Will the VAPOUR trial affect the future of bone augmentation techniques?

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Alexis Kelekis

Is it a come-back for vertebroplasty? Two randomised controlled trials published in 2009 suggested that there is no clear benefit for treatment by vertebroplasty in comparison to a sham procedure. During this period, the US Administration praised the research, encouraging further investigation. This view was propelled through the lay media, where outlets such as CBS and the New York Times still question vertebroplasty’s necessity.1,2 This has had a wide effect on the procedure; reimbursement has became limited and new device research has diminished. This is especially the case for Australia, where there was a termination of funding in 2011. Many practitioners of the procedure remain loyal, observing positive effects in their patients. This has kept the technique alive in many regions of the world—especially Europe and East Asia—writes Alexis Kelekis.

In August 2016, the VAPOUR study by Clark et al was published in the Lancet. Changing the scope of things, this paper clearly states that there is a benefit to the procedure in comparison to a placebo technique. The effect remained significant throughout the study’s follow-up period of six months.

It will be interesting to see the reaction of an administration so keen to cut off a procedure; will they be as speedy in restoring it as they were in dismantling it, since it clearly shows benefit for inpatients? It will also be interesting to see if the device market will take this news seriously, and re-invest in percutaneous bone augmentation techniques.

The study had a few key differences from previous randomised studies on vertebroplasty. The VAPOUR trial specifically looked at treatment earlier, rather than later, in the history of a fracture (>6 weeks of back pain). What is extremely interesting about this study is the way that the data were analysed—setting a threshold of 4/10 in a Numeric Visual Score as the cut-off for pain. This is interesting because it states an obvious trait which affects all of us in our daily lives: the experience of pain, which gets worse with ageing. Setting a threshold of 4/10 assumes the obvious; whilst all of us would want a 0/10 pain score in our daily life, this is usually unattainable. Pain is part of the living world. This statement has a bigger connotation; what is the level of “acceptable” pain and “functional” pain?  How much is okay? On this aspect there is surely a need for further research.

The VAPOUR study has tried its best to simulate the actual challenges in the clinical world. It has shown that vertebroplasty patients have a higher response to treatment than placebo, and experience a better function and quality of life, with shorter hospitalisation. The study showed that it is important to measure improvement over disappearance—especially in the case of pain—which persists to different degrees as part of life. The VAPOUR trial also showed that doing nothing can have severe consequences—two patients from the placebo arm had neural impairment. Whether this message will help reinstate a technique brutally criticised over the years, and allow neglected and denied patients the right to a better life with less pain, remains to be seen.

Alexis Kelekis is an interventional radiologist from the University of Athens, Athens, Greece, and an editor-in-chief of Spinal News International.

References

  1. CBS. Is a Common Medical Procedure Unnecessary? http://cbsn.ws/2jZryr6 [Accessed 25 January 2017]
  2. Gina Kolata. New York Times. Why ‘Useless’ Surgery Is Still Popular. http://nyti.ms/2kiNFGz [Accessed 25 January 2017]

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