Abstract
Cementless biologic fixation surfaces on total joint replacement devices, such as those used in total hip and knee procedures, have evolved over the decades. Historically, various surfaces to allow bone ingrowth or ongrowth have been applied as a coating to a pre-formed solid metal substrate. As shown in Figure 1, from left to right, representative coating surfaces include sintered beads, diffusion-bonded fiber metal, and plasma sprayed titanium. In certain applications, tantalum porous metal (Fig 1, left) can be used without a solid metal substrate, but its most widespread usage is in a modular acetabular cup design with the porous metal diffusion-bonded to a solid metal substrate similar to other coatings. Each of these examples of biologic fixation surfaces has limitations. With comparatively low porosity, bead, fiber metal and plasma spray coatings are simply a surface enhancement onto a rigid machined, forged or cast metal substrate. Furthermore, the thermal process to apply the coatings can adversely affect the mechanical properties of the metal substrate. Released in the 1990's, tantalum porous metal is considered a ‘highly porous metal’ with twice the porosity of the applied surface coatings. With that greater porosity comes lower strength that requires engineers to make standalone tantalum porous metal shapes more bulky. The chemical deposition process to produce tantalum porous metal shapes has also limitations on geometry possibilities. Where bonding the tantalum porous metal to a solid metal substrate is necessary for adequate strength, that diffusion bonding process pressure can diminish the surface coefficient of friction necessary for initial stability.
A new class of manufacturing processing, referred to as ‘additive manufacturing’, allows engineers to create unique porous configurations. These configurations can be fabricated with beneficial properties to a specific implant application. One such enabling additive manufacturing process is called direct metal laser sintering (DMLS). This process utilizes a laser that travels over a fine powder bed. The laser path is determined by a program that mimics a computer model. Where the laser contacts the powder bed, the powder consolidates. Layer by layer, a scaffold porous metal is fabricated. Figure 2 shows a titanium alloy porous metal structure produced by DMLS. This formed biomaterial has 65% porosity, a high coefficient of friction, low stiffness, and strength that is 2 to 3 times that of tantalum porous metal. From a design versatility perspective, with greater strength, relatively thinner and more bone conserving geometries can be developed. When a solid metal surface interface to secure a modular polymer bearing is required, the DMLS process can produce the solid surface and the porous metal at the same time. With no secondary bonding thermal cycle needed, the construct's mechanical integrity is not compromised. Advancing biologic fixation necessitates bone conserving implant designs that have the properties to achieve immediate mechanical stability and longer term bone ingrowth. This novel use of DMLS in this particular porous metal geometry allows engineers to meet those criteria.
