balloon kyphoplasty did not result in a significant increase in new vertebral fractures as shown on X-rays at one year compared to patients receiving non-surgical care.
“This landmark study shows that balloon kyphoplasty is an effective treatment option for patients with acute, symptomatic vertebral fractures. This minimally invasive procedure, which has been performed on more than 500,000 patients worldwide, has been demonstrated in this study to be superior to non-surgical management in restoring patients’ physical function, reducing their pain and improving their quality of life,” said Professor Douglas Wardlaw, lead author of the study and consultant spine surgeon NHS Grampian, Aberdeen, Scotland.
The study was sponsored by the Spine and Biologics business at Medtronic, Inc. (NYSE: MDT) and supports the benefits of surgical intervention specifically with balloon kyphoplasty compared to non-surgical care. Devices to perform balloon kyphoplasty are sold as KYPHON® products by Medtronic.