Balloon Kyphoplasty: Improved ADL's and Low Complication Rate

Ambulatory Status
In a retrospective analysis following 79 patients treated (Ledlie et al., 2002), 80% of all patients were fully ambulatory at one week follow-up. 27 of the patients followed for one year maintained full ambulatory status. 90% of patients (10 out of 12) who were wheelchair-bound pre-operatively were ambulatory at one week follow-up.(14)

Bed Rest and Limited Activity
In the prospective multicenter U.S. study, patients were asked how many days they had spent in bed in the last month due to back pain, as well as how many days their activities had been limited due to back pain. Patients had a 100% reduction in the median number of days spent in bed at the first time point (one month), which was maintained for two years (n=100). Patients also had a 64% reduction in the median number of "days interrupted due to pain" at one month and three months, and a 93% reduction at one year and two years. These differences were statistically significant. (12)

Function
Coumans et al. (2003) reported a statistically significant improvement in function as shown by Oswestry Disability Index (ODI) measurements in the early post-operative period and continuing through long term (12-18 month) follow-up.(2)

The prospective multicenter U.S. study measured back function, including evaluating the ability to bend forward when picking up a light weight object, lift 10 pounds, and stand for one hour. In all three areas, significant improvement was noted at one month follow-up and persisted at two year follow-up.(12)

Low Complication Rate
As with any surgical procedure, there are risks associated with balloon kyphoplasty. In the U.S. study involving 214 fractures with 155 patients enrolled, there were no serious procedure-related adverse events.(12) In the literature review of 1342 vertebrae treated with balloon kyphoplasty, the pooled risk of an adverse event associated with bone cement was 0.2% per fracture (<0 .3% per patient), while the pooled risk of any adverse event was 1% fracture (2% patient). (1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 20, 21, 26, 27, 28, 29) Phillips et al. (2002) demonstrated that ability to compact cancellous bone and create a cavity reduces potential for extravertebral cement leakage during balloon kyphoplasty. (21) The low complication rate is also related way in which viscous delivered into under fine manual control.

Serious adverse events, some with fatal outcome, associated with the use of acrylic bone cements include cardiac arrest, cerebrovascular accident, myocardial infarction, and pulmonary embolism. Other reported adverse events relevant to the anatomy being treated with acrylic bone cements include deep or superficial wound infection, fistula, hematoma, hemorrhage, heterotopic new bone formation, nerve entrapment due to extrusion of bone cement beyond the region of its intended use, pyrexia due to allergy to bone cement, short-term conduction irregularities, thrombophlebitis, and transitory fall in blood pressure.

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.

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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