Why Not Go with Wright Conserve + A-Class?

[Jon44]

I just read through Vicky's summary of her visit to the "Advanced Training Course"* and was struck that under the "Devices" section, Wright's C+ gets a lot of positive mentions.  Dr. De Smet thinks it's one of the top two, along with BHR.  And the A Class material has less metal wear, so I'm assuming since particle wear is related to loosening of the device, the A Class should last longer than comparable devices.

So, why doesn't everyone use C+ with A Class material?  Is it strictly a matter of sticking with devices with a long track record in the body (i.e., BHR)? I would lean to taking the risk with the C+ A Class--or is there some other issue here I'm missing?


* A million thanks to Vicky for the write-up and all the great information.  I'm truly amazed at the generosity one finds here.

[stevenp]

I don't think the metal wear directly affects loosening.  It definitely is relevant to the metal ion concentration, which may have some long-term health effects. Wear of polyethylene-lined implants led to loosening because the body attacked the polymer particles, causing bone erosion. I don't think the metal wear causes a similar reaction around the joint. I'm not positive about this, though.

[Pat Walter]

Hi Jon

The FDA has not approved the Wright C+ for use in this country - that's why few doctors are using it.  The FDA has approved the components separately and that is why some doctors in the US do use it and can get insurance coverage for it.  Dr. Mont has used a lot of Wright C+.  You just have to find a doctor that uses the device. You can travel to Dr. De Smet in Belgium to get one.  Many insurance companies are starting to cover his surgeries. 

There are many off lablel devices are being used in the US - the ASR, Wright C+ and the Biomet.  That means the components are FDA approved, but they are not approved as a system.

It is not easy for some companies to get their devices approved by the FDA.  Actually the Wright C+ was one of the hip devices used in the early trials and still is not yet approved. I have been told that it is getting close to approval.  So we may have a 3rd hip device approved in the US soon.

I hope that answers your question.

Pat

[Debbie]

Does anyone know if the Wright device has been approved by the FDA since this old thread was last addressed?

[Pat Walter]

Hi

As far as I know, it is still not FDA approved.  That doesn't mean that it can not be used off label by surgeons.  The components are FDA approved, but it is not approved as a device.

Pat