Balloon Kyphoplasty: Vertebral Body Height Increase and Correction of Angular Deformity

Percent Vertebral Body Height Increased
In Garfin et al. (2001), among fractures with at least 15% height lost, average anterior vertebral body height was 68% of the predicted value before balloon kyphoplasty and 84% of the predicted value after balloon kyphoplasty. In addition, average midline vertebral body height was 64% of the predicted value before balloon kyphoplasty and 90% of the predicted value after balloon kyphoplasty. (603 fractures were treated, but the number measured was not reported, and the average fracture age was also not reported.) (5)

In Ledlie et al. (2003), average anterior vertebral body height was 66% of the predicated value before balloon kyphoplasty and 89% of the predicted value after balloon kyphoplasty. In addition, average midline vertebral body height was 65% of the predicted value before balloon kyphoplasty and 90% of the predicted value after balloon kyphoplasty. These improvements were maintained at one year. (36 fractures were measured before treatment, 30 after treatment and 23 at one year. The average fracture age before treatment was 2.4 months.) (14)

Theodorou et al. (2002) reported that the vertebral bodies were, on average, 79% of the predicted height before treatment and 92% of the predicted height after balloon kyphoplasty, but they did not specify the measurement site. (24 fractures were treated with an average duration of symptoms prior to treatment of 3.2 months.)(26)

* Predicted vertebral body height is based on the mean height measurement of the closest unfractured vertebrae above and below the treated level.

Decrease in Local Angulation
Theodorou et al. (2002) found that the average kyphosis decreased from 26° to 16° after balloon kyphoplasty in 24 fractures treated.(26)

Phillips et al. (2003) reported that the local angulation for 52 fractures prospectively treated with balloon kyphoplasty decreased from 17.5° to 8.7°, resulting in a mean local angular deformity correction of 8.8° (range, 0-29°). Additionally, among the 30 reducible fractures (defined as having achieved at least 5° change in angulation), mean decrease in local angulation was 14.2°. (20)

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.