Giving patients with acute vertebral fractures balloon kyphoplasty treatment* (a mini-invasive spine repair procedure), improves quality of life and reduces disability and back pain compared with conventional non-surgical management, and is a safe and effective technique, finds an Article to be published Online First and in an upcoming edition of The Lancet.
Globally, there are an estimated 1.4 million painful and debilitating vertebral compression fractures treated every year. Although normally treated non-surgically with painkillers, bed rest, physiotherapy, and back bracing, the pain can sometimes persist and may lead to height loss, a stooped posture, and reduced mobility and pulmonary function.
Because of the associated risks, open surgery is usually reserved for fractures that cause neurological impairment. A few previous studies have reported reduced pain and improved spine function after kyphoplasty, but no randomised trials have been done to assess the procedure's efficacy and safety.
Professor Douglas Wardlaw from Woodend Hospital in Aberdeen, Scotland, and international colleagues did a randomised trial (Fracture Reduction Evaluation [FREE]) to compare the efficacy and safety of kyphoplasty with non-surgical management, at 21 sites in eight countries in Europe between 2003 and 2005.
They randomised 300 patients with between one and three vertebral fractures to receive kyphoplasty or non-surgical care, and assessed their physical abilities up to one month after surgery or randomisation using a physical component summary scale (SF-36 PCS). In addition, quality of life, back pain and function and safety were assessed at regular intervals up to 12 months.
Findings at 1 month showed an improvement in mean SF-36 PCS score of 7.2 points for patients in the kyphoplasty group compared to 2.0 points in the non-surgical group. Kyphoplasty treatment improved quality of life, function, mobility, and pain more rapidly than non-surgical management, with significant differences in improvement between the kyphoplasty and the non-surgical group up to 6 months. However, the differences in improvement between the groups diminished at 12 months.
The authors suggest that this is probably a result of fracture healing. All other measures of quality of life, back pain and function showed that a significant improvement was maintained in the Kyphoplasty group at one year.
Importantly, the frequency of adverse events did not differ between the two groups. Two serious adverse events (haematoma and urinary tract infection) related to kyphoplasty treatment were reported, but other serious adverse events were not a result of the procedure.
Vertebral fractures are associated with an increased risk of future fractures. In this study, Kyphoplasty treatment did not reduce rates of these new fractures, but it did not significantly increase them compared to the non-surgical group.
The authors conclude: "These findings will help to inform decisions about the use of balloon kyphoplasty as an early treatment option for this patient population."
In an accompanying Comment, David Kallmes from the Mayo Clinic in Rochester, USA, and Jeffrey Jarvik from the University of Washington Medical Center in Seattle, USA, say the findings of this study show that: "spinal augmentation can be done with low periprocedural morbidity and can result in substantial clinical improvement in most patients." They also discuss what it means for the treatment of patients and the ongoing debate about vertebroplasty and kyphoplasty.
Professor Douglas Wardlaw, Woodene Hospital, Aberdeen, Scotland, UK.
T) +44 (0)122 455 6055 or +44 (0)122 455 6657 E) d.warlaw@nhs.net
Dr David Kallmes, Mayo Clinic, Rochester, USA.
T) +1 507 266 3350 E) kallmes.david@mayo.edu
For full Article and Comment see: http://press.thelancet.com/kyphoplasty.pdf
Notes to Editors: *Kyphoplasty involves inserting an inflatable balloon through two cannulae into a patient's fractured vertebrae. The balloon is then filled with radio-opaque dye to restore the height and create a space inside the collapsed bone. A form of bone cement-like substance is then injected to prevent the fractured bone from moving and to stabilize the fracture, which provides relief from pain.
Journal
The Lancet