U.S. IDE Study Indicates Mobile Bearing Knees Offer No Clinical Advantages Over Fixed Bearing Knees

NEW ORLEANS, March 8 /PRNewswire/ -- 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(1,2) 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(3,4).

"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(5) and recent articles in the Journal of Arthroplasty(6) and Orthopedics Today(7). 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(8). 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(9).

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."

About Stryker Orthopaedics

Stryker Orthopaedics is a division of the Stryker Corporation, one of the world's leading medical technology companies. Stryker Orthopaedics offers an extensive orthopaedic product portfolio including hip, knee and upper extremity reconstructive devices, bone cement, trauma implants, bone substitutes and spine systems. For more information about Stryker Orthopaedics, visit: http://www.stryker.com/enus/products/Orthopaedics/index.htm.

About Stryker Corporation

Stryker Corporation is one of the world's leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. The Company's products include implants used in joint replacement, trauma, and spinal surgeries; surgical equipment and surgical navigation systems; endoscopic and communications systems; patient handling and emergency medical equipment; as well as other medical device products used in a variety of medical specialties. For more information about Stryker, please visit http://www.stryker.com/.

(1) Data on file at Stryker Orthopaedics, Investigational Device Exemption IDE#G000180

(2) Comparable Clinical Outcomes in a Randomized Clinical Trial of a Fixed Versus Mobile Bearing Posterior Stabilized Cemented Tricompartmental Knee Prosthesis. Ormonde Mahoney, MD; Tracy Kinsey, MSPH. Accepted for presentation at the Symposium on Mobile Bearing Total Knee Replacement Devices, ASTM Meeting, St. Louis, MO, May 18, 2010

(3) "Zimmer Holdings Receives FDA Approval to Market Mobile Bearing Knee."  www.zimmer.com.  December 11, 2007. http://www.zimmer.com/z/ctl/op/global/action/1/id/10006/template/CP

(4) "DEPUY ORTHOPAEDICS, INC. INTRODUCES  LCS® COMPLETE™ RPS FLEXION KNEE."  www.depuy.com. September 12, 2008. http://www.depuy.com/corporate-information/news-and-press/read/depuy%20orthopaedics/2008?page=0

(5) Australian National Joint Replacement Registry 2009

(6) "Fixed vs. Mobile-bearing TKA Does it make a difference? A prospective randomized study." Harrington, M., et al. JOA Vol. 24 No. 6 Suppl. 1 2009

(7) "Mobile-bearing implants more likely to be revised than fixed-bearing knees." Namba, R. 2009 AAOS Annual Meeting ORTHOPEDICS TODAY 2009; 29:13

(8) RD-09-094

(9) 2009 National Joint Registry of England and Wales, p. 102

SOURCE Stryker Orthopaedics