INTEGRA LIMIT UNCERTAINTY

What is PyroCarbon? PyroCarbon is a specific form of carbon that has been tailored for durability and biocompatibility. PyroCarbon exhibits favorable wear characteristics and fatigue endurance.9 PyroCarbon should not be confused with carbon fibers, which are minute particles used to strengthen other materials. Manufacturing a PyroCarbon implant begins with a precision-machined graphite substrate that contains 1 atomic percent tungsten to make the core visible on X-ray. Using patented steady-state process controls, a thick layer of radiolucent On-X® pure carbon is deposited onto the graphite core,...

Integra is a world leader in PyroCarbon implants. Over 50,000 have been implanted worldwide. Patented On-X® PyroCarbon has been shown to be a favorable material for orthopedic applications with advantages over metallic alloys and polymers as it demonstrates:9 • • • • Favorable wear characteristics9 Modulus of elasticity that is similar to cortical bone1 Compatible with joint cartilage and bone2 Non-cemented fixation by bone apposition1 Uniform lucent line represents radiolucent PyroCarbon coating. Sclerotic bone formation adjacent to lucent line demonstrates appositional bone growth, encasing...

Wear Comparison: PyroCarbon on PyroCarbon vs. Cobalt Chrome on Ultra High Molecular Weight Polyethylene (UHMWPE)1 Near Natural Wear Characteristics Natural joints have been shown to lubricate through the adsorption of surfactants surface-active phospholipids (SAPL) to cartilage which provides boundary layer lubrication and a reduction in friction. PyroCarbon surfaces offer the potential for boundary layer lubrication and a low coefficient of friction through the same mechanism.5 Wear Depth (in inches) In laboratory tests, PyroCarbon performed superior to other prosthetic materials in its ability...

PyroCarbon is Bone Friendly Cyclic Wear Test Against Bone Elastic modulus of metal and ceramic are much greater than that of bone or PyroCarbon. Cortical Bone PyroCarbon Titanium Alloy Zirconia CoCr Alloys Wear Penetration Rate into Bone The elastic modulus of PyroCarbon is similar to cortical bone resulting in biomechanical compatibility with bone. Unlike surgical grade metals, PyroCarbon transfers load from implant to bone more effectively, thus reducing stress shielding and potential bone resorption.1,6 After cyclical testing to 5,000,000 cycles, PyroCarbon demonstrated minimal wear into cortical...

PyroCarbon is Cartilage Friendly PyroCarbon has been shown to be much less damaging to native cartilage and bone joint tissues than metal alloys. PyroCarbon’s low surface friction and nonadhesive properties may contribute to preserving cartilage. PyroCarbon offers the ability to extend the functional life of these joints and thus transform extremity hemiarthroplasty. Cartilage Survival A study of cartilage wear in 45 canine acetabula was performed using both PyroCarbon and metal alloy hip prostheses. PyroCarbon showed remarkably less wear damage to cartilage. After 18 months, cartilage articulating...

Decades of biomedical research and clinical outcomes demonstrate that PyroCarbon is a durable and biocompatible material. Integra continues to limit uncertainty with research and development of new applications of PyroCarbon technology for extremity surgery. PyroCarbon Cementless Fixation PyroCarbon has a micro-porous structure that enhances bone fixation without the need for cement. This fixation is achieved initially through a press fit design using specially designed instrumentation. Long term fixation is achieved via appositional bone growth as bone remodels up to the bone-friendly surface...

References 1. Klawitter, J “Replacing joints with pyrolytic carbon.” Joint replacement technology Ed. Peter A Revell. Woodhead Publishing, 2008, 651 2. Cook SD, Thomas KA, Kester MA, “Wear Characteristics of the Canine Acetabulum Against Different Femoral Prostheses,” JBJS, 1989; 71-B(2): 189-197. 3. Yongxing Qiu, Nolan B. Holland, Mark Ruegsegger and Roger Marchant, Biomimetic Engineering of Non-Adhesive Glycocalyx-Like Surface Using Oligosaccharide Surfactant Polymers, Nature, 392:799-801 (1998) 4. Crawford, et. al.,”The Role of SAPL as a Boundary Lubricant in Prosthetic Joints.” Tribology...