Fighting spinal pain with a titanium ‘bullet’

Our Review Summary

This story reports on a new implantable device, the X-Stop prosthesis, that was recently FDA approved for people with spinal stenosis. The story does mention surgery and steroid injections as the alternatives, but fails to mention other conservative treatments, including physical therapy, weight loss, or oral anti-inflammatory medication. The representation of the prevalence and seriousness of spinal stenosis is also questionable. Although approximately 500,000 Americans over age 50 may be experiencing symptoms, it is not clear that they have the formal diagnosis of spinal stenosis. Although there is mention of a trial, there is no description of the study design or duration of follow-up, an important consideration in chronic relapsing conditions like back pain. In fact, this was a single study with a relatively small sample size in which one or more authors received sponsorship from the device manufacturer. More importantly, however, was the use of a questionable control group. The control group in this study was comprised of a mixture of non-operative treatments, including bed rest, lumbar supports, and injections (of variable amounts). Also, no direct comparison was made between the device and laminectomy (the appropriate control group). All of these factors limit the reader’s ability to evaluate the evidence behind the device. Furthermore, no quantitative estimates of benefit are provided and the story downplays the harms of the device. The story should have mentioned that in the study, 17% of the patients in the device group experienced some adverse event and 10% required some sort of re-operation. Although the story mentions the cost of the device, we have no other costs to compare it to. Finally, only a single source is quoted and we can’t be sure of his potential conflicts of interest. The reader should expect the journalist to assess the quality and strength of the evidence supporting a new device. Highlighting a single success story and a single surgeon’s enthusiasm may obscure the truth about the nature of the evidence. It may be that this ‘bullet’ is indeed an important innovation, but the reader is not provided with enough balanced information to come to that conclusion.