In a 2008 study of Titanium alloy pins versus stainless steel pins in external fixation it was discovered that titanium reduced pin-related complications to include a significant reduction in pain levels when compared to stainless steel.
Pin-track complications remain the most troublesome disadvantages of external fixation. Studies have compared pin-related complications and pain levels after the use of external fixation for the stabilization of fractures with pins composed of two different materials. The specific results were significant. The complication rate was 21%, with patient age found to be significantly associated with an increased risk of pin-loosening (p = 0.003) and the rate of premature removal of fixator because of severe pin-track infection (5% vs. 0%). The rate of pin-loosening (10% vs. 5%) was higher in the Ss-pin (stainless steel) group. Furthermore, pain values were significantly reduced in the Ti6Al4V-pin group.
The use of Ti6Al4V-pin (titanium) external fixator yields a trend of reduced pin-related complications and significantly reduced pain levels than does the Ss-pin fixator.
At Umbra Applied Technologies we recognize that external fixation is an essential component of the modern orthopaedic surgeon’s armamentarium and is widely used in traumatic and reconstructive surgery. This treatment modality is almost universal associated with the complication of pin track infection.
These complications can be catastrophic if it leads to the failure of the bone–pin interface and could lead to pin loosening, fracture non-union, sepsis and chronic osteomyelitis. Strategies proposed for the prevention and management of pin track complications are varied and continually evolving.
Prevention of external fixation pin track infection is a complex and ongoing task that requires attention to detail, meticulous surgical technique and constant vigilance.
UAT’s Biotech division has created a product that is the most deliberate evolution of an existing design. A titanium body wrapping a proprietary silver alloy core delineates a singular component of paradigm shifting technology. At UAT we obsess over constantly evolving and looking beyond today so that seeking perfection is the intended purpose that drives groundbreaking discoveries. From sculpting the outer shell and the twin cutting flutes of precise titanium alloy to the innovation of an infection fighting silver core, we have created an elegant and sophisticated design that delivers a singular answer to a complex modality. This refinement of an external fixator pin serves to bring absolute efficiency to a design that until now has been significantly flawed yet redeemed through an expression of uncommon virtuosity.
Aegis® external fixator pins with ASP (Active Silver Protection) are manufactured from Ti6Al4V titanium alloy with chemical composition of 6% aluminum, 4% vanadium, 0.25% (maximum) iron, 0.2% (maximum) oxygen, and more than 89% pure titanium. UAT’s revolutionary new Aegis external fixator pin with UAT’s proprietary ASP compound feature an active silver core engineered to aid in the prevention and management of external fixator pin track sepsis.
Unlike positive profile fixation pins, Aegis® titanium external fixator pins with UAT’s proprietary ASP have a shaft diameter that is equal to its thread diameter resulting in a pin that does not overly stress the integrity of the presumably already compromised bone structure.
The process begins with the insertion of UAT’s ASP assembly into the titanium block utilizing a multi-ton arbor press to place the silver alloy by hand demonstrating an exhaustive attention to detail and remorseless scrutiny typically seen only in the most precisely handcrafted bespoke timepieces or coach builders of fine luxury automobiles.
Conventional CNC lathes usually have three or four axes. UAT chose to manufacture the revolutionary new Aegis fixator pin using a Swiss-type lathe because it provides the type of attention to detail required to be a UAT design by maintaining up to 13 axes. The exterior titanium stabilizing support structure of the pin is first milled using the state of the art machine with a tolerance band of up to 0.0005 inch or one tenth of a millimeter providing tolerances and details that until now, have never been seen in the industry. We chose this process of milling the Aegis form from a singular block of titanium because this uniquely designed lathe bathes the titanium in specialized oils rather than water. The lubricity is greater with one of the significant benefits including freedom from odor-causing bacteria growth. The process shapes the paradigm shifting Aegis pin design at 10,000 revolutions per minute resulting in a process that simultaneously cuts and polishes the biomedical titanium to a near flawless finish. This process shapes the pin shaft, sculpts the dual cutting flute design and removes the top layer of excess material in addition to any surface imperfections while polishing the alloy in preparation for the unique anodizing process.
The newly inaugurated Aegis pin emerges, after undergoing a singular process that provides the advantages of simultaneously hardening and coloring the surface without altering the mechanical properties of the metal or the introduction of potentially toxic dyes, as a true representation of what it means to be a UAT designed and manufactured product. This process is designed to protect the medical component and add our signature color without the introduction of harmful dyes to provide the highest quality external fixator pin in the world.
The titanium alloy reacts to oxygen exposure by forming a clear oxide layer on its exposed surfaces. The specialized anodizing process, specific to the titanium, accelerates oxidation beyond what would be typically found naturally over time, producing thicker layers of oxide. As the layer thickens, it begins to interrupt the process of visible light photon absorption as they pass through and reflect off the metal surface. Through a phenomenon known as the resonance principle, color is created depending on the interference, absorption and vibrational motion of the electrons we have targeted. Since the thickness of the oxide controls the color that is produced, and since anodizing controls the thickness, the color produced in a titanium UAT product becomes controllable through the laws of physics as opposed to the addition of potentially dangerous and non-biocompatible dyes.
By adjusting and precisely controlling the surface oxide level of the metal we alter the spectrum of light, resulting in a perceived pristine color that provides a protective oxide layer. Voltage applied to the component through fixturing, in an electrolytic bath, controls the color without adding any dyes. Therefore, the integrity and properties of the base metal along with its suitability in biomedical applications are not compromised resulting in a precisely produced biocompatible medical device that is ISO 10993 compliant.
By introducing the industry to the Aegis fixation pin, Umbra Applied Technologies has brought forth the most significant advance in bone fixation since the last significant advance made by Raoul Hoffmann in 1938 and more than 100 years since the first threaded pin was used. Uncompromising in its design and engineering the Aegis external fixation pin sets a new industry standard for biotech while enhancing its fundamental purpose. The result of a collective obsession to simplify and create the most efficient design the Aegis pin is the epitome of scientific discipline and uncompromising skill. Umbra Applied Technologies; changing the world, is what we do.