Talk:Vertebral augmentation/Archive 2

Archive 1

Archive 2

Evidence is Important, not Opinion

Much of what has been stated by Korrupt95 and I has been dismissed with general or summary comments without data support. This is a point by point response with high quality literature data in support of the response. Doc James (on NEJM studies): We have other refs that say the NEJM studies are level 1.

Dbeall: This are dated. The meta-analysis from Paul Anderson, et al downgrades the NEJM articles to level II data based on flawed inclusion criteria and high crossover rate based on PRISMA analysis, the Cochrane Risk of Bias table and Levels of Evidence for Primary Research as adopted by NASS.

Doc James (on mortality): Sorry this makes no sense. If this procedure was so effective at decreasing mortality it would have been picked up in the blinded trial. It was not which makes this claim very suspect.

Dbeall: The blinded trials were not designed to measure mortality as a primary or secondary outcomes and the INVEST trial was completed after only 4 weeks. There is ample evidence that vertebral augmentation improves mortality rates as was concluded by A. Edidin, et al who examined 858,978 pts and by MC Gerling who examined hospitalized pts over a 13 year time period. These studies were designed to examine mortality rates specifically.

Doc James (on study power): The claim that not enough people where in the trial is only of importance for small changes in outcomes not large ones. One cannot use the study design in the Edidin paper to say anything definitive about the effect of the procedure on mortality, there are simply to many confounders. For example we do not typically operate on people with very poor outcomes but instead on those with some chance to benefit.

Dbeall: The number of pts is critical for having enough Power to determine statistical significance (usu at an 80% Confidence Interval). The number of pts increases the Power, less pts decreases Power, it is critically impt to have enough pts. The Edidin paper analysis strongly suggested that mortality diff’s betw the groups studied cannot be explained by pt characteristics such as their health status or comorbidities. I will contact Dr. Edidin and ask him to elaborate.

Doc James: In RCTs there is always a chance that the arm someone is randomized (sic) to may have a greater mortality. And this arm may be the one which include vertebroplasty as the evidence stands. Thus first do no harm should mean that those doing the procedure outside of properly done clinical trials should really stop until they have proper evidence. The evidence you quote is not going to be release until April 2013 but is a draft as you state. We will consider it here after it has been published.

Dbeall: The RCT’s always strive to have the cohort groups as possible. A few pts prone to morality randomizing to either group should not affect statistical significance of the study is adequately powered. The NICE data you quote is indeed preliminary but is based on literature that is not preliminary (Edidin, Gerling, Lau, Cauley). Vertebral Augmentation has been shown to give rise to less mortality and it is on a very short list of surgical procedures that do that. This data has changed the way I talk to pts about the procedure. First doing no harm also means first be aware of new information that can affect how pt care is delivered.

Doc James: Thus first do no harm should mean that those doing the procedure outside of properly done clinical trials should really stop until they have proper evidence.

Dbeall: Doc James is advocating a cessation of all Vertebroplasty until proper evidence is obtained. There are There are 1587 vertebral augmentation articles in the English language, more than any other area of spine and more than nearly all of the other areas combined. How much “proper evidence” is needed? The most recent meta-analysis published in 2012 evaluated 27 studies including eight randomized studies. There were nine articles that compared Verteboplasty to Kyphoplasty and three articles that reported on two non-randomized studies. This was all Level I and II data. Is this not proper evidence? Avram Edidin, et al, concluded the the adjusted life expectancy was 115% more for Kyphoplasty pts, 44% more for Vertebroplasty patients and the median life expectancy was 2.2-7.3 yrs more for groups treated with vertebral augmenatation vs. those treated with nonsurgical management. Despite this, Doc James is recommending no treatment of this type. Zad68: Please be reminded that Wikipedia is a general encyclopedia and specifically does not give medical advice. Wikipedia does not take positions on issues of opinion, all it does is summarize results. If the results are reported to be of a certain quality level, we simply state that, we generally don't try to second-guess what really might have or should have happened. Dbeall: That statement is absolutely correct and because it summarizes results and does not give medical advice it is of paramount importance that the data is replete and current. The site currently has literature that is dated and despite the fact that all of the level I and II data (considered in Toto) is in strong support of vertebral augmentation, the editor states that he believes the procedure should be ceased except those done in clinical trials.

Doc James: You will need to convince the rest of the community. A retrospective study simply does not prove the benefit of one treatment over another. The most it can do is generate a hypothesis that requires further study. A number of people have come and presented research however I disagree with some of the interpretations. Doc James Dbeall: Observational studies analyzing retrospective data from administrative and clinical databases contain a substantial amount of information which are often used to supplement findings from randomized trials on the safety and effectiveness of therapies in routine clinical practice. This data specifically does provide information and data from one treatment vs another (Berger ML, Mamdani M, Atkins D, Johnson ML. Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: The ISPOR good research practices for retrospective database analysis task force report—Part I. Value Health 2009;12:1044-52.). This is a valuable adjunct in the analysis of therapies and cannot be dismissed out of hand.

Doc James (on what is needed to show effectiveness of Vertebroplasty): Probably better evidence for the effectiveness of the procedure. I am not sure where we could begin. It appears that members of your group including yourself do not see the procedure as controversial [7] and [8] despite the fact that this controversy is supported by 2 review articles published in 2012.

Dbeall: The meta-analyses by Ming-Min Shi and Paul Anderson specifically analyzing Vertebroplasty provide “strong evidence strong evidence in favor of Vertebroplasty in the treatment of VCF’s”. This procedure has been studied as much or more than anything else in spine and the evidence is strong despite the beloved 2009 articles that are repetively referred to. Doc James states that the controversy is supported by the 2 review articles published in 2012 despite the conclusions of Min-Ming Shi stating: “Different control groups may have accounted for the different conclusions in the literature regarding the ability of PVP to relieve pain and restore function recovery. Compared with nonoperative treatment PVP relieved pain better and improved QOL. PVP did not increase the risk of new fractures” and the conclusions of Paul Anderson who concluded: “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”. 24.249.99.16 (talk) 13:19, 14 January 2013 (UTC)

And there are a number of meta analysis from 2012 that do not support the procedure. I have never specifically referred to the primary research just the secondary research which is not nearly as rosy as the bit your group emphasizes. Doc James (talk · contribs · email) (if I write on your page reply on mine) 17:48, 14 January 2013 (UTC)

Response to Question on Interpreting Evidence

Garamond Lethe states that both sham and VP reduced pain but the diff was not statistically significant. That is entirely correct. To gain full understanding it helps to know that the "sham" treatment in the 2009 studies was the paraspinal injection of Bupivicaine. David Wilson, et al showed that the paraspinal facet/medial branch blocks were effective at significantly decreasing pain. He showed that 34% of pts reported immediate pain relief which lasted only 8 wks (the 2009 sham study by Kallmes only followed pts for 1 month) and out of 29 pts who failed to respond to these injections, 24 had Vertebroplasty with a 94% success rate. Also to elaborate on the pain reduction component of Vertebroplasty it is helpful to understand the statistics of the sham studies. Using the largest (Kallmes' INVEST trial), they reported an avg decrease in VAS scores of pain of 3 at 1-month. This is not that different from the FREE trial that reported avg of a decrease of 3.5 points (FREE trial had statistically significant decreases at all time points). So the results of PRCTs do not appear to be that dissimilar. If we look into the Kallmes trial, out of 128 pts analyzed (3 pts lost to f/u) – p value = 0.06, response rate 64% in VP group & 48% in control group and keeping same response rate with their originally intended number of patients (250), the results become statistically significant at p value = 0.01. In other words if the results were exactly the same and the trial had the originally intended number of pts, Vertebroplasty would have shown a significantly better pain decrease than "sham". Also, if 1 pt had different response (i.e. favorable in VP group or unfavorable in control group)the p value would have been p = 0.04...also showing that Vertebroplasty was significantly better than sham. This is not exacly optimal or statistically solid evidence that you would want to make patient treatment decisions based upon. 24.249.99.16 (talk) 13:37, 14 January 2013 (UTC)

Thanks for the quick response. That was helpful. GaramondLethe 14:41, 14 January 2013 (UTC)

One cannot make the claims this IP does above. If all patients had been enrolled we have no idea what it would show. The meta analysis of these two trials for acute pain did not show benefit. [1] In fact there was greater opioid use at one month. Doc James (talk · contribs · email) (if I write on your page reply on mine) 17:55, 14 January 2013 (UTC)

Bringing New Data to the Forefront

The articles listed above are new and largely result from the controversy generated by the 2009 NEJM articles on Vertebroplasty. The results of these articles were not consistent with the physicians (and patients) experience with vertebral augmentation and this stirred renewed interested in examining vertebral augmenation. The summary articles provided by Korrupt95 are, in my opinion, the best available as it summarizes all of the best information on Vertebroplasty and Vertebral Augmentation to include Kyphoplasty. As Garamond Lethe pointed out the AAOS recommendation is still standing. This recommendation is based solidly on the old articles and, unfortunatley, includes none of the newer meta-analyses that we are privy to now. This is unfortunate as the patients are not receivng the most up to date and best evidence based information. That is, however, what we are trying to do here as objectively as possible. Dbeall01 (talk) 13:41, 17 January 2013 (UTC)

This has been brought up before, but it's worth saying again: Based on what you've written, your goal might be to get the Wikipedia article to highlight the new information, but Wikipedia's content guidelines direct us to summarize the general scientific consensus. The article as it is now is well-balanced and fairly reflects what has been reported in the best-quality secondary sources in proportion to the viewpoints found in them. This is the essence of the Wikipedia content policy regarding due weight. Montagu (July) 2012 sums it up pretty well, "Recent high-quality studies have been contradictory and there is currently a debate surrounding the role of the procedure with no agreement in the literature." The article reflects that pretty well, so I'm not seeing a Wikipedia policy- and guideline-based reason to change the article. Zad68 14:59, 17 January 2013 (UTC)

There really is no debate. CMS guidelines for augmentation are 1)hospitalization for acute back pain caused by a VCF 2) 2 weeks of failed narcotic use to treat VCF 3) six weeks of 'other' failed conservative treatments of VCF 4)metastatic fracture. Link to CMS Assessment The reason CMS has these guidelines is because all of the data shows that this is the best way and best timing to treat VCFs. There is no data in existance that shows conservatve therapy is better than augmentation. There is no data that says back bracing is better. No data that says bed rest and and physical therapy are better. There is no data that says nerve blocks work better. And all the NEJM articles really tell us is that if you have a VAS score of 3, and you decide to either get an injection (not a sham and not 'nothing') or a vertebroplasty - your outcome is going to be the same. I understand that Wikipedia has policies. If you were able to swap the talk page for the actual article, you'd get a more balanced page. Also, the first picture showing vertebroplasty set up, is actually a kyphoplasty, if anyone would like to make that edit. Clay1500 (talk) 17:05, 19 January 2013 (UTC)

Thanks for the fix for the image caption, that was put in place. I really hate to make you feel like you're beating your head against a wall here but, I understand what you're saying--you're an expert and you're making your own analysis in response to "there is currently a debate surrounding the role of the procedure" I cited above based on your expertise... but, on Wikipedia we can't use that, and the policy is no original research. Zad68 03:52, 20 January 2013 (UTC)

The image capture read percutaneous vertebroplasty, yet you show a kyphoplasty picture and suite. Changed the name from 'percutaneous vertebroplasty, to 'kyphoplasty' so the two match up and are not mislabeled. Korrupt95 (talk) 04:57, 20 January 2013 (UTC)

Less Controversial Due to All Level I and II Data

The evidence is indeed less and less controversial. When the entire body of information is considered we must conclude that Kyphoplasty and Vertebroplasty is significantly better than nonsurgical management and is recommended for patients who have painful VCF’s despite optimal pain management. Vertebroplasty and that it is cost effective in the treatment of painful VCF’s. The collection of all Level I and II data shows significant reductions in pain, improvement in quality of life, less subsequent fractures, greater kyphosis reduction and less cement extravasation, and that surgical intervention within the first seven weeks yielded greater pain reduction than fractures treated later.

Same say controversial others say no. So yes still controversial. Less subsequent fractures? Do you have a ref for that? Doc James (talk · contribs · email) (if I write on your page reply on mine) 05:27, 10 January 2013 (UTC)

Meta-analysis by Anderson et al, 'Meta-analysis of vertebral augmentation compared with conservative treatment for osteoporotic spinal fractures' http://www.ncbi.nlm.nih.gov/pubmed/22991246 PMID 22991246 [PubMed] Korrupt95 (talk) 05:10, 20 January 2013 (UTC)

Not Letting Unsubstantiated Comments Slide Past

Zad68 says that: "Wikipedia's content guidelines direct us to summarize the general scientific consensus. The article as it is now is well-balanced and fairly reflects what has been reported in the best-quality secondary sources in proportion to the viewpoints found in them". We have had an online interchange and conversation regarding this topic with most of the North American Experts on Vertebroplasty and this statement is simply not accurate. Out of all of the statements back and forth the overwhelming number were strongly supportive of Vertebroplasty and Vertebral Augmentation. If this is in dispute, I would invide Zad68 to share opinions with this expert group and, as was pointed out by Zad68, the goal is to summarize the general scientific concensus. On this point I agree and will invite all to participate.

• Consensus isn't based on a counting editors' opinions on the talk page. AAOS and UpToDate are the kinds of organizations that have the best (though imperfect) reflection of current scientific consensus. Sometimes they're wrong, and we're cheerfully wrong along with them. If you can change their stance then the article will change as well. GaramondLethe 18:59, 19 January 2013 (UTC)

• I'm puzzled why you are characterizing my comments as "unsubstantiated" when I provided substantiation along with my comments in the form of links to sources, along with the most important summary statements from each source. Generally user-provided content such as logs of Internet chat forums, as you seem to be describing, are not acceptable sources for biomedical information. If the prevailing opinion about these procedures is indeed changing, we can expect over the next months or years to see updated statements from medical organizations or new meta-analysis and review articles appear in journals, and when we have those items available as published sources, we can update the article. Zad68 03:24, 20 January 2013 (UTC)

This article mentions the overall costs associated with vertebroplasty and kyphoplasty both from the under the 'Society & Culture, header and 'Cost' section. Some of these reference sources including the Montagu et al study and NY Times reference have other published sources which suggest opposing opinions. I would like to offer up some additional citations related to the overall 'cost-effectiveness' related to the two procedures in chronological order. Zad681, Garamound, Dbeall and DocJames, please consider these to be referenced in the article.

1. 1. Zampini et al, 'Comparison of 5766 vertebral compression fractures treated with or without kyphoplasty http://www.ncbi.nlm.nih.gov/pubmed/20177836

PMID 20177836 [PubMed - indexed for MEDLINE] PMC 2882011 Free PMC Article

Clin Orthop Relat Res. 2010 Jul;468(7):1773-80. doi: 10.1007/s11999-010-1279-7.

Comparison of 5766 vertebral compression fractures treated with or without kyphoplasty. Zampini JM, White AP, McGuire KJ. Source Department of Orthopaedic Surgery, Hahnemann University Hospital, Drexel University College of Medicine, 245 N 15th Street, Philadelphia, PA, 19102, USA. jay.zampini@tenethealth.com

Abstract
The following discussion has been closed. Please do not modify it.
Abstract BACKGROUND: The majority of the 700,000 osteoporotic vertebral compression fractures (VCFs) that occur annually in the United States affect women. The total treatment costs exceed $17 billion and approximate the total costs of breast cancer ($13 billion) and heart disease ($19 billion). Balloon-assisted percutaneous vertebral augmentation with bone cement (kyphoplasty) reportedly reduces VCF-related pain and accelerates return of independent functional mobility. Kyphoplasty may decrease overall cost of VCF treatment costs by reducing use of posttreatment medical resources. QUESTIONS/PURPOSES: We evaluated complications, mortality, posthospital disposition, and treatment costs of kyphoplasty compared with nonoperative treatment using the Nationwide Inpatient Sample database. METHODS: We identified 5766 VCFs (71% female) in patients 65 years of age or older with nonneoplastic VCF as the primary diagnosis in nonroutine hospital admissions; 15.3% underwent kyphoplasty. Demographic data, medical comorbidities, and fracture treatment type were recorded. Outcomes, including complications, mortality, posthospital disposition, and treatment costs, were compared for each treatment type. RESULTS: Women were more likely to be treated with kyphoplasty than were men. Patients undergoing kyphoplasty had comorbidity indices equivalent to those treated nonoperatively. Kyphoplasty was associated with a greater likelihood of routine discharge to home (38.4% versus 21.0% for nonoperative treatment), a lower rate of discharge to skilled nursing (26.1% versus 34.8%) or other facilities (35.7% versus 47.1%), a complication rate equivalent to nonoperative treatment (1.7% versus 1.0%), and a lower rate of in-hospital mortality (0.3% versus 1.6%). Kyphoplasty was associated with higher cost of hospitalization (mean $37,231 versus $20,112). CONCLUSIONS: Kyphoplasty for treatment of VCF in well-selected patients may accelerate the return of independent patient function as indicated by improved measures of hospital discharge. The initially higher cost of treatment may be offset by the reduced use of posthospital medical resources. LEVEL OF EVIDENCE: Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence. PMID 20177836 [PubMed - indexed for MEDLINE] PMC 2882011 Free PMC Article Publication Types, MeSH Terms, Substances

1. 2 Edidin et al, 'Mortality risk for operated and nonoperated vertebral fracture patients in the medicare population.' http://www.ncbi.nlm.nih.gov/pubmed/21308780

PMID 21308780 [PubMed - indexed for MEDLINE]

J Bone Miner Res. 2011 Jul;26(7):1617-26. doi: 10.1002/jbmr.353.

Mortality risk for operated and nonoperated vertebral fracture patients in the medicare population. Edidin AA, Ong KL, Lau E, Kurtz SM.

Abstract
The following discussion has been closed. Please do not modify it.
Abstract Vertebral compression fractures (VCFs) are associated with increased mortality risk, but the association between surgical treatment and survivorship is unclear. We evaluated the mortality risk for VCF patients undergoing conservative treatment (nonoperated), kyphoplasty, and vertebroplasty. Survival of VCF patients in the 100% U.S. Medicare data set (2005-2008) was estimated by the Kaplan-Meier method, and the differences in mortality rates at up to 4 years were assessed by Cox regression (adjusted for comorbidities) between operated and nonoperated patients and between kyphoplasty and vertebroplasty patients. An instrumental variables analysis was used to evaluate mortality-rate difference between kyphoplasty and vertebroplasty patients. A total of 858,978 VCF patients were identified, including 119,253 kyphoplasty patients and 63,693 vertebroplasty patients. At up to 4 years of follow-up, patients in the operated cohort had a higher adjusted survival rate of 60.8% compared with 50.0% for patients in the nonoperated cohort (p < .001) and were 37% less likely to die [adjusted hazard ratio (HR) = 0.63, p < .001]. The adjusted survival rates for VCF patients following vertebroplasty or kyphoplasty were 57.3% and 62.8%, respectively (p < .001). The relative risk of mortality for kyphoplasty patients was 23% lower than that for vertebroplasty patients (adjusted HR = 0.77, p < .001). Using physician preference as an instrument, the absolute difference in the adjusted survival rate at 3 years was 7.29% higher in patients receiving kyphoplasty than vertebroplasty (p < .001), compared with a crude absolute rate difference of 5.09%. This study established the mortality risk associated with VCFs diagnosed between 2005 and 2008 with respect to different treatment modalities for elderly patients in the entire Medicare population. Copyright © 2011 American Society for Bone and Mineral Research. PMID 21308780 [PubMed - indexed for MEDLINE]

1. 3. Edidin et al, 'Life expectancy following diagnosis of a vertebral compression fracture.' http://www.ncbi.nlm.nih.gov/pubmed/22422305

PMID 22422305 [PubMed - as supplied by publisher] Osteoporos Int. 2012 Mar 16. [Epub ahead of print]

Life expectancy following diagnosis of a vertebral compression fracture.

Edidin AA, Ong KL, Lau E, Kurtz SM.

Abstract
The following discussion has been closed. Please do not modify it.
Abstract The life expectancy of vertebral compression fracture (VCF) patients was evaluated as a function of their treatment. Compared to non-operated patients, the kyphoplasty and vertebroplasty patient cohort had 115% and 44% greater adjusted life expectancy, respectively. Kyphoplasty patients had a 34% greater adjusted life expectancy than vertebroplasty patients. INTRODUCTION: Balloon kyphoplasty and vertebroplasty are minimally invasive procedures for the treatment of painful VCFs. This comparative effectiveness study characterized the life expectancy of VCF patients as a function of their treatment. METHODS: Life expectancy of VCF patients in the 100% U.S. Medicare dataset (2005-2008) was estimated using a parametric Weibull survival model (adjusted for comorbidities), and compared between operated and non-operated patients as well as between kyphoplasty and vertebroplasty patients. A total of 858,978 patients with a newly diagnosed VCF were identified, including 119,253 kyphoplasty patients (13.9%) and 63,693 vertebroplasty patients (7.4%). RESULTS: Adjusted life expectancy was 85% greater for operated than non-operated patients (p < 0.001; 95% confidence interval: 82-89%). Compared to non-operated patients, the kyphoplasty and vertebroplasty patient cohort had 115% (p < 0.001; 95% confidence interval: 111-119%) and 44% (p < 0.001; 95% confidence interval: 42-47%) greater adjusted life expectancy, respectively. Kyphoplasty patients had a 34% greater adjusted life expectancy than vertebroplasty patients (p < 0.001; 95% confidence interval: 31-36%). Across all gender-age groups, the median life expectancy predicted by the parametric Weibull model was 2.2-7.3 years greater for operated than non-operated patients. CONCLUSIONS: Statistically significant and substantial differences in life expectancy were observed between the treated and non-treated cohorts in the Medicare population. Among the treated cohorts, patients in the vertebroplasty group experienced less of a survival benefit than those who received kyphoplasty. The results will be a useful basis for future cost effectiveness studies of VCF treatments for the Medicare population. PMID 22422305 [PubMed - as supplied by publisher]

1. 4. Edidin et al, 'Cost-effectiveness analysis of treatments for vertebral compression fractures.'

http://www.ncbi.nlm.nih.gov/pubmed/22591065 PMID 22591065 [PubMed - indexed for MEDLINE]

Appl Health Econ Health Policy. 2012 Jul 1;10(4):273-84. doi: 10.2165/11633220-000000000-00000.

Cost-effectiveness analysis of treatments for vertebral compression fractures. Edidin AA, Ong KL, Lau E, Schmier JK, Kemner JE, Kurtz SM.

Abstract
The following discussion has been closed. Please do not modify it.
Abstract BACKGROUND: Vertebral compression fractures (VCFs) can be treated by nonsurgical management or by minimally invasive surgical treatment including vertebroplasty and balloon kyphoplasty. OBJECTIVE: The purpose of the present study was to characterize the cost to Medicare for treating VCF-diagnosed patients by nonsurgical management, vertebroplasty, or kyphoplasty. We hypothesized that surgical treatments for VCFs using vertebroplasty or kyphoplasty would be a cost-effective alternative to nonsurgical management for the Medicare patient population. METHODS: Cost per life-year gained for VCF patients in the US Medicare population was compared between operated (kyphoplasty and vertebroplasty) and non-operated patients and between kyphoplasty and vertebroplasty patients, all as a function of patient age and gender. Life expectancy was estimated using a parametric Weibull survival model (adjusted for comorbidities) for 858 978 VCF patients in the 100% Medicare dataset (2005-2008). Median payer costs were identified for each treatment group for up to 3 years following VCF diagnosis, based on 67 018 VCF patients in the 5% Medicare dataset (2005-2008). A discount rate of 3% was used for the base case in the cost-effectiveness analysis, with 0% and 5% discount rates used in sensitivity analyses. RESULTS: After accounting for the differences in median costs and using a discount rate of 3%, the cost per life-year gained for kyphoplasty and vertebroplasty patients ranged from $US1863 to $US6687 and from $US2452 to $US13 543, respectively, compared with non-operated patients. The cost per life-year gained for kyphoplasty compared with vertebroplasty ranged from -$US4878 (cost saving) to $US2763. CONCLUSIONS: Among patients for whom surgical treatment was indicated, kyphoplasty was found to be cost effective, and perhaps even cost saving, compared with vertebroplasty. Even for the oldest patients (85 years of age and older), both interventions would be considered cost effective in terms of cost per life-year gained. PMID 22591065 [PubMed - indexed for MEDLINE] Publication Types, MeSH

These four (4) additional published studies should be discussed and mentioned in the article as the information has gotten better and the information more current. It should be noted that cost-effective is different than previous citations about safety and efficacy. These are more from a health care economic perspective. Enjoy! 98.66.9.8 (talk) 05:48, 20 January 2013 (UTC)

The Tyranny of Unintended Consequences

It has been interesting reading over the recent activity on this page. I am sad to say that those who control the content on this page (Doc James?) are simply reducing the strength of information on this subject by not balancing the discussion. Doc James is not an expert on vertebral compression fractures. He is an expert on creating medical information pages on Wikipedia. He clearly cares more for his cyber reputation than producing reputable content that could be helpful to those seeking knowledge on the subject. To those who are fighting for fact based publishing, I fear your efforts will remain fruitless. What is worse, patients who find their way to this page will not be shown the best and current findings on this topic. It is a continuation of the tyranny of unintended consequences. On a daily basis, patients suffer needlessly as they are misguided by caregivers and 'informed' family members who put their trust in the spin of two articles that the NEJM mistook for good science. Augmentation is not for everyone, but far too many are not given the option to make a clear decision because of content like this. Clay1500 (talk) 15:08, 15 January 2013 (UTC)

Wikipedia's purpose is not to give medical advice. Wikipedia by design does not provide the most-recently published study results, Wikipedia is not a results database or a medical journal, it is a general encyclopedia and per guidelines we prefer to cite secondary sources like reviews, meta-analyses and statements from major medical organizations, and they will always be years behind the latest research results. Patients working with caregivers should be consulting with their caregivers for medical advice, Wikipedia cannot be held responsible if someone makes a suboptimal health care choice for him/herself after reading a Wikipedia article, see WP:MEDICAL. And making personal attacks against other editors is not allowed, see WP:NPA. Zad68 16:30, 15 January 2013 (UTC)

While I agree with you in principle and respect the guidelines you've laid out WP:NPA, the fact of the matter is that most of the lay public believes Wikipedia is a credible reference source. Therefore it should be everyone's common goal to clearly lay out all of the secondary evidence. DBeall and other specialty physicians have cited numerous peer-reviewed publications such as the Papastansiou meta-analysis and Wardlaw studies published in highly respected medical journals, yet for some reason, people are unwilling to recognize them. Additionally, this site slanders kyphoplasty when there is no sham study to compare too. There are only a couple general mentions about the clinical evidence on vertebroplasty and kyphoplasty, yet there is overwhelming evidence which supports the procedures. This is frustrating be because there is no acknowledgement of the positive benefits. They are simply dismissed and edited out. It seems like the medical editors are against these procedures. This is not right and very frustrating and disappointing. Nice try though.Korrupt95 (talk) 02:55, 16 January 2013 (UTC)

Can you provide a link to the references that you are talking about, I.e. "the Papastansiou meta-analysis and Wardlaw studies". I am new to this article, somI haven't been following the editing events here. Thanks. :-)--MrADHD | T@1k? 03:08, 16 January 2013 (UTC)

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 http://www.ajnr.org/content/early/2012/11/22/ajnr.A3363.full.pdf Korrupt95 (talk) 06:34, 20 January 2013 (UTC)

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. http://www.ncbi.nlm.nih.gov/pubmed/19246088

Korrupt95, you (and others) are making an argument based on what you think wikipedia ought to be and Doc James (and others) are making an argument based on current wikipedia policy. At the end of the day the policy argument is going to win out. You're welcome to try to change the policy, but I think your efforts would be more effective if focused on getting the AAOS to change their recommendation. GaramondLethe 04:11, 16 January 2013 (UTC) Korrupt95 (talk) 06:34, 20 January 2013 (UTC)

Hi Garamond you are precisely right! The AAOS guidelines are out of date and must be revisited. The current and emerging evidence makes a strong case for this treatment. I'm following you on the 'policy' of WikiMed. What I still do not understand is, why only Level 1 data is offered and discussed and more importantly what if that data is just wrong? If the level 1 data were performed correctly, than we would all be in agreement. But the evidence everyone so desperately wants to hold as the standard bearer is flawed. Yet everyone dismisses the 'thoughtful' challenges. 51% of the sham subjects crossed over. 12% of the VP group crossed over. Does anyone else see a fundamental flaw with that study outcome? And it wasn't a sham procedure. It is not the Wikipedia policy that is being questioned. It is the fact that the information on this site points to two studies that do not represent what some feel they do. I know that you are neutral here and I appreciate your calm reserve Mr. Lethe! Korrupt95 (talk) 05:23, 16 January 2013 (UTC)

Hi Korrupt95. I appreciate and understand that you're trying to improve this article, and that you're genuinely puzzled as to why we've adopted a set of policies that prevents this from happening. Here's my best attempt at an explanation as to why this is.

Let's hypothesize that you and Doc James eventually decide to escalate your difference of opinion to dispute resolution (say, WP:DRN). We don't have a panel of board-certified physicians to make a final determination. We don't even have a group of medical students doing peer review. What you're going to get is someone like.... me. I don't know what a crossover rate is or why it's important. I can't judge whether or not a sham study is valid. But what I can do (and often all I can do) is give a rough evaluation of the quality of the citations at issue.

So I'm going to score an AAOS study higher than a meta-analysis, and a meta-analysis higher than a single study, and a single study in a high-profile journal higher than one in a vanity journal. Other editors can do this as well, and so there's a reasonable chance that several editors can reach a consensus based on this (overly) simplistic rule of thumb.

I absolutely agree with you that this puts a low ceiling on how good articles can be. What I don't think you appreciate yet is that it also puts a high floor on the quality. AAOS might have completely botched the VP recommendation, but they're going to reflect accurately the consensus view on most topics most of the time, and they'll get around to fixing most of their mistakes eventually. We don't aim to do better than that.

But let's say we wanted to do try to do better than the AAOS. We have several experts here at the moment: can't we just let the people who actually perform the procedure and follow the literature take responsibility for writing the article?

Most of the time, the answer is yes. Most edits to most articles are uncontroversial and unchallenged, and as an expert you're going to have a great deal of leeway in what you decide to introduce and emphasize. But once any editor decides to challenge any edit, we ultimately end up with non-expert editors arbitrating the disagreement. Given this constraint, I can think of many worse rules than a simplistic weighing of citation pedigrees.

I'll leave it at that for the moment. I'm more than happy to discuss this further or point you to people who know more about this than I do. GaramondLethe 06:19, 16 January 2013 (UTC)

Hi Garamond. Terrific response! There are also AANS guidelines (Am. Association of Neurological Guidelines) as well as the UK NiCE council and 97% of public and private insurance payers that have favorable recommendations or positive converge for vertebroplasty and balloon kyohoplasty.

What if we provided this community with the evidence including the study design, peer-reviewed article, study outcomes and the citation for vertebral lastly and kyphoplasty. Not the small single site studies but the large randomized multi-center studies, the meta-analysis and the medical society guidelines. And we agree to simply review and share these 'meaningful' multiple arm comparative studies. Also let's separate out a separate Wikimed page for kyphoplasty. #1 there are 3x more kyphoplasty cases than vertebroplasty. #2. The AAOS guidelines DO recommend Kyphoplasty, just not vertebroplasty. #3. There is no sham or double blinded RCT against kyphoplasty. #4 there are more meaningful articles on kyphoplasty. We could even use your help in formatting and creating a separate kyphoplasty page. Keeping the two procedures separate avoids a lot of this disagreement. You are a gentleman and a statesman. Appreciate your mediation Garamond and Doc James. Kudos on being so passionate yet pragmatic in understanding this request. Korrupt95 (talk) 06:58, 16 January 2013 (UTC)

Just got home tonight from a month of travel. Will pick this back up in a couple of days. GaramondLethe 05:34, 17 January 2013 (UTC)

First, to respond to a minor point: there's some controversy over insurance coverage as well. See this:

• Katharine Cooper Wulff, Franklin G. Miller and Steven D. Pearson. "Can Coverage Be Rescinded When Negative Trial Results Threaten A Popular Procedure? The Ongoing Saga Of Vertebroplasty" Health Affairs, 30, no.12 (2011):2269-2276 doi: 10.1377/hlthaff.2011.0159

Second minor point: the strength of the AAOS recommendation of kyphoplasty was "limited", defined as:

• Definition: A Limited recommendation means that the quality of the supporting evidence is unconvincing, or that well-conducted studies show little clear advantage to one approach over another.
• Implications: Practitioners should exercise clinical judgment when following a recommendation classified as Limited, and should be alert to emerging evidence that might negate the current findings. Patient preference should have a substantial influencing role.

As to your proposal to separate out kyphoplasy: the article was originally separate but was merged with this article relatively recently (see the top of the talk page for details). If there's enough information out there (and you seem to think that there is) then yes, we can definitely separate the topics. I'm not going to write it, though. You're the expert, so you should definitely take the lead on the writing. I'm happy to help answer most questions and can usually find someone to cover areas outside of my own expertise. You can start by putting this into your browser: http://en.wikipedia.org/wiki/User:Korrupt95/sandbox/Kyphoplasty and click on the "Start this page" link, and start writing! You can drop a note on my talk page with questions or drop in at the wikipedia teahouse for an even faster response. Please keep in mind that you don't own the article (see WP:OWN for exactly what that entails) and that anyone can and will edit it. As I've mentioned elsewhere, creating articles in your area of expertise can be frustrating because of the continual need to convince non-experts of the validity of your opinion without resorting to "because I'm the expert and you're not" argument. Even still, writing an article can be a tremendously satisfying (and often humbling) experience, and I hope you decide to have a go at it. GaramondLethe 20:48, 19 January 2013 (UTC)

Hi Garamond thank you. I believe that separate pages to better distinguish kyphoplasty from vertebroplasty are needed. I will try to take a first pass. Appreciate your guidance and I'd appreciate the community's support. I may need help on the formatting and editing. I also acknowledge your point about avoiding topics within one's expertise. The goal is not to make a convincing argument in so much as accurately summarizing the collection of published articles. Cheers Korrupt95 (talk) 05:16, 20 January 2013 (UTC)

Hi MRADHD - here is the Papanastassiou meta-analysis < ref>http://www.ncbi.nlm.nih.gov/pubmed/22543412</ref>. http://www.ncbi.nlm.nih.gov/pubmed/22543412 also see the Wardlaw et al meta-analysis http://www.ncbi.nlm.nih.gov/pubmed/19246088 and the forthcoming Anderson et al meta-analysis http://www.unboundmedicine.com/medline/citation/22991246/Meta_analysis_of_vertebral_augmentation_compared_to_conservative_treatment_for_osteoporotic_spinal_fractures_ . Thanks! Korrupt95 (talk) 05:13, 16 January 2013 (UTC)

Okay

1. Yes Paanastassiou [2] states that VP and KP is better than surgical wait list controls. We already state this in the article.
2. The "Wardlaw et al meta-analysis" [3] is NOT a meta analysis but a primary research paper.
3. The "Anderson et al meta-analysis" [4] shows that VP is better than surgical wait list controls. We are not disputing this.
4. We have this 2012 systematic review [5] that states that VP and KP are equal, that level 1 evidence dose not support its use, and thus cannot be recommended as standard care.

Doc James (talk · contribs · email) (if I write on your page reply on mine) 08:34, 16 January 2013 (UTC)

---

To clarify the sources for anybody who needs clarification, here's a summary of the complete list of sources under discussion:

• Wardlaw 2009 -- Primary study, an RCT
• AAOS 2010 -- Guideline of the American Academy of Osteopathic Surgeons:

"We recommend against vertebroplasty for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact. Strength of Recommendation: Strong"

"Kyphoplasty is an option for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact. Strength of Recommendation: Limited"

• Robinson 2012 -- Systematic review, "Vertebroplasty and kyphoplasty cannot be recommended as standard treatment for osteoporotic VCF."
• Papanastassiou 2012 -- Systematic review, "BKP/VP provided greater pain relief and fewer subsequent fractures than NSM in osteoporotic VCFs." but "the current literature is delivering inconsistent messages and further trials are needed".
• Anderson 2013 (not yet actually officially published) -- Meta-analysis, "This meta-analysis provides strong evidence in favor of cement augmentation in the treatment of symptomatic VCF fractures."

Zad68 14:19, 17 January 2013 (UTC)

UpToDate.com

DocJames points to this reference recommending against Vertebroplasty. This has come to the attention of the experts in Vertebral Augmentation and an Open Letter critiquing the info on the UpToDate.com website has been released to various medical societies, practicing physicians, physician groups, medical device industry groups, and numerous other sites. This Open Letter takes the UpToDate.com information and analyzes all of the points in sequence, highlights inaccuracies and inconsistencies and provides a complete and timely literature based analsis of this information on the UpToDate.com website. The Experts in Vertebral Augmenation conclude: "Most of the best contributions to the literature have been relatively recent and many of the analyses and recommendations have been based on older literature. The data that shows significantly higher mortality in those patients treated with nonsurgical management as compared with those patients treated with vertebral augmentation emphasizes the importance of offering the treatment most likely to benefit the patient. If all of these factors are taken into consideration it appears that the information on uptodate is out-of-date". Dbeall01 (talk) 17:46, 19 January 2013 (UTC)

• The fact that vertebroplasty is more effective than non-surgical management is uncontroversial and reflected in the article. GaramondLethe 19:19, 19 January 2013 (UTC)

Vertebroplasty and kyphoplasty being effective over non-surgical management is not in dispute. I agree with you Garmamond. I would like to see more of the research findings discussing that on the page including the Berenson study about the effectiveness with cancer survivors, published in the Lancet. http://www.ncbi.nlm.nih.gov/pubmed/21333599

PMID 21333599 [PubMed - indexed for MEDLINE]. Korrupt95 (talk) 05:05, 20 January 2013 (UTC)

• Hi Korrupt95. If you put a colon in front of your comment the wiki software will indent it a bit, and the more colons you add the larger the indentation. The convention is to add one more colon than the person to whom you're replying. Who is talking to whom is usually clear enough without this typographic hint, but it does making skimming easier. (If too many colon are piling up, use "outdent", aka {{od}}, which looks like this:

and then continue with zero colons. With that bit of housekeeping out of the way, I would support adding a line that says "Several studies have shown kyphoplasty to be more effective than non-surgical management." and include the Lancent cite in support of this. What would be your two best additional cites to that effect? GaramondLethe 05:20, 20 January 2013 (UTC)

• Hi Garamond. Here are the some of the top studies which support kyphoplasty. Not necessarily against vertebroplasty, but compared to the standard of care which is non-surgical management.

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 http://www.ajnr.org/content/early/2012/11/22/ajnr.A3363.full.pdf

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. http://www.ncbi.nlm.nih.gov/pubmed/19246088

There is even an independent expert review with supports this article. Balloon kyphoplasty in patients with osteoporotic vertebral compression fractures. Expert Rev. Med. Devices 9(4), 423–436 (2012) http://www.ncbi.nlm.nih.gov/pubmed/22905846

Berenson J, Pflugmacher R, Jarzem P, Zonder J, Schechtman K, Tillman J, Bastian L, Ashraf T, Vrionis F (2011) Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. The Lancet Oncology, Volume 12, Issue 3, Pages 225 - 235, March 2011. http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70008-0/abstract

Kim KH, Kuh SU, Chin DK, Jin BH, Kim KS, Yoon YS, Cho YE. (2012) Kyphoplasty versus vertebroplasty: restoration of vertebral body height and correction of kyphotic deformity with special attention to the shape of the fractured vertebrae. J Spinal Disord Tech. 2012 Aug;25(6):338-44. doi: 10.1097/BSD.0b013e318224a6e6. http://www.ncbi.nlm.nih.gov/pubmed/21705918

Edidin AA, Ong KL, Lau E, Kurtz SM. (2011) Mortality risk for operated and nonoperated vertebral fracture patients in the medicare population. J Bone Miner Res. 2011 Jul;26(7):1617-26. doi: 10.1002/jbmr.353. http://www.ncbi.nlm.nih.gov/pubmed/21308780

Edidin AA, Ong KL, Lau E, Kurtz SM. (2012) Life expectancy following diagnosis of a vertebral compression fracture. Osteoporos Int. 2012 Mar 16. http://www.ncbi.nlm.nih.gov/pubmed/22422305

Edidin AA, Ong KL, Lau E, Schmier JK, Kemner JE, Kurtz SM. (2012) Cost-effectiveness analysis of treatments for vertebral compression fractures. Appl Health Econ Health Policy. 2012 Jul 1;10(4):273-84. doi: 10.2165/11633220-000000000-00000. http://www.ncbi.nlm.nih.gov/pubmed/22591065 Korrupt95 (talk) 07:04, 20 January 2013 (UTC)

Unfortunately, if you pile up 7 or 8 citations on the end of a sentence it looks like the editor is either adding every cite google could find or is hoping the mass of evidence will conceal its quality. This isn't a literature review. Out of these, which are the review articles and/or the meta-studies? The guidelines are at WP:MEDRS and (more generally) WP:RS. GaramondLethe 07:34, 20 January 2013 (UTC)

• Was the Open Letter published anywhere by a reputable journal independent of the experts? If so, please provide a PMID so we can see if it might be useful as a source. Zad68 03:19, 20 January 2013 (UTC)

No the open letter was simply sent to Uptodate. IMO we can and often do do a lot better than Uptodate. When Cochrane come out with a meta analysis raising concerns regarding increased complication and no benefits from activated protein C in sepsis we added the content the same week as publication. Uptodate did not adjust their recommendations until the FDA / manufacturer pulled the med globally. We beat them by a few months and potential saved people lives / money :-) Doc James (talk · contribs · email) (if I write on your page reply on mine) 10:52, 20 January 2013 (UTC)

Unmerge proposal

I moved these comments out of the "Merger Proposal" section to their own section in order to make them more visible.GaramondLethe 06:34, 20 January 2013 (UTC)

I find it interesting that this page is on vertebroplasty, yet all of the pictures are on balloon kyphoplasty. There is no sham study that applies to kyphoplasty. These two procedures should be seperated. It is misleading to combine them or to infer that they are the same. The overall conversations and citations almost overlap and confuse the reader. Also there is no comparison of the two procedures which would make it easier to distinguish for the reader. The practice of kyphoplasty is 3:1 over vertebroplasty. Why is this? Why do surgeons perfer kyphoplasty over vertebroplasty? Probably for the safety profile and ability to restore height as the Venmans et al article suggests.Korrupt95 (talk) 02:59, 12 January 2013 (UTC)

We believe that kyphoplasty and vertebroplasty should have seperate articles. They are distinctly different from one another and by combining them, there are too many many varations which lead to confusion. It would be easier and cleaner to seperate the two procedures. #1 There has never been a study comparaing kyphoplasty to sham. #2 AAOS Guidelines recommend kyphoplasty but not vertebroplasty #3 much of the published research favors kyphoplasty over vertebroplasty as far as cement extravisation and overal safety. In the Vertos II study by Venmans et al, found as much as 43% cement leakage in 34 out of 80 treated vertebrae. Korrupt95 (talk) 06:17, 20 January 2013 (UTC)

We disagree that they should have separate pages. They are very similar techniques and can be easily dealt with together. Especially since the evidence shows they are nearly equivalent except that kyphoplasty costs a whole lot more. Doc James (talk · contribs · email) (if I write on your page reply on mine) 10:54, 20 January 2013 (UTC)

Uptodate

Uptodate recommends against this procedure from osteoporotic compression fractures as well "Based upon the available data, we do not recommend vertebroplasty for pain reduction in patients with osteoporotic compression fractures." [6] Doc James (talk · contribs · email) (if I write on your page reply on mine) 23:59, 18 January 2013 (UTC)

You could cut and paste the back and forth on this talk page with Uptodate.com. The authors, like this wiki article, are not spine specialists and put far too much weight in the hyper flawed NEJM articles. Similar efforts have been put forth to have the majority consensus shared on uptodate.com Clay1500 (talk) 16:43, 19 January 2013 (UTC)

It sounds like UpToDate, like Wikipedia, is waiting for the independent reliable secondary sources to pick up on and react to any new study data before changing their published information.

You are right, Wikipedia is not maintained by spine specialists. We are mere quilters. All we do is take the patches of the analysis published by reliable secondary sources and sew them together into an article. If you expect Wikipedia articles to reflect the latest, cutting-edge opinion of industry insiders in the process of revolutionizing a medical specialty, sorry, but you'll be disappointed! Zad68 03:36, 20 January 2013 (UTC)

Yes we realize that the manufacturers of this equipment are very unhappy with this two sham controlled trials. There is more than a billion dollars on the line in the USA alone. If Medicare decides to cut its funding a lot of peoples income could be seriously affected.

While we are not experts in vertebroplasty/kyphoplasty we have a number of things going in our favor. A couple are that we are not influenced by any financial conflicts of interest and many of use have become experts in reading the literature. We know very well the importance of "blinding" and "RCT"s for example. Doc James (talk · contribs · email) (if I write on your page reply on mine) 11:01, 20 January 2013 (UTC)

Kyphoplasty and Vertebroplasty are Cost Effective and Kyphoplasty Does Not Cost More

Simply comparing initial costs of procedures is not accurate. When costs out to two years are compared Vertebroplasty has been shown to be more expensive (Ong KL, et al. Two-Year Cost Comparison of Vertebroplasty and Kyphoplasty for the Treatment of Vertebral Compression Fractures: Are Initial Surgical Costs Misleading?. Osteoporos Int 2012 DOI 10.1007/s00198-012-2100-0). Initial data from the NICE commission has also supported both procedures as being cost effective and Svedbom has also shown Kyphoplasty to be cost effective (Svedbom A, et. al Balloon kyphoplasty compared to vertebroplasty and nonsurgical management in patients hospitalised with acute osteoporotic vertebral compression fracture: a UK cost-effectiveness analysis. Osteoporos Int 2012; DOI 10.1007/s00198-012-2102-y). Dbeall01 (talk) 12:58, 21 January 2013 (UTC)

Edit request on 27 August 2013

Hi... I would like that the source say in which denomination refers the price of this medical proceeding (is not clear if this is in EURO or U$, or pesos). Thanks! 131.155.54.3 (talk) 16:52, 27 August 2013 (UTC)

Clarified. Doc James (talk · contribs · email) (if I write on your page reply on mine) 17:15, 27 August 2013 (UTC)

Edit Request October 22, 2013

The Statement under EFFECTIVENESS "In 2010, the Board of Directors of the American Academy of Orthopaedic Surgeons released a statement recommending strongly against use of vertebroplasty for osteoporotic spinal compression fractures, while the Australian Medical Services Advisory Committee considers both vertebroplasty and kyphoplasty only to be appropriate in those who have failed to improve after a trial of conservative treatment, with conservative treatment (analgesics primarily) being effective in two-thirds of people." compares the AAOS's recommendation for vertebroplasty with the AMSAC's recommendation with vertebroplasty AND kyphoplasty. A comment about the AAOS's recommendation for kyphoplasty needs to be added for a more complete comparison. The AAOS's recommendation for kyphoplasty in article 10 of page vi of the cited source states "We are unable to recommend for or against improvement of kyphosis angle in the treatment of patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms." The statement needs to be changed to add that the AAOS does not recommend for or against the use of kyphoplasty. Thanks Raykwaku (talk) 19:15, 22 October 2013 (UTC)Raykwaku

Not done: You need to detail the exact change you want to make to a 'please change X to Y" degree when using this template. Also, the source gives a limited recommendation to kyphoplasty in 9 before the inconclusive result in 10. Simply stating "does not recommend for or against" is not a neutral summary of the source. Thanks, Celestra (talk) 16:40, 23 October 2013 (UTC)

typo

In the article, words "percutaneous" and "vertebroplasty" should be separated and the hypertext link should be applied to the word percutaneous only :

"which was the reason for the development of percutaneousvertebroplasty"

Thanks and done. Doc James (talk · contribs · email) 05:15, 20 May 2015 (UTC)

Vested interests

There is concern that people with a vested interest in selling equipment for this procedure have been editing this article. See The Covert World of People Trying to Edit Wikipedia—for Pay. Proxima Centauri (talk) 11:35, 12 August 2015 (UTC)

Yes but it was some time ago. One can see it in the talk page history. Doc James (talk · contribs · email) 12:30, 12 August 2015 (UTC)

Cost

Costs are notable and encyclopedic. Not sure why they were removed. Doc James (talk · contribs · email) 06:02, 12 August 2015 (UTC)

Notable why though?

A quick look through List of surgical procedures shows that few/none of the others have their costs mentioned in the lead/intro. As per my edit summary, some note of the costs of Vertebroplasty vs Kyphoplasty vs alternatives might be appropriate - but not actual numbers.

It's possible that's there's something notable to say about the comparative costs, but it's not clear what. Frankly the "Percutaneous_vertebroplasty#Cost" section is just a bad - lots of numbers, but no way to judge whether these are provided as an argument for it being overpriced or not. Snori (talk) 19:07, 12 August 2015 (UTC)

It is something that we have been discussing at WP:MED as including more frequently in articles about drugs and devices. It is good to contextualize costs but discussing of them is definitely within the scope of any article, about any product, in WP. Jytdog (talk) 19:20, 12 August 2015 (UTC)

OK, can you point me to that discussion? I have no particular argument with costs being included in an article, just that of all the things that could go into the intro, this seems the least important - unless there is some context - i.e. "radically cheaper than the alternatives" or "overpriced for the effectiveness". Snori (talk) 20:52, 12 August 2015 (UTC)

We discuss its effectiveness. Than we discuss its costs. That IMO is how we should do it. People are than free to make their own call WRT price for effectiveness. Doc James (talk · contribs · email) 11:53, 13 August 2015 (UTC)

How is the price at one particular point in time and in one particular place notable or even useful? Lovingboth (talk) 15:06, 24 January 2016 (UTC)

Just like the price of other products is often notable and useful. Doc James (talk · contribs · email) 16:22, 24 January 2016 (UTC)

difference

What is the meaningful difference between

Kyphoplasty is a variation of a vertebroplasty which attempts to restore the height and angle of kyphosis of a fractured vertebra (of certain types), followed by its stabilization using injected bone cement.

and

designed to restore diminished vertebral height and correct kyphotic deformity.

? Why do we need to repeat this? Jytdog (talk) 20:36, 28 October 2017 (UTC)

Agree with Jytdog. Was fine before. Doc James (talk · contribs · email) 21:27, 28 October 2017 (UTC)

Since I'm the one who called for it to be taken to the talk page, I certainly don't need a block warning. I asked for this. It's starting to feel like a personal attack. I'm fine with the edits stated above, but a block warning is unsubstantiated and premature. Icarus of old (talk) 21:49, 28 October 2017 (UTC)

This page has been subject to paid editing and thus people are probably a little more jumpy than usual. Best Doc James (talk · contribs · email) 22:28, 28 October 2017 (UTC)

Kyphoplasty and Vertebroplasty Are Not the Same

These are no comparable procedures. There is a mortality benefit to Kyphoplasty as compared with Vertebroplasty. The adjusted life expectancy for the Kyphoplasty was greater for that of Vertebroplasty and was increased 115% compared to the NSM group (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). Pain relief is also better for Kyphoplasty and Kyphoplasty has a significantly greater positive effect on quality of life (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 2012;DOI 10.1007/s00586-012-2314-z). — Preceding unsigned comment added by Dbeall01 (talk • contribs) 21 January 2013

The Article is illegible. Requires deep line edit to conform to rules of english. — Preceding unsigned comment added by 2605:6000:1019:40D:F459:57B2:164A:409 (talk) 01:26, 30 January 2019 (UTC)

Semi-protected edit request on 18 November 2019

Change "It was found not to be effective in treating osteoporosis-related compression fractures of the spine.[1][2]" To "Its effectiveness is controversial. It may be an effective treatment for early, severe pain-related symptoms in patients with osteoporotic compression fractures."

Citation: Clark W, Bird P, Diamond T, et alCochrane vertebroplasty review misrepresented evidence for vertebroplasty with early intervention in severely affected patientsBMJ Evidence-Based Medicine Published Online First: 09 March 2019. doi: 10.1136/bmjebm-2019-111171 Kelcomma (talk) 03:51, 18 November 2019 (UTC)

 Partly done: One disputation by a group or practitioners doesn't justify calling it "controversial" in the lead. I have, however, added this as an additional citation to the statement: "Some vertebroplasty practitioners and some health care professional organizations continue to advocate for the procedure." Eggishorn (talk) (contrib) 23:24, 21 November 2019 (UTC)

Semi-protected edit request on 29 September 2020

Dear Wikipedia

I am the first author of the VAPOUR trial for vertebroplasty as well as being an investigator in two of the three other placebo trial of vertebroplasty. VAPOUR is the only placebo designed, blinded trial of vertebroplasty to restrict enrolment in the trial to fractures less than 6-weeks duration and to include hopsitalized inpatients. Our trial was published in The Lancet. This proved vertebroplasty more effective than placebo in patients with severe uncontrolled pain due to fractures less than 6-weeks duration. In fact most patients in the trial had fractures less than 3-weeks duration which clearly distinguishes VAPOUR from the negative placebo trials which are cited in the Wikipedia report.

The Medicare Services Advisory Committee (MSAC) in Australia has recently recommended (application 1466 is available on-line) Medicare funding for vertebroplasty in patients with early (not more than 3-weeks) osteoporotic thoracolumbar spinal fractures which are causing severe pain.

None of this is included in the Wikipedia review, with no mention of the VAPOUR trial.

The Cochrane vertebroplasty review (2018) is a severely conflicted document as published in our criticism published in the Journal of Evidence based Medicine.

The facts are that public funding for vertebroplasty is supported in Australia (MSAC) , UK (NICE) and The USA. This article needs to be completely re-written or removed as in current form it is actively misleading.

The findings of the VAPOUR trial need to be referenced and included as well as the controversy over the Cochrane review which is tarnished.

I can write a draft review if you wish - please advise.

All the best
Dr William Clark
(Redacted)
Lead investigator in the VAPOUR trial
Investigator in the Kallmes 2009 trial (INVEST)
Investigator in VERTOS4 2018 trial
Investigator In Diamond et al 2006 trial
Author Clark, William; Bird, Paul; Diamond, Terrance; Gonski, Peter; Gebski, Val (9 March 2019). "Cochrane vertebroplasty review misrepresented evidence for vertebroplasty with early intervention in severely affected patients". BMJ Evidence-Based Medicine

Williamxrayclark (talk) 07:27, 29 September 2020 (UTC)

​See WP:MEDRS, we aim to only summarize what review articles and textbooks have said, and we don't mention the results of specific trials. If you can point to other reviews or textbooks that we can summarize, that would be good. – Thjarkur (talk) 08:55, 29 September 2020 (UTC)