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As much as we have all come to loathe the cumbersome FDA approval

process here in the U.S., it could be these same stringent

guidelines to the approval process that protect us from

such " deviations " in reporting protocol as discussed in this

article.

Chris

> I was doing some research for my soon to be filed appeal for my

soon

> to be received denial from my insurance company for resurfacing.

I

> came across an interesting article that I thought I would share

with

> the group since comparisons have been made the last couple of

days.

> Also, the site where I found the article is a nice site for

> information. There are several other articles that were

interesting

> and most likely will be others in the future. This may have

already

> been shared but I missed it. Sorry if it is repetitive!

>

> The site I found

> it was:

> http://www.totaljoints.info/what_new1.htm

>

> It's called TEST/News

>

> "

> March 2004

>

> 24 / 03 / 2004

>

> THE BIRMINGHAM SURFACE HIP – more details

>

> The report about the excellent results of the Birmingham surface

hip

> replacement device (see the 19/03 2004 NEWS: Surface hip

replacement)

> raised several questions among the readers of the NEWS page (see

also

> the Opinion page).

>

> Many readers were surprised by the difference between the results

of

> the American (Amstutz 2004) and the British ( 2004)

surgeons.

>

> According to doctor Amstutz report, 94.4% of his entire surface

hip

> group survived for four years; in the Birmingham group 99.7% of

all

> surface hips survived seven years.

>

> Doctor Amstutz observed both surface hip dislocations and

fractures

> of the femoral collum stump; no such complications were observed

in

> the Birmingham patient group.

>

> Doctor Amstutz used the Conserve Plus model manufactured by

MT

> Company, the British surgeon doctor McMinn used the Birmingham Hip

> Resurfacing devices manufactured by MMT Company. Naturally, the

> question arises whether the two different surface hip models in

some

> way influenced the results, if the one resurfacing hip model is

> better than the other one.

>

> I do think that the difference in the results between doctor

Amstutz

> group and the doctor McMinn patient groups does not depend on the

> type of the surface replacement device used. The difference in the

> results depends in my opinion on different patients selection by

the

> two surgeons.

>

> Doctor Amstutz's patients have had a wide range of hip diseases.

Only

> two thirds of them have had primary osteoarthritis of the hip as

the

> reason for surgery; 10% of them have had severe osteonecrosis of

the

> femoral head, 8% have had previous hip fracture, and 6% have had

> previous surgery. These diagnoses are known to bear greater risk

for

> eventual failure of the surface replacement.

>

> On the other hand, the Birmingham patient group consisted of very

> closely selected patients with only one diagnosis: idiopathic hip

> osteoarthritis. The hip joints of these patients have had no

> deformities, cysts, bone necrosis or other defects in the

skeleton;

> these patients did not have previous operations, hip fracture or

> other joint diseases that increase the risk of failure of the

surface

> hip replacement.

>

> Moreover, doctor McMinn excluded from the study 30% of his

patients

> who have had high failure rates! He says that these excluded

> patients have had a wrongly manufactured surface replacement

device

> that caused the high failure rates.

>

> In my belief the excellent " 99% + " results of the Birmingham hip

can

> be reproduced only on patients with the idiopathic osteoarthritis

of

> the hip joint. Patients with other hip joint diseases and

> deformities, such as developmental hip dysplasia, avascular

necrosis,

> rheumatoid arthritis, and previous fracture should rather expect

the

> more realistic results achieved by doctor Amstutz.

>

> Actually, there are reports about very disappointing results with

the

> McMinn Resurfacing Hip Arthroplasty. Japanese surgeons published a

> report that demonstrated 3 failures among 11 patients operated on

> with the McMinn Resurfacing Hip Arthroplasty. (Watanabe 2000). Two

of

> their patients sustained femoral neck fractures, and the third

> developed loosening in the acetabular component early after the

> surgery. The Japanese surgeons believe that this surface

replacement

> device is not appropriate for patients with brittle or soft bones

> because of its biomechanical characteristics.

>

> Doctor Amstutz discusses extensively the appropriateness of

surface

> hip replacement for these patient categories, but such discussion

is

> lacking in the McMinn paper.

>

> Your opinion?

>

> ____________

>

> References:

>

> Amstutz H et al.: J Bone Joint Surg-Am 2004; 86-A : 28 - 39

>

> J et al.: J Bone Joint Surg- Br 2004; 86- B : 177 – 84

>

> Watanabe Y et al: J Arthroplasty 2000; 15: 505 - 11

>

>

> -------------------------------------------------------------------

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