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Stryker Presents Data Of Investigational Device Exemption Study

Stryker Corp's Orthopaedics division at the American Academy of Orthopaedic Surgeons (AAOS) Conference has reported 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.

Stryker has reported that it is pleased with the success of its fixed bearing Triathlon Knee System with X3 Advanced Bearing Technology, which offers advantages over mobile bearing knees on wear rates and overall value.

Comparing a fixed and mobile bearing knee similar to those currently offered on the market, Stryker’s IDE study results are said to be consistent with findings published in the Australian National Joint Replacement Registry and recent articles in the Journal of Arthroplasty and Orthopedics.

In addition, laboratory tests demonstrated that Stryker’s Triathlon Knee System with X3 Advanced Bearing Technology showed 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.

Patrick Treacy, vice president and general manager of knee business at Stryker, said: “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.

“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.”