A recent taskforce report charged by the American Society for Bone and Mineral Research (ASBMR) concluded that current evidence does not support the routine use of vertebroplasty for the treatment of pain from vertebral fractures. However, as someone who strongly believes the evidence supports the use of this procedure to alleviate pain, Douglas Beall has significant concerns about the impact this report will have on patient numbers.
This article published in the Journal of Bone and Mineral Research (JBMR) is dangerous and puts patients at an increased risk of morbid injury and death. The manuscript focuses on recommendations by a task force from the American Society for Bone and Mineral Research (ASBMR). Most of the taskforce do not even perform the procedure they are writing about (vertebral augmentation) and the ones that do it still do it after writing negative articles about it. I would never continue to do a surgery or procedure that I found to be ineffective, but it is well documented that authors of this trial do. One can only conclude that either they do not believe their own recommendations, or that they perform the procedure for reasons other than clinical effectiveness. I would also never write any article, especially a highly critical one about a technique that I did not personally do, but the taskforce is filled with authors from the departments of Internal Medicine, Clinical Sciences, Epidemiology and Human Metabolism that have never seen the inside of an operating room in their current professional positions.
So what is dangerous about these recommendations? The task force says there is insufficient evidence to recommend vertebral augmentation. This will assuredly decrease the number of patients treated. This situation has been seen previously after two vertebroplasty versus sham trials were published in the New England Journal of Medicine (NEJM) in 2009. What happened afterwards was recently described by Kevin Ong (Philadelphia, USA) et al who documented the decreasing number of patients treated and estimated that 75,452 patients were at higher mortality risk and that 6,814 lives were lost due to the downward trend in treatment. The inevitable increase in patient morbidity and mortality is not even been addressed by the task force despite the fact that this has been studied by many authors from many countries in the USA, Europe and Asia. If the ASMBR taskforce has their way, they would like to ban a procedure that is demonstrably life-saving and life prolonging.
The taskforce states that there is “insufficient evidence to support kyphoplasty over non-surgical management, percutaneous vertebroplasty, vertebral body stenting or Kiva” but is apparently unaware of a large kyphoplasty randomised control trial (RCT), the FREE [Fracture Reduction Evaluation] trial published in 2009 provided Level 1 evidence supporting kyphoplasty over non-surgical management and a recent meta-analysis by Ioannis Papanastassiou (Rimini, Greece) that showed prominent pain, function and quality of life improvements with vertebral augmentation. The meta-analysis examined 1,587 articles in the English language including 27 Level I or II articles compared to the task force’s five articles.
Why only five articles? They only examined the vertebroplasty versus sham trials. Despite this severely limited dataset this didn’t stop the taskforce from making recommendations about implant augmentation and kyphoplasty which has been shown to be highly effective. The taskforce incorrectly stated that “a sham procedure means that local anaesthetic was administered to the skin and the procedure was simulated”, which is only true for one of the positive trials, not the three negative ones. The negative studies use a sham that involved injecting anaesthetic onto the bone in the location of the medial branch of the dorsal ramus, a technique that has Level I evidence supporting its efficacy in significantly decreasing back pain. Not only is this not a sham, it is an active treatment that significantly decreases back pain. This active treatment called a sham by the authors of VERTOS IV decreased the pain by a massive 4.75 points on the numerical rating scale. So how does this rate? If you accout for their calculations for significance, this is better than spine injections, radiofrequency ablations, cervical discectomy, total hip arthroplasty and virtually everything we do in medicine. Yes, even the gold standards in spine and orthopedic surgery—the cervical discectomy and fusion and the hip arthroplasty—are nowhere close to as good as the fake surgery for the authors of VERTOS IV.
The fundamental problem is that by comparing mean pain scores, as was inadvisably done in VERTOS IV, the authors created an impossibly high benchmark for comparison that almost nothing significantly outperforms, except for, ironically, kyphoplasty. In the largest clinical trial ever done on kyphoplasty with 354 patients, the pain decreased by an average of 6.3. The world’s largest registry recently completed in the USA showed real world results on data collected from sites around the country and featured a mean pain score reduction of 6.7 points and a median pain reduction of 9 points. These two data sources are the largest real world post-market data sources in the world for vertebral augmentation but were not even mentioned by the ASBMR task force.
The bottom line is that we know better than to produce recommendations like this that are completely divorced from the reality of today’s treatment of vertebral compression fractures and we know better to recommend something that has been shown to result in increased morbid suffering and death. The best way I can describe these recommendations is that they are shameful.
Douglas Beall is the chief of Radiology Services at the Clinical Radiology of Oklahoma in Oklahoma City, USA.
- Consulting: Medtronic, Spineology, Merit Medical, Lilly, Johnson & Johnson, SpinTech, Imaging3, IZI, Medlantis, Techlamed, Consultant, Peterson Enterprises, Medical Metrics, Radius Pharmaceuticals, Halyard, Vertiflex, Sollis Pharmaceuticals, Simplify Medical, Stryker
- Research Funding: Medtronic, SpinTech, Medical Metrics, Avanos, Relievant, Vertiflex, Stryker, Sollis Pharmaceuticals, Simplify Medical
- Advisory Board: Medtronic, Imaging3
- Board Member: SpinTech, Nocimed
- Stock Holder: Metactive, Sophiris, Eleven Biotherapeutics, Radius Pharmaceuticals, Flow Forward
- Editorial Support: Thieme, Springer, Humana
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Like Dr. Beall, I’m a spine specialist physician, however I tend to collect patients who need more conservative treatment. Nonetheless, I am 100% in agreement with Dr. Beall’s stance on this issue. A good number of my patients have required kyphoplasty, and they have all done well. Let me repeat: every single patient of mine who has had kyphoplasty had a great outcome and would likely say they would do it again in a heartbeat. I have no idea where this taskforce report came from, but I suspect that insurance companies had something to do with it. Insurance companies are refusing to pay for nearly everything nowadays, and they would love nothing more than bogus taskforce reports like this to have an excuse to deny payment for yet another procedure.
It was very successfully used with my wife. It eliminated her pain immediately.
OK, a counter view. I have seen dozens of kyphoplasties and vertebroplasties in patients with edema on their fractures on MRI and less than 4 months old. One stands out as successful, the rest were dismal failures. No change in pain, and waste of everyone’s time and effort, and of cour$e, money. As one who referred these patients out for kypho’s and vertebro’s and saw the end results months after the procedures, I can’t share the same enthusiasm of others on this page. Sure, I’m speaking as someone who doesn’t do the procedures. I’m just the doc who lives with the failures long after the interventionalist has collected his billables.