Spinal-fracture patients receiving Kyphon's kyphoplasty show long-term pain relief

By E. Janene Geiss

Philadelphia, Jan. 11 - Kyphon Inc. said that outcomes data for patients followed for two years post-treatment with balloon kyphoplasty showed the procedure markedly improved pain and function and restored vertebral height and normal vertebral body shape indexes.

The retrospective single-center case series was analyzed by Jon Ledlie and Mark Renfro, neurosurgeons from the Tyler Neurosurgical Associates in Tyler, Texas, according to a company news release.

The case series studied clinical and radiological outcomes in consecutive patients before and after balloon kyphoplasty, a minimally invasive procedure for the treatment of spinal fractures caused by osteoporosis or cancer.

"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," Ledlie said in the release.

"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," Ledlie continued.

This study contributes to the growing body of evidence published in the peer-reviewed clinical literature that consistently shows balloon kyphoplasty to be effective for treating spinal fractures caused by osteoporosis or cancer, said the company.

"While earlier reports included short- and mid-term follow-up, the study published by Drs. Ledlie and Renfro is the first publication of two-year maintenance of balloon kyphoplasty benefits, further establishing the durable effects of the procedure," Richard Mott, president and chief executive officer of Kyphon, said in the release.

In the study, 117 consecutive patients (151 spinal fractures) treated with balloon kyphoplasty were assessed for change in spinal deformity, pain scores, analgesic usage and ambulatory status.

Data were collected preoperatively, at 1 week and 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, officials said.

Forty patients were lost to follow-up, either due to inability to contact or to death for reasons unrelated to the study. The average patient age was 77 years.

Analysis of demographic and clinical parameters showed no differences between subjects who completed two years of follow-up versus those who did not; therefore, the authors said they believe that the two-year results are valid and can be extended to the entire study population.

The majority of patients suffered spinal fractures due to osteoporosis and did not respond to conventional therapy, comprising one or more of pain therapy, bed rest and bracing, prior to undergoing balloon kyphoplasty, officials said.

The retrospective analysis results were published in the Jan. 1 issue of Spine, a leading subspecialty, peer- reviewed journal reporting on spinal disorders.

Sunnyvale, Calif.-based Kyphon develops and markets medical devices designed to restore spinal function using minimally invasive technologies.

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