Surgeons treating fractures with many small osteochondral fragments have often expressed the clinical need for an adhesive to join such fragments, as an adjunct to standard implants. If an adhesive would maintain alignment of the articular surfaces and subsequently heal it could result in improved clinical outcomes. However, there are no bone adhesives available for clinical indications and few pre-clinical models to assess safety and efficacy of adhesive biomaterial candidates. A bone adhesive candidate based on water, α-TCP and an amino acid phosphoserine was evaluated in-vivo in a novel murine bone core model (preliminary results presented EORS 2019) in which excised bone cores were glued back in place and harvested @ 0, 3, 7, 14, 28 and 42days. Adhesive pull-out strength was demonstrated 0–28 days, with a dip at 14 days increasing to 11.3N maximum. Histology 0–42 days showed the adhesive progressively remodelling to bone in both cancellous and cortical compartments with no signs of either undesirable inflammation or peripheral ectopic bone formation. These favourable results suggested translation to a large animal model.

A porcine dental extraction socket model was subsequently developed where dental implants were affixed only with the adhesive. Biomechanical data was collected @ 1, 14, 28 and 56 days, and histology at 1,14,28 and 56 days. Adhesive strength assessed by implant pull-out force increased out to 28 days and maintained out to 56 days (282N maximum) with failure only occurring at the adhesive bone interface. Histology confirmed the adhesive's biocompatibility and osteoconductive behavior. Additionally, remodelling was demonstrated at the adhesive-bone interface with resorption by osteoclast-like cells and followed by new bone apposition and substitution by bone. Whilst the in-vivo dental implant data is encouraging, a large animal preclinical model is needed (under development) to confirm the adhesive is capable of healing, for example, loaded osteochondral bone fragments.

Acknowledgements: The murine study was supported, in part, by the Swedish Foundation for Strategic Research (#RMA15-0110).

An ex vivo biomechanical test model for evaluating a novel bone adhesive has been developed. However, at day 1 in the in vivo pilot, high blood flow forced the study to halt until the solution presented here was developed.

The profuse bleeding after bone core removal affected the bond strength and was reflected in the lower mean peak value 1.53N. After considering several options, we were successful in sealing the source of blood flow by pressing adhesive into place after bone core removal. After the initial adhesive had cured additional adhesive was used to secure the bone core in place. The animals were sacrificed after 24 h and a tensile test was undertaken on the bone core to failure.

The ex vivo study produced mean peak tensile loads of 7.63N SD 2.39N (n=8, 4 rats 8 femurs). Whilst the mean peak tensile loads in the day 1 in vivo pilot were significantly lower 1.53N SD1.57 (n=8, 6 rats 8 femurs − 4 used for other tests). The subsequent layered adhesive bone cores showed a mean peak tensile force of 6.79N SD =3.13 (n=8, 4 rats 8 femurs). 7/8 failed at the bone to glue interface. This is the first successful demonstration of bonding bone in vivo for this class of adhesives.

The development of a double adhesive method of fixing a bone core in the distal femur enabled mean peak tensile forces to be achieved in vivo at 24 hours that were comparable with the ex vivo results previously demonstrated. This method supports application in further animal series and over longer time scales. Biomaterials researchers that intend to use gel or paste like preparations in distal femur defects in the rat should be aware of the risks of biomaterial displacement by local blood flow.

There are clinical situations in fracture repair, e.g. osteochondral fragments, where current implant hardware is insufficient. The proposition of an adhesive enabling fixation and healing has been considered but no successful candidate has emerged thus far. The many preclinical and few clinical attempts include fibrin glue, mussel adhesive and even “Kryptonite” (US bone void filler). The most promising recent attempts are based on phosphorylating amino acids, part of a common cellular adhesion mechanism linking mussels, caddis fly larvae, and mammals. Rapid high bond strength development in the wetted fatty environment of fractured bone, that is sustained during biological healing, is challenging to prove both safety and efficacy. Additionally, there are no “predicate” preclinical animal and human models which led the authors to develop novel evaluations for an adhesive candidate “OsStic^tm” based on calcium salts and amino acids. Adhesive formulations were evaluated in both soft (6/12 weeks) and hard tissue (3,7,10,14 & 42 days) safety studies in murine models. The feasibility of a novel adhesiveness test, initially proven in murine cadaver femoral bone, is being assessed in-vivo (3,7,10,14 & 42 days) in bilateral implantations with a standard tissue glue as the control. In parallel an ex-vivo human bone model using freshly harvested human donor bone is under development to underwrite the eventual clinical application of such an adhesive. This is part of a risk mitigation project bridging between laboratory biomaterial characterisation and a commercial biomaterial development where safety and effectiveness have to meet today´s new medical device requirements.

Introduction and Aims: The extremely low wear rates of third generation alumina-alumina bearings in traditional hip simulators are not reflected in vivo. Separation of the bearing during swing phase and edge loading with heel strike is reported to account for this discrepancy.

Method: We have had the opportunity to visually inspect 21 bearings at re-operation from a group of 1588 hip arthroplasties with third generation alumina ceramic-ceramic bearings. Re-operations were for heterotopic ossification (one), loosening (three), femoral fracture (six), psoas tendonitis (six), sepsis (three) and dislocation (two). There were no re-operations for bearing failure. Sixteen of these 21 bearings (16 heads and 12 inserts) were retrieved and analysed. We mapped the location and we measured the volume of the wear and we performed microscopy and measured roughness of worn and unworn areas.

Results: Eleven bearings had visual evidence of edge loading wear, making an incidence of 52% in the 21 patients having re-operations. These 11 bearings and five visually undamaged bearings were analysed. The wear on the insert was always located at the rim indicating edge loading. The location and orientation of the stripe on the head was not consistent with subluxation during normal gait but was consistent with subluxation and edge loading with the hip flexed at 90 degrees. The average wear volume was 0.7mm3 per year (heads plus liners). Longer service bearings had signs under SEM of repolishing of the wear area suggesting that the process of edge loading wear will be self-limiting. The heads without a wear scar showed very little damage: under SEM, a slight relief polishing of individual grains and minor pitting was noted.

Conclusion: The subluxation causing the stripe wear in these patients did not occur during normal walking gait. It probably occurred with rising from a chair. Simulator testing of third generation alumina-alumina components must include edge loading if it is to give a realistic indication of in vivo performance. Alumina-alumina bearings remain an excellent option for total hip arthroplasty, however more work is required to understand the clinical consequences.

Introduction: Alumina exhibits excellent hardness and wear properties, however it is a brittle material with an inherent risk of fracture. Therefore, the feasibility of a new family of Alumina based ceramics with improved toughness for hip joint articulation applications was investigated.

Materials and methods: The addition of 25% Zirconia to Alumina during the manufacturing process to achieve the objective has been proposed. Two types of Zirconia Toughened Alumina (ZTA) ceramics were analysed; one binary and the other pentary by composition. Following tests were used: structural analysis, mechanical testing of components, determination of hardness (HV), fl exural strength (ASTM C1161), indentation fracture toughness, X-ray diffraction (XRD), aging (accelerated and real-time) and wear simulator testing. The test data was analysed by descriptive statistics.

Results: The structure of the two ZTAs is similar with small-grained Zirconia dispersed in a matrix of larger grained Alumina. X-ray diffraction analysis showed no phase transformation after accelerated and real-time aging and the strength values did not change. Flexural strength was statistically significant increased by > 50% over Alumina. The indentation fracture toughness was also increased by up to 50% while the hardness of the ZTA ceramics was not affected. The wear testing showed that ZTA – ZTA couples articulating against themselves produce not significant lower wear than Alumina – Alumina couples, but the combination of ZTA ball-heads with Alumina inserts produced significantly lower wear rates, also in micro-separation.

Conclusions: The toughness and bending strength of the Alumina was successfully increased while all other properties of the Alumina were maintained. No change in properties after aging was observed and the wear properties of the ZTA were lower wear than for Alumina. Zirconia Toughened Alumina looks promising for the next generation of fracture and wear resistant ceramic bearings.

The reported revision rate of total hip arthroplasties (THAs) due to wear and osteolysis is around 10% at 10 years. However, the actual rate is probably higher: the incidence of osteolysis is reported to be 10% to 45%. Apart from design improvements, improved or new materials and/or and combinations are important in reducing particle-induced osteolysis, especially in young and active patients.

Wear reduction of up to 40% after inert gas sterilisation of polyethylene (PE) has been demonstrated, both in vitro and in vivo. An effective means of providing further increases in wear resistance is to cross-link PE extensively. Early clinical results of non-melt-annealed PE at three years showed wear reduction of up to 85% compared to inert gas radiation-sterilised PE.

In hip joint simulator investigations, bearings with a ceramic ball-head articulating against a composite cup demonstrated wear rates similar to those of ceramic-ceramic bearings. The wear particles are benign. Clinical data collected over two years suggest no disadvantages compared to the standard articulation controls.

The wear resistance of alumina-alumina articulation has been enhanced. In-vitro investigation demonstrated that even with a cup inclination of 60° the wear rate is not increased. The effect of micro-separation of the artificial joint is also minimised. Several prospective multi-centre alumina-alumina studies have shown no additional complications with this articulation. However, alumina is a brittle material with an inherent risk of fracture. The addition of 25% zirconia to alumina (ZTA) in the manufacturing process improves its fracture resistance, increasing its strength by more than 50%, while maintaining its other properties. The wear properties of ZTA are even better than that of alumina, especially in micro-separation articulation mode.

Highly cross-linked and optimised PE and composite technology are promising concepts in address wear particle-induced osteolysis.

Aims: Stribeck analyses were performed using both unimplanted and carbon (C) implanted heads of alumina, zirconia, zirconia-toughened-alumina and stainless steel so as to study the influence of C implantation on the frictional behaviour of these orthopaedic bearing materials. Methods: The selected biomaterials were implanted using an ion dose of 1 and 2.5 x 10¹⁷ C ions/cm² (75 keV). Friction testing was carried out on unimplanted and C implanted heads using a Hip Joint Friction Simulator with aqueous solutions of carboxy-methyl cellulose (CMC). Results: Both the unimplanted and C implanted bearing couples displayed a similar trend, i.e. by increasing the viscosity of the CMC fluid, the friction factor was found to decrease due to the formation of a fluid film between both bearing surfaces. However, the friction factor for the treated couples at low viscosities was lower than that of their unimplanted counterparts, with a drop of approximately 10% for the steel-on- UHMWPE and a drop of up to 85% being observed in the friction between the ceramic-on-ceramic bearing couples. This decrease can be explained by ion beam smoothening of the treated surface. Conclusions: The results from this study indicate a beneficial reduction in the friction factor of the C ion implanted surfaces. These results indicate that the use of C ion implantation to modify the bearing surfaces of present-day orthopaedic implants may be an effective means of reducing detrimental wear debris at the bearing interface.