Beneficial Method of Prosthesis Still Searching for FDA Approval

Updated: 09/11/2013 2:36 PM KSTP.com By: Naomi Pescovitz



Imagine a medical device, a form of prosthesis, changing lives on the other side of the world, given a stamp of approval by doctors and patients alike. But it is not available in America, because it is not yet approved by the Food and Drug Administration.

It is called Osseointegrated Prosthesis for the Rehabilitation of Amputees, or OPRA.

In the United States, the standard connection point for a prosthetic limb is a socket.

"Unfortunately we are still at the basic classical stage," said Dr. Anna Kulidjian, Orthopaedic Surgeon at the University of California, San Diego.

Prosthetics themselves are advancing, but Kulidjian says there is still a disconnect.

"The devices have undergone significant improvement so you can see some people can run on various of their external devices, but that coupling to the body is where we are lacking," Kulidjian said.

"We have these 50th century all this brand new crazy technology, available, but the way that it attaches to us is from the stone ages still," said John Kriesel, Director of Anoka County Veterans Services. Kriesel lost part of both legs while serving in Iraq in 2006.

Sockets can also cause irritation and sweating.

"If you are not coupling it to the body, then you end up in a situation where there is a lot of energy that's lost between your body and that implant," Kulidjian said.

Across the Atlantic Ocean and decades ago, an idea was born in Sweden. Originally used for dental implants, it is called the osseointegration. Instead of an external socket, doctors surgically implant a titanium screw into the bone. A prosthetic is then attached to the screw.

There have been international studies on the system since the late 1980's with more underway.

"The results have shown that the device overall is extremely safe," Kulidjian said.

Infection is the main concern.

"Most of the infections fortunately are just the skin little irritations, but the internal bone infection is very very low," Kulidjian said.

However, OPRA is not FDA approved in what can be a long and rigid process.

"Coming from outside the country, with no studies inside the US, I think that's also another level of scrutiny that the device has to undergo. The unfortunate part is that's time lost in people's life years," Kulidjian said.

"There's going to come a point where the prosthetic is too advanced to even put on a person. It will be to heavy or do too many things and it will just pop off and so this is something that is going to have to move forward," Kriesel said.

"It's truly a payback our veterans I think deserve that they would be allowed to return after the service they've provided to their regular activities, to their jobs to their families, and play sports with their kids. I think it's an important overdue development that has to be encouraged to be brought into this country," Kulidjian said.

Integrum, the Swedish company that developed the system, has filed a humanitarian device exemption with the FDA, which could get it to market sooner.

Dr. David Polly, Professor of Orthopedic Surgery at the University of Minnesota, says with some implants, the clinical trial process can take four to five years. With an innovative product like OPRA, it can be even more complicated.

"We really don't have a lot of experience in any other part of the body with a durable bone-metal implant implant interface, where it protrudes through the skin. So even coming up with a clinical trial design is a challenge, selecting the right patients is a challenge, and then collecting the data and saying we hope that this device is going to work for decades or longer. And so how do you know what's going to happen 10 years down the road, until you've been doing it for 10 years, that's the challenge both for the manufacturer and for the FDA," Polly said.

The FDA says they cannot comment on the existence of any current or pending applications.

Some of the video and images in this story are from www.sahlgrenskaic.com.

The link below gives a look at the history of osseointegration research.

Warning the research contains graphic photos of open wounds.

Click here to learn more about the research.