Balloon Kyphoplasty: Correction of Vertebral Body Deformity

Three studies have analyzed how many fractures in the study populations were "reducible" (that is, achieved a measurable correction). In the U.S. study, among measurable fractures where at least 15% of predicted height was lost due to fracture (n=52), 78% were reducible. The mean duration of symptoms prior to treatment was 4.3 months, while the median symptom duration was 1.9 months.(12) Lieberman et al. (2001) reported that, among 70 fractures treated, 70% were reducible.(15) The mean duration of symptoms prior to treatment was 5.9 months. Both studies used the definition of Lieberman et al. 2001, where a fracture was reducible if at least 10% of lost vertebral body height was restored with balloon kyphoplasty.(15) Phillips et al. (2003) measured local angulation and found that 58% of fractures (mean fracture age=3.8 months) were reducible as defined by a decrease in local angulation of at least 5 degrees.(20)

Percent Lost Vertebral Body Height Restored
In the prospective multicenter U.S. study, among measurable fractures (n=65), average midline height restored for all fractures was 30.2%, while among the fractures that were reducible,† average midline height restored was 58%. There was no evidence of loss of improvement at two year follow-up. Mean fracture age before balloon kyphoplasty was 4.3 months.(12)

Lieberman et al. (2001) reported that among 70 fractures prospectively treated, 70% were reducible.† Average lost midline height restoration for all fractures was 35%, while among the group of fractures that were reducible, average lost midline height restoration was 47%. Mean fracture age before balloon kyphoplasty was 5.9 months.(15)

Theodorou et al. (2002) reported that, among 24 fractures treated, average lost anterior height restored was 52%, average lost midline height restored was 66% and average lost posterior height restored was 53%. Mean fracture age before balloon kyphoplasty was 3.2 months.(26)

NR = Not Reported

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.