cmf ol1000

"Under the Food, Drug, and Cosmetic Act (FDAC) at U.S.C. 21 §§301-97, manufacturers are prohibited from directly marketing for a use other than the FDA approved indication. The Food and Drug Administration Modernization Act of 1997 created an exception to the prohibition of off-label marketing. Manufacturers are now able to provide medical practitioners with off-label information in response to an unsolicited request."



"The FDA does not have the legal authority to regulate the practice of medicine, and the physician may prescribe off label. Contrary to popular notion, it is legal in the United States and in many other countries to prescribe off label"



Ortho here -----
the above is correct
the poster is smart
smarter than the reps on here I see

 

++++++++++++ wow cant you guys at S&N read? +++++++++++++++++








THE FACTS:

Two studies, both by Emami et al., were cited: one was published in the Journal of Orthopaedic Trauma and one, in Clinical Orthopaedics and Related Research.

The first states that Exogen Inc. provided the ultrasound devices used in this study. The authors have received nothing else of value. The second article provides no information about financial support of the study.

Both studies by Emami et al. were prospective, randomized, blinded, and placebo-controlled.

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.

reread that again ok..........

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.



EXOGEN = PLACEBO

 

Yeah I had an exogen bone stim and it was a piece of junk

I wish I knew about those studies because I'd sue the damn company that makes it
What a piece of junk that exogen thing was
In fact I'm going back to the doc that gave it to me and ask WHY
It didn't work

sounds like he was PAID to give it to me

 

VERY busy surgeon here [incredibly busy actually]

yes this patient is right on
and althogh 99.9% of my cases heal well
when they do not I chose the best device for my patient


and it is NOT exogen!!
The above patient should find a good attorney

 

It doesn't. The DJ ortho stimulator has been noted in several economical articles that it is unworthy and is not a consideration based on outcomes.

On the other hand Exogen has multiple level one studies and has an overall efficacy rate of 86% verses the DJ stimulator at 60%.

DJ has a buy and bill, bone stim scheme set up with Clincs and Hospitals which is questionable and has created unessecary orders, financial hardship to patients and loss to clinics.

 

Yeah I had an exogen bone stim and it was a piece of junk

I wish I knew about those studies because I'd sue the damn company that makes it
What a piece of junk that exogen thing was
In fact I'm going back to the doc that gave it to me and ask WHY
It didn't work

sounds like he was PAID to give it to me

 

THE FACTS:

Two studies, both by Emami et al., were cited: one was published in the Journal of Orthopaedic Trauma and one, in Clinical Orthopaedics and Related Research.

The first states that Exogen Inc. provided the ultrasound devices used in this study. The authors have received nothing else of value. The second article provides no information about financial support of the study.

Both studies by Emami et al. were prospective, randomized, blinded, and placebo-controlled.

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.

reread that again ok..........

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.



EXOGEN = PLACEBO

 

Someone please close this useless string of idiotic posts
Exogen proved in 2 studies they are PLACEBO
'nuf said

 

obviously we seem to have a clinically retarded distributor rep posting for us here. Which is nothing new from my 20+ years if experience here.

hey asshat- you do realize, r.e. the emami study, just because it appeared in two journals doesn't mean it counts as two separate studies.

And please enlighten us on ANY clinical proof that the DJ device does anything to help fracture healing with non-uinions without talking about your competitors:


(crickets)

 

Yeah I had an exogen bone stim and it was a piece of junk

I wish I knew about those studies because I'd sue the damn company that makes it
What a piece of junk that exogen thing was
In fact I'm going back to the doc that gave it to me and ask WHY
It didn't work

sounds like he was PAID to give it to me

 

VERY busy surgeon here [incredibly busy actually]

yes this patient is right on
and althogh 99.9% of my cases heal well
when they do not I chose the best device for my patient


and it is NOT exogen!!
The above patient should find a good attorney

 

Two studies, both by Emami et al., were cited: one was published in the Journal of Orthopaedic Trauma and one, in Clinical Orthopaedics and Related Research.

The first states that Exogen Inc. provided the ultrasound devices used in this study. The authors have received nothing else of value. The second article provides no information about financial support of the study.

Both studies by Emami et al. were prospective, randomized, blinded, and placebo-controlled.

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.

reread that again ok..........

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.

 

He can't. He is retarded and all he can do is copy and paste. He wouldn't know an evidence based, well designed study if it bit him on his Moob.

 

++++++++++++ wow cant you guys at S&N read? +++++++++++++++++




THE FACTS:

Two studies, both by Emami et al., were cited: one was published in the Journal of Orthopaedic Trauma and one, in Clinical Orthopaedics and Related Research.

The first states that Exogen Inc. provided the ultrasound devices used in this study. The authors have received nothing else of value. The second article provides no information about financial support of the study.

Both studies by Emami et al. were prospective, randomized, blinded, and placebo-controlled.

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.

reread that again ok..........

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.



EXOGEN = PLACEBO

 

This report summarises the efficacy, safety and cost-effectiveness of Exogen bone growth stimulator, a low-intensity ultrasound treatment (LIUS) for the acceleration of bone healing, on the basis of the currently available evidence.

The quality of evidence available for the current review was variable. Only low-level patient case series and registry evidence was available regarding fractures exhibiting non-union. In the case of non-union, no direct comparisons with active interventions such as surgery have been undertaken.

Effectiveness:

On the basis of the evidence currently available, it is not possible to conclude that LIUS is consistently more efficacious than other treatments of fresh fractures. We identified only two high quality, randomised, placebo-controlled studies (Kristiansen et al, 1997;Emami et al, 1999) conducted in distal radius and tibial fractures, respectively. The results of these studies are contradictory.

With respect to the treatment of fractures exhibiting non-union, only poorly controlled patient registry or case series data are currently available. It is concluded that this represents minimally acceptable, low-level evidence to support the efficacy of LIUS for treatment of non-unions.

Recommendation

We recommended that on the basis of the evidence available on low intensity ultrasound treatment for acceleration of bone fracture healing, public funding should not be supported for this procedure.



ANOTHER GOVERNMENT REVIEW DECIDES EXOGEN = PLACEBO

 

Okay r*****s

Show me ANY study on DJO. There is none. Oh yeah- only one study after being approved in over a decade. A crappy study showing it didn't work and patients were AMPUTATED. Hiding something? If your product works why don't you do another study? You might be able to yell like a 4 year old but its so easy to sell against you with you glossy brochure of misleading information -post market data that no one else uses.

Show me studies on Exogen= over 200. Acute fracture indication YES. 86% non-union heal rate baded on FDA approval YES.

Sorry DJO you have nothing but smoke a mirrors.

 

And all you have is PLACEBO!!!!

 

++++++++++++ wow cant you guys at S&N read? +++++++++++++++++




THE FACTS:

Two studies, both by Emami et al., were cited: one was published in the Journal of Orthopaedic Trauma and one, in Clinical Orthopaedics and Related Research.

The first states that Exogen Inc. provided the ultrasound devices used in this study. The authors have received nothing else of value. The second article provides no information about financial support of the study.

Both studies by Emami et al. were prospective, randomized, blinded, and placebo-controlled.

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.

reread that again ok..........

Both studies showed NO difference in healing between the patients who were treated with ultrasound and those who were not.

Both studies were prospective, randomized, blinded, and placebo-controlled.

AND THE 'TREATMENT' WAS NO BETTER THEN THE PLACEBO!!






EXOGEN = PLACEBO

 

where are the DJO studies???????????????? NONE! Must suck. If I were you I would never mention studies to a doctor. It's actually funny, I have doctors who have asked and all they ever get is someone from corporate will send you something, but never do.

 

++++++++++++ wow cant you guys at S&N read? +++++++++++++++++








THE FACTS:

Two studies, both by Emami et al., were cited: one was published in the Journal of Orthopaedic Trauma and one, in Clinical Orthopaedics and Related Research.

The first states that Exogen Inc. provided the ultrasound devices used in this study. The authors have received nothing else of value. The second article provides no information about financial support of the study.

Both studies by Emami et al. were prospective, randomized, blinded, and placebo-controlled.

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.

reread that again ok..........

Both showed NO difference in healing between the patients who were treated with ultrasound and those who were not.



EXOGEN = PLACEBO