Introduction

The increase in revision joint replacement surgery and fractures of bone around orthopaedic implants may be partly addressed by keeping bone healthy around orthopaedic implants by inserting implants with mechanical properties closer to the patient's bone properties. We do not currently have an accurate way of calculating a patient's bone mechanical properties. We therefore posed a simple question: can data derived from a micro-indenter be used to calculate bone stiffness?

Introduction

Bisphosphonates (BP) are the first-line therapy for preventing osteoporotic fragility fractures. However, concern regarding their efficacy is growing because bisphosphonate use is associated with over-suppression of remodeling. Animal studies have reported that BP therapy is associated with accumulation of micro-cracks (Fig. 1) and a reduction in bone mechanical properties, but the effect on humans has not been investigated. Therefore, our aim was to quantify the mechanical strength of bone treated with BP, and correlate this with the microarchitecture and density of micro-damage in comparison with untreated osteoporotic hip-fractured and non-fractured elderly controls.

Bones are thought to become fragile with advancing age due to a loss of mass and structure. However, there are important aspects of bone fragility and fracture that cannot be explained simply by a loss of bone: 30% of all patients told they have healthy bone based on bone mineral density (BMD) measurements go on to fracture.

It has been suggested that increased fracture risk might also be due to ageing at the nanoscale, which might deteriorate the overall mechanical properties of a bone. However, it is not clear how mechanics at the level of the collagen-mineral matrix relate to mechanical properties of the whole bone, or whether nano-mechanics contribute to fracture risk. In order to answer these questions our group is developing state of the art methods for analysing the structure and function of the collagen mineral matrix under loading.

To image the collagen mineral matrix we obtained beam time on a synchrotron particle accelerator at the Diamond Light Source (Didcot, UK). Electrons are accelerated to near light speed by powerful electromagnets, then slowed to create high energy monochromatic X-Ray beams. Through a combination of X-Ray computed tomography and X-Ray diffraction we have been able to image the collagen/mineral matrix. Furthermore, using in situ loading experiments it has been possible to visualise collagen fibrillar sliding and mineral crystal structure.

Our group is analysing how age related changes in nano-structure affect bone mechanical behaviour. As well as comparing fragility fracture patients with ‘healthy’ age matched controls to investigate whether ageing at the nano-scale could increase fracture risk. We are also assessing the effect of common treatments for bone fragility (e.g. bisphosphonate) on nano-mechanics.

Unfortunately the expense and high radiation dose associated with synchrotron imaging prevents the technology from being adapted for patients. Therefore the next step will be to identify and test tools that can be used to indirectly assess bone chemistry and mechanical properties at point of care (e.g. laser spectroscopy and indentation). The data could be used to improve the diagnosis, monitoring and treatment of bone fragility.

Most glenoid implants rely on centrally located large fixation features to avoid perforation of the glenoid vault in its peripheral regions [1]. Upon revision of such components there may not be enough bone left for the reinsertion of an anatomical prosthesis, resulting in a large cavity that resembles a sink hole. Multiple press-fit small pegs would allow for less bone resection and strong anchoring in the stiffer and denser peripheral subchondral bone [2], whilst producing a more uniform stress distribution and increased shear resistance per unit volume [3] and avoiding the complications from the use of bone cement. This study assessed the best combination of anchoring strength, assessed as the ratio between push in and pull out forces (Pin/Pout), and spring-back, measured as the elastic displacement immediately after insertion, for five different small press-fitted peg configurations (Figure 1, left) manufactured out of UHMWPE cylinders (5 mm diameter and length).

16 specimens for each configuration were tested in two types of Sawbones solid bone substitute: hard (40 PCF, 0.64 g/cm3, worst-case scenario of Pin) and soft (15 PCF, 0.24 g/cm3, worst-case scenario of spring-back and Pout). Two different interference-fits, Ø, were studied by drilling holes with 4.7 mm and 4.5 mm diameter (Ø 0.3 and Ø 0.5, respectively). A maximum Pin per peg of 50 N was defined, in order to avoid fracture of the glenoid bone during insertion of multiple pegs. The peg specimens were mounted into the single-axis screw-driven Instron through a threaded fixture. A schematic of the experimental set up is made available (Figure 1, centre). The peg was pushed in vertically for a maximum of 5 mm at a 1 mm/s rate, under displacement control, recording Pin. The spring-back effect was assessed by switching to load control and reducing the load to zero. The peg was then pulled out at a rate of 1 mm/s, recording Pout. The test profile is depicted in Figure 1 (right).

Average Pout/Pin, spring back (in mm) and force-displacement curves for all 80 specimens tested are shown in Figure 2. These were split into groups according to the type of bone substitute and interference-fit, with the right column showing the average values for the Pin. High repeatability among samples of the same configuration tested is noted. Configurations #1, #3 and #5 all exceed the maximum Pin per peg for at least one type of bone. Configuration #2 has the lowest Pin of all (best thread aspect ratio), followed by configuration #4 (thinner threads). The peg configurations #4 and #2 had the highest Pin/Pout. The peg configurations with lowest spring-back after insertion were configuration #2 and #4. Interference fit of Ø 0.3 mm was shown to reduce Pin below maximum limit of 50 N without great influence in spring-back.

Common post-operative problems in shoulder arthroplasty such as glenoid loosening and joint instability can be reduced by improvements in glenoid design shape, material choice and fixation method [1]. Innovation in shoulder replacement is usually carried out by introducing incremental changes to functioning implants [2], possibly overlooking other successful design combinations.

We propose an automated framework for parametric analysis of implant design in order to efficiently assess different possible glenoid configurations. Parametric variations of reference geometries of a glenoid implant were automatically generated in SolidWorks. The different implants were aligned and implanted with repeatability using Rhino. The glenoid-bone models were meshed in Abaqus, and boundary conditions and loading applied via a custom-made Python script. Finally, another MATLAB script integrated and automated the different steps, extracted and analysed the results.

This study compared the influence of reference shape (keel vs. 2-pegged) and material on the von Mises stresses and tensile and compressive strains of glenoid components with bearing surface thickness and fixation feature width of 3, 4, 5 or 6 mm. A total of 96 different glenoid geometries were implanted into a bone cube (E = 300 MPa, ν = 0.3). Fixed boundary conditions were applied at the distal surface of the cube and a contact force of 1000 N was distributed between the central nodes on the bearing surface. The implants were assigned UHMWPE (E = 1 GPa, ν = 0.46), Vitamin E PE (E = 800 MPa, ν = 0.46), CFR-PEEK (E = 18 GPa, ν = 0.41) or PCU (E = 2 GPa, ν = 0.38) material properties and the bone-implant surface was tied (Figure 1). The von Mises stresses, compressive and tensile strains for the different models were extracted. The influence of design parameters in the mechanical environment of the implant could be assessed. In this particular example, the 95^th percentile values of the tensile and compressive strains induced by modifications in reference shape could be evaluated for all the different geometries simultaneously in form of radar plots. 2-pegged geometries (green) consistently produced lower tensile and compressive strains than the keeled (blue) configurations (Figure 2). Vitamin E PE and PCU glenoids also produced lower maximum von Mises stresses values than CFR-PEEK and UHMWPE designs (Figure 3).

The developed method allows for simple, direct, rapid and repeatable comparison of different design features, material choices or fixation methods by analysing how they influence the mechanical environment of the bone surrounding the implant. Such tool can provide invaluable insight in implant design optimisation by screening through multiple potential design modifications at an early design evaluation stage and highlighting the best performing combinations. Future work will introduce physiological bone geometries and loading, a wider variety of reference geometries and fixation features, and look at bone/interface strength and osteointegration predictions.