Kyphon completes patient enrollment in kyphoplasty study

By Lisa Kerner

Erie, Pa., Jan. 6 - Kyphon Inc. enrolled a total of 300 patients in its FREE (Fracture Reduction Evaluation) Study.

The patients were enrolled in 21 international centers, primarily in the United Kingdom, Belgium, Germany, Sweden and other European locations. Enrollment began in February 2002 and ended in December 2005.

The FREE study is designed to compare balloon kyphoplasty to non-surgical management in the treatment of acute vertebral compression fractures. This is the world's first fully enrolled, randomized, controlled multi-center trial of its type, according to the company.

The study includes evaluations of adverse events, pain, quality of life, physical function, spinal deformity and subsequent fracture at various intervals post-randomization. Two independent radiologists will perform radiographic evaluations.

The clinical measurements will include the Roland-Morris Disability Questionnaire, the Visual Analog Pain Scale (VAS), the EQ-5D, and the SF-36 Quality of Life Questionnaire. The study will also evaluate and compare the cost of back-related care.

Kyphon anticipates publication of the full two-year follow-up results in 2009.

"The FREE Study is a critical step in advancing the clinical evidence supporting the value of balloon kyphoplasty in treating osteoporotic spinal fractures. This study design is the most rigorous and clinically significant in the field of surgical treatment of osteoporotic vertebral compression fractures to date in the U.S," said Richard Mott, president and chief executive officer of Kyphon, in a news release.

The majority of spinal fractures are caused by osteoporosis, a progressive disease that causes bones to become weak and susceptible to fractures. More than 700,000 spinal fractures occur annually in the United States, according to the National Osteoporosis Foundation. It is estimated that one in two women and one in four men over the age of 50 in the U.S. will have a spinal fracture. Up to two-thirds of these fractures could go undiagnosed.

First performed in 1998, balloon kyphoplasty is a minimally invasive procedure. It is designed to treat the fracture, reduce pain, restore quality of life, and repair some or all of the associated spinal deformity. More than 200,000 spinal fractures have been treated using the balloon kyphoplasty procedure worldwide.

Kyphon, headquartered in Sunnyvale, Calif., markets the KyphX line of products is used in balloon kyphoplasty.

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