Balloon Kyphoplasty: Significant Pain Reduction and Improved Quality of Life

Coumans et al. (2003) prospectively followed 78 consecutive patients for 12 to 18 months and reported substantial improvement (p<0 .001) in bodily pain as measured by SF-36.(2) These results were not different at three month follow-up.

In the prospective multicenter U.S. study, there was an average of 60% reduction in pain (pre-op VAS = 7.5, 7 days post-op VAS = 3, p<0 .01) at one week follow-up. Results persisted for two years (n="100).(12)" Ledlie et al. (2002) reported similar results, with a continuation in improvement year.(14)

Improvement in Quality of Life
VCFs have demonstrated physical, functional and psychological consequences that can dramatically impact quality of life. (6) Studies show that geriatric patients quickly return to a higher activity level after balloon kyphoplasty, gaining more independence at both short and long-term follow-up.

Coumans et al. (2003) reported that, in 78 patients with 188 fractures, patient quality of life significantly improved following balloon kyphoplasty, as reflected by marked increases in seven of eight sub-scales in SF-36, including Physical Function, Role Function, Social Function, Role Emotional, Vitality, and Mental Health.(2) Only General Health did not improve. These results are consistent with the U.S. study where significant improvements in the same seven out of eight domains were seen at one month follow-up, as well as significant improvements in the Physical Component Score and the Mental Component Score. These benefits persisted or continued to improve during the two year follow-up (n=100).(12)

KyphX® Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus. KyphX® HV-R™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Kyphon is a registered trademark and HV-R and Ahead of the Curve are trademarks of Kyphon Inc. © 2004 Kyphon Inc. All rights reserved. 16000320-03

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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.