Study Challenges Value of Popular Cement Repair of
Osteoporotic Vertebrae Fractures
Percutaneous vertebroplasty is regularly recommended
by doctors and specialists around the world
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Aug. 6, 2009 - Injecting bone cement into broken
vertebrae, a popular procedure known as “vertebroplasty,” is not an
effective treatment for patients suffering painful osteoporotic
fractures suggests a new study led by Mayo Clinic researchers. They
report that relief of pain from vertebral compression fractures, as well
as improvement in pain-related dysfunction, were similar in patients
treated with vertebroplasty and those treated with simulated
vertebroplasty, without cement injections.
The article, “A Randomized Controlled Trial of
Vertebroplasty for Osteoporotic Spine Fractures,” was released yesterday
in the New England Journal of Medicine.
Vertebroplasty is a widely applied procedure in
which medical cement is injected into the spine to relieve pain and
improve function in patients who have osteoporotic fractures. This
study, funded by the National Institutes of Health, was the first of its
kind, using a double-blinded research model to examine the impact of
vertebroplasty.
The treatment, percutaneous vertebroplasty, is
regularly recommended by doctors and specialists around the world.
“Though the medical community has been using
vertebroplasty for many years, there were no research results to prove
whether the efficacy of the treatment relates to the cement injections,
patient expectations, or other factors,” says the study’s leader, David
Kallmes, M.D., a Mayo Clinic physician who specializes in radiology and
neurosurgery.
“The cement is a permanent medical implant, and
there is some concern that it places patients at future risk for
additional spinal fractures.”
Researchers from eight medical centers in the
United States, United Kingdom and Australia enrolled a total of 131
patients in the trial. The baseline characteristics of pain and function
were similar in the vertebroplasty group containing 68 patients and the
control group containing 63 patients.
Within
days of treatment, both groups showed similar improvements in function
and pain. Researchers continue to follow study participants, and one
year results will be released at a later date.
American Family Physician
Percutaneous Vertebroplasty:
New Treatment for
Vertebral Compression Fractures
By Thomas A. Predey, M.D., Luke E. Sewall, M.D.,
And Steven J. Smith, M.D.
La Grange Memorial Hospital, La Grange, Illinois
Interventional radiologists have been performing
image-guided spinal procedures for many years. Percutaneous
vertebroplasty is a newer technique in which a medical grade cement is
injected though a needle into a painful fractured vertebral body.
This
stabilizes the fracture, allowing most patients to discontinue or
significantly decrease analgesics and resume normal activity.
The impact
of this procedure on the morbidity and expense associated with
symptomatic osteoporotic vertebral compression fractures in the United
States may be significant.
Patients who are unresponsive to conservative
therapy of bed rest, analgesics, and back bracing should be considered
for vertebroplasty.
This procedure is contraindicated in patients with
active infection, untreated coagulopathy, and certain types of fracture
morphology.
“We aren’t saying the vertebroplasty doesn’t work,
because it somehow does,” says Dr. Kallmes. “But both sets of patients
experienced significant improvements in pain and function a month
following the procedure, whether they received cement injections or not.
Improvements may be the result of local anesthesia, sedation, patient
expectations, or other factors.”
“Patients should seek medical advice from their
care provider before making a decision about treatment options,” Dr.
Kallmes advises.
Dr. Kallmes says that several related research
projects are in progress at Mayo Clinic, including a study of
kyphoplasty, which uses a balloon to make space for cement injections,
as well as an unblinded trial to measure the impact of local anesthesia
on pain.
Other centers involved in the research included the
University of Washington, Seattle; Nuffield Orthopaedic Centre NHS
Trust, Oxford, UK; St. George Hospital, University of New South Wales,
Sydney, Australia; Gartnavel General Hospital, Glasgow, UK; Department
of Social Medicine, Bristol, UK; Nottingham University Hospital NHS
Trust, UK; and Western General Hospital, University of Edinburgh, UK.
University of Washington researcher Jerry Jarvik, M.D., coordinated the
data gathering and analysis for the project.
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Within
days of treatment, both groups showed similar improvements in function
and pain. Researchers continue to follow study participants, and one
year results will be released at a later date.