INTRODUCTION

Autologous bone grafts are considered gold standard in the repair of bone defects. However they are limited in supply and are associated with donor site morbidity. This has led to the development of synthetic bone graft substitute (BGS) materials, many of which have been reported as being osteoinductive. The structure of the BGS is important and bone formation has been observed in scaffolds with a macroporous morphology. Smaller pores termed ‘strut porosity’ may also be important for osteoinduction. The aim of this study was to compare the osteoinductive ability of one silicate-substituted calcium phosphate (SiCaP) with differing strut porosities in an ectopic ovine model. Our hypothesis was that SiCaP with greater strut porosity would be more osteoinductive.

Numerous in vitro studies have utilised bone models for the assessment of orthopaedic medical devices and interventions. The drivers for this usage are the low cost, reduced health concerns and lower inter-specimen variability when compared to animal or human cadaveric tissues. Given this widespread exploitation of these models the push for their use in the assessment of spinal augmentation applications would appear strong. The aim of the research was to investigate the use of surrogate-bone vertebral models in the mechanical assessment of vertebroplasty.

Nine surrogate-bone whole vertebral models with an open-cell trabeculae configuration were acquired. Initial μCT scans were performed and a bone marrow substitute with appropriate rheological properties was injected into the trabeculae. Quasistatic loading was performed to determine the initial fracture strength in a manner previously used with human cadaveric vertebrae. Following fracture, vertebroplasty was undertaken in which there was a nominal 20% volume fill. Following augmentation the VBs were imaged using uCT and then subjected to an axial load using the same protocol.

The surrogate models had a substantially thicker cortex than that of human osteoporotic vertebrae. During compression, the surrogate-bone models did not exhibit the characteristic ‘toe-region’ observed in the load-deformation profile of cadaveric vertebrae. The mean initial and post-augmentation failure strength of the surrogate vertebrae were 1.35kN ± 0.15kN and 1.90kN ± 0.68kN, respectively. This equates to a statistically significant post-vertebroplasty increase by a factor of 1.38. In comparison with human osteoporotic bone, no significant difference was noted in the relative increase in fracture strength between the artificial and human VB following augmentation.

Despite the apparent equivalence of the strength and stiffness of the artificial vertebrae compared to that of the cadaveric specimens, there are significant differences in both pre- and post augmentation behaviour. In particular, the load-deformation curve shows significant differences in shape particularly at the toe end and in post failure behaviour. There are also issues surrounding where the marrow and cement flows during the injection process thus affecting the final distribution of the cement.

Introduction: Incorporation of Silicon into the HA structure enhances the bioactivity of Hydroxyapatite (HA). Silicon substituted calcium phosphate (SiCaP/SiHA) has been introduced as an osteoconductive material for bone formation. However, the osseoinductive capacity of this biomaterial has not been assessed. A previous study by Hing et al shows that bioactivity of stoichiometric hydroxyapatite bone substitute materials is enhanced by increasing the level of porosity within the implant struts [1].

The aim of this study was to test the hypothesis that SiCaP bone graft results in superior osseoinduction compared to stoichiometric HA and osseoinduction enhancement using high microporosity materials.

Methods: Implantation of 32 bone graft plugs (16 granular and 16 blocks) with 3 different strut porosities: 20% SiHA, 35% SiHA, 10% SiHA and 20% HA, all with matched 80% total porosity supplied by ApaTech Ltd into the paraspinalis muscle of 4 sheep for 12 weeks. HA and %SiHA locations were randomized at implant sites.

Following euthanasia at 12 weeks histomorphometry was carried out to calculate Percentage of bone, soft tissue and implant area and Percentage of the amount of bone in contact with the calcium phosphate surface (% Bone attachment). Further evaluation of Calcium, Phosphate and Silicon levels within the implants and surrounding bone was carried out by Scanning Electron Microscopy (SEM) and EDAX.

Results: Bone formation was observed within the pores of both granules and blocks of SiCaP and HA implants. Greater bone formation and attachment was detected in scaffolds with higher strut porosity (SiHA35) compared to implants of the same chemical composition but lower strut porosity (SiHA10, SiHA20. More bone formation and contact was observed in SiHA implants (SiHA20) compared to matched porosity HA implants where the amount of bone formed was minimal. Uniform distribution of Silicon (Si) was visible within the SiHA scaffold struts according to EDAX results. Greater quantities of Si existed in newly formed bone as compared to soft tissue adjacent to the SiHA implants. Silicon was not detected in either soft or hard tissues adjacent to HA implants.

Conclusion: Both microporous HA and SiCaP promote bone ingrowth, as ectopic bone formation was observed in all four groups of synthetic materials. Matched porosity SiCaP is more osseoinductive than HA. Increasing strut porosity results in promotion of osseoinductivity. High strut porosity (> 10%) block environment contributes to greater osseoinductive behaviour. In conclusion we report that presence of silicon and the strut porosity influence the osseoinductive capacity of calcium phosphate bone substitute biomaterials.

An experimental sheep model was used for impaction allografting of 12 hemiarthroplasty femoral components placed into two equal-sized groups. In group 1, a 50:50 mixture of ApaPore hydroxyapatite bone-graft substitute and allograft was used. In group 2, ApaPore and allograft were mixed in a 90:10 ratio. Both groups were killed at six months. Ground reaction force results demonstrated no significant differences (p > 0.05) between the two groups at 8, 16 and 24 weeks post-operatively, and all animals remained active. The mean bone turnover rates were significantly greater in group 1, at 0.00206 mm/day, compared to group 2 at 0.0013 mm/day (p < 0.05). The results for the area of new bone formation demonstrated no significant differences (p > 0.05) between the two groups. No significant differences were found between the two groups in thickness of the cement mantle (p > 0.05) and percentage ApaPore-bone contact (p > 0.05).

The results of this animal study demonstrated that a mixture of ApaPore allograft in a 90:10 ratio was comparable to using a 50:50 mixture.