First-Ever Publication of Two-Year Balloon Kyphoplasty Data

Outcomes data for patients followed for two years post-treatment with balloon kyphoplasty were published for the first time in the January 1, 2006 issue of Spine. The retrospective single-center case series was analyzed by Jon Ledlie, M.D. and Mark Renfro, M.D., neurosurgeons from Tyler Neurosurgical Associates in Tyler, Texas. Based on clinical and radiological outcomes before and after balloon kyphoplasty, the authors concluded that kyphoplasty markedly improved pain and function, and resulted in significant vertebral height restoration and normalization of vertebral body shape indexes that persisted for at least two years following treatment.

"Our study shows that using balloon kyphoplasty to repair spinal fractures provides immediate and sustained improvements in function and mobility, a significant benefit for elderly patients," commented Dr. Ledlie. "Prior to treatment, the vast majority of patients could not walk without assistance and required the strongest prescription medications to control pain. One week after the procedure, more than three quarters of the patients could walk independently and without difficulty, and more than half no longer needed pain medication of any type. Two years after treatment, patients reported continued and, in some cases, improved, pain relief as well as ability to ambulate independently. Though not reported in the study, some patients have reached five years of follow-up, reporting continued pain relief," continued Dr. Ledlie.

Study Details
117 consecutive patients (151 spinal fractures) treated with balloon kyphoplasty were retrospectively assessed for change in spinal deformity, pain scores, analgesic usage and ambulatory status. Data were collected preoperatively, at 1 week and at 1, 3, 6, 12, and 24 months following the procedure, with a subset of 77 patients (97 spinal fractures) completing at least two years of follow- up.

Correction of Vertebral Deformity
Nearly half of all fractures included in the case series had at least a 50% collapse prior to treatment. Vertebral heights significantly increased and were sustained throughout follow-up, with 90% of fractures treated demonstrating at least a 10% height increase compared to adjacent control vertebrae. The rate of new symptomatic fractures per patient was less than 5% per year.

Significant and Maintained Improvement in Pain and Ambulation
Among the 77 patients followed for two years, 2% could walk with no difficulty prior to treatment and 81% required narcotic analgesics for pain. One week after balloon kyphoplasty, 76% of the patients could walk without difficulty, 19% required narcotic analgesics and more than 50% required no type of pain medication. Two years later, 81% of the treated patients could walk with no difficulty, 10% required narcotic pain medications and 80% did not need any pain medications. 68% of patients reported complete pain relief at one week, 86% complete pain relief by six months and 90% of patients reported complete pain relief at two years. There were no balloon kyphoplasty-related complications in the 117 patients treated.

Fracture Line
Volume 2, Number 2, Winter 2005

The Fracture Line is published by Kyphon Inc. to educate and inform our customers about the latest advances in vertebral compression fracture management.

To receive a copy of this study as reported in Spine, please contact your Kyphon Spine Consultant or submit your request to info@kyphon.com.

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.