WEDNESDAY, Feb. 25 (HealthDay News) -- A minimally-invasive procedure called kyphoplasty reduces disability and back pain for people with acute vertebral fractures, according to researchers who studied 300 patients at 21 sites in eight European countries.
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In kyphoplasty, a balloon is inserted to restore the fractured vertebra to its proper shape and height. A form of bone cement is then injected to stabilize the vertebra.
Participants in the study had one to three vertebral fractures. They were randomly assigned to receive either kyphoplasty or non-surgical care, which included painkillers, bed rest, physiotherapy and back bracing.
A month after treatment, people in the kyphoplasty group showed an improvement of 7.2 points on a standardized scale, compared with an improvement of 2.0 points for those in the non-surgical group.
The researchers found that kyphoplasty improved quality of life, function, mobility and pain more rapidly than nonsurgical treatment, with differences in improvement between the kyphoplasty and nonsurgical group for up to six months after treatment.
Those differences in improvement diminished by a year after treatment, which the researchers attributed to healing of the fractures. All other measures of quality of life, back pain and function showed that the kyphoplasty group maintained significant improvement after one year.
People who have a vertebral fracture are at increased risk of future fractures. Kyphoplasty did not reduce the risk of future fractures, nor did it significantly increase the risk, compared with non-surgical treatment, the study found.
There were two serious adverse events (hematoma and urinary tract infection) related to kyphoplasty.
"These findings will help to inform decisions about the use of balloon kyphoplasty as an early treatment option for this patient population," wrote Prof. Douglas Wardlaw, of the Woodend Hospital in Aberdeen, Scotland, and colleagues.
The study was published online and was schedule for publication in an upcoming edition of The Lancet.
-- Robert Preidt
SOURCE: The Lancet, news release, Feb. 25, 2009
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