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Ivanhoe Broadcast News Interview Transcript with Mark Feldman, D.P.M., Podiatric Surgeon, Parkway and Hialeah, Miami TOPIC:  ANKLE RELPACEMENT,

When did this ankle replacement procedure first become available?

Dr. Feldman: The Buechel-Pappas total ankle prosthesis became available to Americans in October of 1998. It was used in Europe for almost 15 years. Multiple European surgeons have used the implant and have reported that 81 or 82 percent of almost 1,000 patients have totally pain free ankles after ten years. That statistically approaches the hip and the knee success rates.

How many surgeons are approved to do this procedure? Dr. Feldman: The FDA now permits the surgery to be done in the United States by 10 selected surgeons. There will be more after a year or two, but for now, the FDA classifies this as an investigational device.

What does that mean?

Dr. Feldman: Investigational means it can be implanted by a limited number of surgeons. The FDA will take the statistical results and then expand it. Considering the remarkable success of the European surgeons, I expect it will take less than a year to become available for a multiplicity of surgeons.

So right now it is approved, but not every doctor can do it? Dr. Feldman: Correct. There will never be a time when every doctor who wants to do it can do it. The procedure is very much like heart surgery in that they're going to limit the number of surgeons who can do it because of technical difficulty. Not every surgeon can implant the heart, and not every surgeon will be able to implant the ankle. A year from now, there will be significantly more surgeons permitted to perform the procedure.

When did you start doing the procedure yourself?
Dr. Feldman: I started in December of 1998. It takes a while for the patient population to realize that the ankle is available. I'm quite certain that when patients know it is available, there will be a greater interest. The number of patients with rheumatoid arthritis or arthritis from a broken ankle in the United States is, I estimate, more than 20,000.  There are
a lot of patients who are desperately seeking this procedure because it is the only other option to a new ankle joint besides the fusion of their foot to their ankle. One of the significant features of the Buechel-Pappas is that I can take down an ankle that was fused and give that patient a functioning ankle joint again. After 20 years in development, it's an extraordinary implant and will be able to help so
many thousands of patients.

Describe the procedure.
Dr. Feldman: The implant is the Buechel-Pappas total ankle replacement. It is a three-piece ankle joint made of titanium and ultra high molecular weight polyethylene. It is implanted both in the tibia at the ankle and the bone beneath it, the talus. A portion of the bone is removed, and the implant is inserted.

Is the procedure similar to the hip or knee implant? Dr. Feldman: It is similar, except it's much smaller. Development took a long time because ankles support five times their body's weight every time a step is taken. The hip and the knee only take twice their body's weight. It's a much more complicated device, much smaller and much more difficult to insert because the operation area is much smaller.

What are the advantages of the ankle replacement? Dr. Feldman: The advantage is that patients can walk, swim and climb stairs after the ankle replacement. They have an 80 percent chance of being totally pain-free. Generally, patients who need this procedure are in such pain that sometimes they want their limbs removed. These are patients who have rheumatoid arthritis or who have arthritis from a broken ankle. Many waited for years for the ankle replacement to be perfected because the only alternative is to have their ankles fused. When that is done, the patient walks with a limp. Four or five years later, because the
stress that the ankle takes up is now taken up by the foot, two or three joints that are affected in the foot have to be fused. It's a devastating operation to fuse an ankle, but now we have the implant.

Why is this considered such an incredible medical breakthrough? Dr. Feldman: This was in development for a little over 20 years. In the early 70s, there were a number of different ankle prosthesis that failed. The designs were poor because they were cemented. Now the metal and the designs are totally different.

Would you say this is a breakthrough? How would you describe it? Dr. Feldman: I would call it a limb-saving device. It gives life back to patients with severe pain. I've seen that happen over and over, all over the world.

How many patients have benefited from this? Dr. Feldman: According to the United States government, there are almost 10,000 patients over 65 five years of age that break their ankles every year. The numbers are similar under that age. If you multiply that through the last 10 years as an example, that's a very large number of patients who have either
severe arthritis from rheumatoid disease or patients who have fractured their ankles. That gives you some indication of the numbers of patients in the United States who stand to benefit from this new ankle joint.

What is the success rate?
Dr. Feldman: The success rate is right at 81 to 82 percent. This is figured after patients have used the ankle for 10 years of longer.

Is there a rehabilitation period?
Dr. Feldman: Yes. After surgery the patient is put in a short leg cast that goes from just below the knee to the end of the toe. That stays on for six weeks. After six weeks, they begin to walk and go to rehab for another six weeks, two to three times a week. After the six weeks of rehabilitation, they go back to their normal daily lives.

This procedure isn't for everyone, is it? Dr. Feldman: No. This is for patients who have severe rheumatoid disease in their ankles or who have severe arthritis secondary to an ankle fracture.

What is the cost?
Dr. Feldman: I don't know the hospital charges, but I can say that between surgeons fees, hospital bills and the implant itself, it's right around $20,000. That is far less than having a few of your teeth implanted, especially for such a significant device.

On a scale of one to 10, how would you rate this breakthrough? Dr. Feldman: You should ask that question to the patients. They would probably say it's comparable to having a new heart since it allows them to walk again. As a surgeon, I'm delighted to see that it came along during my career because I've been interested in the ankle for many years. I've seen quite a few similar things fail. Since this has been so successful for so many years, it's a joy to have and use.

How many patients are currently waiting to have the procedure done in the future?  Dr. Feldman: I will perform six and possibly even eight in the month of March.

How do you identify candidates for this procedure?
Dr. Feldman: We require two things, a set of X-rays that is very specific in terms of ankle position and an examination. The X-rays help me determine whether I can implant the ankle replacement and whether or not I can take down a patient's fusion and give them an ankle joint again.  END OF INTERVIEW

This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.

Copyright, 1999, Ivanhoe Medical Breakthroughs.


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