Ossatron vs. Dornier, part 1Posted by elliott on 2/24/04 at 10:36 (145175)
Let's start by looking at the 12-week FDA Summary of Effectiveness for each machine. Here again are the links:
Since there is always someone who asks about sample size and duration, the Ossatron had more people (235 active and placebo; there was also a nonrandomized group) and a longer mean duration of symptoms (around 2.8 years) than the Dornier (150 and just under 2 years).
There were some differences between the studies in the inclusion criteria. While the Ossatron was more restrictive in some respects, it was more lenient in others. A rather minor leniency is that it seems to allow a score of 5 or higher on the VAS scale for first few minutes of walking in the morning as compared to Dornier's strictly > 5 (although the Ossatron link to the long paper given further below seems to claim the strictly as well). Much more crucial to this discussion, there was a major difference in the inclusion criteria with regard to the Roles & Maudsley scale (FYI, here is a description of the 4-point R&M
): there was a requirement of at least a 3 out of 4 for the Dornier, and no requirement at all for the Ossatron. In fact, the Ossatron used a 5-point scale (not a 4-point scale) both for baseline (Table 5) and for the success criteria.
The Ossatron study initially defined 'success' at the 12-week mark only if all of 4 of the following criteria were met:
1. investigator's assessment of heel pain (minimum 50% improvement over baseline upon applying pressure to the heel to elicit pain, with a score no greater than 4.0 on VAS)
2. subject's self-assessment of pain upon first few minutes of walking in the morning (min 50% improvement over baseline with a score no greater than 4.0 on VAS)
3. subject's self-assessment of activity level, measured by the distance and time the subject is able to walk without heel pain (a 5-point scale (0-4), requiring at least 1 point improvement OR maintain a baseline score of 0 or 1).
4. use of pain meds (none must be taken at 12-week mark)
OTOH, Dornier gave no overall criteria for success, but rather defined two primary efficacy endpoints and three secondary efficacy endpoints:
1. Difference in VAS for first few minutes of walking between the groups (close to or the same as 2. above)
2. Proportion of patients achieving at least 60% improvement in first few minutes of walking
Secondary (all separate):
1. Pain evaluation on AOFAS Scale score, 2. 4-point Roles & Maudsley score, 3. SF-12 heath status questionnaire, 4. pain due to pressure (this seems to be close to or the same as Ossatron's 1.), and 5. ROM Assessment from AOFAS Ankle-Hindfoot Scale score.
For the Ossatron, at 12 weeks, 56 out of 119 in the treatment group achieved overall success, while 35 out of 116 in the placebo group did. So the treatment group was
(56/119)/(35/116) – 1 = 56% better than the placebo group. (The calculation itself was not given, so I derived it myself, but as a check, the 56% figure does appear explicitly in the literature:
71% of the actives and 67% of the placebos satisfied the 5-point R & M criteria as stated.
For the Dornier, at 12 weeks, the primary outcome numbers were 56.5/46.6 – 1 = 21% better and 56.2/45.2 –1 = 24% better for the actives over the placebos. (So Ossatron's overall success over placebo was far greater than success for Dornier using its primary outcomes.) The AOFAS Ankle-Hindfoot scale and SF12 did not show any significant changes between groups. Using Roles & Maudsley, 61.6% of active treatment group achieved good or excellent as compared to 39.7% of sham, so the treatment group was an impressive 61.6/39.7 – 1 = 55% better than sham, a figure comparable to the Ossatron's overall success rate. Data for the other categories for some reason aren't given in the study (interesting, since the Ossatron study had considered the pressure test to be one of the most important measures; for a fascinating discussion in front of a panel on the Ossatron by its leading researchers, see
Warning: it's very long. I have not yet read the whole thing. If you have the patience to do so, you will find a treasure trove of info worth sharing on these boards. One gets the impression that the Ossatron study seems to have been very carefully thought out. To get to the criteria, do a find on the word 'assessment', and keep reading as long as you can bear it).
Yes, the Dornier's best score was with the R&M measure. It can be argued, however, that it is disingenuous to select and highlight only the best measure after the fact and ignore the others. More on this later.
If there's any mistakes, I apologize in advance, and it's OK to point them out if you like. Regardless, I don't think the thrust of the argument will change.
IN SUMMATION: The Ossatron FDA study differed from the Dornier FDA study both in terms of how success was defined, as well as with regard to the Roles-Maudsley scale--both in the inclusion criteria and in the scale itself. It should never be assumed that any two studies will have the exact same design. Therefore, before a statistical comparison of success was to be made between the two machines, it would have been a good idea to spend a little time (it took me about 15 minutes) doing a page-by-page comparison of the two publicly available FDA summaries, and these differences would have immediately stood out. Next, we discuss the 1-year results.
Re: Ossatron vs. Dornier, part 1Dr. Z on 2/24/04 at 11:35 (145176)
As a clinician the low VAS of 5 for the ossatron compared to the much great 7.7 for the dornier is a very significant factor when determining just how much pain these patients from the start. There are many clinicians including myself that wouldn't perform ESWTa patient with a VAS of 5.0
Did you ever consider that just maybe the description of the R/M below take into account the same criteria that you have listed with the ossatron description of sucess. For example: With R/M one and two levels of evaluation I am sure the patients aren't taking any pain medication. Don't you agree?
I am also sure that the FDA wouldn't allow any patient to take pain medication and then be considered a sucess.
On another note when something uses the term R/M that is exactly what it is. So you can compare R/M to R/M Now if something pick another endpoint that is a different comparison.
I believe both Scott and Dr. Rompe both pointed out that the population in the study after a certain point doesn't need to increase. I believe Dr. Rompe used a population of 50 as the correct number that shouldn't change the results whey it is 100, 200 and or 5000.
I amn't a stat person but I believe that is what he told us. Why would the FDA allow 150 for the dornier and ossatron used 263. Do you know the why
You are assuming that YOUR conclusions change something. They don't but keep going. Next time don't run past that VAS score so fast. ITS really important which I will explain after your are finished.
No pain, full movement, full activity
Occasional discomfort, full movement, and full activity
Some discomfort after prolonged activity, need for further treatment
Pain limiting activities, need for further treatment
Re: Ossatron vs. Dornier, part 1Pauline on 2/24/04 at 12:41 (145183)
This is good work. I for one am glad you took the time to post it. Your research reminds me of Qualitative Chemistry in a way. You've taken an unknown and told us what it is? As in chemistry, it's all right there, one just has to decipher and identify the material.
Personally, I think your doing a good job putting the entire study on the table in layman's language. Thanks.
Re: Ossatron vs. Dornier - it's absurd to compareScott R on 2/24/04 at 12:46 (145184)
Elliott, since you basically accused Dr Z of fraud for saying dornier is better than ossatron, i ruled that saying one machine is better than another is not allowed. I thought you'd be pleased.
The statistical significance in these studies is marginal. For study populations of 100, the error is about +/-10% for each group, so they have to show almost a 20% difference between placebo and controls before the difference can be called statistically significant. For comparison, a election poll requires at least a 1,000 sample population size (3% error). Pharmaceuticals also require substantially larger populations. The significant benefit of these machines is NOT to say that the treatment provides a significant benefit to the patient; it merely shows there is a 95% chance that there is a MEASURABLE difference, however small or large the benefit to the patient may be. It's up to the individual study's design to see if this is accounted for. How each machine defines success has a big effect, almost as much as all the other effects that make up a study. There is a REASON, elliott, that there are controls and placebos in every study and not just the first one ever conducted. If a manufacturer can show their machine is marginally better than another, then let them do an FDA study to show it (using the other machine as the placebo), and the FDA will allow them to advertise that their machine is better.
Providing info about each study is good. Implying that the studies can determine which machine is better is not because it's junk science, makes one company look worse than another when maybe it is not, steers patients potentially the wrong way, and may get me in legal trouble. I don't want patients here lied to about one machine being better than another based on faulty science/statistical manipulation.
We know who Dr Z is but elliot's private information is not similarly available, so it's an even greater issue of legitimacy and willingness to take responsibility and legal liability when it's an anonymous 'advertiser' for a product with unknown ties or grievances to twist statistical info to some company's advantage, to the disadvantage of another.
Re: Ossatron vs. Dornier - it's absurd to compareScott R on 2/24/04 at 12:49 (145185)
PS to elliott:
I may not have said a word if you had not included the phrase
'(So Ossatron's overall success over placebo was far greater than success for Dornier using its primary outcomes.)'
Re: Ossatron vs. Dornier - it's absurd to compareelliott on 2/24/04 at 14:48 (145211)
Scott, first of all, I did not basically accuse Dr. Z of fraud. I said his statements comparing success rates are misleading, if not wrong. I would not call that fraud. Concerning your comment that it is absurd to compare machines, maybe Dr. Z should have been stopped from doing so a long time ago, without my prompting.
I am *not* going to prove that one machine is better than the other; I intend only to show that the statistics were used improperly. I am not quite sure why that one sentence bothered you so much, but I'm certainly not perfect, it's hard to put together a post like that, and I appreciate the feedback. I reposted it without the questionable sentence, and if you'd like to delete this thread to eliminate the appearance of that sentence, that's fine with me. I initially debated whether to insert that sentence on the grounds of relevance, but I decided to only to indicate that success rates relevant to each study's initial success criteria sometimes don't look quite as rosy as might have been expected, and that may lead to a questionable subsequent selection of a subset of the success criteria after the fact, as pointed out to us by a respected researcher here.
Regarding my identity, I'm just like any other non-card-carrying heel pain sufferer here. Dr. Z has seen my TTS scars in person. Anyway, I'm trying to give all sources of everything I quote so that it shouldn't really matter who I am, as all the evidence will be there for anyone to judge for himself.
Re: Ossatron vs. Dornier - it's absurd to compareDr. Z on 2/24/04 at 16:10 (145220)
Come on Elliott when ever you state that some is receiving money from a procedure that maybe he shouldn't be that is called fraud. There is no way around this that is what you did.
Re: Ossatron vs. Dornier - it's absurd to compareelliott on 2/24/04 at 16:43 (145225)
Dr. Z, you've been misrepresenting my comments (including some that were deleted) from the very start; I haven't made an issue of it. If you give a comparison of success rates that happens to be misleading, that might entice business you otherwise wouldn't get. That's all I said.
Re: Ossatron vs. Dornier - it's absurd to compareScott R on 2/24/04 at 21:05 (145251)
Dr Z, fraud is lying for personal gain to the detriment of the one being lied to. I believe all 3 of those elements are necessary: the lie, the gain, and the harm. Saying Dr Z 'misled' is probably close enough to the lying element to make that one element true. But there's a lot of fuzziness to ever knowing if the other two elements are present.
I agree Dr. Z shouldn't have indicated one machine might be better than another. I never said anything to him because it was only recent that one of elliott's posts pointed it out. I mean, i don't read anything here unless someone calls my attention.
I think everyone has had their say. Let's drop it and move on.
Elliott, please email me if you see Dr Z post something that might be harmful to patients. In all other circumstances, i think it hardly needs to be said that you shouldn't post anything defamatory.
Re: Ossatron vs. Dornier - it's absurd to compareDr. Z on 2/24/04 at 21:38 (145253)
I will move on but will things ever be the same.? I am not sure
Re: Ossatron vs. Dornier - it's absurd to comparePauline on 2/24/04 at 22:11 (145258)
Of course. Put it in prospective. No catastrophic illness and no loss of life----life is good.
Re: Ossatron vs. Dornier - it's absurd to compareDr. Z on 2/24/04 at 22:24 (145260)
Health is the only thing that does really matter. I just returned from the Shiva of a close friend's father now his life will never be the same.
Re: Ossatron vs. Dornier - it's absurd to comparePauline on 2/25/04 at 08:40 (145292)
On this you are correct. Health matters. Life is about change, from the day that we are born to the day that we die, we will experience some form of it.
Learning to accept, adjust, and live with it is a challenge we all face. That process is called living.
Re: Ossatron vs. Dornier - it's absurd to compareEd Davis, DPM on 2/25/04 at 11:23 (145312)
I am not even going to get into other that to say that I have used 3 machines available in the US --- Ossatron, Dornier, both high energy and FDA approved for PF; Sonocur, approved by the FDA for tennis elbow but used off label for PF. They all work equally well. Period.
Re: Ossatron vs. Dornier - it's absurd to compareRob D. on 2/25/04 at 15:15 (145335)
I'm looking forward to reading Elliott's 2nd installment and a discussion/comparison of the 12-month data, if it's available, on both machines.
The subject title of the thread is, I believe erroneous. It is not at all absurd to compare Ossatron vs. Dornier's Epos Ultra, if it's in the best interests of payors, practitioners and patients alike. I know it was a hot topic in my discussions with physicians at the recent ACFAS meeting last week in San Diego.
Re: Ossatron vs. Dornier - it's absurd to compareelliott on 2/25/04 at 15:49 (145339)
Scott, I just wanted to clear the air about all this fraud stuff, which I wish never would have come up. There is a famous saying that goes something like, 'statistics are the most objective thing around and yet can be the most misleading'. If, say, someone gathers a statistic a bit too rashly--without realizing what exactly it stands for--and then uses it in good faith in an out-of-context comparison, that statistic can lead people to arrive at conclusions they otherwise may not have arrived at (this is what I mean by 'misleading statements'). Even if the user profits from it, I wouldn't call that fraud, although he definitely should have been more careful to avoid getting into the problem and the appearances it brought. This is what I think happened. See, for example, the conclusions arrived at in this thread:
I don't want to police Dr. Z's every post, and this didn't get started because of one post. I'm not trying to 'win'. By nature I'm not a rules guy, and while I realize the alternative might be problematic, if it were up to me, I wouldn't even have a rule that machines can't be compared. Which machine is 'better' is something every consumer wants to figure out, and discussions on this board may help to that end. As another example, what if ESWT study designs are made more uniform precisely so machines can be compared? What if there is overwhelming evidence that one machine is indeed better than the other? However, I do feel the onus should be on the one who is selling a product to be extra-careful to make sure that whatever is being said does not lead others to arrive at unjustified conclusions, and that sometimes he or she might have to face consequences caused by the error.
Re: Ossatron vs. Dornier - it's absurd to compareDr. Z on 2/25/04 at 16:30 (145342)
You continue to add more fuel to the fire. This did gets started with your accusations toward Dr. Z that were so obvious ( even ScottrR has made the comment about your accusation about fraud )
Why you just can't drop it is just leading you toward legal action.
I am entitled to my opinion and my conclusions. As for standing behind what I say I do, the real question is why you just won't admit what other have already pointed out to Dr. Z. YOU ACCUSED DR Z OF FRAUD AND MISLEADING THE PUBLIC FOR PROFIT WHICH IS SO OUTRAGEOUS.
Re: Ossatron vs. Dornier - it's absurd to comparePauline on 2/25/04 at 16:32 (145344)
I think you have a point because repetition does bring about belief. Evidence to such can be found during wartime and domesticly in abusive relationships and homes .
Re: Ossatron vs. Dornier - it's absurd to compareDr. Z on 2/25/04 at 16:45 (145348)
Let see we are going from ESWT to Hitler to domestic abuse. What are you on?
Re: Ossatron vs. Dornier - it's absurd to compareDr. Z on 2/25/04 at 16:48 (145349)
What areas were hot for discussion?
Re: Ossatron vs. Dornier - it's absurd to comparePauline on 2/25/04 at 16:59 (145350)
I never mentioned Hitler. My point is simply that repetition brings about belief in many different situations. What is being repeated can be true or not true, makes no difference.
Good examples of this 'type of learning' if you want to call it learning happen to be in wartimes and in abusive situations.
I'm sure we could list other examples as well. A good one would be multiplication tables. Learned by repetition and believed to be true.
Re: Ossatron vs. Dornier - it's absurd to compareRob D. on 2/25/04 at 17:18 (145352)
Among the topics of discussion (during breaks, not in public presentations) re: ESWT were:
Success rates experienced,
Ossatron vs. Dornier, not only machine comparisons but 'type of company' and protocol comparisons,
Reimbursement issues, and
There seemed to be little or no controversy over whether ESWT is effective in treating PF or not, in my conversations.
Re: Ossatron vs. Dornier - it's absurd to compareDr. Z on 2/25/04 at 17:30 (145353)
What were the sucess rates experienced> What were the main advantages and disadvantages for both machine.? I have found sometimes you learn more in the hallways then you do in the lecture halls
Re: ACFAS/StorzEd Davis, DPM on 2/25/04 at 18:44 (145356)
Storz was exhibiting their system which is an RSWT system at a booth at ACFAS. The rep. claimed that they expect FDA approval by the end of the year.
Re: ACFAS/StorzPauline on 2/25/04 at 19:16 (145357)
How will it differ from ESWT and compare in cost both for the doctor and
Re: ACFAS/StorzDr. Z on 2/25/04 at 19:33 (145358)
Is this different then the Dolocast device that is undergoing FDA pma testing?
Re: ACFAS/StorzScott D. on 2/25/04 at 20:58 (145364)
Dolocast isn't from Storz, theirs is called the 'minilith'.
Re: ACFAS/StorzEd Davis, DPM on 2/26/04 at 00:37 (145375)
They could not quote a price as it is not officially for sale in the US (although I guess they must have a quote for the veterinary profession).
The technolgy of RSWT appears simpler, delivers a shockwave without 'cavitation' (the need of which has been the subject of prior discussion here). It is a relatively compact 'table top' device with the implication that it was significantly cheaper than existing ESWT technology.
Re: ACFAS/StorzEd Davis, DPM on 2/26/04 at 00:40 (145377)
Link to Storz products: http://www.storzmedical.ch/English/Products/Products.html
Re: Oops!Ed Davis, DPM on 2/26/04 at 00:46 (145379)
I think I made a mistake. The model shown at the ACFAS was indeed a Doloclast: http://www.ems-medicalamerica.com/products/dolorclast.htm
It was not the Storz product. The Storz product, I beleieve, is 'classical' ESWT while the Doloclast is RSWT -- the veterinary verseion and 'human ' versions are differrent in appearance although I have not compared the specs.
Re: psEd Davis, DPM on 2/26/04 at 00:48 (145380)
You may note that they call their technology ESWT on the link.
Re: Oops!Ed Davis, DPM on 2/26/04 at 00:50 (145381)
I remember being instructed by my residency director never to say 'oops' when doing surgery :) It is late and I can get away with it here.
Re: Oops!wendyn on 2/26/04 at 06:57 (145391)
Ed, my father heard that while the doctor was performing his vasectomy.
(The doctor was a buddie of his with a weird sense of humour)
Re: Oops!Pauline on 2/26/04 at 08:07 (145396)
And after that you were conceived right:* Now we've heard the 'REST OF THE STORY'.
Re: Ossatron vs. Dornier - it's absurd to compareRob D. on 2/26/04 at 12:09 (145427)
The success rates were comparable to that reported in the literature, some better, some worse, depending on the protocol being used, but all anecdotal.
The advantages and disadvantages of each machine were pretty much along the lines summarized by Michael Horwitz. I have reduced his observations to a factor-importance vs. performance-rating matrix (a so-called 'ESWT Machine Selection Comparison' form) which I am thinking of using for physician input at the upcoming AAOS meeting in San Francisco in March. I would be pleased to send it for knowledgeable input by qualified persons. Just email me at (email removed), stating your background, for a draft copy.
Re: ACFAS/StorzRob D. on 2/26/04 at 12:49 (145433)
The DolorClast, a radial shock wave therapy machine by EMS (Electro Medical Systems, Nyon, Switzerland), will sell for about $50,000. So Till Gumz, EMS' head of orthopaedics sales and marketing, told me at the ACFAS meeting. EMS is looking for a U.S. distributor like Boston Scientific, only with expertise in orthopedics. I believe Dr. Weinberg's group in Chicago is doing some of the PMA work.
They claim their patented, desktop computer-sized machine with pistol-sized applicator will transform ESWT. Their literature says a maximum of 2,000 impulses are applied per treatment. Impulse frequencies ranging from 1 to 15 Hz can be selected. Positioning is accomplished through biofeedback in consultation with the patient. I imagine a Google search of their name will yield more information as well as their web site.
How significant a role, if any, might a machine like the DolorClast play in ESWT?
Re: Oops!wendyn on 2/26/04 at 13:11 (145435)
Nope - I was 'on purpose' (a decision I'm sure my parents regretted from the time I was around 11 until I was around 16)
Re: Oops!Pauline on 2/26/04 at 14:59 (145445)
I certain you were wanted, but I doubt they ever regretted their decision.
Re: Ossatron vs. Dornier - it's absurd to compareDorothy on 2/26/04 at 15:04 (145446)
Multiplication tables 'believed to be true'...
Round(ish) earth...'believed to be true'....??
I think if you subject the multiplication tables to a question of belief or not, then you just might be carrying skepticism too far.
Re: Ossatron vs. Dornier - it's absurd to comparePauline on 2/26/04 at 15:37 (145449)
One need only do the addition to check the truth when it comes to multiplication.
Re: ACFAS/StorzEd Davis, DPM on 2/26/04 at 20:48 (145476)
If the device is efficacious it may have a major impact on things. This process is still in evolution...
Re: Ossatron vs. Dornier - it's absurd to compareScott D. on 2/26/04 at 20:49 (145477)
What is your affiliation?
Re: Ossatron vs. Dornier - it's absurd to compareEd Davis, DPM on 2/26/04 at 20:50 (145478)
Would you consider posting the matrix on this site for all to look at?
I would like to see a copy myself and my email is (email removed)
Re: Ossatron vs. Dornier - it's absurd to compareRob D. on 2/27/04 at 15:26 (145527)
I am a private market analyst engaged to research the ESWT opportunity for a group of potential investors. I am not affiliated with any of the organizations, commercial or professional, in this industry.
Re: Ossatron vs. Dornier - Evaluation MatrixRob D. on 2/27/04 at 15:55 (145531)
I have sent the matrix for your review. I would be pleased to post it here for all to look at, but I am assuming just pasting it here will cause the (Excel) formatting to be lost. If there is a way you know to post it here so that the column formatting and formula are retained, feel free to do so, if it will benefit others.
As I wrote to you and Dr. Z, the current weights and ratings are such that both machines' performance scores are forced to be equal, for now. However, we assume the machines are not equal. Depending on what factors are important to which purchaser (physician), and how the potential purchaser believes each machine performs within each factor, the machines may have vastly different scores. I would be pleased to receive any knowledgeable person's evaluation. If you wish, I could post the evaluations received through this site.
Re: Healthtonic's dilemnaEd Davis, DPM on 2/28/04 at 11:23 (145587)
Healthtronics has an effective machine in their Ossatron. Their treatment model, though, is too expensive, in my opinion for the current healthcare environment -- it is a model that would have worked in the early 1980's. The units are getting smaller, less expensive and if one looks closely at the evolution of the technology in Europe (after all that is where the machines are made and the majority of studies are done)
the trend will be toward lower cost models. That trend can be slowed but don't think it can be stopped. Healthronics, somehow, needs to revise their 'treatment model' stop trying to buck the trend...
Re: Healthtonic's dilemnaDr. Z on 2/28/04 at 12:28 (145593)
Do we know what the trend is? The units in the USA still have to go and get a Class three FDA approval. Insurance companies have to start to place medical policy into place which is fair, honest and correct. It is my opinion that ESWT can be performed in an office setting under a local anesthetic if needed. The ASC model is a direct result of insurance companies not paying for the tech fee or combining it with the facility fee.
This all starts at the top with the FDA and that won't change for years. Let see how many years did it take ESWL to go from Class three to Class two.
It would a new day if ALL of the ESWT companies banded together to straight out the insurance problems that face this revolutionary procedure.
This is an opening for a company that can meet these needs
Re: Healthtonic's dilemnaEd Davis, DPM on 2/28/04 at 15:26 (145604)
Sometimes it is logic and common sense vs. politics and political decisions (i.e. making ESWT devices class 3) can take a long time to change. There is absolutely no logic in taking a higher power machine that is applied to a vital organ (the kidneys) as in ESWL, making that Class 2 while smaller, less powerful, safer machines which are used to treat tendons and ligaments Class 3! History teaches us that corrupted, flawed political institutions eventually fall. Unfortunately, it can take a long time.
Re: Healthtonic's dilemnaDr. Z on 2/28/04 at 15:55 (145609)
I agree with you 100% however the process is going to take a very long time with alot of patients being hurt by this ridiculous process.