Thursday, August 18, 2011

My Pinnacle Summary and remaining questions

1) Below, you can see the cumulative conventional hip revisions as a percent of total vs the Depuy ASR which has a high cumulative revision rate (taken from the Australian 2010 Joint registry data.)


1 year
3 years
5 years
7 years
9 years
Depuy ASR
1.8%
5.9%
9.3%


Total conventional hip revisions
1.5%
2.6%
3.4%
4.3%
5.3%

2.  Below are the revision rates at 5 years for the Pinnacle with different Femurs

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Revision rates @5 years from the 2009 report
Revision rates @5 years from the 2010 report
Depuy Corail** Pinnacle*
2.6%
2.9%
Depuy S-Rom Pinnacle
3.7%
3.7%
Depuy Summit Pinnacle
1.6%
2.0
Depuy Summit ASR (FYI)

7.1%
 * acetabular component.
** femoral component
So it looks to me as though the revision rates for the Pinnacles above are well within normal revision rates.  What I don't know for certain  is whether the acetabular metal on metal  component in question is the same component as those above  in the chart.  As I understand it, Pinnacle provides  three   choices:

metal-on-metal,

ceramic-on polyethylene

or metal-on-polyethylene

So which components above are combined to yield Metal on metal in the chart?  I don't know.

Pinnacle® Acetabular Cup System (48mm-66mm)
Pinnacle Hip Solutions was designed to help provide a more fluid range of natural motion. DePuy Orthopaedics remains the leader in metal-on-metal technology, offering several advantages, including larger diameter bearings that can improve hip range of motion and stability. In fact, one study conducted since the device was approved in 2002 observed that an estimated 99.9 percent* of Pinnacle Hip components remain in use. Only Pinnacle Hip Solutions feature TrueGlide™ technology, allowing the body to create a thin film of lubrication between surfaces. The result is a smooth, more fluid range of natural motion.
3)  So in terms of questions, these are mine before I would ok the use of this acetabular component:
  • Are there data on the revision rates broken down by the  combinations that indicate which combinations are in fact MOM?  (MoM/C on Poly/Metal on Poly)?
  • What is behind the surge in complaints to the FDA on the Pinnacle component recently? 
  • Are the complaints summarized by MoM/Con Poly/Metal on Poly 
  • Has the Pinnacle market penetration surged in which case  revisions would rise as well?

I will be moving off this topic for now until I can get some answers to questions.  Will come back and complete this post at that point.

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