Putting Risk In Perspective

[Guest guest]

> Ther have been many posts regarding the theoretical risk

> from metal ions as a result of M-O-M prostheses. Relax, soon most

> THRs and other joint prosteheses will be made of the same materials.

>

>

> michael in NC

" >Relax, soon most THRs and other joint prosteheses will be made of

the same materials.< "

>

>>Not so.The use of M-O-M THR's is declining.

>>dawkins

[Guest guest]

> " >Relax, soon most THRs and other joint prosteheses will be made of

> the same materials.< "

> >

>

> >>Not so.The use of M-O-M THR's is declining.

>

> >>dawkins

I would really like to see a reference to the data that says MOM's

are declining. Thanks.

Cheers,

Don W

[Guest guest]

>

> > " >Relax, soon most THRs and other joint prosteheses will be made

of

> > the same materials.< "

> > >

> >

> > >>Not so.The use of M-O-M THR's is declining.

> >

> > >>dawkins

>

>

> I would really like to see a reference to the data that says MOM's

> are declining. Thanks.

>

> Cheers,

> Don W

>>Hi, Don. The data came straight from my orthopaedic surgeon. I

asked him about the popularity of m/m and he said from all

indications, and talking with other orthos at conventions and

lectures,it is on the decline. He said it is not being used that much

anymore. The reason: concern about metal particles. In cadavers with

m/m THR's, they are finding actual metal particles in the heart,

lungs, lymph nodes, and other organs of the body. The elevated metal

levels in the blood also puts a strain on the kidneys.But it's the

particles that they are becoming more concerned about.

dawkins

[Guest guest]

> >

> > > " >Relax, soon most THRs and other joint prosteheses will be

made

> of

> > > the same materials.< "

> > > >

> > >

> > > >>Not so.The use of M-O-M THR's is declining.

> > >

> > > >>dawkins

> >

> >

> > I would really like to see a reference to the data that says

MOM's

> > are declining. Thanks.

> >

> > Cheers,

> > Don W

>

> >>Hi, Don. The data came straight from my orthopaedic surgeon. I

> asked him about the popularity of m/m and he said from all

> indications, and talking with other orthos at conventions and

> lectures,it is on the decline. He said it is not being used that

much

> anymore. The reason: concern about metal particles. In cadavers

with

> m/m THR's, they are finding actual metal particles in the heart,

> lungs, lymph nodes, and other organs of the body. The elevated

metal

> levels in the blood also puts a strain on the kidneys.But it's the

> particles that they are becoming more concerned about.

>

> dawkins

Hi Dawkins,

It would be nice to be pointed to some research that documsnts this

fact. And I'm sure a lot of others on this board would really like

that too. Is there any chance he could be contacted to provide

same? Appreciate, thanks.

Don W.

[Guest guest]

I'm rather new to this group and I'm not sure what your protocols are. I

don't want to step on anyone's toes or sound contradictory but I would be

very hesitant to make blanket statements about what hips are going to be

made of in the future.

Metal / Poly will continue to be the first choice for " Low Demand " (older or

less active) patients as long as they cost less than others.

Metal / Metal will be popular with a wide variety of patients who want

durability or are concerned about Poly wear problems and particles.

Metal / Metal - large diameter (includes both THR and Resurf) will be the

choice for younger, more active patients who value the low incidence of

dislocation, durability and (in the case of Resurf.) ease of future

revision.

Ceramic / Ceramic will be the choice for people concerned about wear

debris*.

*(although metal/metal is showing little wear at all and we don't know much

about ceramic wear particles yet)

Hopefully the pros and cons of all of these choices have been discussed here

in this group. Each type or combination has strengths and weaknesses that

make it vital for the patient and surgeon to discuss all available options

and make a choice that's customized for the best result, for the individual

patient. I would always be wary of any surgeon with only one choice in his

bag of tricks.

I predict more diversity in the future of hip replacement, not less.

Dr T

Re: Putting risk in perspective

>

> >

> > > " >Relax, soon most THRs and other joint prosteheses will be made

> of

> > > the same materials.< "

> > > >

> > >

> > > >>Not so.The use of M-O-M THR's is declining.

> > >

> > > >>dawkins

> >

> >

> > I would really like to see a reference to the data that says MOM's

> > are declining. Thanks.

> >

> > Cheers,

> > Don W

>

> >>Hi, Don. The data came straight from my orthopaedic surgeon. I

> asked him about the popularity of m/m and he said from all

> indications, and talking with other orthos at conventions and

> lectures,it is on the decline. He said it is not being used that much

> anymore. The reason: concern about metal particles. In cadavers with

> m/m THR's, they are finding actual metal particles in the heart,

> lungs, lymph nodes, and other organs of the body. The elevated metal

> levels in the blood also puts a strain on the kidneys.But it's the

> particles that they are becoming more concerned about.

>

> dawkins

>

>

>

>

[Guest guest]

It would be nice to know the name of The Orthopaedic Surgeon who told you this

and the Hospital he works from. I am concerned that he is stating this. At

American Academy of Orthopaedic Surgeons New Orleans Convention this February

(2003) they were told the following by British OS's:

The bone preserving aspect of hip resurfacing combined with minimal wear

metal-metal technology provides a very attractive solution for the younger

arthritic hip. The long term effects of the inevitable metal ion release

however, remain a concern. Serum ion levels from metal-metal resurfacing hip

patients were measured pre-operatively and then every year for up to five years.

Blood was collected using a standardised technique to ensure no metallic

contamination. Chromium analysis was by graphite furnace atomic absorption

(ETA-AAS) using a 4100ZL or A800 perkineimer instrument. Cobalt was analysed by

inductively coupled plasma mass spectrometry (ICP-MS). Measurements were taken

from 39 patients with 7 bilateral cases. Pre-operative levels were only taken

from 15 patients, and these were universally low (below 20nmol/l). In all

patients the serum levels of cobalt and chromium increased following resurfacing

although the extent of the increase varied greatly between patients. The data

shows a definite trend of decreasing ion levels after 4 years. This may be

consistent with running-in wear and healing of the peri-prosthetic tissues

providing a smooth, stable joint. Younger patients (<40) had significantly

higher ion levels than older patients (>60). Anecdotally, there was some

evidence of increased ion levels associated with steep cup angles.

At the 1996 AAOS convention the following was stated by American OS's

Liver, spleen, and para-aortic lymph nodes were collected at autopsy and

examined for metallic particulate debris in nine patients with primary total hip

replacement (THR), six with revision THR, four with primary total knee

replacement, and nine with no orthopaedic implants. Electron microprobe analysis

identified particles <1 to 7 micrometers in size of cobalt-chromium,

stainless-steel, commercially pure titanium, or titanium-aluminum-vanadium alloy

in histiocytes within the liver, spleen, and lymph nodes of patients with

implants. These particles were observed most frequently in patients with

multiple implants, revision THR, cases with wires or cables, and primary

arthroplasties of long duration.

Also at the same meeting

Between 1990 and 1994, 73 patients received total hip replacements with

metal-on-metal articulation. The authors report the results of 60 of these

patients who have two to four-year follow-up. Seventeen (23%) patients have

bilateral total hip replacement, 1 with metal-on-metal articulation and the

other with metal-on-polyethylene or ceramic-on-polyethylene. Of these 60

patients, there were 3 deaths, 1 revision (secondary to recurrent dislocation

and impingement), 1 infection, no loose components, and no osteolysis.

hip scores increased from 49 to 93. Patients with bilateral hip replacements do

not notice any difference between the two nor do they favor one over the other.

Serial radiographs demonstrate no signs of wear, loosening, or osteolysis.

Synovial fluid samples from 12 patients of more than one year implantation show

no significant amount of particular debris. Metal particles of 1 to 10 microns

were present in 5 of these patients. Metal particles were also found in 4 of 7

patients with metal-on-polyethylene prothesis. The satisfactory results of

metal-on-metal hip replacements are encouraging and warrant continued study.

It should also be noted that MOM THR devices have been in use since the 1960's

and no problem with the metal particles has been highlighted. In the UK a check

was made for cancer statistics - the % was the same for those with MOM and those

not having had hip surgery.

Rog

Re: Putting risk in perspective

>

> > " >Relax, soon most THRs and other joint prosteheses will be made

of

> > the same materials.< "

> > >

> >

> > >>Not so.The use of M-O-M THR's is declining.

> >

> > >>dawkins

>

>

> I would really like to see a reference to the data that says MOM's

> are declining. Thanks.

>

> Cheers,

> Don W

>>Hi, Don. The data came straight from my orthopaedic surgeon. I

asked him about the popularity of m/m and he said from all

indications, and talking with other orthos at conventions and

lectures,it is on the decline. He said it is not being used that much

anymore. The reason: concern about metal particles. In cadavers with

m/m THR's, they are finding actual metal particles in the heart,

lungs, lymph nodes, and other organs of the body. The elevated metal

levels in the blood also puts a strain on the kidneys.But it's the

particles that they are becoming more concerned about.

dawkins

[Guest guest]

Oh yeah, - I definitely love you! Thank you for this detailed

info - not that I was very worried anyway

From a totally unscientific-but-commonsense standpoint; there's been

many more things in my lifetime so far that have posed serious

hazards to my health. Nuclear tests would rate high on that list;

along with probable exposure to DDT, and in Michigan a certain

ingestion of PBB....exposure to benzene, lead, and asbestos by the

boatload...and of course, every lucky kid had a small vial of

mercury to play with - it was fun stuff!

How did we ever live long enough to need our hips fixed..LOL!!!

Best wishes!

Deb

> It would be nice to know the name of The Orthopaedic Surgeon who

told you this and the Hospital he works from. I am concerned that

he is stating this. At American Academy of Orthopaedic Surgeons

New Orleans Convention this February (2003) they were told the

following by British OS's:

>

> The bone preserving aspect of hip resurfacing combined with

minimal wear metal-metal technology provides a very attractive

solution for the younger arthritic hip. The long term effects of the

inevitable metal ion release however, remain a concern. Serum ion

levels from metal-metal resurfacing hip patients were measured pre-

operatively and then every year for up to five years. Blood was

collected using a standardised technique to ensure no metallic

contamination. Chromium analysis was by graphite furnace atomic

absorption (ETA-AAS) using a 4100ZL or A800 perkineimer instrument.

Cobalt was analysed by inductively coupled plasma mass spectrometry

(ICP-MS). Measurements were taken from 39 patients with 7 bilateral

cases. Pre-operative levels were only taken from 15 patients, and

these were universally low (below 20nmol/l). In all patients the

serum levels of cobalt and chromium increased following resurfacing

although the extent of the increase varied greatly between patients.

The data shows a definite trend of decreasing ion levels after 4

years. This may be consistent with running-in wear and healing of

the peri-prosthetic tissues providing a smooth, stable joint.

Younger patients (<40) had significantly higher ion levels than

older patients (>60). Anecdotally, there was some evidence of

increased ion levels associated with steep cup angles.

>

> At the 1996 AAOS convention the following was stated by American

OS's

>

> Liver, spleen, and para-aortic lymph nodes were collected at

autopsy and examined for metallic particulate debris in nine

patients with primary total hip replacement (THR), six with revision

THR, four with primary total knee replacement, and nine with no

orthopaedic implants. Electron microprobe analysis identified

particles <1 to 7 micrometers in size of cobalt-chromium, stainless-

steel, commercially pure titanium, or titanium-aluminum-vanadium

alloy in histiocytes within the liver, spleen, and lymph nodes of

patients with implants. These particles were observed most

frequently in patients with multiple implants, revision THR, cases

with wires or cables, and primary arthroplasties of long duration.

>

> Also at the same meeting

>

> Between 1990 and 1994, 73 patients received total hip replacements

with metal-on-metal articulation. The authors report the results of

60 of these patients who have two to four-year follow-up. Seventeen

(23%) patients have bilateral total hip replacement, 1 with metal-on-

metal articulation and the other with metal-on-polyethylene or

ceramic-on-polyethylene. Of these 60 patients, there were 3 deaths,

1 revision (secondary to recurrent dislocation and impingement), 1

infection, no loose components, and no osteolysis. hip scores

increased from 49 to 93. Patients with bilateral hip replacements do

not notice any difference between the two nor do they favor one over

the other. Serial radiographs demonstrate no signs of wear,

loosening, or osteolysis. Synovial fluid samples from 12 patients of

more than one year implantation show no significant amount of

particular debris. Metal particles of 1 to 10 microns were present

in 5 of these patients. Metal particles were also found in 4 of 7

patients with metal-on-polyethylene prothesis. The satisfactory

results of metal-on-metal hip replacements are encouraging and

warrant continued study.

>

> It should also be noted that MOM THR devices have been in use

since the 1960's and no problem with the metal particles has been

highlighted. In the UK a check was made for cancer statistics - the

% was the same for those with MOM and those not having had hip

surgery.

>

> Rog

>

[Guest guest]

FYI, this is what Cucchi from Midmedtec had to say about this:

Dear Donna,

Well I would love to know who this Surgeon is; certainly he needs his

information updating. At present the growth in use of MOM devices has

never been stronger, BHR is increasing in usage at an incredible rate

and other companies would also highlight ever increasing interest.

Some of the major ortho companies are indicating large increases in

sales of `large head' MOM total hip replacements, so in fact the

reverse of this `information' is true.

On the subject of metal particles we are only aware of one long term

cadaveric study that is even ready for publication, this is from an

American group and unfortunately until it is published (quite soon)

we cannot even hint at what has been found, so where this ortho

Surgeon has got his information from I would also like to know.

On the subject of metal ion clearance by the kidneys, well, in all

the ongoing studies no specific issues of this nature have been

highlighted to date and certainly in the studies of patients with the

first generation Metal on Metal devices, some of which have been in

patients for 30yrs, this has not been shown to be an issue.

In all of these areas more work will always need to be done and much

research is in progress by us and many other groups however so far

results would seem to indicate that if you use the correct metallurgy

(non heat-processed product – not post cast heat treated or sintered)

then at the current state of knowledge these are not issues, although

as I have stated before in reality we will only know for certain in

the fullness of time.

Best regards,

Cucchi

International Marketing & Clinical Education Manager

Midland Medical Technologies

[Guest guest]

>

> FYI, this is what Cucchi from Midmedtec had to say about this:

>

> Dear Donna,

> Well I would love to know who this Surgeon is; certainly he needs

his

> information updating. At present the growth in use of MOM devices

has

> never been stronger, BHR is increasing in usage at an incredible

rate

> and other companies would also highlight ever increasing interest.

> Some of the major ortho companies are indicating large increases in

> sales of `large head' MOM total hip replacements, so in fact the

> reverse of this `information' is true.

>

> On the subject of metal particles we are only aware of one long

term

> cadaveric study that is even ready for publication, this is from an

> American group and unfortunately until it is published (quite soon)

> we cannot even hint at what has been found, so where this ortho

> Surgeon has got his information from I would also like to know.

>

> On the subject of metal ion clearance by the kidneys, well, in all

> the ongoing studies no specific issues of this nature have been

> highlighted to date and certainly in the studies of patients with

the

> first generation Metal on Metal devices, some of which have been in

> patients for 30yrs, this has not been shown to be an issue.

>

> In all of these areas more work will always need to be done and

much

> research is in progress by us and many other groups however so far

> results would seem to indicate that if you use the correct

metallurgy

> (non heat-processed product – not post cast heat treated or

sintered)

> then at the current state of knowledge these are not issues,

although

> as I have stated before in reality we will only know for certain in

> the fullness of time.

>

> Best regards,

> Cucchi

> International Marketing & Clinical Education Manager

> Midland Medical Technologies

>FYI, my surgeon is very up-to-date on all info regarding THR's and

resurfacing.He, himself, does both m/p and m/m, so it is very much of

interest to him. Seems to me that this J.Cucchi is biased. No doubt

that THE COMPANY HE WORKS FOR is involved with m/m. Of course he's

going to refute this current info.

dawkins

[Guest guest]

Dawkins:

Do we get to find out who this OS is? I don't remember

if you stated his name, what country he is in or what

devices he installs. Enquiring minds want to know.

Lois

(L) C+ 3/27/03 Dr. Mont

Re: Putting Risk In Perspective

>

> FYI, this is what Cucchi from Midmedtec had to say about this:

>

> Dear Donna,

> Well I would love to know who this Surgeon is; certainly he needs

his

> information updating. At present the growth in use of MOM devices

has

> never been stronger, BHR is increasing in usage at an incredible

rate

> and other companies would also highlight ever increasing interest.

> Some of the major ortho companies are indicating large increases in

> sales of `large head' MOM total hip replacements, so in fact the

> reverse of this `information' is true.

>

> On the subject of metal particles we are only aware of one long

term

> cadaveric study that is even ready for publication, this is from an

> American group and unfortunately until it is published (quite soon)

> we cannot even hint at what has been found, so where this ortho

> Surgeon has got his information from I would also like to know.

>

> On the subject of metal ion clearance by the kidneys, well, in all

> the ongoing studies no specific issues of this nature have been

> highlighted to date and certainly in the studies of patients with

the

> first generation Metal on Metal devices, some of which have been in

> patients for 30yrs, this has not been shown to be an issue.

>

> In all of these areas more work will always need to be done and

much

> research is in progress by us and many other groups however so far

> results would seem to indicate that if you use the correct

metallurgy

> (non heat-processed product – not post cast heat treated or

sintered)

> then at the current state of knowledge these are not issues,

although

> as I have stated before in reality we will only know for certain in

> the fullness of time.

>

> Best regards,

> Cucchi

> International Marketing & Clinical Education Manager

> Midland Medical Technologies

>FYI, my surgeon is very up-to-date on all info regarding THR's and

resurfacing.He, himself, does both m/p and m/m, so it is very much of

interest to him. Seems to me that this J.Cucchi is biased. No doubt

that THE COMPANY HE WORKS FOR is involved with m/m. Of course he's

going to refute this current info.

dawkins

[Guest guest]

Dawkins,

You offered a point of view; I simply offered another. I purposely

prefaced it with, " FYI " . I think being well-informed requires that

you listen to all the facts and then decide for yourself which is the

most credible. Bring it on; I'm certainly willing to listen.

> >

> > FYI, this is what Cucchi from Midmedtec had to say about

this:

> >

> > Dear Donna,

> > Well I would love to know who this Surgeon is; certainly he needs

> his

> > information updating. At present the growth in use of MOM devices

> has

> > never been stronger, BHR is increasing in usage at an incredible

> rate

> > and other companies would also highlight ever increasing

interest.

> > Some of the major ortho companies are indicating large increases

in

> > sales of `large head' MOM total hip replacements, so in fact the

> > reverse of this `information' is true.

> >

> > On the subject of metal particles we are only aware of one long

> term

> > cadaveric study that is even ready for publication, this is from

an

> > American group and unfortunately until it is published (quite

soon)

> > we cannot even hint at what has been found, so where this ortho

> > Surgeon has got his information from I would also like to know.

> >

> > On the subject of metal ion clearance by the kidneys, well, in

all

> > the ongoing studies no specific issues of this nature have been

> > highlighted to date and certainly in the studies of patients with

> the

> > first generation Metal on Metal devices, some of which have been

in

> > patients for 30yrs, this has not been shown to be an issue.

> >

> > In all of these areas more work will always need to be done and

> much

> > research is in progress by us and many other groups however so

far

> > results would seem to indicate that if you use the correct

> metallurgy

> > (non heat-processed product – not post cast heat treated or

> sintered)

> > then at the current state of knowledge these are not issues,

> although

> > as I have stated before in reality we will only know for certain

in

> > the fullness of time.

> >

> > Best regards,

> > Cucchi

> > International Marketing & Clinical Education Manager

> > Midland Medical Technologies

>

> >FYI, my surgeon is very up-to-date on all info regarding THR's and

> resurfacing.He, himself, does both m/p and m/m, so it is very much

of

> interest to him. Seems to me that this J.Cucchi is biased. No doubt

> that THE COMPANY HE WORKS FOR is involved with m/m. Of course he's

> going to refute this current info.

>

> dawkins