Treating acute or subacute osteoporotic vertebral fractures with medical-grade cement does not provide more clinically important benefits than placebo and may even cause harm, an updated Cochrane review concludes.
The review, which updates evidence published since 2015, included five studies comparing vertebroplasty versus placebo, eight studies on the procedure compared to usual care, seven studies on kyphoplasty and one study on facet joint steroid injection.
The trials were performed in hospitals in 15 countries, the majority of participants were female, aged between 62.6 and 81 years, and symptom duration ranged from a week to six months or more.
Eight of the trials received at least some funding from medical device manufacturers and only two of these reported that they had no role in the trial.
“Based upon high- to moderate-quality evidence, our updated review does not support a role for vertebroplasty for treating acute or subacute osteoporotic vertebral fractures in routine practice,” concluded the review authors from Australia, Canada and the United States.
“We found no demonstrable clinically important benefits compared with placebo (sham procedure) and subgroup analyses indicated that the results did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks,” they said.
Lead author of the review Professor Rachelle Buchbinder, Director of the Monash Department of Clinical Epidemiology, Cabrini Institute said that despite the 2015 Cochrane review finding no evidence to support the use of the procedure in routine practice it was still used in Australia and other countries.
“This updated Cochrane Review includes the results of further trials and strengthens our previous conclusions – there is now high quality evidence that there are no clinically important benefits over placebo although there is potential to cause harm,” she said.
“We hope that this updated Cochrane Review with the best available evidence will help inform policy in Australia and in other countries,” she added.
The controversial procedure was once listed on the Medical Benefits Scheme in Australia but was removed after studies found no evidence of benefit.
However, last year the Interventional Radiology Society of Australasia made an application to the Medicare Services Advisory Committee to secure MBS funding for “vertebroplasty for severely painful osteoporotic vertebral fractures of less than 6 weeks duration”.
At the time a spokesperson for the department of health told the limbic that “based on current timing and straightforward progression through each step of the process, MSAC should consider the application in 2018.”