WARSAW, IN – December 12, 2011 – DePuy Orthopaedics, Inc.
(DePuy) has received Premarket Approval (PMA) from the U.S. Food and Drug
Administration (FDA) for use of the new AOX ™ Antioxidant Polyethylene material
with its SIGMA® Rotating Platform Knee System and LCS® COMPLETE® Mobile
Bearing Knee System. DePuys market-leading rotating-platform and mobile
bearing knee systems and the new antioxidant polyethylene are designed for
optimal wear resistance and long-term oxidative stability.
In knee implants, polyethylene is a very strong plastic that
is highly durable, but it has the potential to oxidize over time. To help
prevent oxidation, AOX Polyethylene utilizes a new antioxidant that stabilizes
free radicals without affecting the mechanical properties or strength of the
polyethylene.1,2 Lab tests show that the AOX material provides high material
strength.3
“AOX Antioxidant Polyethylene, which was developed by DePuy,
represents a next generation polyethylene material that when coupled with the
design benefits of rotating platform technology offers function, wear
resistance and oxidative stability,” said Andrew Ekdahl, President, DePuy
Orthopaedics. “AOX Polyethylene provides surgeons with another advancement from
DePuy Orthopaedics to meet the needs of their patients.”
The FDA approval of DePuy’s rotating platform knee systems
with AOX Polyethylene was based in part on mechanical, material,
biocompatibility and wear testing.
SIGMA ® Knee System
The SIGMA ® Knee System, which includes fixed-bearing and rotating-platform
options, is the leading knee system in the U.S.
and has been provided for nearly 1.7 million patients.4 According to the
National Joint Registry for England
and Wales,
at five years, more than 98% of the SIGMA Knees were still in use.5
One SIGMA Fixed-Bearing Study has shown that 10 years after
surgery, 99.6% of patients still depend on SIGMA Knees and most reported
excellent relief of pain, improved range of motion and better function of the
knee.6 SIGMA Fixed-Bearing Knees are based on the clinically proven P.F.C. ®
Knee.7 DePuys SIGMA Rotating Platform Knees allow more natural movement with
less wear to the implant than traditional knee replacements.8
LCS COMPLETE Knee
The LCS COMPLETE ® Knee includes primary and revision implant options, and is
based on the clinically proven LCS Mobile Bearing Knee System. More than one
million LCS Mobile Bearing Knees have been provided worldwide since 1977.9
According to the National Joint Registry for England
and Wales,
at five years, more than 97% of LCS COMPLETE Knees are still in use.10 One
study shows that after 20 years, more than 96% of the LCS Knee implants were
still in use.11
Important Safety Information
The performance of a knee replacement depends on a patients age, weight,
activity level and other factors. There are potential risks, and recovery takes
time. People with conditions limiting rehabilitation should not have this
surgery. Patients should consult with an orthopaedic surgeon to determine if
knee replacement surgery is appropriate for them.
About DePuy Orthopaedics
DePuy Orthopaedics, Inc., a Johnson & Johnson company, is a leading global
provider of orthopaedic devices for hip, knee, and trauma and extremities as
well as bone cement and operating room products. It is part of the DePuy Family
of Companies, which has a rich heritage of pioneering a broad range of products
and solutions across the continuum of orthopaedic and neurological care. These
companies are unified under one vision – Never Stop Moving ® – to express their
commitment to bring meaningful innovation, shared knowledge and quality care to
patients throughout the world. Visit www.depuy.com for more information.
2 Data on File at DePuy Orthopaedics, Inc. WR070248.
3 Standard Specification for Ultra-High-Molecular-Weight
Polyethylene Powder and Fabricated Form for Surgical Implants. ASTM
Designation: F648-00
4 Data on file at DePuy Orthopaedics, Inc.
5 National Joint Registry for England and Wales 2011 Annual
Report (Table 3.36, page 161).
6 Dalury, et al. Midterm results with the P.F.C. SIGMA Total
Knee Arthroplasty System. The Journal of Arthroplasty. 2008; 23: 175-181.
7 Dixon
M., et al. “Modular Fixed-Bearing Total Knee Arthroplasty with Retention of the
Posterior Cruciate Ligament. A Study of Patients Followed for a Minimum of
Fifteen Years.” The Journal of Bone and Joint Surgery Am. 2005; 87:598-603.
8 McNulty DE, Swope SW, Auger DD, Smith T. The effect of
crosslinking UHMWPE on in vitro wear rates of fixed and mobile bearing knees.
ASTM STP 1445. Gsell, R. et al. American Society for Testing and Materials, West Conshohocken, PA. Available online at www.astm.org
(2004).
9 Data on File at DePuy Orthopaedics, Inc.
10 National Joint Registry for England and Wales 2011 Annual Report
(Table 3.36, page 161).
11 Cemented Rotating-Platform Total Knee Replacement: A
Concise Follow-up, at a Minimum of Twenty Years, of a Previous Report.
Callaghan JJ, Wells CW, Liu SS, Goetz DD, Johnston RC. The Journal of Bone
& Joint Surgery Am. 2010; 92:1635-1639
Posted by Sean Fenske, Editor-in-Chief, MDT
