Vertebroplasty Cement Procedure Provides No Benefits: Study
New research has found that a popular spine surgery involving the use of bone cement for painful spinal fractures may actually provide no benefits when compared to patients who underwent a fake surgery.
The procedure, known as vertebroplasty, was performed about 100,000 times in the U.S. last year. It involves injecting a substance known as bone cement into spinal fractures usually caused by osteoporosis.
Two studies published in this week’s edition of the New England Journal of Medicine suggest that the procedure has no greater actual effect than fake treatments where patients were only told they had received the bone cement.
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Learn MoreVertebroplasty procedures are out-patient treatments that are usually performed by a radiologist and cost between $2,000 and $5,000. Considered low-risk, the spine surgery became popular in the 1990s and involves the use of acrylic cement injected into the spinal column meant to act as additional support.
In the New England Journal of Medicine, one study in the United States looked at 131 patients and a second study in Australia examined included 78. Both studies gave some patients the actual vertebroplasty treatments and performed fake treatments on others, even going as far as preparing the vertebroplasty cement so patients could smell it and believe they were getting the treatment.
Researchers from both studies reported that actually receiving the treatment made no difference in whether patients’ felt that their conditions had improved. Researchers say that the evidence indicates that the vertebroplasty procedure is no more effective than the “placebo effect,” a phenomenon where patients report feeling better because they believe they should feel better after having a medical procedure known to be effective.
Researchers from the Australian study said health care professionals should stop performing the procedure. Co-author of the U.S. study, Dr. David F. Kallmes, has said there need to be more studies to determine if the procedure helps a specific subgroup of patients.
Kallmes, a professor of radiology at the Mayo Clinic, suggested that doctors only give the treatment to patients willing to be part of a clinical study so that more data could lead to a better understanding of the effectiveness of the procedure.
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4 Comments
BarbaraJuly 13, 2017 at 3:57 pm
In 2009 I had surgery faulty vertebron hardware was placed in my back is had to have more surgery
ANNSeptember 9, 2011 at 5:28 pm
WOULD LIKE TO KNOW IF KYPHOPLASTY IS SAME THING WHICH IS WHAT I HAD AND DID NOT WORK.
WCHSeptember 2, 2009 at 4:30 am
I have been performing this procedure for several years with generally excellent, though certainly not 100%, success. Over the past 35 years of practice, as novel treatment modalities come into use, I have generally been able to reconcile my own clinical experience with the overall medical literature results, good, bad or equivocal. I have also been able to sort out, again in general, why most [Show More]I have been performing this procedure for several years with generally excellent, though certainly not 100%, success. Over the past 35 years of practice, as novel treatment modalities come into use, I have generally been able to reconcile my own clinical experience with the overall medical literature results, good, bad or equivocal. I have also been able to sort out, again in general, why most of the failure or success variables occur, when there are discrepancies. Not so this time. In this case, there is something seriously flawed in the New York times article. The selection criteria, especially the time allowed for conservative measures prior to offering vertebroplasty, the followup period, perhaps others. It strikes me that these cases have been increasingly done by interventional radiologists. That likely means the case was referred to them for the specific purpose of doing a vertebroplasty. So the radiologist did a vertebroplasty, not an overall pain evaluation. The selection criterion for referral appears to be done by non-pain specialists, and non-spine specialists as well. The time to implement conservative measures appears to be rather short. These are important selection criteria. Other criteria may have been omitted. That is why the almost universal response by the medical community is that this demands a closer look. More study. Given my own very positive results in carefully selected, seriously pain ridden, opiate dependent, long term patients, who have been able to significantly reduce their opiate use and increase activities of daily living; these studies, more than anything, suggest the need for better integration of medical services by an all too often very disparate, fractionated, procedure oriented medical system. They suggest that selection criteria may have been badly implemented and poorly thought out. They suggest that followup and overall pain medicine management be carefully reviewed. That this legal forum is so soon Johnny-on-the-spot with solicitation of people who may be unhappy or just want a crack at get-rich-quick, suggest motivation by "lotto-justice" in an effort to make some easy big dough off the misfortunes of others and the piling on to an interesting, but very incomplete line of proper intellectual and scientific inquiry that has been sensationalized and thus largely stripped of its legitimate scientific and medical value. Logic, science and compassionate patient care will quickly go out the window. No money in that, is there? But I doubt anyone here will lose much sleep over theses lapses of intellectual honesty. For my part, I will continue to offer vertebroplasty as an option for certain patients, with the careful selection criteria and the caveats as to risk and expected success or lack thereof that I do with all interventional pain procedures. My overall clinical impression after 7 years: It works. Pretty well. And the morbidity is acceptably low.
MarkAugust 7, 2009 at 12:09 am
There are a variety of smaller studies that have been refuted in larger clinical trials. An entire past-proven pain treatment modality should not be discredited by two small trials. Instead, this should prompt further investigation into the discrepancies of these recently published trials with the mass amount of previous literature indicating substantial benefit of vertebroplasty. In 2006, Spine J[Show More]There are a variety of smaller studies that have been refuted in larger clinical trials. An entire past-proven pain treatment modality should not be discredited by two small trials. Instead, this should prompt further investigation into the discrepancies of these recently published trials with the mass amount of previous literature indicating substantial benefit of vertebroplasty. In 2006, Spine Journal released a systematic review of all available data showing 87% relief of pain with vertebroplasty. A 2007 study in the American Journal of Neuroradiology concluded that "Percutaneous Vertebroplasty is a safe and effective method to treat vertebral compression fractures. An immediate improvement in pain is expected for most patients, and disability, mobility, and pain medication use are improved during the short- and long-term periods." Responding to these surveys, Paul Lynch, MD, co-founder of Arizona Pain Specialists, notes that "these studies actually show that both treatments are effective. The studies did not use a true control group condition, where patients would receive no treatment. The 'control' patients actually received a different effective treatment and both groups demonstrated highly clinically significant reductions in pain. This demonstrates that vertebroplasty is an effective procedure, although facet injections are also effective."