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Cryo-Surgery: A lasting solution for a painful problem

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  #1  
Old 23rd October 2004, 04:49 AM
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Default Cryo-Surgery: A lasting solution for a painful problem

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Date: 10/12/2004


Lawrence Fallat, DPM, director of the Podiatric Surgical Residency program at Oakwood Healthcare System (OHS) is pioneering a new, minimally invasive surgical procedure to treat the problem of heel pain.

“It’s an innovative technique,” said Dr. Fallat. “Cryo-surgery has been used for decades to treat prostate cancer and melanoma. Now, we’re taking it and applying it to the foot, specifically for those people who are suffering from plantar fasciitis, which is the inflammation of a tough band of tissue on the bottom of the foot. This inflammation causes extreme heel pain. And we are seeing dramatic results.”

The procedure to treat the heel pain lasts about six to seven minutes and happens right in Dr. Fallat’s office. A three-millimeter incision is placed in the heel of the foot where a two-millimeter tube is then inserted. The tube is extremely cold. It freezes and destroys the pain nerves in the heel.

“Those nerves will grow back but the pain does not come back with them,” explained Dr. Fallat. “There is no permanent damage to the foot, no permanent numbness or balance and mobility problems.”

The healing period lasts about two to three days.

“It’s nothing like the six-week healing period for other types of surgeries that treat plantar fasciitis,” said Dr. Fallat.

One of the other assets of this program is its success rate.

“This treatment is very effective,” said Dr. Fallat. “The procedure has a 90 percent success rate, and these are people who have failed all of the other conventional treatments available.”

Currently, Dr. Fallat is the only physician in Michigan to perform this procedure as a treatment for plantar fasciitis.
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Old 27th October 2004, 06:44 PM
podrick podrick is offline
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Default Cryosurgery

I Have Seen A Demonstration Of It And It Seems Easy Enough To Learn.i Have Followed The Same Patient For Over Three Months And She Is 80% Better.however,my Question With THE Procedure Deals With Long Term Follow Up. I Mean What Percentage Of PatientS Treated Are Actually Pain Free A Year Or Two After Treatment.
Furthermore,we Need To Have A Better Idea As To The Mechanism Of Action Of This Modality.in Its Other Uses,the Mechanism Of Action Is Well Understood.

Rick

Last edited by podrick : 27th October 2004 at 06:45 PM. Reason: GRAMMAR
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  #3  
Old 20th November 2004, 05:20 AM
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Default Rick

Did Dr. Fallat give the demonstration?

Can you give the forum a technical overview of the technique / equipment used - that would be interesting. For instance, how does Dr. Fallat localize the nerve so accurately through a 3 mm incision?
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Old 20th November 2004, 09:21 AM
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Default demonstration

it is the same company,who by the way hired dr.fallat as its speaker and instructor.in order to attract doctors to purchase the system which approximately $30,000 dollars.once a practitioner purchases the system.he is trained by dr.fallat and is then paid $500.00 per session in order to conduct demonstrations and to teach the procedure in their office.
the procedure is identical to what you described.although the incisions this practitioner made were about 1cm in length.
my problem with this system is the following: there are no long term studies as to real effectiveness,technically,it is still blind surgery.you really can't be entirely sure that you are truly freezing the medial plantar nerve or any of its tributaries.finally,the cost of the system seems hefty considering its limited application.
however,i will be the first to admit that i just don't know enough about it.i would like to know of other practitioners( not just the ones hired as consultants by the manufacturer) who are using this sytem in their offices,in order to see efficacy as well as return on investment.
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Old 21st November 2004, 03:53 AM
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Default Rick

Thanks for the information. Is there a website or do you have any other contact details? I would like to take a closer look.
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Old 21st November 2004, 10:37 AM
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yes, they are on the web.i don't recall their exact website.however,if you get on google and write in cryo surgery podiatry you will get them.they will send you a demo disc,where you may see an entire procedure.
let me know if you find out anything else in the way of research.
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Old 21st November 2004, 02:20 PM
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Default Rick

Seems the technolgy originates in England, Nottingham no less, 45 minutes by car, from where I am sitting right now. I am contacting the firm to find out more. Will keep you posted!
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Old 21st November 2004, 11:30 PM
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thanks dieter,by the way i would be interested in knowing how much the unit is in the uk,in dollar amounts vs what they charge in the states.

best wishes rick
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Old 4th December 2004, 05:32 AM
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Default Dollars .....

Rick

I have now received the information from Cryostar (UK) who are quoting the princely sum of a 24 995 UK Sterling Pound to buy the system. Lets assume an exchange rate of say 1.8 US dollars x 24 995 = circa $45 000.

If this is correct it seems we are getting charged a good deal more here in the UK (which seems typical). Are you sure the system costs $30 000 in the US? If so let me know and I will ask Cryostar to explain. Of course if the system can deliver the goods in terms of clinical outcomes, it might be a worthwhile investment. Apparently a UK trial will start in the New Year.

The firm has promised to supply research papers, and I will let you know when I have received them.

Best wishes
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Old 4th December 2004, 01:24 PM
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Default cryo surgery

dieter,
thanks for the reply. it is definitely $30,000 according to what they are quoting me.they do have research,published by dr.fallat of course.however,i am near the barry university school where i graduated from and the surgical department there is taking a wait and see attitude.their research,obviously is based on a very small test group and even smaller follow up period.i will let you be the judge when you read it.please try to have them send you the dvd with the demo.
on another note,i am curious do you feel cryosurgery could be marketed to a fee for service patient and at what rate, after a $30,000, investment.i am assuming that in your practice as in mine in the states,public insurance wont reimburse for this procedure.thus we are kind of in the "same boat" as we say with these kinds of services.
i look forward to your insight.

regards,
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Old 17th December 2004, 04:58 AM
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Default cryosurgery

The wait and see approach seems reasonable given the large capital investment required for this equipment. I have arranged a meeting with the firm's rep with demonstration of the equipment to evaluate this further.

I am curious how this treatment was conceived - I am not aware if other disciplines are freezing tissue when addressing nerve or connective tissue pathology, in this way, but no doubt I will soon know or another poster will explain this.

I have now read the available research data, and I agree, it is way to early to know. A much larger trial is required and I have offered to participate. To date I have not had a response from the company. My service is a countywide provider of surgical care, so we have a reasonably large potential patient pool (around 660,000 in the county)

As yet Cryostar does not have an EC license - this is required to sell the equipment to the National Health Service. Would I buy the system for private patients? Not yet - at the very least I would want to spend time with a number of teams to evaluate their outcomes first hand.

How to market / cost: I guess you have to estimate how many patients in your practice per year might benefit from the treatment. Comparative costs for other current treatments e.g. surgery / ECSW need to be balanced against - and this is the critical component - the likely cure rates. I would be happier if the company offered a lease arrangement, and if it has confidence in the system this should be made available to easy the cost pressure.

If I bought the system for private (i.e. non NHS ) patients I would want to know the equipment has paid for itself within at least 18 months. That kind of money could buy a very nice car! Without doing the maths and analysing in any detail, I would charge around $1000 for this treatment. How does this compare to the US market? I really hope the system does as well as the marketing people suggest ...
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Old 17th December 2004, 07:09 AM
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Default cryosurgery

dieter,
you bring up very valid points in your email.if the company had confidence in its product a lease would be a better way of gaining a large practitioner customer base.i can use the anodyne led unit as an example,i purchased one through a lease,and these units are only approximately $6,000.so go figure.
your cost analysis go hand in hand with what is considered acceptable in the states.the unit should pay for itself in 18 months,and with its price tag,$1000.00 is about right.
however,i still contend that at such a price and with such a poorly researched modality.the risks of complications and litigation (at least in the states) could be very costly for a solo practitioner.so i think i will wait until you get yours first.
always a pleasure to exchange with you,rick
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Old 19th December 2004, 11:12 AM
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Default Cryo-stuff

Hey guys,

I've been reading the threads a bit after getting an e-podiatry update that you were talking about the Cryo-star unit. I have one of these things and yes, they are expensive. I paid 24K American for the thing and I have gone through 16 tanks of Nitrous (at 30.00 a tank and a 5/month rental fee). However, I am leasing the unit with a dollar buy-out at the end of the lease. I am not sure why there is no info out on this, but you can lease it.

Disclosure: Yes I am a training center and I get the fee if people come in and learn about the Cryo and buy one so maybe I am biased. However, it works. Especially for neuromas. It also pays very well if you use the right codes. I am one of those strange people who actually reads the coding book during the day trying to figure out which is the best code to use for certain procedures.

I have been doing more procedures for plantar fasciitis with the unit and getting very good results. Basically, one has to realize that this device is a tool and provides pateints with another option prior to having mor invasive surgery. Does everyone qualify for this procedure? No. Don't let anyone tell you that. It is like the Ossatron (ESWT) unit. These procedures are for patients who have failed an exhaustive conservative treatment plan (injections, strappings, orthotics, PT, etc.) These procedures, although done "blind" are effective and follow several principles originated by the minimal incision surgeons several years ago. For the neuroma surgery, you know the neuroma is just under the intermetatarsal ligament so when doing the procedure you can actually feel the probe go through the ligament. Once this happens you pull back slightly and then freeze. We have done about 30-40 of these and only 2-3 people have needed a second procedure or had a failure. This is fairly comparable to excising the neuroma. For the plantar fasciitis patient, this works well in combination with KOBE's surgical kit for neuromas and plantar fasciitis. Basically, you identify the plantar fascia with the KOBE kit and then place the probe in the appropriate location and freeze. Again, very effective, done in the office and helps the patient avoid a more invasive procedure.

Again, understand that this is not a cure all or a miracle machine. Nothing is. What the Cryo-surgery provides is another tool to help treat patients who have failed conservative therapies but do not want a more invasive procedure done. Consider a training visit or find some of us who have used the unit and (at least I will) try and find some pateints who will vouch for its' effectiveness.

Feel free to ask any questions, I am a slacker usually responding to e-mails but I'll try and get back to you fairly quickly.

Enjoy the day.

Chuck Oehrlein, DPM
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Old 20th December 2004, 08:47 AM
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Default cryo surgery

i appreciate dr.oehrlein's candor with regards to its day to day application of this modality.i would argue that in the manner in which he describes it,one has a hard time determining whether the mis dissection via the kobe instrument is doing the job or the cryo unit.
i use the kobe instrument in my practice for both plantar fasciatomies and plantar neuroma decompressions,with the same level of success.and at a $600.00 investment (u.s. dollars),the kobe system sounds a bit more attractive.
in terms of leasing,you can find any leasing agent that will finance equipment for you.however,the company has no arrangements with any leasing agents,which can make it very difficult to do for some practitioners.
finally,the question of physicians acting as company agents,luring other physicians as company customers in an office setting,is in my opinion some what conflictive.
you are selecting patients,procedures and clinical outcomes with a specific financial goal,other than the usual patient /doctor compensation.
this is in no way an attack on dr.oehrlein who is presented the facts very honestly.
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Old 21st December 2004, 10:13 AM
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Default kobe

Hi Doc(s)

Do you have a URL contact for the KOBE system. ?

Thanks

Dr Oehrlein's findings are of interest. In the particular setting described, the subject of bias must always be a concern.
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Old 16th January 2005, 03:27 AM
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Default Cryostart: Poor Show ....

Sometime before Christmas I arranged to meet with a Cryostar rep. I set aside an hour in my schedule. Rep didn't show - no phone call, letter or e-mail.

Having heard about similar experiences from colleagues it seems Cryostar UK are acquiring a tarnished reputation in respect to customer relation. Doesn't exactly inspire much confidence, especially when the system is as yet not proven to deliver or live up to the marketing hype.

Do I still want to spend 26 000 Sterling Pound on this system...... no.
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Old 9th May 2005, 02:42 PM
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Default Endoscopic approach

Similar to the ISOGARD KOBE system, I have been using the Endoscopic Plantar procedure for years now with over a 95% success rate. Although I can't count the number I have done, it is in the 350+ range for failed conservative care. The procedure takes roughly 4 minutes (in my hands) with only the weekend for healing. The patient has 2 small incision ports which they are allowed to get wet on the 4th postoperative day and place bandaids on the incisions. Some simple excercizes are given on the 4th day, and full activity is usually allowed. The procedure is essentially the same as the ISOGARD, although, a slotted canula is used to insert the endoscope from one side, and the blade from the other side. It is done under direct visualization wheras the ISOGARD is done blind. You can take intraoperative photos for documentation and education as well, which I do.


The downside is the procedure is usually done under a general anesthetic in the hospital, and although the actual surgical equipment is relatively inexpensive, the endoscope is costly. The actual equipment is from ENDOTRAC. It can be done for neuromas, and there are reports of doing it for tarsal tunnel syndrome, but alas, I'm not that brave.
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Old 12th May 2005, 01:34 AM
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Default Kobe / Cryosurgery

Hello colleagues

I would like to ask those with experience of the systems if you are aware of any subgroups of patients who benefit more ?

For example, neuroma patients: are these treatments more effective in the early cases ? I am speculating that extensive proliferation with massive enlargment of the nerve bundle is likely to respond less well than early cases in which the nerve bundle is essentially of normal size. It is difficult to speculate how the Kobe / cryo can help those patients.

In treating Morton's neuroma, I don't understand the long term treatment rationale when selecting sectioning of the intermetatarsal ligament. What happens when the ligament has healed ? The factors causing the pathology presumably are still acting on the nerve, so that in the mid-to-long term one would assume the problem will then return.
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Old 12th May 2005, 11:22 AM
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Default Mortons Neuroma

We have had some good results in relatively early stages using a deyhdrated alcohol solution. Usually 7 - 14 injections spaced 2 weeks apart. The neurolysis procedure is rather well documented and does work a good percentage of the time
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Old 14th June 2005, 11:00 PM
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Lightbulb Cryo-Surgery for painful problem

Has any one done any research into cryo-surgery for this problem without an incision ?
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Old 16th June 2005, 12:16 PM
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Default neuromas

dieter,

the nerve decompresion i perform for a neuroma consists of transection of the intermetatarsal ligament and an ostectomy of the medial aspect of the fourth metatarsal.this creates enough of a space whereby the same forces acting to create the neuroma will not reoccur.it must also be understood that once the patient is discharged they are to wear an orthosis with a flexible metatarsal bar in order to allow the ligament to reattach in a more lax position.
however,i first try to treat these patients with the dehydrated alcohol,at least 4 injections in a 3 week(look up dr.dockery's work on the subject) period.it has been known to be very effective.

take care,

rick
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Old 30th June 2005, 03:52 AM
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Default Ostectomy....

Rick

Interesting insight - this is a procedure I have not heard of or read about in the journals / books.

Summers approach makes me wonder ..... if someone stuck a needle in my foot 7 - 14 times I would be extremely tempted to tell them anything they want "Sure Doc the foot is MUCH better .... no more needles....PLEASE! and yes I am hiding Sadam's WMD and whatever else ...... just stop torturing me "
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Old 19th April 2006, 11:51 PM
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Quote:
Originally Posted by Dieter Fellner
Sometime before Christmas I arranged to meet with a Cryostar rep. I set aside an hour in my schedule. Rep didn't show - no phone call, letter or e-mail.

Having heard about similar experiences from colleagues it seems Cryostar UK are acquiring a tarnished reputation in respect to customer relation. Doesn't exactly inspire much confidence, especially when the system is as yet not proven to deliver or live up to the marketing hype.

Do I still want to spend 26 000 Sterling Pound on this system...... no.
Further to this posting, I have now met with Cryostar representative, Brian Clark and colleague. I am pleased to relate to you the customer relations aspect has now substantially improved and I can recommend Brian as a contact in the UK. He is very professional, with a 'down to earth' approach and appears genuine and transparent in his dealings; and he also keeps his scheduled appointments, even when I forgot ! (ouch) ... I remain interested in this technology but await the outcome of a robust NHS trial; I have expressed an interest in leading this trial.
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Old 3rd March 2007, 10:21 AM
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Default Re: Cryo-Surgery: A lasting solution for a painful problem

Cryosurgery: an innovative technique for the treatment of plantar fasciitis.
J Foot Ankle Surg. 2007 Mar-Apr;46(2):75-9
Allen BH, Fallat LM, Schwartz SM
Quote:
A prospective study testing the efficacy of cryosurgery on painful plantar fasciitis of the heel was performed. Cryosurgery, a minimally invasive, percutaneous, office-based technique, was used to treat 59 consecutive patients (61 heels), who had failed prior conservative therapy and were considered surgical candidates. Patients were evaluated on an 11-point visual analog scale administered preoperatively and up to 1 year of follow-up. The mean pain rating (8.38) before cryosurgery (day 0) is statistically significant to the mean pain rating (1.26) at day 365 postoperatively. Pain decreased significantly after the procedure (analysis of variance, P < .0001). These results suggest cryosurgery is significantly effective in treating patients with recalcitrant plantar fasciitis. Cryosurgery offers a highly effective treatment modality after failed conservative treatment without resorting to open invasive outpatient surgery.
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Old 3rd March 2007, 10:43 AM
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Default Re: Cryo-Surgery: A lasting solution for a painful problem

Quote:
Originally Posted by NewsBot
Cryosurgery: an innovative technique for the treatment of plantar fasciitis.
J Foot Ankle Surg. 2007 Mar-Apr;46(2):75-9
Allen BH, Fallat LM, Schwartz SM
Am I missing something? Control group? duh?
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