National research study to assess new treatment for painful vertebral fractures

October 28, 2010

Physicians at The Medical College of Wisconsin are conducting the KAST clinical trial at Froedtert Hospital to assess the safety and effectiveness of a new vertebral augmentation treatment (Kiva) for painful vertebral compression fractures (VCFs) due to osteoporosis.

Sean Tutton, M.D, associate professor of radiology and surgery at the Medical College, is principal interventional radiology investigator for this multi-institutional, national trial. This prospective, randomized, controlled trial will compare outcomes of the investigational Kiva device using a coil implant with cement, to the current treatment, kyphoplasty using small orthopedic balloons and cement to repair painful of the spine.

"The study will evaluate whether the Kiva procedure, using a more elastic implant and less cement placed strategically, will be equally safe and effective to kyphoplasty" says Dr. Tutton. It may also demonstrate that the more elastic implant and use of less will prove superior to kyphoplasty.

VCFs occur when a vertebra cracks, fractures, or collapses. These fractures are extremely painful and often debilitating. Over 700,000 osteoporosis-related vertebral compression fractures occur each year in the US alone. It is estimated that two-thirds of vertebral compression fractures are never diagnosed because many patients dismiss their back pain as a sign of aging and/or arthritis.

When bones become fragile and brittle from , everyday activities can trigger vertebral compression fractures. Bending to lift an object, missing a curb, or slipping on a wet surface can put the spine at risk of fracture. Multiple vertebral compression fractures significantly changes the structure and shape of the spine and can affect the internal organs and body functions, negatively impacting the overall health of the individual, daily activities, and quality of life.

The primary treatment for VCFs is typically conservative care consisting of bed rest, analgesics, and . 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.

Related Stories

Recommended for you

Testing shows differences in efficacy of Zika vaccines after one year

December 15, 2017
(Medical Xpress)—A large team of researchers with members from Harvard Medical School, Walter Reed Army Institute of Research, Bioqual Inc. and MIT has found that the efficacy of the three types of Zika vaccines currently ...

How to regulate fecal microbiota transplants

December 15, 2017
(Medical Xpress)—A small team of researchers at the University of Maryland, some with affiliations to the Veterans Affairs Maryland Health Care System, has written and published a Policy Forum piece in the journal Science ...

New cellular approach found to control progression of chronic kidney disease

December 15, 2017
Researchers have demonstrated for the first time that extracellular vesicles - tiny protein-filled structures - isolated from amniotic fluid stem cells (AFSCs) can be used to effectively slow the progression of kidney damage ...

Urine test developed to test for tuberculosis

December 14, 2017
(Medical Xpress)—An international team of researchers has developed a urine test that can be used to detect tuberculosis (TB) in human patients. In their paper published in Science Translational Medicine, the group describes ...

40 years after first Ebola outbreak, survivors show signs they can stave off new infection

December 14, 2017
Survivors of the first known Ebola outbreak, which occurred in the Democratic Republic of the Congo in 1976, may be key to development of vaccines and therapeutic drugs to treat future outbreaks, according to a new study ...

Lactic acid bacteria can protect against Influenza A virus, study finds

December 13, 2017
Lactic acid bacteria, commonly used as probiotics to improve digestive health, can offer protection against different subtypes of influenza A virus, resulting in reduced weight loss after virus infection and lower amounts ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.