Knee Arthroplasty

Rotating-hinge knees made using our biomaterials can improve wear performance for implant longevity, stability & potentially minimize the need for revision.

In 2016 it is estimated that there were 160,000 knee revision surgeries in the US and Europe.1 This indicates that some 4% of all knee implant procedures result from failure of the initial knee implant. In revision, a number of clinical indications lead to the requirement for a stabilized hinged knee.

Hinge constructs made from PEEK-OPTIMA Reinforced and PEEK-OPTIMA Wear Performance offer superior cold-flow resistance2, 3 as well as dimensional stability during the device lifetime (>15 years) compared to traditional hinge mechanisms that use Ultra-high-molecular-weight polyethylene (UHMWPE), to provide constrained stability.1

In addition, the PEEK-OPTIMA polymer has proven biocompatibility and biostability in implantable devices worldwide provides safety, longevity and reassurance to patients and surgeons alike. Unicondylar knee testing reported a 70% reduction in wear compared with literature values for similar UHMWPE-base prostheses.4

Hinged-mechanism constructs made from PEEK-OPTIMA Reinforced or Wear Performance grades have been used in CE and FDA approved revision knee systems since the beginning of 2010. Several thousand knee-revision implants containing these parts are already in clinical use.1

PEEK-OPTIMA is paving the way in knee arthroplasty, with leading applications such as the Aesculap® EnduRo Rotating Hinge Knee System by Aesculap AG5 and MULTIGEN PLUS H Knee by Lima Corporate S. p. a.6

References:

  1. Supportive information available on request.
  2. In an In-vitro knee wear simulation study, the wear resistance of PEEK-OPTIMA Reinforced was found to be very low compared to traditional polymers such as UHMWPE. The wear particulate response was equivalent to the inflammatory response of UHMWPE, but due to lower particle load less activity is expected. (Grupp et al, European Orthopaedic Research Society (EORS), 19th Annual Meeting Vienna, 2011; Utzschneider et al, Acta Biomaterialia, 2010)
  3. Further wear simulation revealed comparable low wear and no macroscopic surface fatigue in a new rotating-hinge knee design with highly congruent flanges and axles bushings made of CFR-PEEK articulating to zirconium nitride and cobalt-chromium. (Grupp et al, Acta Biomaterialia, 2013)
  4. Scholes, S. C. and Unsworth, A. Pitch-based carbon-fiber-reinforced poly (ether–ether–ketone) OPTIMA™ assessed as a bearing material in a mobile bearing unicondylar knee joint. Proc. Instn. Mech. Engrs. Part H, Journal of Engineering in Medicine, Vol. 223, H1, 2009, pp. 13-26.
  5. “Aesculap” registered trademark is the property of Aesculap, Inc. and others
  6. “MULTIGEN PLUS H” trademark is the property of Lima Corporate S.p.a

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