A new frontier for vertebroplasty?

Bone health

By Amanda Sheppeard

26 Oct 2016

Vertebroplasty has been a topic of strong debate between rheumatologists, interventional radiologists and other health professionals for more than half a decade. But new research has thrust it back into the spotlight again. And while it seems the tide could be turning in favour of the controversial treatment, specialists are cautious. Amanda Sheppeard reports.

 Elizabeth* was 87 when Sydney interventional radiologist Dr William Clark first met her.

She had been sleeping in a chair for the past 10 days, and a few days prior to that she had sustained an osteoporotic vertebral fracture in the thoracolumbar region.

Lying down gave her some relief but getting up or moving caused such relentless pain that she had opted to sit in a chair, too afraid to lay down.

This gave little respite from the pain and after 10 nights trying to sleep in her chair, she was also suffering terribly from severe lymphedema in both legs.

“She was in excruciating pain and her legs were big and swollen,” Dr Clark recalls.

In a bid to relieve the pain from her vertebral fracture, Dr Clark carried out a textbook vertebroplasty, filling the fractured bone up with a specially designed surgical cement. Other specialists were called in to treat the lymphedema.

Two days later he called in to her hospital room to check on her progress.

“She was sitting up and she said, ‘the back’s fine, it’s just the legs that need fixing’,” he remembers. “That to her was a game changer.”

Dr Clark said cases like these were not uncommon.

“Some patients respond so dramatically it is amazing,” he said. “We all know back pain is an area of witchcraft of sorts, but we have the evidence to show its benefits.”

Say the word vertebroplasty at a dinner party filled with rheumatologists, endocrinologists and interventional radiologists and you will have an instant – and probably fiery – debate.

The procedure has been used for many years to treat difficult osteoporotic vertebral fractures, and was first listed on the MBS in 2005.

However in 2009, two papers were published in the New England Journal of Medicine (see here and here) that raised questions about the efficacy of the procedure.

The papers reported on two masked trials that enrolled patients with fractures up to 12 months’ duration and found vertebroplasty no more effective than placebo in pain reduction.

Individual patient meta-analysis combining these masked trials (see here) identified patients with fractures of less than 6 weeks’ duration, and found vertebroplasty no more effective than placebo in this acute fracture subgroup.

In 2011, after a systematic literature review, the Australian Medicare Services Advisory Committee (MSAC) decided to remove vertebroplasty due to its finding there was substantial evidence of lack of efficacy.

In 2015 it was again in the spotlight when it was listed as a ‘do-not-do’ treatment in the Grattan Report.

In the face of what appeared to be overwhelming evidence, Dr Clark and a handful of Australian interventional radiologists have continued to provide the procedures. Dr Clark estimates the procedure costs patients about $2000, and none of this is reimbursed through Medicare or private health insurers.

“If it offers hope of relief from the pain, many patients will say, just do it doctor,” Dr Clark said.

But he concedes the lack of MBS rebate has seen numbers drop in recent years.

“There’s no doubt the number of referrals for the procedure have dropped around the country,” he said. “Part of that is financial.”

Dr Clark is an unashamed proponent of the procedure, so much so that he embarked on his first – and probably only – trial that looked only at the use of vertebroplasty in osteoporotic spinal fractures that were less than 6 weeks old.

The findings of the multicentre, randomised, double-blind, placebo-controlled trial known as the VAPOUR trial were reported in The Lancet in August.

“Our trial demonstrates clinical efficacy for vertebroplasty in reducing pain from osteoporotic spinal fractures of less than 6 weeks when compared with a true placebo control,” the researchers concluded.

Dr Clark and other vertebroplasty supporters now believe there is a good case for having the procedure relisted on the MBS, with an application expected as early as this month.

The researchers concluded that the procedure was ideally suited to patients over the age of 60 who are in severe pain with osteoporotic spinal fractures that are less than six weeks old.

“No masked studies have exclusively examined acute fractures of less than 6 weeks’ duration but only in a subgroup analysis with small patient numbers,” the authors wrote.

“Our study will allow those people with acute painful fractures to have an additional modality of pain management that is known to be effective.”

Whether MSAC agrees remains to be seen, but some health professionals believe there could be a case for using it in a select group of patients.

Leading Melbourne researcher and endocrinologist, Professor Peter Ebeling, was one of the authors of the original 2009 NEJM papers.

Preventing vertebral fractures the priority

As Professor of Medicine at the Department of Medicine/ School of Clinical Sciences at Monash Health, Monash University and International Osteoporosis Foundation Board Member since 2012, he has watched the debate with interest.

He told the limbic that while it was clear the procedure was not for everybody with an osteoporotic spinal fracture, the latest research was compelling.

“I think vertebroplasty should not be used too early (e.g in the first ten days) following a vertebral fracture as the pain will often remit by then in most patients,” he said.

“The recent study showed vertebroplasty was superior to placebo when performed a few weeks after pain onset, but only for low thoracic or high lumbar fractures with relatively severe pain.”

He said he had used the procedure in ‘a couple of patients and it’s worked very well’.

“I think this procedure works very well in carefully selected patients, particularly with low thoracic and upper lumbar fractures with moderately severe pain not helped by other measures after 2 weeks,” he said.

And while it may have a place in osteoporosis treatment Professor Ebeling believes the priority should be treating more patients with osteoporosis to prevent vertebral fractures in the first place.

“The drugs we have available now reduce vertebral fractures by 40-70%,” he said.

“Importantly, patients having vertebroplasty for pain relief also need to continue anti-osteoporotic drugs to reduce their risk for subsequent fractures.”

Time for a rethink?

Professor Mark Cooper, Head of the Discipline of Medicine at Concord Hospital, Head of the Adrenal Steroid Lab at the ANZAC Research Institute and a member of Osteoporosis Australia’s Medical and Scientific Committee, agrees it could be time for a rethink, describing the Lancet paper as “exciting”.

He said part of the problem with the procedure seemed to have stemmed from the fact it was largely used later in patients whose fractures weren’t healing as well as expected.

While the research had clearly showed this didn’t work, the new research showed it did have a place in early fractures.

He said he expected many specialists would not wait for it to be relisted on the MBS to reintroduce it as a treatment option, and would likely start to retrain in preparation.

“Many people who were doing it stopped doing it because of lack of funding and as a result they have become deskilled,” he said.

“Even before this gets approval, I think people will start to retrain in the procedure.”

Related story: Moves to re-list vertebroplasty on the MBS

Professor Cooper said he had seen the procedure work effectively prior to its removal from the MBS.

“It really did have some spectacular results,” he said.

He said it would be important to clearly define the patient population best suited for the procedure, and he hoped there would be more research.

“It’s a new frontier for vertebroplasty,” he said.

Professor Ebeling also wants to see more studies to ensure the risk for subsequent vertebral fractures is not increased by vertebroplasty and to determine whether a pedicular injection of local anaesthetic may have a similar benefit to the vertebroplasty itself.

This was the sham procedure in the two NEJM papers that showed negative results. The same sham procedure was not used in the VAPOUR trial, however, local anaesthetic was used.

Professor Ebeling said he and a number of other researchers were currently preparing a new task force report on the issue, taking into account previous data and the findings of the VAPOUR trial.

This will also look at kyphoplasty and other non-surgical interventions and it is hoped it will be published in a major journal in the coming months.

Small benefits unlikely to outweigh potential harms

Rheumatologist and clinical epidemiologist Professor Rachelle Buchbinder has been a vocal proponent for establishing whether or not vertebroplasty works in high quality trials. Like Professor Ebeling, she was a co-author on the previous NEJM article. She is also working on the new task force report with Professor Ebeling and colleagues.

She is not sold on the idea that the procedure has a place in the treatment of osteoporotic spinal fracture.

Professor Buchbinder is the current president of the Australian Rheumatology Association, NHMRC Senior Principal Research Fellow and Director of the Monash Department of Clinical Epidemiology in Melbourne, and has followed the issue closely. She is also a member of the Medical Services Advisory Committee (MSAC), which will be called on to consider any application to relist vertebroplasty in the MBS.

Professor Buchbinder told the limbic she could not comment on anything relating to the MSAC process.

However she did say she had a “number of concerns with the conduct of the [VAPOUR] trial suggesting that the trial results may have overestimated the effects of this treatment.”

These mainly related to concerns about the credibility of the placebo, success of blinding of participants, lack of benefit in important secondary outcomes and selective reporting.

“The placebo differed significantly from the placebo treatment in the previous trials – neither of the components of the procedure that patients remember – the pungent odour of the cement or the tapping against the vertebra – were incorporated in the VAPOUR trial. There was a large difference in the proportion of people who correctly guessed their treatment at 14 days, while a self-confessed strong proponent of the treatment performed most procedures.

Taking the results on their merit the trial suggests that there might be a small benefit in terms of the proportion of elderly people who have an improvement in pain of 3 or below for the subset of people who had the procedure within 3 weeks of symptom onset and have a fracture in the thoracolumbar area” she said.

“People who had symptoms for more than 3 weeks didn’t seem to benefit and people who had fractures other than the thoracolumbar junction appeared to do worse.

Overall, the effects on mean pain do not seem to be clinically importantly different from the control group at any time point except possibly 3 days.”

She said this suggested that very small benefits for a very small subset of people were unlikely to outweigh the potential harms.

“Furthermore our two year radiologic outcomes (not discussed in the VAPOUR trial) and other observational data suggest that there might be an increased risk of further vertebral fractures, something that this short term trial was unable to address,” she said.

“Injecting cement into broken bones might seem like an appealing idea; but it clearly does not fix the problem. One month after the vertebroplasty, three quarters of the patients still needed to take painkillers and even by six months over half still required painkillers.

“That does not seem like a successful treatment to me. Importantly the results of the VAPOUR trial for people with symptoms for more than 3 weeks appear to be entirely consistent with the negative results of both previous placebo-controlled trials.”

Professor Buchbinder said she did not believe the VAPOUR trial provided the final word on the controversial issue.

“There are a number of other trials that have still not published their results,” she said.

“It is very important to look at the whole body of research, not one isolated study.”

*Not patient’s real name

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