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National research study to assess new treatment for painful vertebral fractures
Date:10/28/2010

vative care consisting of bed rest, analgesics, and physical therapy. Interventional treatments for VCFs, include balloon kyphoplasty and vertebroplasty. These treatments aim to stabilize the fractures, providing earlier pain relief, and functional improvement.

Dr. Tutton pointed out that recent studies comparing vertebroplasty to sham procedures have resulted in confusion as they, on first glance, failed to demonstrate significant clinical improvement. When the trials are evaluated more critically, it is apparent that difficulties with patient selection and under-enrollment limited these trials' ability to prove their hypotheses. The prospective randomized FREE trial and recently published Vertos II trial (Lancet) both support the efficacy and safety of kyphoplasty and vertebroplasty. From the available data we know that patients who failed conservative care at four to six weeks and then received vertebroplasty or kyphoplasty experienced significant reduction in pain, earlier resumption of normal activities and most importantly preservation of independence.

Individuals eligible for the KAST study must have one or two osteoporotic spine fractures, be over age 50, and have been unsuccessfully treated by conservative care for at least 6 weeks.

The Kiva System, considered the next generation in the treatment for VCFs, is approved in Europe. The results of the current study will be submitted to the FDA for potential clearance in the US.


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Contact: Toranj Marphetia
toranj@mcw.edu
414-955-4700
Medical College of Wisconsin
Source:Eurekalert

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