Trial Finds New Expensive Back Procedure Ineffective

Main Category: Back Pain
Also Included In: Bones / Orthopedics;  Clinical Trials / Drug Trials
Article Date: 08 Aug 2009 - 0:00 PDT

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A world-first study involving Monash University and the Cabrini Research Institute in Melbourne has revealed the injection of bone cement into broken vertebrae is not an effective treatment for patients suffering painful osteoporotic fractures.

The treatment, known as percutaneous vertebroplasty, is regularly recommended by doctors and specialists around the world. About 600 patients across Australia undergo the procedure every year.

The study results were published in the prestigious New England Journal of Medicine (NEJM).

Director of the Monash Department of Clinical Epidemiology at Cabrini Hospital, part of the Monash University School of Public Health and Preventive Medicine, Professor Rachelle Buchbinder said the trial results clearly show that vertebroplasty does not work and therefore potential risks outweigh any potential benefits.

"The technique has no significant benefits at any time during a patient's recovery. We assessed each patient at the one-week, one-month, three-month and six-month stage of their recovery," Professor Buchbinder said.

78 patients with osteoporotic fractures participated in the six-month randomized trial. 38 patients were given vertebroplasty as a treatment and 40 were given a 'sham' treatment. Both sets of patients received the same hospital care, local anaesthetic, were exposed to the smell of the bone cement and received an injection, but only 38 of the 78 patients had the bone cement injected into their vertebrae.

"We found that both patient groups - untreated and treated - improved by the same amount. Those who had undergone the vertebroplasty treatment showed no additional improvement in symptoms such as pain at night or at rest, function, quality of life or perceived improvement over patients in the placebo group," Professor Buchbinder said.

She said previous, scientifically weaker studies had led to vertebroplasty receiving an interim listing on the Medicare Benefits Scheme.

"Our results indicate that there is no benefit of vertebroplasty over six months but some potential risks do exist. These include infection, leakage of the bone cement outside of the broken vertebrae and the procedure might increase the already high risk of having more fractures in the spine," Professor Buchbinder said.

Patients who participated in the study will continue to be followed up for two more years to assess their condition including any increased risk of further spinal fractures in the longer term.

The research is funded by the National Health and Medical Research Council along with contributions from Arthritis Australia, Cabrini Institute and Cook Australia.

Source:
Samantha Blair
Monash University

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