Abstract

Aseptic loosening is the most common cause of failure in load bearing orthopaedic implants. This is most often attributed to stress shielding, which is caused by a mismatch in mechanical properties between the implant and bone, predominantly stiffness. The implant causes a redistribution of the forces through the bone leading to localised tissue resorption in low stress areas and over time loosening of the implant. To address this, the implant design may be modified to introduce porous structures that reduced overall stiffness.

Conventional methods of creating porous structures include the space holder method and gas foaming, although these allow control of the pore size and volume fraction, the position of the voids is random and potentially non-uniform, creating unpredictable mechanical properties. Using additive manufacture predictable porous lattice structures can be built. Two methods for creating lattice structure are explored here: controlled stochastic lattices, and layers of repeating unit cells. Due to the predictable nature of these design methods the mechanical properties can be tailored to suit the needs of the implants. In addition to mechanical optimisation the porous lattice structures can be optimised for osseointegration properties. The ability of the tissue to grow into the implant are affected by; the size of the pores, how interconnected the pores are, the overall void fraction (porosity), the shape and roughness of the pores, and whether the structure is coated.

Although additive manufacture allows great design freedoms, there are also some manufacturing constraints to consider including resolution which is determined by powder and laser spot size, and strut angle since these cannot be too close to horizontal or they will collapse during the build unless supported. This preliminary work uses Finite Element Analysis to model the compressive properties of lattice structures with different design parameters, with the intention to optimise for mechanical, osseointegration and manufacturability properties.

Cylinders of the lattice structures were generated in Simpleware ScanIP (Synopsys, Exeter, UK) and their compression was modelled in Ansys Workbench 18.2 (Canonsburg, PA, USA) in accordance with ISO 13314. Stress distributions for each lattice structure were produced which showed the stochastic lattice did not undergo banded deformation unlike the repeating unit cell based lattices. Future work will physically test the lattices and feed that data back into the model for further optimisation. Other relevant mechanical testing will be modelled and performed in order to choose the optimal lattice design for future implants.

Implant loosening is one of the primary mechanisms of failure for hip, knee, ankle and shoulder arthroplasty. Many established implant fixation surfaces exist to achieve implant stability and fixation. More recently, additive manufacturing technology has offered exciting new possibilities for implant design such as large, open, porous structures that could encourage bony ingrowth into the implant and improve long-term implant fixation. Indeed, many implant manufacturers are exploiting this technology for their latest hip or knee arthroplasty implants. The purpose of this research is to investigate if the design freedoms offered by additive manufacturing could also be used to improve initial implant stability – a precursor to successful long-term fixation. This would enable fixation equivalent to current technology, but with lower profile fixation features, thus being less invasive, bone conserving and easier to revise.

250 cylindrical specimens with different fixation features were built in Ti6Al4V alloy using a Renishaw AM250 additive manufacturing machine, along with 14 specimens with a surface roughness similar to a conventional titanium fixation surface. Pegs were then pushed into interference fit holes in a synthetic bone material using a dual-axis materials testing machine equipped with a load/torque-cell (figure 1). Specimens were then either pulled-out of the bone, or rotated about their cylindrical axis before being pulled out to quantify their ability to influence initial implant stability.

It was found that additively manufactured fixation features could favourably influence push-in/pull-out stability in one of two-ways: firstly the fixation features could be used to increase the amount pull-out force required to remove the peg from the bone. It was found that the optimum fixation feature for maximising pull-out load required a pull-out load of 320 N which was 6× greater than the least optimum design (54 N) and nearly 3× the maximum achieved with the conventional surface (120 N). Secondly, fixation features could also be used to decrease the amount of force required to insert the implant into bone whilst improving fixation (figure 2). Indeed, for some designs the ratio of push-in to pull-out was as high as 2.5, which is a dramatic improvement on current fixation surface technology, which typically achieved a ratio between 0.3–0.6 depending on the level of interference fit. It was also found that the additively manufactured fixation features could influence the level of rotational stability with the optimum design resisting 3× more rotational torque compared to the least optimum design.

It is concluded that additive manufacturing technology could be used to improve initial implant stability either by increasing the anchoring force in bone, or by reducing the force required to insert an implant whilst maintaining a fixed level of fixation. This defines a new set of rules for implant fixation using smaller low profile features, which are required for minimally invasive device design.

Orthopaedic reconstruction procedures to combat osteoarthritis, inflammatory arthritis, metabolic bone disease and other musculoskeletal disorders have increased dramatically, resulting in high demand on the advancement of bone implant technology. In the past, joint replacement operations were commonly performed primarily on elderly patients, in view of the prosthesis survivorship. With the advances in surgical techniques and prosthesis technology, younger patients are undergoing surgeries for both local tissue defects and joint replacements. This patient group is now more active and functionally more demanding after surgery. Today, implanted prostheses need to be more durable (load-bearing), they need to better match the patient's original biomechanics and be able to survive longer.

Additive manufacturing (AM) provides new possibilities to further combat the problem of stress-shielding and promote better bone remodelling/ingrowth and thus long term fixation. This can be accomplished by matching the varying strain response (stiffness) of trabecular or subchondral bone locally at joints. The purpose of this research is therefore to determine whether a porous structure can be produced that can match the required behaviour and properties of trabecular bone regardless of skeletal location and can it be incorporated into a long-term implant.

A stochastic structure visually similar to trabecular bone was designed and optimised for AM (Figure 1) and produced over a range of porosities in multiple materials, Stainless Steel 316, Titanium (Grade 23 – Ti6Al4V ELI) and Commercially Pure Titanium (Grade 2) using a Renishaw AM250 metal additive manufacturing system. Over 150 cylindrical specimens were produced per material and subjected to a compression test to determine the specimens' Elastic Modulus (Stiffness) and Compressive Yield Strength. Micro-CT scans and gravimetric analysis were also performed to determine and validate the specimens' porosity. Results were then graphed on a Strength vs. Stiffness Ashby plot (Figure 2) comparing the values to those of trabecular bone in the tibia and femur.

It was found that AM can produce porous structures with an elastic modulus as low as 100 MPa up to 2.7 GPa (the highest stiffness investigated in this study). Titanium structures with a stiffness <500MPa had compressive strengths towards the bottom range of similar stiffness trabecular bone. Between 500 MPa − 1 GPa Titanium AM porous structures match the compressive strength of equivalent stiffness trabecular bone and from 1 GPa − 2 GPa the Ti structures exceed the strength of equivalent stiffness trabecular bone up to ∼2.5 times and consequently increase by a power law.

These results show that AM can produce structures with similar stiffness to trabecular bone over a range of skeletal locations whilst matching or exceeding the compressive strength of bone. The results have not yet taken into account fatigue life with the fatigue life of these types of structures tending to be between 0.1 – 0.4 of their compressive strength. This means that a titanium porous structure would need to be 2.5 – 10 times stiffer or stronger than the portion of trabecular bone it is replacing. This data is highly encouraging for AM manufactured, bone stiffness matched implant technology.