Talk:Vertebral augmentation

Merger proposal

The following discussion is closed. Please do not modify it. Subsequent comments should be made in a new section. A summary of the conclusions reached follows.

The result was merge from Kyphoplasty. -- heat_fan1 (talk) 18:25, 24 September 2010 (UTC)

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I'm proposing that kyphoplasty and this article be merged together and renamed vertebral augmentation. This is similar to the spinal fusion article that includes the various approaches. Since kyphoplasty and vertebroplasty are basically the same procedure but the addition of a cavity in kyphoplasty. heat_fan1 (talk) 13:33, 31 August 2010 (UTC)

I support merging the articles but I do not feel that vertebral augmentation is the recognized term to describe these two procedures. As kyphoplasty is an expansion of vertebroplasty I propose that the article be called vertebroplasty and that kyphoplasty queries should be redirected to the vertebroplasty article. CrunchyChewy (talk) 05:06, 1 September 2010 (UTC)

The discussion above is closed. Please do not modify it. Subsequent comments should be made on the appropriate discussion page. No further edits should be made to this discussion.

Evidence

There is more than one reader of NEJM on Wikipedia.  :-) Keith Henson (talk) 03:24, 6 August 2009 (UTC)

I removed the part stating that some physicians disagreed with the NEJM articles because the control patients did not receive a facet injection (in any case there is no agreement that facet injections help anyone), the section implied that the trivial difference in pain score could be meaningful but the difference did not even approach statistical significance, and a reference citing a press release issued by a group of private physicians is a weak counter to material that cites the NEJM. CrunchyChewy (talk) 16:06, 7 August 2009 (UTC)

After the last edit, the article seemed to suggest that vertebroplasties had been discredited or proven ineffective--which is certainly not the case. There are a variety of smaller studies in medicine 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.

I added some additional information to the research section, citing several larger studies that demonstrate vertebroplasty as an effective and clinically proven procedure for treating VCF's. I also added some details to the procedure section. Last, I created a Risks section, summarizing the potential risks associated with the procedure.

MarkEgge (talk) 16:50, 7 August 2009 (MST)

CrunchyChewy, I too swore an oath to evidence-based medicine. But Wikipedia follows WP:NPOV and there are doctors out there who still believe on the basis of their first-hand experiences that vertebroplasty works.

Double-blind studies are the gold standard in medicine - this fact is not my personal opinion. There are no perfect studies, but two separate double-blind randomized controlled studies (the only two ever done for this procedure) have come to the same conclusion. Some pretty extraordinary flaws will need to discovered within these studies before the conclusion of case studies (no matter how numerous) supersedes the conclusions of double-blind randomized controlled studies.CrunchyChewy (talk) 18:11, 23 August 2009 (UTC)

We can't just delete opinions that are wrong. We should explain why this apparent success isn't real. And there is no such thing as a perfect double-blind study. Some patients crossed over. So there are flaws or at least limitations in the study. The NEJM authors didn't say we shouldn't do vertebroplasties any more, they said we should only do them in well-designed investigational studies.

There were some good newspaper stories which covered this debate among doctors pretty well. I'll be reading them more carefully today.

And if you have to suffer with the American political system, you know that some of the industry-funded political groups are using this as an example of how the government will take away their free choice in health care. --Nbauman (talk) 16:02, 9 August 2009 (UTC)

Regarding the attempt to profoundly deemphasize the results of the double-blind randomized controlled studies - It is not productive to constantly recite how many heartfelt testimonials (i.e. case studies) there are in favor of vertebroplasty. Given the completely subjective clinical endpoint of these studies it is also not beneficial to constantly cite the results of the smaller number of unblinded studies done. The absolute gold standard in medicine is the double-blind randomized controlled study. A single blinded study has more weight than all of these case reports and unblinded studies put together -- but we don't have just a single blinded study but two independent studies with identical results.

As an analogy it doesn't matter how many people swear that Vitamin C cures the common cold. It doesn't matter if every single unblinded study ever done shows that people report feeling better after Vitamin C. A single blinded study (let alone two blinded studies) holds more weight than a million people put together screaming that Vitamin C cures the common cold.

The NEJM studies are both well done and they supersede all of the other studies. The criticism by Dr.Clark is responded to in the same issue of the NEJM. It should also be pointed out that although Dr.Clark served as an investigator in one of the studies his letter does not reveal any inside information; anyone who read the study could have made the same comments. Also it should be noted that almost every criticism made about the trial could have been made before the trial even started. Why didn't this 'investigator' object to the trial from the start? The most likely reason is that he (like every other vertebroplasty practitioner) was confident that the trial would prove the benefit of vertebroplasty. The subjects of the trial were the absolute ideal patients to receive the procedure; it seems like only after the results came out that the the vertebroplasty community 'realized' that it must be all of the other patients that were benefiting from the procedure.

This is getting tedious, so stop distorting the evidence based reality of the article. CrunchyChewy (talk) 08:36, 3 February 2010 (UTC)

Regarding the “Double Blinded Gold Standard Randomized Controlled Studies”- Double blinded clinical studies may be the gold standard but the two NEJM articles on vertebroplasty by Kallmes et al. and Buchbinder et al. are not double blinded. Double blinded means both the physician and patient do not know who belongs to the control group and the treatment group. The operators in both studies clearly understood what procedure they were doing. See the definition of double blinded at: http://www.thefreedictionary.com/double-blind+study.

Regarding the Vitamin C/placebo effect analogy: What is missing from this analogy is the fact that you must have people with a documented common cold before you run a randomized, blind, controlled clinical trial. If the patients don’t have a cold, you can’t run a valid clinical study and report on the results. This is what the all of the major Neurosurgical and Interventional Radiology societies have been clamoring about: Proper patient selection. Patients with a 3 out 10 on a pain scale do not need minimally invasive surgery- they need Tylenol.

There were a number of physicians including IRB boards who did raise concerns about the study design prior to the commencement of the studies and saw ethical problems with doing a sham surgery procedure when vertebroplasty/vertebral augmentation are already considered the standard of care. These points were mentioned in the editorials to the NEJM regarding the vertebroplasty studies. Further evidence of this fact was the 4+ year enrollment periods required for these two studies to enroll a grand total of 218 patients with 64% and 70% of patients who met the inclusion criteria, declining to participate in these studies. This indicates there were significant patient selection biases in both of these studies that do not allow them to make the broad sweeping conclusions they have stated.

The term evidenced based was also used in your response. Evidence based medicine is not strictly randomized controlled clinical trials. There are three elements that need to be considered: clinical research, clinician experience and economic considerations. Looking at the full picture, these studies clearly do not address clinician experience as evidence by the response of the professional societies nor did they look at the economic implications of leaving these patients bedridden in hospitals.

Please do not block the full picture of information to Wikipedia users who want fair, balanced information that tells both sides of the story to make their medical decisions. Vertebralcompressionfractures (talk) 03:31, 4 February 2010 (UTC)

I was on Wikipedia last night researching vertebroplasty because my uncle was recommending this procedure (he experienced first hand) to my dad. Now my dad is scheduled for this procedure next week and I'm a little concerned. My uncle's experience was beyond positive but any form of spinal surgery is something to research. I saw two completely different responses being posted for the subject matter. Having read through both of these I am convinced vertebralcompressionfractures is a better version of the page as it provides both points of view. I’m a little concerned crunchychewy has an agenda here. I also agree with Keith Henson’s comment below that there is more than one NEJM reader on Wikipedia.Wordstir (talk) 16:35, 4 February 2010 (UTC)

WARNING - The recent edits that essentially negate the evidence that vertebroplasty doesn't work and transforms the article into an advertisement are being done by DFINE, Inc. This is a medical equipment manufacturer that sells kyphoplasty devices. The problem is that this company knows their equipment is useless but they are trying to sell it anyway. DFINE Inc. must stop manipulating the article! On a side note I suggest that the officers of this company pursue an honest living.

I will point out that I, on the other hand, am a unbiased source. I obviously have nothing to gain financially by making sure that the article reflects the failings of vertebroplasty. I am merely out to guarantee that patients are not misled. CrunchyChewy (talk) 17:44, 4 February 2010 (UTC)

CORRECTION - It is not simply DFine’s position, but the organizations, thousands of treating physicians, the rebutting physicians in NEJM (including an operator), and the hundreds of thousands of patients who have benefited from the procedure. Do we believe in our product/procedure? Of course we do, that’s why we’re in the business!

To this end, DFine Inc has gone to great lengths to provide the last 20 years of history of vertebroplasty in a full, accurate and balanced way. It is also important to point out that vertebroplasty is a competitor procedure to kyphoplasty- the products we manufacture. We have also included other competitors within the kyphoplasty area which use a balloon as well in fairness to them. We have not tried to use a hiddened IP address but preferred to be straightforward and open on our approach to this site. Pain staking measures have been taken to present all of the views regarding vertebroplasty including numerous citations of published clinical literature in prestigious journals around the world (20+ citations have been added). The NEJM articles and their conclusions are clearly spelled out and responses from the professional societies have been included as well with citations. The purpose has always been to provide a clear, fair and balanced prospective on the issues.

DFine Inc would like to reach out to you CrunchChewy to have an open, honest dialog about these issues as we believe with objective and clear thinking, we can uncover the sticking points and move forward in our understanding of how the treatment paradigms between nonsurgical management and minimally invasive treatments fit together in the continuum of care for patients suffering from vertebral compression fractures.

How can we connect to discuss in more detail? Vertebralcompressionfractures (talk) 23:20, 4 February 2010 (UTC)

Great Information!- I too have an unbiased view and getting both sides on this procedure has been fantastic! CrunchChewy brought the NEJM article to light and DFine rebutted with 20+ citations to refute NEJM. I'm sure Vertebroplasty has a place in medicine just as I'm sure a minimally invasive approach has its place as well. Wikipedia, can we just provide the description of the procedure? To say Vertebroplasty doesn't work would be like saying radiation therapy doesn't work. I have friends that are alive today because of radiation therapy and I have one friend that died of cancer after radiation treatment. Does that mean radiation treatment doesn't work and killed my friend? No! I never make a decision based on one doctor's opinion and that's why this discussion is ridiculous. Wikipedia is a great source of information but anyone can add information to this site. So I recommend you ask your doctor or even better ask an orthopedic surgeon or chiropractor how they would treat their mothers if they had a vertebral fracture. Well done Wikipedia! Your platform is a great sounding board for medicine.Evoicevision65 (talk) 18:23, 5 February 2010 (UTC)

I'm trying to provide a more balanced presentation. Sure, double-blind studies are the gold standard. But the VERTOS II study (and many others) present Level 1 data. In the scaling of research presentation, Level 1 data, which comes from a randomized controlled trial is the highest level of data. The NEJM articles DO NOT negate other Level 1 data, but compliment it. Double-blinding is not always possible.

In addition, there are many flaws to the NEJM articles. There was a very low enrollment rate (which suggests selection bias), they didn't get the enrollment they needed (250; they got barely half), and the results would have been different if only 1 patient in either group performed differently. Also, the crossover rate was much higher in the sham group. So while very good studies, they are not perfect and should not define this Wiki article. heat_fan1 (talk) 12:30, 26 July 2011 (UTC)

The NEJM articles in a way do support the outcome of pretty much every other trial and clinical observation done concerning vertebroplasty: Patients who underwent it (or believed they underwent it) felt better. The NEJM articles are significant because they demonstrate that the placebo effect provides the benefit.

I'm sure you can do a thousand unblinded studies that overwhelmingly show that vitamin C prevents colds, but pretty much every blinded study would show that this was just the placebo effect. I wouldn't say that the NEJM negates the results of the other studies; more accurately one can say that it explains those results.

Whatever flaws these studies have they are still by far the best studies in the field. It is incorrect to say that having one patient in either group perform differently would have affected the results. It definitely would not have come close to effecting the primary outcome, although it is possible that some secondary outcome or subgroup analysis could have been impacted.

If vertebroplasty were a drug and if it failed its blinded studies would the FDA approve it? The answer is that no one would even bother to submit it.

The article was already overly generous to an ineffective procedure.CrunchyChewy (talk) 02:35, 27 July 2011 (UTC)

I understand the value of a blinded, placebo-comparing study. In theory they were great studies. In execution, they were seriously flawed and are controversial, at best. They were picked up by the mainstream media, which is what made them so big. But that does not make them "by far the best studies." Other studies with larger sample sizes are nearly as valuable.

Statisticians have reviewed the papers and determined that in the Kallmes study, the difference in pain improvement, which had a p-value of 0.06 (0.05 is needed to show a difference), would have been significant if a single patient performed differently in either group. Also, significantly more sham patients than vertebroplasty patients crossed. The results of the studies do not provide conclusive PROOF that vertebroplasty is ineffective.

You're slamming the VERTOS II study, which is an excellent, Level-1 evidence RCT. I'm trying to present it fairly by acknowledging that it's not an unblinded study. If you're going to continue to change the article so that it presents one side, I'm going to present ALL of the criticisms and flaws of the NEJM studies. Instead, let's present the facts without trying to slant them. Before I revert your changes, you tell me which way you want to go. heat_fan1 (talk) 12:39, 1 August 2011 (UTC)

The NEJM articles actually support the results of the VERTOS II study as well as the results of nearly every other study in the field as patients felt better when they believed they had a procedure. What the NEJM articles refute is the conclusion drawn from all of those studies. We now know from two completely separate blinded trials that the placebo effect is behind the efficacy seen in all other trials - or at least we are obligated to say that the null hypothesis still stands (that vertebroplasty does not work) until a blinded trial proves otherwise. Arguing that one of the secondary endpoints in one of the trials came close to p<0.05 is not going to impress anyone. We must assume that vertebroplasty does not work until trials are done that show its efficacy and that control for the placebo effect. Really only a highly biased person could defend vertebroplasty at this point. I am not directly affected in any way whether vertebroplasty/kyphoplasty continues, but I suspect that you may have a direct financial stake in the matter.CrunchyChewy (talk) 16:31, 1 August 2011 (UTC)

I understand what a placebo-effect study means. You are correct in that it likely explains the method by which vertebrplasty works. But likely does not mean definitively. There are flaws in the studies, and I'll add more information regarding those. I also don't know why you continue to completely slam and disregard the VERTOS study. It is an excellent study that also has flaws. I note, at least 3 times, that it is unblinded. That doesn't mean it's pointless. One of the significant advantages it has over the NEJM articles is its longer follow-up period. That's significant! I'll also expand the Reaction section to include changes in the referral and reimbursement landscape.

While you think I'm biased, I can't figure out why you seem to hate vertebroplasty so much. You're a cunning one. heat_fan1 (talk) 19:53, 1 August 2011 (UTC)

About your Third Opinion request: In accordance with the guidelines at the Third Opinion project page, since no editor has chosen to give an opinion upon your request within six days, it has been removed. While you may re-list it there if you still desire an opinion, you are much more likely to obtain assistance if you move on to some other form of dispute resolution. Regards, TransporterMan (TALK) 19:18, 8 August 2011 (UTC)

J Bone Miner Res. 2012 Sep 18. doi: 10.1002/jbmr.1762. [Epub ahead of print] Meta-analysis of vertebral augmentation compared to conservative treatment for osteoporotic spinal fractures. Anderson PA, Froyshteter AB, Tontz WL Jr. Source Department of Orthopedics & Rehabilitation Centennial Building, 1685 Highland Ave, 6th floor, Madison, WI 53705-2281. anderson@ortho.wisc.edu. Abstract INTRODUCTION: Cement augmentation is a controversial treatment for painful vertebral compression fractures (VCF). Our research questions for the meta-analysis were: is there a clinical and statistical difference in pain relief, functional improvement and quality of life between conservative care and cement augmentation for VCF and, if so, are they maintained at longer time points? METHODS: A search of MEDLINE from January 1980 to July 2011 using PubMed, Cochrane Database of Systematic reviews and Controlled Trials, CINAHL and EMBASE. Searches were performed from Medical Subject Headings. Terms "vertebroplasty" and "compression fracture" were used. The outcome variables of pain, functional measures, health related quality of life (HRQOL), and new fracture risk were analyzed A random effects model was chosen. Continuous variables were calculated using the standardized mean difference comparing improvement from baseline of the experimental to control group. New vertebral fracture risk was calculated using log odds ratio. RESULTS: Six studies met the criteria. The pain VAS mean difference was 0.73 (CI 0.35, 1.10) for early (<12 weeks) and 0.58 (CI 0.19, 0.97) for late time points (6-12 months) favoring vertebroplasty (p< 0.001). The functional outcomes at early and late time points were statistically significant with 1.08 (CI 0.33, 1.82) and 1.16 (CI 0.14, 2.18). The HRQOL showed superior results of vertebroplasty compared with conservative care at early and late time points of 0.39 (CI 0.16, 0.62) and 0.33 (CI 0.16, 0.51). Secondary fractures were not statistically different between the groups, 0.065 (CI -0.57, 0.70). DISCUSSION: This meta-analysis showed greater pain relief, functional recovery, and health related quality of life with cement augmentation compared to controls. Cement augmentation results were significant in the early (<12 weeks) and the late time points (6-12 months). This meta-analysis provides strong evidence in favor of cement augmentation in the treatment of symptomatic VCF fractures. © 2012 American Society for Bone and Mineral Research. Copyright © 2012 American Society for Bone and Mineral Research. PMID: 22991246

1) A search of MEDLINE from January 1980 to July 2011 using PubMed, Cochrane Database of Systematic reviews yielded s 2) Articles of only randomized control trials comparing either vertebroplasty or kyphoplasty to conservative or sham treatment for osteoporotic compression fractures were identified and reviewed 3) Eight articles met criteria as being Level I or Level II studies based upon the Levels of Evidence for Primary Research as adopted by the North American Spine Society6. Six of these articles represent unique studies while two articles describe the same study at two different time points. 4) A total of eight prospective randomized control trials met inclusion criteria after a complete systematic review was performed. 5) All papers in the study were initially determined to be Level I evidence prior to NASS Guideline application. In the Kallmes paper, there was a downgrade from Level 1 to Level II evidence based upon inclusion criteria and subsequent high crossover.2 In a similar manner Buchbinder’s paper was downgrade to Level II evidence based upon concerns of inclusion criteria.1 Voormolen et al and Farrokhi were both downgraded for lack of power analysis.4, 10 The Rousing study was eliminated from the efficacy analysis as baseline data was missing but was included in adverse events assessment.

All papers in the study were initially determined to be Level I evidence prior to NASS Guideline application. In the Kallmes paper, there was a downgrade from Level 1 to Level II evidence based upon inclusion criteria and subsequent high crossover.2 In a similar manner Buchbinder’s paper was downgrade to Level II evidence based upon concerns of inclusion criteria.1 Voormolen et al and Farrokhi were both downgraded for lack of power analysis.4, 10 The Rousing study was eliminated from the efficacy analysis as baseline data was missing but was included in adverse events assessment.

The studies by Buchbinder and Kallmes had negative results which may have been due to changes in study design during the trial, as well as low power.1, 2 The study design of both trials was reported before publication of the results.16, 17 Both studies enrolled fewer patients and had shorter follow-up periods than stated in their power analyses and were further weakened by loss to follow-up and in Kallmes’ case, crossover patients.2 Thus, both studies had study design changes and ultimately may have lacked statistical power. — Preceding unsigned comment added by 98.66.59.217 (talk) 00:56, 6 January 2013 (UTC)

Aggressive promotion

The company that makes these devices have been aggressively promoting them beyond the evidence. The procedure from my reading should only be done as part of a clinical trial.--Doc James (talk · contribs · email) 22:34, 5 February 2010 (UTC)

The problem with the merger

I have no problem with the combination of the two surgeries into one section. I do have a problem with how the article is written. As it stands, the order is logical (kyphoplasty after vertebroplasty), but misleading. First, kyphoplasty is not immediately defined and differentiated from vertebroplasty, leaving the impression that one is a minor variation of the other. Because the two are not immediately defined and differentiated, with details of each to follow, the implication is that whatever is said about vertebroplasty holds for kyphoplasty. However, the kind of solid information about kyphoplasty by itself is far less extensive. I think the combination of the two surgeries into one article may have been logical and have spared duplication of writing, but improperly conflated the evidence. That is, the solid evidence against vertebroplasty may not hold in its entirety for kyphoplasty.

The effectiveness section for kyphoplasty uses evidence from vertebroplasty instead of evidence of kyphoplasty. The worst sentence begins with "However earlier unblinded studies also suggested a similar benefit to the closely related procedure vertebroplasty..." The assumption is that the results of studies of kyphoplasty would have been the same as we have seen in vertebroplasty, which is unproven. The prejudice against vertebroplasty ruins the discussion of kyphoplasty. This bias and conflation is clearly evident on this talk page where sweeping charges of impropriety against equipment makers and surgeons runs rampant.

I suggest rewriting the initial section of the article to clearly assert that these are two different surgeries despite their being related, and rewriting the kyphoplasty sections to rid them of their evidentiary bias.

Finally, the description of kyphoplasty as a procedure does not describe the most interesting part, how the collapsed vertebrae are [perhaps] repaired rather than simply fixated. [Edit: My concluding point is less firm than is implied by its tone. I think the differences between the two surgeries should be emphasized in the article rather than minimized.] Lonnie Nesseler 19:15, 17 February 2011 (UTC)

I think it is fine to clarify the difference between vertebroplasty and kyphoplasty but we should keep in mind that kyphoplasty really is an offshoot of vertebroplasty. The primary rational for these procedures is relief of pain, and kyphoplasty was never 'supposed' to be more effective than vertebroplasty in terms of relieving pain as each procedure supposedly stabilized the vertebra. Kyphoplasty has never been subjected to a double blind trial but there is no credible rational to presume that kyphoplasty will relieve pain in situations where vertebroplasty has failed.

Being an "offshoot" of an older procedure does not necessarily mean that it cannot represent a significant improvement. Although both procedures are for collapsed vertebrae and both use cement, there the similarity ends. For one thing, there is much less tissue damage with kyphoplasty as the cement is inserted inside the bone through a small hole. If my understanding is correct, vertebroplasty must "skin," as it were, tissue away from the bone in order to apply the cement. This creates a much greater wound and associated pain. Describing the steps involved in the two procedures may clarify just how different they are from each other.Lonnie Nesseler 05:17, 28 March 2011 (UTC)

The one additional claimed benefit of kyphoplasty is that it is supposed to restore the height of the vertebrae. This can be seen radiologically but so far there has not been a blinded assessment demonstrating a clinical benefit of this restoration of vertebral height. With the existing paltry clinical evidence we cannot say that kyphoplasty repairs vertebrae. Patients aren't getting these procedures to become taller (if that really occurs), they are getting it in the hope that it will relieve pain.

CrunchyChewy (talk) 19:55, 19 February 2011 (UTC)

I have found an excellent description of the kyphoplasty procedure. I want to try to work it into the article. I am also looking for a similarly detailed description of the procedure of vertebroplasty. I will also try to soften what clearly seems to be the opinions of editors rather than observations supported by authorities and properly footnoted. Lonnie Nesseler 05:17, 28 March 2011 (UTC)

CrunchyChewy- wow lousy example of being non-biased

CrunchyChewy - fanciful reports are typically indicative of publications NOT associated with the U.S. DoD and the U.S. VA. I started to delve into the sordid history of this page. But it wasn't necessary. The assumptions and directions listed on this page are simply wrong. There is a living example in Nashville Tennessee by the name of Stephen Cochran. Hence we are now discussing the probability of a positive outcome, not the possibility of the Kyphoplasty working. Your ambiguous "Effectiveness" sections need changing. They do not accurately portray the knowledge bases current state. — Preceding unsigned comment added by Pnpointer (talk • contribs) 19:10, 27 March 2011 (UTC)

Kyphoplasty does not decompress the spinal cord or the cauda equina, and no practitioner of kyphoplasty would publicly claim that it does. From reading your citations the recommendation to do the procedure did not come from a physician but from what a nurse said to the patient's mother. Likely the nurse thought "hey, kyphoplasty fixes the spine so that's what he needs". The doctors at his medical center appropriately refused to do this procedure. I'm guessing that the doctors who did the procedure ALSO physically decompressed his spine after realizing that the only way to help the patient was to give into his crazy request -- this is all just speculation though as there are no reports in the medical literature to say what really happened.CrunchyChewy (talk) 20:24, 27 March 2011 (UTC)

Vertebroplasty appears no better than placebo in clinical trial

Austria, for one, is no longer going to cover the procedure. Others to follow. Vertebroplasty appears no better than placebo for painful osteoporotic spinal fractures, and has potential to cause harm.

This information does not reflect in any way on kyphoplasty. Any incorporation of this information should be careful not to suggest that the results of a similar trial for kyphoplasty, which looks similar only to non-surgeons, would also hold for kyphoplasty. In my opinion, it was a mistake to combine the two surgeries in the same article, but that's water under the bridge until a similar clinical trial for the second operation is published. Lonnie Nesseler 13:58, 21 October 2011 (UTC) — Preceding unsigned comment added by Lnesseler (talk • contribs)

Dbeall01 edits

Hello Dbeall01. As I mentioned on your talk page, I've reverted your recent edits. Could we discuss them here? There were several formatting issues (which are relatively easy to fix), but I'm more concerned with your conclusion that the two double-blind trials have been discredited. Could you sketch out that argument here with the citations you'd like to use? Thanks! GaramondLethe 05:55, 2 January 2013 (UTC)

Kallmes-Buchbinder Analyses

Sure, let me give it a shot. In regard to the two RCT’s published in 2009, these studies are highly controversial and have generated a large amount of discussion. Most of the issues focus on the execution of these two trials. Some of the primary criticisms include that the INVEST trial was underpowered (target enrollment was 250 versus the actual enrollment of 131) and both studies suffered from prominent selection bias. The crossover of patients in the INVEST trial was far greater for those patients crossing over from sham to VP (51%) as compared to the sham patients crossing over to VP (13%). The clinical and imaging diagnostic criteria for inclusion was very different from most RCT’s with patients having a pain score of 3 or more on the visual analog scale being eligible for inclusion and there was no requirement for Magnetic Resonance (MR) imaging or nuclear bone scanning for diagnosing the VCF’s. There was also no description of a clinical exam used to determine if the pain came from a VCF or from another issue and the Buchbinder trial had an assessment of “overall pain” rather than spine related pain. There was also criticism that the INVEST trial was not a true sham with 63% of the sham patients correctly guessing the their treatment and the injection was performed with a paraspinal injection of local anesthetic which has been used to successfully palliate patients pain from VCF’s for up to eight weeks (1). Despite all of these limiting factors, when analyzing the structure and execution of the trial itself, if the same response rate for the 131 patients had been carried out for the originally intended 250 patients, VP would have been found to be significantly better than sham treatement at a p-value of < 0.01. Even with the 131 patients, if one patient had a different response (i..e a favorable response in the VP group or an unfavorable response in the sham group), VP would have been found to be significantly better than sham with a p-value of < 0.04. Given the near equivocal nature of this information it is not an optimal trial on which to base significant recommendations and, in our opinion, the quality of assessment in these trials is far less than other trials that have a greater number of patients (2, 3, 4, 5). 18. Wilson D, Owen S, Corkill R. Facet injections as a means of reducing the need for vertebroplasty in insufficiency fractures of the spine. Eur Radiol. 2011 Aug;21(8):1772-8. Epub 2011 Apr 13 8. Papanastassiou ID, Phillips FM, Meirhaeghe JV, et al. Comparing effects of kyphoplasty, vertebroplasty, and nonsurgical management in a systematic review of randomized and non-randomized controlled studies. Eur Spine J DOI 10.1007/s00586-012-2314-z 10. Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S (2009) Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet 373(9668): 1016–1024. doi:10.1016/S0140-6736(09)60010-6. 16. Klazen CA, Lohle PN, de Vries J, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 2010; 376:1085. 17. Shi MM, Cai XZ, Lin T, Wang W, Yan SG. Is There Really No Benefit of Vertebroplasty for Osteoporotic Vertebral Fractures? A Meta-analysis. Clin Orthop Relat Res DOI 10.1007/s11999-012-2404-6

Also, if I had your email it would be easier to engage in a discussion. You reference Dr. Evans, Dr. Kallmes and others. I know these individuals and other in the spine intervention community and we can discuss it as a group that way. — Preceding unsigned comment added by Dbeall01 (talk • contribs) 14:02, 2 January 2013 (UTC)

First, here are a few hints to make your text easier to read. When you make a comment on a talk page, "sign" your comment with four tildes, like this: ~~~~. That'll be transformed into your user name and a timestamp. Second, try to break comments into shorter paragraphs—they're much easier to read, esp. on a laptop (and putting a blank line between paragraphs will help a lot, too). Colons as the beginning of a paragraph control how much that paragraph is indented: that gives the reader and idea of who is replying to what. Citation formatting is its own dark art... we'll leave that be for the moment.

I'd be happy to discuss this with you and others over email. If you go to my user page here, there's a link on the left that reads "Email this user". Send me your address and I'll send you mine. (You can enable this for your account as well by clicking on the "Preferences" link on your user page.)

GaramondLethe 15:38, 2 January 2013 (UTC)

So the first line of the 2012 review is "Pain scoring was similar between the PVP group and the sham injection group at 1 to 29 days and 90 days."

Shi, MM (2012 Oct). "Is there really no benefit of vertebroplasty for osteoporotic vertebral fractures? A meta-analysis". Clinical orthopaedics and related research. 470 (10): 2785–99. PMID 22729693. {{cite journal}}: Check date values in: |date= (help); Unknown parameter |coauthors= ignored (|author= suggested) (help)

If their is a significant clinical different from a therapy a large trial is not needed. You only need a large trial if you are looking for small differences.

Risk of bias is much greater in the non sham controlled trials. So while all trials have issues the sham controlled ones are still better than the group that compared to no operation as 100% of that group know what treatment they received. I assume that it is still being studied so hopefully in the future we will have a clearer answer.

By the way welcome to Wikipedia. We carry out discussion on these talk pages in a very open format rather than via email. Doc James (talk · contribs · email) (if I write on your page reply on mine) 13:00, 4 January 2013 (UTC)

Appreciate your inquiry Doc James and these complex questions have created controversy and confusion, by over simplifying the analysis, and therefore contribute to misleading general practitioners and the general public with wrong conclusions.

Doc James Wrote: When discussing Shi, MM; Cai, XZ; Lin, T; Wang, W; Yan, SG (2012 Oct). "Is there really no benefit of vertebroplasty for osteoporotic vertebral fractures? A meta-analysis.". Clinical orthopaedics and related research 470 (10): 2785-99. PMID 22729693, your question of “If their is a significant clinical different from a therapy a large trial is not needed. You only need a large trial if you are looking for small differences?”

You have pointed out an interesting observation when you said, ‘If there is a significant clinical difference from a therapy…?’ The answer and reconciliation to your question is that the 2009 NEJM studies by Buchbinder and Kallmes had poor patient selection and poor patient enrollment - which contributed to underpowered results, failure to achieve their power and failed to be clinically or statistically meaningful. Because these studies are not statistically significant, we shouldn’t even be discussing them.

The easy answer to your question is that the Kallmes and Buchbinder studies had poor patient selection and selected patients with low VAS scores. Even without giving a local anesthetic injection, it would be challenging for any procedure to demonstrate statistically significance in pain reduction if the patient subjects had VAS scores of 3 or 4 as a baseline to begin with. That is why there has been so much criticism of the 2009 NEJM studies, because of their poor study protocol, bad patient selection and the under power of those studies needed to achieve meaningful significance.

Our goal is to provide fair and accurate information and representation of clinical based evidence. We are not hear to discredit Dr. Kallmes or Dr. Buchbinder. I know them both and they are tremendously gifted and contribute greatly to the science of evidence based medicine. I am a long-time member of the Society of Interventional Radiology (SIR) who said, “While we welcome the two studies by researchers David F. Kallmes, M.D., and Rachelle Buchbinder, Ph.D., to the body of literature on this technique, the results of these trials are discordant with personal experience and more than 15 years of accumulated medical literature espousing the benefits of vertebroplasty,”

The fact of the matter in this discussion is that there are “Hundreds of thousands of patients have greatly benefited from vertebroplasty with almost complete resolution of their pain; tens of thousands dependent on intravenous narcotics have been discharged from the hospital virtually pain- and drug-free following their treatment,” noted SIR President Brian F. Stainken, M.D., FSIR, who represents the national organization of nearly 4,500 doctors, scientists and allied health professionals dedicated to improving health care through minimally invasive treatments. “Before treatment, many of these osteoporotic patients are in constant pain and cannot manage everyday activities. Many are confined to bed for up to six weeks. These are the people we help; with vertebroplasty they can go home in one to two days. Candidates for the procedure are those who have failed to respond to conventional medical treatment (such as rest, analgesics and narcotic drugs). Vertebroplasty can give patients their lives back,” said Stainken, president of the Imaging Network of Rhode Island and chair of the diagnostic imaging department at Roger Williams Medical Center in Providence, R.I

There were numerous short-comings and limitations with the 2009 NEJM studies by Buchbinder and Kallmes. But there are three big short-comings of these studies or limitations:

1) Difficulty enrolling patients Both the Buchbinder study and the Kallmes study had difficulty in enrolling patients. This is recognized by the authors and the clinical community. The small percentage of patients screened that entered into the study, most likely led to selection bias because patients with more pain may have chosen another treatment. The Australian Trial (Buchbinder) took 4.5 years from April 2004 through October 2008 to enroll just 78 patients. While the Buchbinder study was a multicenter trial, more than 67% of the patients (52 out of 78) came from a single site and the procedures were performed by a single radiologist. The INVEST Trial (Kallmes) screened 1,812 patients to get 131 (7.2% enrollment).

2) Low VAS Score VAS pain score was low – 3 out of 10 for inclusion on VAS (or no pain requirement for Buchbinder) allow patients into the trial with lower pain scores than many physicians would require to initiate treatment Kallmes reported average decrease of 3 VAS points at 1-month Buchbinder reported average decrease of 2.3 VAS points

3) Not a True Sham Not a True Sham – sham intervention was not true sham as the periosteum was infiltrated with local anesthetic. Australian Trial (Buchbinder) used a blunt stylet docked on pedicle and gently tapped and used PMMA prepared for smell permeation INVEST Trial (Kallmes) Injected a long-acting anesthetic (bupivacaine) used verbal cues, put pressure on patient’s back and opened monomer (simulate mixing of PMMA) to simulate the procedure. Sham patients were injected with 1% of lidocaine and infiltrated the periosteum of the pedicles with 0.25% bupivacaine.

Doc James Wrote: “Risk of bias is much greater in the non sham controlled trials. So while all trials have issues the sham controlled ones are still better than the group that compared to no operation as 100% of that group know what treatment they received.” Again as you can appreciate, patients are not randomized in real life. Additionally when talking about the 2009 NEJM articles, it those were not a true sham.

Additionally in Kallmes et al A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures (Original Article, N Engl J Med 2009 ; 361 : 569 – 579 the cross-over rate was egregiously high. Many patients guessed treatment – at 14 days 63% of sham patients and 51% of vertebroplasty patients guessed correctly what treatment they were assigned.

Sham failure rate was too high and higher than originally reported – at 3 months, 9 patients out of 68 (13%) in the vertebroplasty group and 32 patients out of 63 (51%) in the Sham control group had crossed over to the other group that had undergone the alternative procedure. Originally Kallmes reported that 43% in the Sham group and 12% in the vertebroplasty group were reported to cross over. On March 8, 2012 nearly three years after the initial publication the New England Journal of Medicine issued a Restatement: A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures (Original Article, N Engl J Med 2009 ; 361 : 569 - 579) . In the Abstract (page 569), the parenthetical information in the penultimate sentence of Results should have been “51% vs. 13%, P<0.001,” rather than “43% vs. 12%, P<0.001.” In the Patients subsection of Results (page 574), the first sentence of the fourth paragraph should have read, “At 3 months, 9 patients (13%) in the vertebroplasty group and 32 patients (51%) in the control group had crossed over to the other group and had undergone the alternative procedure (P<0.001),” rather than “. . . 8 patients (12%) in the vertebroplasty group and 27 patients (43%) . . . .” Because there was a slight error in the reported number of crossover patients, there were minor changes to the graphs and numbers in Figure 3. The article is correct at NEJM.org. (http://www.nejm.org/doi/full/10.1056/NEJMx120006)

• High crossover (ITT) un-interpretable – there was a higher rate of crossover (51%) of the Sham control group versus the vertebroplasty group, suggesting that the sham treatment was not effective, or more importantly that the lidocaine and bupivacaine wore off and the Sham patients needed vertebroplasty.

• No evaluation for Sham procedure – there was no proper evaluation as to the Sham arm failed and patients crossed-over (51% crossed-over). Proper evaluation would be imaging studies (MRI or Scan), evaluation of other etiologies of pain.

• Alternative treatment not well defined – Kallmes paper also fails to define what alternative treatment was administered to patients who crossed over? For example 13% of vertebroplasty patients crossed over, what treatment did they receive?

• Difference between cross over and non-crossover – the crossover patients and the patients who did not crossover were significantly different after the alternative treatment

• Cross over patients reported higher disability and pain – the patients in the vertebroplasty group who crossed over reported higher levels of disability and pain at 3 days and 14 days, as compared with those who did not cross over.

• Sham’s early improvements disappeared – patients in the control group (Sham) who crossed over had some early improvement after the control procedure but this improvement had disappeared by the 1-month assessment. — Preceding unsigned comment added by Dbeall01 (talk • contribs) 00:42, 6 January 2013 (UTC)

Doug, please log in and sign your responses with ~~~~. Also, please add a line between paragraphs. Otherwise, wikipedia will ignore paragraphs and you'll end up with an unreadable wall of text. You can click on the "preview" button to see what your text will look like. I've formatted the above to make it easier to read. Please feel free to revert any of the changes I made if they don't match your intent. GaramondLethe 02:02, 6 January 2013 (UTC)

Expert opinion is not given much weight. Thus “Hundreds of thousands of patients have greatly benefited from vertebroplasty with almost complete resolution of their pain; tens of thousands dependent on intravenous narcotics have been discharged from the hospital virtually pain- and drug-free following their treatment,” noted SIR President Brian F. Stainken, M.D., FSIR"

On Wikipedia we need a high quality secondary source. We do not typically do in depth analysis of these sources as we expect the journals to do this. Is vertebroplasty controversial? We do have multiple sources to support this. What exact word change are you proposing? Doc James (talk · contribs · email) (if I write on your page reply on mine) 18:10, 6 January 2013 (UTC)

Good evening Doc James et al. I think we need to stand back for a second and acknowledge that the current content on Wikipedia needs to be updated with more recent clinical analysis. The changes that I am proposing are to simply bring the content on Wikipedia up to date to that all clinical points are represented. Our shared goal is to ensure that the content on this page are fair, balanced and representative.

Before I go any further, I invite you and others to read the United Kingdom’s NICE Appraisal Committee on vertebral augmentation. They are an independent group and are finishing a two-year analysis on the clinical efficacy of vertebral augmentation.

http://www.nice.org.uk/nicemedia/live/13445/61318/61318.pdf

As you know, the National Institute for Health and Clinical Excellence (NICE) was established in 1999 and is a Health Care Technology Assessment Committee, whose (independent) evidence-based recommendations help resolve uncertainty about which medicines, treatments, procedures and devices represent the best quality care and which offer the best value for money for the National Health Service (NHS) to the United Kingdom. Therefore, it is the largest Health Care Technology Assessment Committee and should not be discounted. There are new insights that we should make sure get updated to this page.

I am very familiar with the 2009 NEJM studies. They do have a place in the clinical literature for vertebroplasty. But what is missing is the over 70 positive articles that Dr. Kallmes has done in favor of vertebroplasty and the over-whelming evidence in support of vertebral augmentation. The way the content has been present is to focus only on the negative sham studies which does not offer up the other side of the evidence. I hope we can agree on that point, because if not, it will be difficult to move this argument forward (constructively). I will take you up on your invite to withhold my personal, expert opinion, if you agree to evaluate the clinical data for what it is and that our Wikipedia audience should ultimately be well informed and consult a qualified opinion before seeking out medical attention.

My colleagues and I have always maintained that surgical intervention should be the last line of treatment. And the data supports our position. You acknowledge that there are 750,000 osteoporotic vertebral compression fractures each year in the United States, per the National Osteoporosis Foundation. There are also 150,000 vertebral compression fractures each year due to cancer. Out of these 900,000 annual compression fractures less than 150,000 are treated surgically. That means that only 16% of people with vertebral compression fractures are treated with either vertebroplasty or balloon kyphoplasty. The other 84% or 752,000 patients are either not being treated or are being treated conservatively with physical therapy, narcotics or back bracing. Vertebroplasty and balloon kyphohplasty then by definition cannot be overused, if less than 1 out of every 5 patient receives this minimally invasive procedure. Again, this is not expert opinion, as I remain respectful and deferent to your desire to not interject my own opinion, these are simply facts about the condition and treatment of these patients.

Meta-Analysis by Papanastassious et al 2012. There have been a series of new meta-analyses from Papanastassious et al entitled, ‘Comparing effects of kyphoplasty, vertebroplasty, and nonsurgical management in a systematic review of randomized and non-randomized controlled studies’ which concluded that vetebroplasty and balloon kyphohplasty resulted in significantly better improvement in quality of life than non-surgical management. This meta-analysis was taken from 1,587 articles on vertebral augmentation, more articles than in any other area of spine. Based on this, it would appear that there is more than enough adequate information upon which to base a decision that vertebroplasty and balloon kyphoplasty are effective. [1]

In this study the authors concluded that reduction in pain, EQ-5D, QOL, patient satisfaction, and kyphotic angulation remain statistically significant at all-time points throughout the 2 years measured.

Meta-Analysis by Anderson et al 2012. Additionally, a new meta-analysis by Anderson et al, from the Journal of Bone and Mineral Research PMDI: 22991246 performed a meta-analysis on vertebroplasty and balloon kyphoplasty and found eight articles which met criteria as being Level I or Level II studies based upon the Levels of Evidence for Primary Research as adopted by the North American Spine Society. Six of these articles represent unique studies while two articles describe the same study at two different time points. Data were entered into Review Manager (RevMan) software used by Cochrane reviews and bias determined using “Cochrane Risk of Bias table”.7 In addition, the quality of this meta-analysis was assessed using the PRISMA checklist which is a 27 point set of standards for publication of systematic reviews of randomized trials. [2]

A search of MEDLINE from January 1980 to July 2011 using PubMed, Cochrane Database of Systematic reviews and Controlled Trials, CINAHL and EMBASE. Searches were performed from Medical Subject Headings. Terms “vertebroplasty” and “compression fracture” were used. The outcome variables of pain, functional measures, health related quality of life (HRQOL), and new fracture risk were analyzed A random effects model was chosen. Continuous variables were calculated using the standardized mean difference comparing improvement from baseline of the experimental to control group. New vertebral fracture risk was calculated using log odds ratio.

Results: Six studies met the criteria. The pain VAS mean difference was 0.73 (CI 0.35, 1.10) for early (<12 weeks) and 0.58 (CI 0.19, 0.97) for late time points (6-12 months) favoring vertebroplasty (p< 0.001). The functional outcomes at early and late time points were statistically significant with 1.08 (CI 0.33, 1.82) and 1.16 (CI 0.14, 2.18). The HRQOL showed superior results of vertebroplasty compared with conservative care at early and late time points of 0.39 (CI 0.16, 0.62) and 0.33 (CI 0.16, 0.51). Secondary fractures were not statistically different between the groups, 0.065 (CI -0.57, 0.70).

Risk of Doing Nothing vs. Surgical Intervention Lastly, when evaluating the 2009 NEJM studies, nobody ever discusses what happened to those patients who never received the vertebroplasty treatment? What type of comorbidities did those patients have? What is not addressed on this page is the age of these patients and ultimately mortality. Conservative treatment implies treatment that is safer and has less complications associate with it and for this reason we prefer the designation non-surgical management. The risk of performing Kyphoplasty or Vertebroplasty should be balanced with the risk of not doing the procedure as these patients are typical debilitated and have a rate of mortality of 8.6 times age matched controls and have a 40% greater mortality after 8 years. [3,4] In the first longitudinal, population-based comparison of mortality risk between surgical and nonsurgical groups, a Medicare dataset from 2005 to 2008 containing 858,978 patients with vertebral compression fractures was analyzed. [5] This included 119,253 patients treated with balloon kyphoplasty, 63,693 patients treated with vertebroplasty and the remainder treated with non-surgical management. The findings at the 4 year follow-up showed that the vertebral augmentation treatment group was 37% less likely to die than the NSM group and that the adjusted life expectancy was 85% greater for the VA group. The adjusted life expectancy for the BKP was greater for that of VP and was increased 115% compared to the NSM group. Overall the median life expectancy was increased between 2.2 and 7.3 across all treated groups as compared with nonsurgical management. A retrospective review of the treatment of refractory osteoporotic vertebral compression fractures by Gerling, et al where treatment with VA was compared with NSM in a hospital setting found a significant survival advantage (p<0.001) for patients treated with VA over those patients treated with NSM, regardless of co-morbidities, age or the number of fractures diagnosed at the start-date. I just want the data to be updated, accurate and presented holistically so that this Wikipedia audience has the entire picture of this procedure. Do you think we can agree on that much? I’d be happy to share this newer clinical evidence with you and you are free to pull them up on PubMed or email me and I’d be happy to send them to you.

End notes

[1] Papanastassiou ID, Phillips FM, Meirhaeghe JV, et al. Comparing effects of kyphoplasty, vertebroplasty, and nonsurgical management in a systematic review of randomized and non-randomized controlled studies. European Spine Journal, Volume 21, issue 9 (September 2012), p. 1826 - 1843.ISSN: 0940-6719 DOI: 10.1007/s00586-012-2314-z Springer-Verlag, Berlin/Heidelberg . http://rd.springer.com/article/10.1007/s00586-012-2314-z#

[2] Anderson PA, Froyshteter AB, Tontz WL Jr.. Meta-analysis of Vertebral Augmentation Compared to Conservative Treatment for Osteoporotic Spinal Fractures. Journal of Bone and Mineral Research 2012 Sep 18. doi: 10.1002/jbmr.1762

[3] Cauley JA, Thompson DE, Ensrud KC, et al. Risk of mortality following clinical fractures. Osteoporos Int. 2000;11(7):556-61.

[4] Lau E, Ong K, Kurtz S, et al. Mortality followign the diagnosis of a vertebral compression fracture in the Medicare population. J Bone Joint Surg Am. 2008 Jul;90(7):1479-86

[5] Edidin A, et al. Mortality Risk for Operated and Non-Operated Vertbral Fracture Patients in the Medicare Population. JBMR, 2011: Feb 9. DOI: 10.1002/jbmr.353 Dbeall01 (talk) 06:27, 7 January 2013 (UTC)