High quality evidence shows that vertebroplasty does not provide more clinically important benefits than placebo but may cause people harm.
Osteoporosis is characterised by thin, fragile bones and may result in minimal trauma fractures of the spine bones (vertebrae). They can cause severe pain and disability. Vertebroplasty involves injecting medical-grade cement into a fractured vertebra through a needle, under light sedation or general anaesthesia. The cement hardens in the bone space to form an internal cast. This procedure has been widely used to treat osteoporotic vertebral fractures, although two placebo-controlled trials published in the New England Journal of Medicine in 2009 found that the benefits were no greater than placebo. Since then three further placebo-controlled trials have been completed that limited inclusion to people with symptoms up to only 6 or 8 weeks.
A team of Cochrane authors based in Australia, Canada, and the United States worked with Cochrane Musculoskeletal to update the 2015 Cochrane Review on available evidence of the benefits and harms of vertebroplasty for the treatment of osteoporotic vertebral fractures. Studies compared vertebroplasty versus placebo (no cement injected) (five studies, 541 participants); usual care (eight studies, 1136 participants); kyphoplasty (similar but before the cement is injected a balloon is expanded in the fractured vertebra; seven studies, 968 participants); and facet joint steroid injection (one study, 217 participants). 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 trials received at least some funding from medical device manufacturers and only two of these reported that they had no role in the trial.
High quality evidence shows that vertebroplasty does not provide more clinically important benefits than placebo. The results did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks (4 trials, up to 332 participants) and these findings were supported by a 5th placebo-controlled trial (42 participants with pain up to eight weeks), that also showed no clinically important benefits of vertebroplasty compared with placebo.
We are less certain of the risk of new vertebral fractures or other serious effects; quality was moderate due to the small number of events. Serious adverse events that may occur include spinal cord or nerve root compression, rib fractures, infection in the bone, fat leaking into the bloodstream, damage to the covering of the spinal cord that could result in leakage of cerebrospinal fluid, anaesthetic complications, and death.
“In 2015, we published a Cochrane review and concluded that based upon moderate quality evidence, our review did not support a role for vertebroplasty for treating osteoporotic vertebral fractures in routine practice. While the procedure was removed from the Medical Benefits Scheme in Australia following publication of the initial placebo-controlled trials, the procedure continues to be used here and in other countries,” says Professor Rachelle Buchbinder, Director of the Monash Department of Clinical Epidemiology, Cabrini institute and Monash University, Australia and Cochrane Review lead author as well as lead author of one of the first placebo-controlled trials. “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.”
“We hope that this updated Cochrane Review with the best available evidence will help inform policy in Australia and in other countries,” added Buchbinder.
