Mar 9 2010
Stryker Corporation's (NYSE: SYK) Orthopaedics' division today announced at the American Academy of Orthopaedic Surgeons (AAOS) Conference that its recent FDA-monitored Investigational Device Exemption (IDE) study found no statistical difference in clinical outcomes between its mobile bearing and traditional fixed bearing knee systems. In contrast, Stryker continues to be very pleased with the success of its fixed bearing Triathlon Knee System with X3 Advanced Bearing Technology, which offers significant advantages over mobile bearing knees on wear rates and overall value.
The aging boomer generation and young high-intensity athletes have driven increased demand for advancements in the design of knee replacement technology. To capitalize on this demand, several orthopaedic device makers have recently introduced updates to previous generations of their mobile bearing knees citing improved motion, lower post-op complications and reduced wear.
"The results from this IDE study are in line with other studies and national joint registries that suggest the promise of mobile bearing knee systems are not fulfilled when clinically compared to their fixed bearing counterparts. The data to date demonstrate that mobile bearing knee systems offer no clinical advantages over fixed bearing knee systems," said Patrick Treacy, Vice President and General Manager of Stryker's Knee business.
Comparing a fixed and mobile bearing knee similar to those currently offered on the market, Stryker's IDE study results are consistent with findings published in the Australian National Joint Replacement Registry and recent articles in the Journal of Arthroplasty and Orthopedics Today. In addition, laboratory tests demonstrate that Stryker's Triathlon Knee System with X3 Advanced Bearing Technology shows a 97% reduction in total polyethylene volume loss compared with competitive mobile bearing knee systems. The Triathlon Knee System's high flexion design offers the lowest risk of revision on the National Joint Registry for England and Wales, a risk of revision over four times lower than the best performing mobile bearing knees.
Treacy added, "Stryker is committed to meaningful and value-based innovation that will improve clinical outcomes. Because mobile bearing knees in general offer no clinical advantages, carry an increased cost to their fixed bearing counterpart and result in a higher rate of revision surgery than fixed bearing knees, Stryker has decided not to offer a mobile bearing knee system to the US market."
SOURCE Stryker Orthopaedics