Clinical Measurement Unit - Cabrini

Vertebroplasty for acute painful osteoporotic spinal compression fractures - a 4 year NHMRC funded randomised double-blind placebo-controlled trial.

A/Prof Rachelle Buchbinder, Dr David Connell, Dr Richard Osborne, Prof John Wark, A/Prof Peter Ebeling, Prof Steven Graves, Dr Peter Mitchell, Prof Ken Thomson, A/Prof Stephen Hall, Mr Anthony Harris, A/Prof Kim Bennell, Prof Ian Wicks, Ms Lainie Wengier. In Australia, 20-25% of women and 15-20% of men over the age of 50 will develop one or more fractures of their spine in their lifetime. Up to a half of these fractures will result in severe pain and disability. While these fractures generally heal within weeks or a few months, some are so painful that they require strong painkillers such as morphine to control the pain, admission to hospital, and/or long-term nursing home care. They may also lead to chronic problems such as persisting back pain, curvature of the spine and loss of height and mobility. Up to now, there are no treatments that have been shown to effectively manage the pain and shorten the recovery time.

Vertebroplasty is a new procedure that involves injection of a type of 'bone cement' directly into the spinal fracture. It is thought that this might result in an immediate and sustained improvement in pain. However so far this is unproven, as proper studies that compare this new treatment to usual medical care have not been performed. In addition, complications such as rib fracture and cement leakage have been reported. One particular concern is that the mechanical changes to the spine caused by the bone cement may increase the risk of future fractures in the spine. Despite these safety concerns and a lack of scientific evidence of its benefit, vertebroplasty is becoming an increasingly accepted treatment.

We have a unique opportunity to evaluate vertebroplasty through a randomised placebo-controlled trial being performed at Cabrini, Alfred and Royal Melbourne Hospitals, together with Monash Medical Centre. The outcome of our proposed research will be to establish whether vertebroplasty is effective and safe for painful osteoporotic spinal fractures. The Australian National Health and Medical Research Council (NHMRC) is funding the 4-year trial, with contributions from the Arthritis Foundation of Australia, the Cabrini Education and Research Institute and Cook Australia.

Patients who fulfil the strict eligibility criteria (including the presence of one or two painful osteoporotic spinal fractures with symptoms for 12 months or less, and evidence of recent fracture on MRI scan) will be randomised to receive either a vertebroplasty or a sham vertebroplasty procedure. Neither the patients nor the people assessing the outcome of the treatment will know which treatment has been given. All treatments will take place in the Radiology Department and patients will be admitted to the day procedure ward for the day. All treatment will be provided free of charge and patients will be followed up for two years.

Further information about the trial can be obtained by calling A/Professor Rachelle Buchbinder or one of the trial coordinators, Lainie Wengier or Melissa Barber at the Monash Department of Clinical Epidemiology at Cabrini Hospital, Tel: 9508 1652.